MEDIANA

HEARTON
AED A10

OPERATOR’S
OPERATOR’S MANUAL
MANUAL
®
HeartOn
HeartOnA10
A15®
Automated
Automated External
External Defibrillator
Defibrillator

www.medianadefib.co.uk

Distributed by:
Reliance Medical LTD, West Avenue,
Talke, Stoke-on-Trent, Staffordshire,
ST7 1TL, United Kindom.

Part Number-Revision: A7300-0

Revised Date: 0613

Copyright © 2013 All rights reserved.

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 A10. 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 A10 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.
 CONTENTS
CONTENTS .................................................................................................................................................... i
SAFETY INFORMATION .............................................................................................................................. 1
General Safety Information ................................................................................................................... 1
Warning ................................................................................................................................................. 1
Cautions ................................................................................................................................................ 3
INTRODUCTION ........................................................................................................................................... 5
Intended Use for the AED ...................................................................................................................... 5
About This Manual................................................................................................................................. 5
Training .................................................................................................................................................. 6
Training .................................................................................................................................................. 6
DESCRIPTION OF THE AED ....................................................................................................................... 7
Top and Right Panel Components......................................................................................................... 7
Bottom Panel Components ................................................................................................................... 8
Rear Panel Components ....................................................................................................................... 8
Symbols and Labels .............................................................................................................................. 9
SETTING UP THE AED .............................................................................................................................. 11
Unpacking and Inspection ................................................................................................................... 11
List of Components.............................................................................................................................. 11
Soft Carry Case ................................................................................................................................... 12
SD card ................................................................................................................................................ 12
IrDA port .............................................................................................................................................. 12
Setting up the AED .............................................................................................................................. 13
BATTERY OPERATION .............................................................................................................................. 15
Operating the AED on Battery Power .................................................................................................. 15
Battery Status Indication ...................................................................................................................... 16
Self Test ............................................................................................................................................... 17
USING THE AED ........................................................................................................................................ 19
2010 AHA Guidelines for CPR and ECC ............................................................................................. 19
Major changes in the 2010 AHA Guidelines for CPR and ECC .......................................................... 19
2010 CPR GUIDELINES ..................................................................................................................... 20
Pre Defibrillation Action ....................................................................................................................... 20
Operating the AED............................................................................................................................... 21
AHA 2010 configuration ....................................................................................................................... 25
Note Performing CPR .......................................................................................................................... 25
Note User and Bystander Safety ......................................................................................................... 26
MAINTENANCE .......................................................................................................................................... 27
Recycling and Disposal ....................................................................................................................... 28
Returning the AED and System Components ..................................................................................... 28
Service ................................................................................................................................................. 28
Periodic Safety Checks ....................................................................................................................... 28
Cleaning .............................................................................................................................................. 29
Battery Maintenance ........................................................................................................................... 29
Pads Maintenance ............................................................................................................................... 29
The AED Maintenance ........................................................................................................................ 30
TROUBLESHOOTING ................................................................................................................................ 31
General ................................................................................................................................................ 31
Corrective Action ................................................................................................................................. 31
EMI (Electromagnetic Interference)..................................................................................................... 32
Obtaining Technical Assistance ........................................................................................................... 32
GLOSSARY................................................................................................................................................. 33
SPECIFICATION ......................................................................................................................................... 35
Compliance.......................................................................................................................................... 40
Manufacturer’s Declaration ................................................................................................................. 43

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Figures
Figure 1. Top and Right Panel Components ................................................................................................. 7
Figure 2. Bottom Panel Components ............................................................................................................ 8
Figure 3. Rear Panel Components ................................................................................................................ 8
Figure 4. Battery Placement ........................................................................................................................ 15
Figure 5. Action Icon – Step 1 ..................................................................................................................... 22
Figure 6. Action Icon – Step 2 ..................................................................................................................... 22
Figure 7. Action Icon – Step 3 ..................................................................................................................... 22
Figure 8. Action Icon – Step 4 ..................................................................................................................... 22
Figure 9. Action Icon – Step 5 ..................................................................................................................... 23
Figure 10. Pads Placement ......................................................................................................................... 23
Figure 11. Action Icon – Step 6 ................................................................................................................... 23
Figure 12. Action Icon – Step 7 ................................................................................................................... 24
Figure 13. Action Icon – Step 8 ................................................................................................................... 24
Figure 14. Use by date of Pads ................................................................................................................... 30

Tables
Table 1. Panel and Label Symbols ................................................................................................................ 9
Table 2. Accessories.................................................................................................................................... 11
Table 3. The battery Status Icon .................................................................................................................. 16
Table 4. Electromagnetic Emissions (IEC60601-1-2) ................................................................................. 43
Table 5. Electromagnetic Immunity (IEC60601-1-2) ................................................................................... 43
Table 6. Electromagnetic Immunity (IEC60601-1-2) (continued) ................................................................ 44
Table 7. Recommended Separation Distances ........................................................................................... 45
Table 8. Cables (IEC60601-1-2) .................................................................................................................. 45

ii
SAFETY INFORMATION
General Safety Information
This section contains important safety information related to general use of the HeartOn
A10®. Other important safety information appears throughout the manual. The HeartOn
A10® will 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 are identified by the WARNING symbol shown above.

Warnings alert you to potential serious outcomes (death, injury, or adverse events)
to the patient or user.

WARNING: 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 authorized Mediana dealer.

WARNING: 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.

WARNING: 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 when
a shock is to be delivered.

WARNING: To safeguard against interference you must operate the AED at 2

meters (6 feet) away from all RF devices and other susceptible equipment.
Alternatively switch off equipment affected by or causing Electromagnetic
Interference.

WARNING: The AED has been designed to work on unresponsive, non-breathing

and pulseless* patients. If the patient is conscious or breathing, do not use the
AED to provide treatment. (*: healthcare provider only)

WARNING: 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 while ECG analysis is being carried out. The AED will instruct you
when it is safe to touch the patient.

WARNING: 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.

WARNING: 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 or concentrated oxygen.

1
 

WARNING: The Adult pads must be used on patients over 8 years old. The
Pediatric pads must be used on patients less than 8 years old or less than 25 kg
(55lb). Do not use the AED on patient less than 1 year old.

WARNING: 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.

WARNING: 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.

WARNING: Do not allow the pads to contact other electrodes or metal parts that
are in contact with the patient.

WARNING: Avoid contact between parts of patient’s body and conductive fluids
such as gel, blood or saline and metal objects which may provide unwanted
pathways for defibrillating current.

WARNING: Do not use the AED near or within puddles of water.

WARNING: Do not reuse electrodes to many patients.

WARNING: Use the AED or accessories only as described in this manual.

Improper use of the AED can cause death or injury.

WARNING: Do not use or place the AED in service if the status indicator of AED
displays “X”.

WARNING: 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.

WARNING: 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.

2
Cautions

Cautions are identified by the CAUTION symbol shown above.

Caution statements identify conditions or practices that could result in damage to

the equipment or other property.

CAUTION: The AED may not operate properly if it is operated or stored at

conditions outside the ranges stated in this manual.

CAUTION: 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.

CAUTION: 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.

CAUTION: The pads pouch shall not be opened until immediately prior to use.

CAUTION: Do not use or place the AED in service until you have read the AED
Operator’s manual.

CAUTION: 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.

CAUTION: Handling or transporting the patient during ECG analysis can cause
incorrect or delayed diagnosis.

CAUTION: Periodic checks of this AED must be undertaken to ensure among other
things that the AED is not damaged in any way.

CAUTION: 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.

CAUTION: Do not use training pads with this AED.

