Mediana HeartOn A15 Operator's Manual
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Mediana HeartOn A15 Operator's Manual

Automated external defibrillator
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OPERATOR'S MANUAL
HeartOn A15
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: (82) 2 542 3375 (82) 33 742 5400
Fax: (82) 2 542 7447 (82) 33 742 5483
Revised Date: 2022-06
Part Number-Revision: A7300-14
Copyright © 2022 All rights reserved.

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Phindile Agnes Sondlo
March 4, 2025

may you kindly send me an operator's manual for Mediana Hearton A 15 for model 0434

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Summary of Contents for Mediana HeartOn A15

  • Page 1 OPERATOR’S MANUAL HeartOn A15 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: (82) 2 542 3375 (82) 33 742 5400 Fax: (82) 2 542 7447 (82) 33 742 5483...
  • Page 2  Damage due to neglect of specified maintenance checks.  This warranty only covers the hardware of the HeartOn A15. The warranty does not cover the following selections:  Whatever damage or loss results from the attachment of accessories or their operation.

  • Page 3: Table Of Contents

    USING THE AED ............................27 AHA/ERC guidelines (Rescue protocol) ....................27 Pre Defibrillation Action ........................29 Operating the AED..........................29 Operation of HeartOn A15 ........................31 Operation of HeartOn A15-G4 ......................35 Performing CPR ..........................39 Note User and Bystander Safety ......................39 MAINTENANCE ............................
  • Page 4 SPECIFICATION ............................49 Manufacturer’s Declaration ......................... 56 Figures Figure 1. HeartOn A15: Top and Right Panel Components ................ 11 Figure 2. HeartOn A15-G4: Top and Right Panel Components ..............11 Figure 3. Rear Panel Components ......................12 Figure 4. Replacing the handle/battery – Right Panel ................21 Figure 5.

  • Page 5: Safety Information

    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.
  • Page 6 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.

  • Page 7: Cautions

    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.
  • Page 8 This page is intentionally left blank.

  • Page 9: Introduction

    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).

  • Page 10: About This Manual

    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. Configuration Reference No. Description HeartOn A15 A15M-G8-0(E) AED Standard (8 Action Icons) HeartOn A15-G4 A15M-G4-0(E) AED Standard (4 Action Icons) Note: The alphabet “E”...

  • Page 11: Description Of The Aed

    DESCRIPTION OF THE AED Top and Right Panel Components Figure 1. HeartOn A15: Top and Right Panel Components Figure 2. HeartOn A15-G4: Top and Right Panel Components...

  • Page 12: Rear Panel Components

    Table 1. Top and Right Panel Components Cover is used to protect the action icon, the patient mode switch, Cover the shock button. Status indicator displays the AED status, the temperature status Status indicator and the battery status. Pad connector Pad connector links the pads.

  • Page 13: Symbols And Labels

    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 Environmental shipping/storage...
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  • Page 15: Setting Up The Aed

    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 HeartOn A15 HeartOn A15-G4 Operator’s manual Adult/Pediatric