CAUTION: Carefully observe pacemaker patients. Patient history and physical

examination 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.

CAUTION: 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.

3
 

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4
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 2010 version of the AHA/ERC guidelines on Cardiopulmonary Resuscitation (CPR)
and Emergency Cardiovascular Care (ECC). You should have been 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 users should be skilled at
level of a doctor, nurse, medical specialist or trained user.

Note: 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.

Note: The intended patient populations are adult and pediatric (1-8 years old or less than
25 kg (55lb)) can be treated with the appropriate pads.

Note: The AED is intended for trained user who knows how to use the AED. Potential user
should be trained in cardiopulmonary resuscitation (CPR), the use of the AED.
Many training institutes have courses that combine performing CPR and using the
AED. The training course can be accomplished for various durations, but crash
course/most basic course can be accomplished in one day. For further information
on training course, contact your local authorized supplier or Mediana technical
support.

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.

5
Training
SCA is a condition requiring immediate emergency medical intervention. This intervention,
due to the nature of the condition, can be performed prior to seeking the advice of a
physician. In order to properly diagnose this condition Mediana recommends that all
potential users of the AED as a minimum, are fully trained in cardiopulmonary
resuscitation (CPR), the use of the AED, specifically the AED. It is also recommended that
this training be kept up to date by means of regular refresher courses and when
recommended by your training provider. If potential users of the AED are not trained in
these techniques contact your Mediana dealer or Mediana directly either of whom can
arrange for training to be provided. Alternatively contact your local government health
department for information on certified training organizations in your region.

Note: There is limited published data on AED used by minimally trained rescuers in the
home. It is not clear what safety issues may occur from AED use in such an
environment.

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 an internal battery which is the non-rechargeable battery.

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.

6
DESCRIPTION OF THE AED
Top and Right Panel Components

7
8 9
10

Figure 1. Top and Right Panel Components

Cover shields the LED indicator, the power on/off button, the
1 Cover
speaker, the shock button.
2 Status indicator Status indicator displays the unit status and the battery status.
3 Pad connector Pad connector links the pads.
4 LED indicator LED indicator flashes red LED under the relevant action icon.
5 Power on/off button Power on/off button turns on/off the AED.
6 Speaker Speaker is acoustic indicator for guidance.
7 Push button Push button opens the cover.
8 Shock button Shock button delivers the shock.
9 SD card port SD card is used to save the data and update the AED firmware.
Infrared
10 Infrared communication port is used to communicate with the PC.
communication port

7
Bottom Panel Components

1. Battery pack

Figure 2. Bottom Panel Components

Rear Panel Components

1. Handle

Figure 3. Rear Panel Components

8
Symbols and Labels

The following symbols may be used in this manual, related documentation, or appear on
system components or packaging.

Table 1. Panel and Label Symbols

Symbols Description Symbols Description

Ready to use CE mark

Not ready to use Caution

Battery capacity Follow instructions for use

Environmental
Contains no latex shipping/storage
altitude limitations
Environmental
Use by date shipping/storage
humidity limitations
Environmental
EU representative shipping/storage
temperature limitations

Manufacturer Fragile-handle with care

Date of manufacture This way up

Reference number Keep dry

Type CF – Defibrillator
Serial number
proof

Single patient use only Dust and water resistance

Disposal instructions UL mark

9
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10
SETTING UP THE AED
WARNING: 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.

WARNING: 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 2. Accessories
Standard Accessories Qty
HeartOn A10®  1
Operator’s manual  1
Adult Pads (1.7m)  1
Non-rechargeable LiMnO2 Battery (15V, 4200mAh) 1
Soft Carry Case 1
Optional Accessories Qty
Pediatric Pads (1.7m) -
SD card (2Gbyte) -
HeartOn A10 Event Review Software -
HeartOn A10 Event Review Software - User Guide -
Infrared communication adaptor -
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 -

11
Soft Carry Case

WARNING: The AED should not be used on someone who is responsive when
shaken or breathing normally.

The soft carry case has been designed to allow the AED not to move in the soft carry
case by using the AED’s 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. Other two
pockets on the right and left side of the carry case are used for spare battery.

SD card
The SD card is inserted into the SD card port on the AED’s right 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
A10 Event Review Software. If you want to use the SD card to use the HeartOn A10
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 pressing the Power on/off button.
2. Open the SD card port cover.
3. Insert the SD card into the SD card port.
4. Close the SD card port cover.
5. Turn on the AED by pressing the Power on/off button.
6. After complete the update, automatically turn off itself.

Infrared communication port

Infrared communication port provides wireless communications from the AED to a PC
through the Infrared communication data download cable and DC adaptor which is
connected to PC. The Infrared communication is used to update the AED firmware and 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.

12
Setting up the AED

WARNING: Use only Mediana-approved and specified parts, accessories, optional

parts, consumables, and components. Use of unauthorized accessories may
cause the device to operate improperly and provide false measurements. Follow
all labeling instructions on the defibrillation pads and the battery.

WARNING: Always follow your facility’s infection control procedures and

applicable regulations when disposing of anything that has been used on patients.

CAUTION: Do not open the pads from packaging previously until the time of
emergency use when pads are used for patient.

Install 1
1. Remove defibrillation pads from its packaging.
2. To open the cover, press the Push button.
3. Plug in defibrillation pads.

Note: When pads are already connected to the AED in packaging, take out the AED from
the packaging and then move to Install 2.
Note: Do not open defibrillation pads protective packaging until the time of emergency use
when they are applied to a patient.
Note: To prepare of an emergency, pads must be pre-attached to the AED and keep the
pads cable connected to the AED at all times.

Install 2
Check that the AED is working optimally.

1. Push the Power on/off button.

2. Ensure that you can hear the voice prompts:
 “Unit ok”
 “Adult pads” or “Pediatric pads”
3. Ensure you can see the status indicator display “O”.
4. Turn off the AED by pushing the Power on/off button.
5. Close the Cover with placing the defibrillation pads inside the AED.

Install 3
Place the AED into its Soft Carry Case.

Install 4
Put into a storage or safe visible location.
The AED should be kept in a convenient central area. Place it near a telephone so that
the rescuer can call Emergency Medical Services and retrieve the AED without wasting
time. Some important points to remember when storing:
 Store the AED in a suitable location for easy access.
 Do not lock the location where AED is being placed.
 Store the AED in a clean and dry environment.
 Install the AED in the environmental operation condition described in this manual.
Make all necessary arrangements to ensure that the AED is accessible at all times.
Inform any possible users of the location of the AED.

Note: Storage differs in some countries. Ask qualified service personnel or your local
supplier.

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14
BATTERY OPERATION
WARNING: Test battery regularly, when the voltage of battery is very low. A
battery that does not pass its test might shut down expectedly.

WARNING: Do not use a battery that is damaged, leaking, or wet.

WARNING: Do not use or store the battery in a place that may be exposed to high
temperature.

CAUTION: To ensure the availability of adequate power during an emergency,

keep a fully charged spare battery pack with the AED at all times.

CAUTION: When the voltage of the battery is very low, it is a possibility of not
operating.

CAUTION: If the battery shows any signs of damage, leakage or cracking, it must
be replaced immediately.

CAUTION: Discarded batteries may explode during incineration. Dispose used

batteries properly. Do not dispose of batteries in refuse containers.

CAUTION: Check battery capacity regularly. Replace the new battery if you need.

CAUTION: Except for inspection, if the AED is frequently turned on, turned off or
discharged, battery standby life will not last longer than the intended standby life
by manufacturer.

Operating the AED on Battery Power

The AED has an internal non-rechargeable battery. The battery status icon appears on
the Status indicator when the AED is on battery power.

Figure 4. Battery Placement

15
Replacing the battery

1. Turn off the AED.

2. Push the hole on the left side using the small regular (-) screwdriver.
3. Carefully remove the battery pack.
4. Insert the new battery pack carefully.

The AED uses the non-rechargeable battery. Used battery is changed to new battery.
Before turning on the AED with a battery that has been completely discharged, first
replace the battery. The AED may then be powered on.

Battery Status Indication

A new battery’s life time is as below;

- Shelf life (in the original packaging): 2 years from manufacture date when stored and
maintained according to direction provided in the operator’s manual.
- Standby life (inserted in the AED): 5 years from manufacture date when stored and
maintained according to direction provided in the operator’s manual.
- Discharge: A minimum of 200 shocks (excepting the CPR period between the
defibrillation therapies) or 10 hours of operating time under the ambient temperature at
20°C.

Mediana recommends that although the battery is used only one time, used battery is
changed to new battery.

Note: After 200 times of shock, the voice prompt “Low battery, replace new battery” will be
emitted.
Note: Due to the physical dimensions of the battery compartment, only batteries supplied
by Mediana should be used. Using other types of replacement batteries may result
in damage to the AED and void the limited warranty.

When operating on batteries, the battery status icon in the status indicator indicates the
battery condition. See Table 3.

Table 3. The Battery Status Icon

Battery Status Icons Battery Status
full charged
(≤ 200 shocks or 10 hours of
operating time)

used

used (≤ 9 shocks)

discharged (no shock)

If you hear the voice prompt “low battery, replace new battery” when the AED is turned on
or is being used, the AED would be available 9 shocks. If the last bar of the battery
indicator is invisible, buzzer would be sounded 2 times and then turned off automatically.

16
Self Test
Before using the AED, confirm that the AED is working properly and is safe to use as
described below.

WARNING: If the self test is not completed successfully, do not try to use the
AED.

CAUTION: When power is applied, the AED automatically starts the self test, which
tests the AED circuitry and functions. During performing Power On Self Test(POST),
confirm that the AED status indicator turns on. If the AED status indicator does not
function properly, do not use the AED. Instead, contact qualified service personnel
or your local supplier.

Performing Power On Self Test (POST)

1. Turn on the AED by pressing the Power on/off button.

2. The AED automatically starts the Power On Self Test (POST).
3. If the AED detects an error during POST, the status indicator will display “X”. Contact
qualified service personnel or your local supplier for assistance.
4. Upon successful completion of the POST, the AED sounds voice prompt “Unit ok” and
status indicator displays “O”.
5. Turn off the AED by pressing the Power on/off button.

Automatic Self Test

The AED includes an automatic self test which is performed on a daily basis. The self
test will run automatically and requires no user interaction. If there is an error, the status
indicator displays “X”.
The self test will test your AED and ascertain if its basic functions are running.
 Daily self test : MCU and Memory(RAM, ROM) integrity, Battery capacity, ECG
algorithm
 Weekly self test : Waveform delivery circuit low (2J) energy test, ECG circuit test
in addition to the daily self test
 Monthly self test : Waveform delivery circuit high (50J) energy test in addition to
the weekly self test
Note: When the battery is discharged, the status indicator displays “X”. Contact qualified
service personnel or your local supplier if the status indicator still displays “X” after
replace the new battery.
Note: Self test is not able to determine if the battery and the pads currently inserted in
AED are within their use by date. You must remember to check the use by date on
the pads and standby life on the battery regularly.

17
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18
USING THE AED
WARNING: The AED should not be used on someone who is responsive when
shaken or breathing normally.

WARNING: Do not use the pads if the pad gel is dried or the pad is damaged.

WARNING: Disconnect non-defibrillation protected electronic devices or equipment

from patient before defibrillation.

WARNING: Never lift the AED by the pads cable or any other accessory. Such
accessories could detach, causing the AED to fall on the patient.

CAUTION: Prolonged or aggressive CPR to a patient with pads attached can

damage the pads. Replace the pads if they are damage during use or handling.

The AED is designed for the treatment of sudden cardiac arrest (SCA). It should only be
used to treat someone who may be a victim of a SCA and is:

 Unresponsive,
 Non-breathing,
 Pulseless, (healthcare provider only)

If the person is unresponsive but you are unsure that they have suffered from a SCA
begin CPR. When appropriate apply the AED and follow the voice prompts.

2010 AHA Guidelines for CPR and ECC

The 2010 AHA Guidelines for CPR and ECC are based on the most current and
comprehensive review of resuscitation literature ever published, the 2010 ILCOR
International Consensus on CPR and ECC Science with Treatment Recommendations.
Bystanders, first responders and healthcare providers all play key roles in providing CPR
for victims of cardiac arrest. In addition, advanced providers can provide excellent
periarrest and postarrest care.

Major changes in the 2010 AHA Guidelines for CPR and ECC
 The BLS algorithm has been simplified, and “Look, Listen and Feel” has been removed
from the algorithm. Performance of these steps in inconsistent and time consuming.
(The use for non-healthcare provider)
 Encourage Hands-only (compression only) CPR for the untrained lay rescuer. Hands-
Only CPR is easier to perform by those with no training and can be more readily
guided by dispatchers over the telephone.
 Initiate chest compressions before giving rescue breaths. (Compression-Airway-
Breathing rather than Airway-Breathing-Chest compressions)
 There is an increased focus on methods to ensure that high-quality CPR is
performed. The following action put emphasis on the important factor of high-quality
CPR.
- Adequate chest compressions (100 ~ 120/min)
- Compression depth of at least 2 inches (5 cm) in adults
- Allowing complete recoil of the chest after each compression
- Minimizing any pauses in compressions
- Avoiding excessive ventilation

19
2010 CPR GUIDELINES

Person not responsive?

No signs of life?

Address person and shake on shoulder!

Perform the CPR Engage other people to help you and alternate CPR!
Call for help, get AED

Open the airway.

Check for breathing!

Note: “Open the airway, check for breathing” is removed from the CPR
Open the airway, Check for
sequence for assessment of breathing after opening the airway
breathing.
in 2010 guidelines. But 2010 guideline recommends that the
If the user is not a healthcare
healthcare provider briefly checks for breathing when checking
provider, the sequence for
responsiveness to detect signs of cardiac arrest.
assessment of breathing after
opening the airway might be
eliminated.

Perform CPR until an AED is available or arrival of

emergency physician

Note: Elimination of “2 ventilations” from sequence makes

recommendations to continue the chest compressions.
30 Compressions 2 Breaths UNTIL
EMC ARRIVE 30/2
If the AED available, turn on and follow instructions
ANALYSIS SHOCK DECISION

YES NO

Repeat every 2 minutes. DELIVER SHOCK

Continue CPR for about 5 cycles

(approximately 2minutes)

Pre Defibrillation Action

Prior to using the AED, it is advised to perform the following checks and actions in order
to prepare the patient:

 Remove clothes to expose bare chest.

 If excessively hairy shave hair from areas to which defibrillation pads are to be
applied.
 Ensure that the patient chest is dry. If necessary, dry chest area.

20
Operating the AED

WARNING: For Pediatric use, or for use on patients between 1-8 years old or <25
kg. (55lb) please remove Adult pads and insert Pediatric pads if available. Refer to
operating instructions for Pediatric pads supplied with that AED. If not available,
AHA/ERC guidelines suggest continuing to defibrillate if required using the Adult
configured system.

WARNING: If the pads placement is inappropriate, the AED could harm the patient.
To place the accurate position, must follow the voice prompt and action icon.
When pads placement is inappropriate, treatment could not work or shock could
burn the patient’s skin.

WARNING: Do not place pads near the generator of an internal pacemaker. The
analyzing heart rhythm of patient who is implanted pacemaker could inaccurate or
the pacemaker might be damaged by defibrillator discharges.

WARNING: Do not perform chest compressions (CPR) through electrodes. These

actions may damage the electrode pads cause the AED to function improperly.

WARNING: Always apply pads to flat areas of skin. Avoid application over folds of
skin such as those underneath the breast or on obese patients. Excessive hair,
poor adhesion, or air under pads may produce burns or ineffective energy transfer.

WARNING: To apply the pads to patient chest properly, shave hair from areas
which defibrillation pads are to be applied if necessary.

WARNING: Always check the use by date on the pads and do not use the pads if
the packaging has been previously opened. The AED may interpret excessively dry
pads as an attached pads cable.

WARNING: Touching the patient during the analysis phase of treatment can cause
interference with the diagnostic process. Avoid contact with the patient while
analysis is being carried out. The AED will instruct you by voice prompt when it is
safe to touch the patient.

WARNING: The AED delivers shocks which can cause serious harm to operators
and bystanders. Caution must be taken to ensure no-one is in contact with the
patient when a shock is delivered.

Note: Only pads supplied by Mediana should be used. Using other types of pads may
result in damage to the patient and AED.

1. Check the status indicator displays “O”.

2. Press the Push button to open the cover.
3. Turn on the AED by pressing Power On/off button.
4. The AED automatically starts the Power-On-Self Test.
5. The test result is displayed on the status indicator and the voice prompt sounds.
 Self test is passed : Voice prompt “Unit ok”, Status indicator “O”
 Self test is failed : Voice prompt “Unit failed”, Status indicator ”X”
6. If the pad is not inserted you will hear the voice prompt:
 “Plug in pads. Insert connector firmly”
If the pad is inserted you will hear the voice prompt:
 “Adult pads” or “Pediatric pads”
7. Verify the AED is activated normally and follow voice prompt and action icon. The red
LED will flash under the relevant action icon.

21
STEP 1

 “Check for response. Are you all right?”

Figure 5. Action Icon – Step 1

STEP 2

 “Call for help.”

Figure 6. Action Icon – Step 2

STEP 3

 “Open the airway.”

Figure 7. Action Icon – Step 3

STEP 4

 “Check breathing.”

Figure 8. Action Icon – Step 4

22
STEP 5

Remove clothes to expose the patient's chest. If the patient has an excessively hairy
chest, shave the area where the pads are about to be applied.
 “Remove clothes from the patient’s chest. Place pads exactly as shown in the
picture. Press pads firmly to patient’s bare chest.”

When pads are disconnected to the AED, the following voice prompt will be emitted.:
 “Plug in pads. Insert connector firmly.”

Figure 9. Action Icon – Step 5

Adult: age ≥ 8, weight ≥ 25kg(55lbs)

Pediatric: age < 8, weight < 25kg(55lbs)
Figure 10. Pads Placement

WARNING: Apply freshly opened and undamaged pads, within use by date, to
clean and dry skin to minimize burning.

STEP 6

When the pads are attached correctly to the patient you will hear the voice prompts:
 “Analyzing heart rhythm. Do not touch the patient.”
 “Shock advised. Charging. Do not touch the patient.”
or
 “Analyzing heart rhythm. Do not touch the patient.”
 “No shock advised”.

Figure 11. Action Icon – Step 6

23
 Note: If “No shock advised”, the AED will move to step 8 which demonstrate CPR
progress directly.
Note: The AED performs the Step 6 directly when it is turned on after the rescuer
attaches the pads to the patient properly. Also, the Step 6 would be started if the
pads are attached to the patient even if the AED is under the Step 1 to 5. This can
reduce the preparing time for electric shock in case of trained rescuer.
Note: Follow voice prompt. Do not touch patient or allow any others to touch the patient
while the AED is analyzing. After completion of analysis the AED will advise you of
treatment recommended. Care must be taken to keep the patient still. A moving
patient can lead to incorrect, delayed or less effective diagnosis and therapy.

STEP 7

 “Press the shock button now.”

 “Deliver shock now.”
 “Shock delivered.” or “Shock button not pressed.”

Figure 12. Action Icon – Step 7

Note: The AED will only administer a shock if it is needed. A voice prompt will tell you
when to press the shock button to administer defibrillation therapy.
STEP 8

 “It is safe to touch the patient.”

 “Begin CPR.” [Beep] or “If needed, Begin CPR.” [Beep]
 “Give two breaths.”
 “Stop CPR.”

Figure 13. Action Icon – Step 8

Note: After finished the STEP8, the AED will move to the STEP 6 to analyze heart rhythm
again.

Note: If you hear following voice prompt while the AED is analyzing you should perform
the following actions:
 Rhythm changed, “Shock cancelled.”:
Move to Step 8. → Perform the CPR.
 “Shock button not pressed.” or “Disarms.”:
Move to Step 6. → ECG analyzing again. → non-shockable rhythm → Move to

24
 Step 8.
or
Move to Step 6. → ECG analyzing again. → shockable rhythm → Move to Step 7.
→ Move to Step 8 after disarm.
 “Low battery, replace new battery.”:
Move to Step 1 after replace the new battery and complete the power on self test.

AHA 2010 configuration

After the electric shock is delivered, the following voice prompt would be emitted.

 “It is safe to touch the patient.”

 “Begin CPR.”

Use the metronome sound from the AED for compression rate – the unit emits a tone
corresponding at least more than 100 beats per minute (to current AHA guidelines). Note
too that the “Begin CPR.” Icon flashes at the same rate for additional guidance. At this
point, adequate chest compressions require that compressions be provided at the
compression depth of at least 2 inches (5 cm) in adults.

Rescuer performs 5 cycles of CPR, each cycle include 30 times of chest compression
and 2 times of rescue breath at the rate of 30times of chest compression/2min. Or
perform the chest compression without rescue breath. The AED will remain in CPR mode
for 2 minutes or 5 cycles. After 2 minutes of CPR you will hear the following voice
prompt:

 “Stop CPR.”

The AED will then return to Step 6 which is analyzing ECG and repeat this procedure.
Ensure that no-one is in contact with the patient and proceed as before. This instruction
will be lasted until emergency physician arrives and then hand over patient to emergency
physician.

Note Performing CPR

When performing CPR watch and listen to the AED, the voice prompt “Begin CPR” will
flash. The AED emit beeps and flashing action icon at the rate of 100 times per minute
and “Give two breaths.” Voice prompt as a guide to CPR.

At least more than 2 inches (5cm) of compression depth and 100 – 120 beats per
minutes of rate are the recommended compressions under AHA 2010 guidelines.

Note: Your Mediana dealer will have trained you in the particular SCA treatment protocol
you have chosen. In all cases follow the voice prompts and visual instructions given
by the AED.

25
Note User and Bystander Safety

WARNING: Make sure no one is touching the patient before you press the Shock
button. Loudly announce, “Stand back! Do not touch the patient.” And look down
the entire length of the patent to ensure there is no contact before pressing the
Shock button.

Do not touch the patient while the AED is analyzing or delivering a shock is in process.
Defibrillation energy can cause injury.

As long as the AED is used according to the directions, and no one is in contact with the
patient when the Shock button is pressed, there is no risk of harm to the rescuer or
bystanders. The AED cannot deliver a shock unless the pads are applied to someone
whose heart is in need of a shock.

Note: See warnings and cautions for more details.

26
MAINTENANCE
WARNING: Improper maintenance may damage the AED or cause it to function
improperly. Maintain the AED according to directions.

WARNING: Do not let fluids to get into the AED. Avoid spilling any fluids on the
AED or its accessories. Spilling fluids into the AED may damage it or cause a fire
or electric shock hazard. Do not sterilize the AED or its accessories.

WARNING: Do not immerse any part of the AED in water or any type of fluid.
Contact with fluids may seriously damage the AED or cause fire or electric shock
hazard.

WARNING: WARNING: Do not attempt to warm the electrodes with a heat source
greater than 35°C (95°F).

WARNING: Do not clean the AED with abrasive materials, cleaners or solvents.

CAUTION: Follow local government ordinances and recycling instructions

regarding disposal or recycling of AED components, including batteries.
CAUTION: Do not short-circuit the battery, as it may generate heat. To avoid short-
circuiting, do not let the battery come in contact with metal objects at any time,
especially when transporting.
CAUTION: Do not solder the battery directly. Heat applied during soldering may
damage the safety vent in the battery’s positive cover.
CAUTION: Do not deform the battery by applying pressure. Do not throw, hit, drop,
fold or impact the battery.
CAUTION: Do not use the battery with other maker’s batteries, different types or
models of batteries such as dry batteries, nickel-metal hydride batteries, or Li-ion
batteries together, as they might leak electrolyte heat or explode.
CAUTION: Do not mistreat the battery, or use the battery in applications not
recommended by Mediana.
CAUTION: Keep the battery out of reach of babies and children to avoid any
accidents.
CAUTION: If there are any problems with the battery, immediately put the battery in
a safe place and contact qualified service personnel or your local supplier.
CAUTION: Replacing new battery and placing the pads should carry out in
environmental conditions described in this manual. If the AED is operated in out-of-
range for environmental conditions, the AED can’t be operated properly.

After using the AED, Mediana technical support recommend you perform the following
actions:

1. Use the HeartOn A10 Event Review Software to download information about the
therapy performed and store appropriately. (If you do not have the HeartOn A10 Event
Review Software, please contact your dealer who can arrange for the incident to be
downloaded).
2. Remove the used the pads from your AED and dispose of in a suitable manner. (For
recommended disposal methods please refer to section the recycling and disposal)

27
 3. Check the exterior of the AED for cracks or other signs of damage. Contact your
distributor or Mediana technical support immediately if any damage is found.
4. Check the exterior of the AED for dirt or contamination. If necessary, clean AED with
approved cleaning products.
5. Check supplies, accessories and spares for damage or expiration. Replace
immediately if any damage or expiration is found. Contact your local Mediana
approved dealer.
6. Install the new pads. Before installing the new pads check that its use by date has not
been exceeded.
7. After installation of the new pads. Check the Status Indicator. If the Status Indicator is
not displaying “O” refer to the troubleshooting section of this manual. If the problem
persists, contact Mediana or your local approved dealer for technical support.
8. Turn on the AED and verify that the AED operates in the correct manner i.e. voice
prompt “Unit OK” can be heard. Turn off the AED.
9. Contacting Mediana after use. At Mediana we like to hear from our customers
whenever they have any occasion to use any of our products, even if therapy is not
delivered as part of the incident. This information is vital to the continued development
and constant improvement we strive for in the treatment of sudden.

Recycling and Disposal

When the AED, battery or accessories reach the end of useful life, recycle or dispose of
the equipment according to appropriate local and regional regulations.

Note: The AED should be disposed of separately from the municipal waste stream via
designated collection facilities appointed by the government or the local authorities.

Note: The correct disposal of your old appliance will help prevent potential negative
consequences for the environment and human health.

Note: For more detailed information about disposal of your old appliance, please contact
your city office, waste disposal service or the shop where you purchased the AED.

Returning the AED and System Components

To return the AED and/or accessories, contact qualified service personnel or your local
supplier.

Service
The AED requires no routine service other than cleaning, battery maintenance, and
service activity which is mandated by the user’s institution. For more information, refer to
the AED service manual. Qualified service personnel in the user’s institution should
perform periodic inspections of the AED. If service is necessary, contact qualified service
personnel or your local supplier.

Periodic Safety Checks

It is recommended that the following checks be performed every year.
 Inspect the equipment for mechanical and functional damage.
 Inspect the external safety labels for legibility.

28
Cleaning
To clean the AED, wipe the AED with a soft cloth that has been dampened by one of the
following:

 Soapy water
 Isopropyl alcohol (70% solution).

For cables and pads, follow cleaning instructions in the directions for use shipped with
those components.

Avoid spilling liquid on the AED, especially in connector areas. If liquid is accidentally
spilled on the AED, clean and dry thoroughly before reuse. If in doubt about AED safety,
refer the unit to qualified service personnel or your local supplier for checking.

Battery Maintenance
The battery lifetime in use can be up to 10 hours monitoring or 200 shocks (excepting the
CPR period between the defibrillation therapy) or a combination of both. The battery in
the standby mode (inserted into the AED) has standby life (5 years from manufacture
date). If the battery status indicator is flashing one bar, you may need to replace the fresh
battery. If the battery is not inserted into the AED, the battery has a shelf life (2 years
from manufacture date).

For diagnosis of the reason for status indicator display “X”, please refer to the
troubleshooting section.

Pads Maintenance
Replacement of the pads must be carried out if:

 The use by date of the pads has been exceeded.

 When the pads have been used (it is a single use item) it must be replaced with
new pads.
 The package of new pads has been previously damaged.
 The pads have been vent.

Replacing Pads

1. Take the replacement pads from its protective bag.

2. Remove the old pads which are to be replaced.
3. Push the pads firmly to ensure it is fully inserted.
4. Turn on the AED.
5. Check status indicator. If the pads have been inserted correctly, Status Indicator
displays “O” after approximately 6 seconds.
6. If necessary inform relevant safety officer or person responsible for maintenance of the
AED.
7. Update the relevant records to show the date that the replacement the pads was placed
into service.
8. Dispose of the old pads.

29
The AED Maintenance
Mediana recommends users perform regular maintenance checks. A suggested 
maintenance check would be.

1. Check the Status Indicator. If the Status Indicator displays “X”, a problem has been
detected. Refer to the troubleshooting section of this manual.
2. Check the use by date of the pads. If the pads have exceeded its use by date, remove
it and replace with the pads. Contact qualified service personnel or your local supplier
for replacements.

Figure 14. Use by date of Pads

3. Check AED and accessories for damage or use by date. Replace any accessories
found to be damaged or that have exceeded their use by date.
4. Check the exterior of the AED for cracks or other signs of damage. Contact qualified
service personnel or your local supplier if any damage is found.
5. Check that trained users are aware of the AED location and that it is easily accessible
for those Responders at all times.
6. Ensure all trained responders have up to date training for both CPR and AED use. For
recommended retraining intervals please consult the organization or body used to
provide the training.

30
TROUBLESHOOTING
WARNING: If you are uncertain about the accuracy of any measurement, check
the patient’s vital signs by alternate means; then make sure the AED is
functioning correctly.

WARNING: To reduce the risk of electrical shock, do not attempt to remove the
cover under any circumstances. There are no operator serviceable components
and only a qualified technician should service the AED.

General
If the AED detects an error, it can display the “X” on the Status indicator. Check the
appropriate section or write down the description and contact qualified service personnel
or your local supplier. Before calling to qualified service personnel or your local supplier,
make sure it meets environmental conditions provided in the manual as temperature,
humidity, altitude and so on.

Corrective Action
Check use by date the pads. Change the pads if use by date has been exceeded. Check
shelf life or standby life of the battery. Change the battery if the shelf life or standby life
has been exceeded.

Following is a list of possible errors and suggestions for corrective action.

If the status indicator is still not displaying “X” or a warning message is heard when AED
is turned on or if for any reason, you have suspicions that your AED is not working
correctly contact qualified service personnel or your local supplier or Mediana directly for
support. (info@mediana.co.kr).

1. There is no response to the Power on/off button.

 A CPU module may be malfunctioned. Notify qualified service personnel or your
local supplier to check and replace the CPU module.
 The battery may be missing or discharged. If the battery is missing, insert the
battery (See Battery Operation section). If the battery is discharged, change the
battery (See Maintenance section).
2. The beep tones do not sound during the operation.
 Do not use the AED; contact qualified service personnel or your local supplier.
3. The beep tones sound but voice does not function properly.
 Reconnect the wire or replace the speaker.
4. The voice prompt “Plug in pads. Insert connector firmly”.
 Reconnect the pad firmly or replace the pad.
5. The action icon does not flash.
 Do not use the AED, contact qualified service personnel or your local supplier.
6. The voice prompt is unclearly heard.
 Do not use the AED, contact qualified service personnel or your local supplier.
7. The battery status does not indicate 3 bar despite of replacing new battery.
 If the battery status still not displayed 3 bar despite of replacing new battery, do not
use the AED and contact qualified service personnel or your local supplier.

31
EMI (Electromagnetic Interference)

WARNING: Keep patients under close surveillance during delivering a shock. It is

possible, although unlikely, that radiated electromagnetic signals from sources
external to the patient and the AED can cause inaccurate measurement readings.
Do not rely entirely on the AED readings for patient assessment.

WARNING: It is possible that any radio frequency transmitting equipment and

other nearby sources of electrical noise may result in disruption in the AED
operation.

WARNING: It is possible, although unlikely, that large equipment using a

switching relay for its power on/off may affect the AED operation. Do not operate
the AED in such environments.

This device has been tested and found to comply with the limits for medical devices to
the IEC60601-1-2, and the Medical Device Directive 93/42/EEC. These limits are
designed to provide reasonable protection against harmful interference in a typical
medical installation.

However, because of the proliferation of radio-frequency transmitting equipment and

other sources of electrical noise in health care environments (such as electrosurgical
equipment, cellular phones, mobile two-way radios, electrical appliances, and high-
definition television), it is possible that high levels of such interference due to close
proximity or strength of a source may affect AED operation.

WARNING: The AED is designed for use in environments in which the signal can
be obscured by electromagnetic interference. During such interference,
measurements may seem inappropriate or the AED may not seem to operate
correctly.

The AED disruption may be indicated by erratic readings, cessation of operation, or

other incorrect functioning. If this occurs, survey the site to determine the source of this
disruption. Try the following actions to see if they eliminate the disruption:

 Turn equipment in the vicinity off and on to isolate the offending equipment.
 Reorient or relocate the interfering equipment.
 Increase the separation between the interfering equipment and this equipment.

The AED generates, uses, and can radiate radio frequency energy. If the AED is not
installed and used in accordance with these instructions, the AED may cause harmful
interference with other devices in the vicinity.

If assistance is required, contact qualified service personnel or your local supplier.

Obtaining Technical Assistance

For technical information and assistance, or to order the AED service manual, call your
local supplier. The service manual provides information required by qualified service
personnel or your local supplier when servicing the AED.

32
 GLOSSARY
Sudden Cardiac Arrest (SCA)

Sudden cardiac arrest is a condition in which the heart suddenly stops pumping effectively
due to a malfunction of the heart's electrical system. Often victims of SCA have no prior
warning signs or symptoms. SCA can also occur in people with previously diagnosed
heart conditions. Survival for an SCA victim depends on immediate cardio-pulmonary
resuscitation (CPR). The use of an external defibrillator within the first few minutes of
collapse can greatly improve the patients' chances of survival. Heart attack and SCA are
not the same, though sometimes a heart attack can lead to a SCA. If you are experiencing
symptoms of a heart attack (pain, pressure, shortness of breath, squeezing feeling in
chest or elsewhere in the body) seek emergency medical attention immediately.

Heart Rhythm

The normal electrical rhythm by which the heart muscle contracts to create blood flow
around the body is known as Sinus Rhythm. Ventricular Fibrillation (VF) caused by
chaotic electrical signals in the heart is often the cause of SCA, but a shock can be
administered to re-establish sinus rhythm. This treatment is called defibrillation. The AED
is designed to automatically detect ventricular fibrillation (VF) and perform defibrillation on
victims of sudden cardiac arrest.

Ventricular Tachycardia / Ventricular Fibrillation

Is a life-threatening heart rhythm that is treatable with the therapy using the AED.

Sinus Rhythm
Sinus Rhythm is the normal electrical rhythm by which the heart muscle contracts and
expands to create blood flow around the body.

Biphasic Shock

A biphasic shock is an electrical current that is passed through the heart, firstly in one
direction and then in another.

Biphasic Truncated Exponential (BTE) waveform

Biphasic Truncated Exponential (BTE) waveform stands for Self-Compensating Output
Pulse Envelope Waveform.

Pads
Pads are the electrodes that are connected to the patient's chest in order to administer
therapy.

Electromagnetic Interference

Electromagnetic interference is radio interference that may cause erroneous operation of

electronic equipment.

Impedance Measurement
Impedance measurement is a check that is performed to check the integrity of AED
patient contact.

33
Detecting Fibrillation

The electrical rhythm by which the heart muscle contracts can be detected and used for
medical diagnosis and the resulting reading is called an Electrocardiogram (ECG). The
AED has been designed to analyze a patient’s ECG in order to detect ventricular
fibrillation (VF) in the heart. If ventricular fibrillation (VF) is detected the AED will deliver a
carefully engineered electrical shock designed to stop the chaotic electrical activity
experienced within the heart muscle during SCA. This may allow the victim's heart to
return to a normal sinus rhythm.

HeartOn A10®

The AED is a semi-automatic device used for the delivery of external defibrillation
therapy to resuscitate victims of SCA, who are unresponsive, are not breathing, or
without life signs.

HeartOn A10 Event Review Software

HeartOn A10 Event Review Software is software that can be used in conjunction with the
AED and SD card (or Infrared communication cable). It can retrieve and view information
about therapy delivered using the AED. Also, HeartOn A10 Event Review Software can
be used to configure the AED.

More Information
If you have had any occasion to use your AED or if you require any further information on
the AED, its accessories or any other products please contact us.

34
SPECIFICATION
Defibrillation Electric Shock

Biphasic Truncated Exponential (BTE) waveform

Waveform
(impedance compensation)
Adult: 185 to 200J (±5%)
Energy
Pediatric: 45 to 50J (±5%)
Operating mode Semi-Auto

ECG

Lead II (RA, LL)

Patient impedance 25 to 175 ohm
Heart Rate 20 to 300 per min
Accuracy 1 per min
Detection V/F more than 200 µV
V/T more than 160 per min
Lead off detection Detected and voiced.
Filter 0.5 to 30 Hz

Indication

Controls
Standard Green Power on/off button, Red Shock button
Indicators
Visible ICON (LED) Indicator, Status LCD
Audible Audio speaker (Voice prompt), Beep (CPR indication)

Physical

Dimensions 341 × 259 × 109 (mm) (W×H×D)

Weight Approx. 2.95 kg including the battery

35
Environmental Conditions

Operation
Temperature 0 to 43°C (32 to 109.4°F)
Relative Humidity 5 to 95% RF (Non-condensing)
Altitude 0 to 4,575 m
Shock Acceleration: 100 G (+/- 10%)
Time: 6 msec
The number of shocks: 3 times/axis (6 axes (+/- X, Y, Z)
Vibration Frequency: 10Hz to 2000Hz
Acceleration : 10 Hz to 100 Hz: 5,0 (m/s²)²/Hz
100 Hz to 200 Hz: -7 dB per octave
200 Hz to 2000 Hz: 1,0 (m/s²)²/Hz
Drop height 1m
Water and dust IP54 (IEC60529)
resistance
Storage (in shipping container)
Temperature -20 to 60°C (-4 to 140°F)
Relative Humidity 5 to 95% Non-condensing
Altitude 0 to 12,192 m

Self Test

Cycle Every 24 hours, 1 week, 1 month

Power on self test
Test result Status LCD displays “O”/ “X”.

Data Backup and Communication

Standard SD card, Infrared communication port

36
Accessories Specifications

Pads
Adult Pads
Standby life 2 years from manufacture date
Electrodes Disposable pads
Placement Anterior-lateral
Active gel area 96.25 cm2
Cable length 1.7 m
Pediatric Pads (Option)
Standby life 2 years from manufacture date
Electrodes Disposable pads
Placement Anterior-posterior
Active gel area 69.53 cm2
Cable length 1.7 m
Environmental Conditions
Temperature Operation: 0 to 43°C (32 to 109.4°F)
Storage: 0 to 43°C (32 to 109.4°F)
Relative Humidity 5 to 95% Non-condensing

Battery
Battery
Type LiMnO2, Disposable, Long-Life Primary Cell
Voltage/Capacity 15V, 4200 mAh
Shelf Life (in the 2 years from manufacture date
original packaging)
Standby Life 5 years from manufacture date
(inserted in the AED)
Discharge A minimum of 200 shocks (excepting the CPR period
between the defibrillation therapy) or 10 hours of operating
time at 20°C
Environmental Conditions
Temperature Operation: 0 to 43°C (32 to 109.4°F)
Storage: 0 to 43°C (32 to 109.4°F)
Relative Humidity 5 to 95% RH (Non-condensing)

37
Defibrillation

Defibrillation waveform
Waveform Waveform parameters are automatically adjusted as a
parameters function of patient defibrillation impedance. In the diagram at
left, A is the width of pulse 1 and B is the width of pulse 2 of
the waveform, C is the inter-pulse delay, Ip is the peak current,
and If the final current.
The AED delivers shocks to load impedances from 25 to 175
ohms. The duration of each pulse of the waveform is
dynamically adjusted based on delivered charge, in order to
compensate for patient impedance variations, as shown
below:
Adult defibrillation
Load Pulse width 1 Pulse width 2 Delivered
Resistance (Ω) (ms) (ms) Energy (J)
25 3.3 3.1 195
50 4.7 4.1 190
75 6.7 4.7 185
100 8.3 5.9 195
125 9.7 6.7 190
150 11.3 7.9 185
175 11.7 8.7 180
Pediatric defibrillation
Load Pulse width 1 Pulse width 2 Delivered
Resistance (Ω) (ms) (ms) Energy (J)
25 3.3 3.1 51
50 4.7 4.1 50
75 6.7 4.7 49
100 8.3 5.9 51
125 9.7 6.7 50
150 11.3 7.9 49
175 11.7 8.7 47
Charge control Controlled by patient analysis system for automated
operation.
Charging Time < 10 seconds typical
Shock Analysis 8 to 13 seconds
Time

38
ECG Analysis Performance

Rhythm class ECG analysis performance

Shockable rhythm, Complies with IEC60601-2-4:2002
Ventricular Fibrillation (sensitivity > 90%)
Shockable rhythm, Complies with IEC60601-2-4:2002
Ventricular (sensitivity > 75%)
Tachycardia
Non-Shockable Complies with IEC60601-2-4:2002
rhythm (specificity > 95%)

Database for ECG Analysis

 From AHA (American Heart Association) official database

 From MIT (Massachusetts institute Technology) official database
(MIT-BIH Arrhythmia Database and Creighton University Ventricular Tachyarrhythmia
Database)

ECG rhythm to determine if a shock is appropriate

 Ventricular Fibrillation at a amplitude greater than or equal to 0.2mV

 Ventricular Tachycardia at a heart rate greater than or equal to 160 bpm

39
Compliance

Item Standard Description

Classification IEC60601-1:1988 Internally powered (on battery power)
+A1:1991+A2:1995,
EN 60601-1:1990
+A1:1993 +A2:1995
+A13:1996
Type of IEC60601-1:1988 Type CF – Applied part
protection +A1:1991+A2:1995,
EN 60601-1:1990
+A1:1993 +A2:1995
+A13:1996
Mode of IEC60601-1:1988 Continuous
operation +A1:1991+A2:1995,
EN 60601-1:1990
+A1:1993 +A2:1995
+A13:1996
Degree of IEC60529:2001, IP54 (provided by enclosures)
protection EN60529:1991+A1 2000
General 93/42/EEC as amended Medical Device Directive (class IIb)
by 2007/47/EC
21CFR820 Code of federal regulations
2012/19/EU Waste Electrical and Electronic Equipment
93/86/EEC Battery disposal directive
2006/66/EC as amended Battery directive
by 2008/103/EC
ISO13485:2003, Quality systems - Medical Devices -
EN ISO13485:2012 Requirements for regulating purposes
/AC:2012
ISO14971:2007, Application of risk management to Medical
EN ISO14971:2012 devices
IEC60601-1:1988 General requirements for safety of medical
+A1:1991+A2:1995, electrical equipment
EN60601-1:1996
IEC60529:1989+A1:1999, Degree of Protection Provided by Enclosures
EN60529:1991+A1:2000 Water Ingress Testing (IP54)
ISO14155:2011 Clinical investigation of medical devices for
EN ISO14155:2011 human subjects - Good clinical practice
AAMI HE75:2009 Human factors engineering guidelines and
preferred practices for the design of medical
devices
IEC60601-1-1:2000, Collateral standard for medical electrical systems
EN60601-1-1:2001
IEC62304:2006, Medical device software - Software life-cycle
EN62304:2006 /AC:2008 processes
IEC60601-1-6:2010 Usability
EN60601-1-6:2010
IEC62366:2007, Medical devices - Application of usability
EN62366:2008 engineering to medical devices

40
 Item Standard Description
IEC60601-1-11:2010 Requirements for medical electrical equipment
EN60601-1-11:2010 and medical electrical systems used in the home
healthcare environment
ISO10993-1:2009 Biological evaluation of medical devices – Part 1:
EN ISO10993-1:2009 Evaluation and testing within a risk management
/AC:2010 process
ISO10993-5:2009 Biological evaluation of medical devices – Part 5:
EN ISO10993-5:2009 Tests for in vitro cytotoxicity
ISO10993-10:2010 Biological evaluation of medical devices – Part 10:
EN ISO10993-10: Tests for irritation and delayed-type
2010 hypersensitivity
EN 1789:2007 +A1:2010 Medical vehicles and their equipment
– road ambulance
EN13718-1:2008 Medical vehicles and their equipment – Air
ambulances – Part1: Requirements for medical
devices used in air ambulances.
RTCA/ DO-160G Environmental Conditions and Test Procedures
for Airborne Equipment
Defibrillator IEC60601-2-4:2002 Safety of cardiac defibrillators
EN60601-2-4:2003
AAMI DF80:2003 Safety of cardiac defibrillators (including
automated external defibrillators)
EMC IEC60601-1-2:2007 Electromagnetic compatibility-requirements & test
EN60601-1-2:2007
/AC:2010
IEC61000-4-2:2008 Electrostatic discharge (ESD) Ed.2.0
EN61000-4-2:2009
IEC61000-4-3:2006 Radiated RF electromagnetic field Ed.3.1
+A1:2007 +A2:2010
EN61000-4-3:2006
+A1:2008 +A2:2010
IEC61000-4-8:2009 Power frequency (50/60Hz) Magnetic field Ed.2.0
EN61000-4-8:2010
CISPR11:2009+A1:2010 Limits and methods of measurement of radio
EN55011: 2009 +A1:2010 disturbance characteristics of industrial scientific
and medical (ISM) radio-frequency equipment
RF emissions, Group 1, Class B
Package ISTA (Procedure 1A, Pre-Shipment test procedures (Package)
2001)
ASTM D4169:2009 Standard practice for performance testing of
shipping containers and system
Reliability IEC60068-1:1988 Environmental testing, Part1: General guidelines
+A1:1992
EN 60068-1:1994
IEC60068-2-27:2008, Environmental testing – Shock
EN60068-2-27:2009
IEC60068-2-6:2007, Environmental testing – Vibration
EN60068-2-6:2008
IEC60068-2-64:2008, Environmental testing: vibration, broad-band
EN60068-2-64:2008 random (digital control) and guidance
IEC60068-2-31:2008 Environmental testing - Part 2-31: Tests - Test Ec:

41
 Item Standard Description
EN60068-2-31:2008 Rough handling shocks, primarily for equipment-
type specimens
Labeling EN1041:2008 Information supplied by the manufacturer with
medical devices
Marking IEC /TR60878:2003 Graphical symbols for electrical equipment in
medical practice
EN980:2008 Graphical symbols for use in the labeling of
medical devices
ISO15223-1:2012 Medical devices - Symbols to be used with
medical device labels, labeling and information to
be supplied - Part 1: General requirements
ISO15223-2:2010 Medical devices - Symbols to be used with
medical device labels, labeling, and information to
be supplied - Part 2: Symbol development,
selection and validation
ISO7000:2012 Graphical symbols for use on equipment-index
and synopsis
EN50419:2006 Marking of electrical and electronic equipment in
accordance with article II (2) of directive
2002/96/EC (WEEE)
Others With respect to electric shock, fire and mechanical hazards only in accordance
with UL60601-1 AND CAN/CSA C22.2 NO.601.1 ADDITIONAL IEC60601-2-4

42
Manufacturer’s Declaration 
WARNING: For best product performance and measurement accuracy, use only
accessories supplied or recommended by Mediana. Use accessories according
to the manufacturer’s directions for use and your facility’s standards. The use
of accessories, transducers, and cables other than those specified may result
in increased emission and/or decreased immunity of the AED.

The AED is suitable for use in the specified electromagnetic environment. The customer and/or
user of the AED should assure that it is used in an electromagnetic environment as described
below;

Table 4. Electromagnetic Emissions (IEC60601-1-2)

Emission Test Compliance Electromagnetic Environment

RF emission Group 1 The AED must emit electromagnetic energy
CISPR 11 in order to perform its intended function.
Nearby electronic equipment may be
affected.
RF emissions Class B The AED is suitable for use in all
CISPR 11 establishments.

Table 5. Electromagnetic Immunity (IEC60601-1-2)

Immunity Test IEC60601-1-2 Compliance Electromagnetic

Test Level Level Environment Guidance
Electrostatic ±6 kV contact ±6 kV contact Floor should be wood,
discharge (ESD) ±8 kV air ±8 kV air concrete, or ceramic tile. If
IEC 61000-4-2 floors are covered with
synthetic material, the relative
humidity should be at least
30 %.
Power 80 A/m 80 A/m It may be necessary to position
frequency the AED further from the
(50/ 60 Hz) sources of power frequency
magnetic field magnetic fields or to install
magnetic shielding. The power
IEC 61000-4-8 frequency magnetic field
should be measured in the
intended installation location to
assure that it is sufficiently low.

43
 Table 6. Electromagnetic Immunity (IEC60601-1-2) (continued)

Immunity IEC60601 Compliance Electromagnetic

Test test level level environment guidance
The AED is intended for use in the electromagnetic environment specified below. The
customer or the user of the AED should assure that it is used in such an environment.
Potable and mobile RF
communications equipment
should be used no closer to any
part of the AED including cables,
than the recommended separation
distance calculated from the
equation appropriate to the
frequency of the transmitter.

Recommend separation
distance

Radiated RF 10 V/m, 20 V/m 10 V/m, 20V/m d = 1.2 √P 80 MHz to 800 MHz

IEC 61000-4-3 80 MHz ~ 2.5 GHz
d = 2.3 √P 800 MHz to 2.5 GHz

(These values are Where P is the maximum output

set in accordance power rating of the transmitter in
with IEC60601-2-4) watts (W) according to the
transmitter manufacturer and d is
the recommended separation
distance in metres (m).

Field strengths from fixed RF

transmitters as deter-mined by an
electromagnetic site survey,a
should be less than the
compliance level in each
frequency range.b

Interference may occur in the

vicinity of equipment marked with
the following symbol:

Note: At 80 MHz and 800 MHz, the higher frequency range applies.
Note: These guidelines may not apply in all situations. Electromagnetic propagation is
affected by absorption and reflection from structures, objects, and people.
a
Field strengths from fixed transmitters, such as base stations for radio (cellular/ cordless)
telephones and land mobile radio, AM and FM radio broadcast, and TV broadcast cannot be
predicted theoretically with accuracy. To assess the electromagnetic environment due to fixed
RF transmitters, an electromagnetic site survey should be considered. If the measured field
strength in the location in which the AED is used exceeds the applicable RF compliance level
above, the AED should be observed to verify normal operation. If abnormal performance is
observed, additional measures may be necessary, such as re-orienting or relocating the
AED.
b
Over the frequency range 80 MHz to 2.5 GHz, field strengths should be less than 10 V/m

Recommended Separation Distances between Portable and Mobile RF

Communications Equipment and the AED. (IEC60601-1-2)

44
 Table 7. Recommended Separation Distances
Recommended separation distance between
Portable and mobile RF communications equipment and the AED

The AED is intended for use in an electromagnetic environment in which radiated RF

disturbances are controlled. The customer or the user of the AED can help prevent
electromagnetic interference by maintaining a minimum distance between portable and
mobile RF communications equipment (transmitters) and the AED as recommended below,
according to the maximum output power of the communications equipment.

Rated Maximum Separation distance according to frequency of transmitter in

Output Power of meter
Transmitter in 80 MHz to 800 MHz 800 MHz to 2.5GHz
watt d = 1.2 √P d = 2.3 √P
0.01 0.12 0.23
0.1 0.38 0.73
1 1.2 2.3
10 3.8 7.3
100 12 23
For transmitters rated at a maximum output power not listed above, the recommended
separation distance d in metres (m) can be estimated using the equation applicable to the
frequency of the transmitter, where P is the maximum output power rating of the transmitter in
watts (W) according to the transmitter manufacturer.
Note: At 80MHz and 800MHz, the separation distance for the higher frequency range applies
Note: These guidelines may not apply in all situations. Electromagnetic propagation is
affected by absorption and reflection from structures, objects, and people.

Table 8. Cables (IEC60601-1-2)

Maximum
Cables and Sensors Complies with
Length
-RF emissions, CISPR 11, Class B/ Group 1
-Electrostatic discharge (ESD), IEC 61000-4-2
Pads cable 1.7 m
-Radiated RF, IEC 61000-4-3
-Power frequency Magnetic field, IEC 61000-4-8

45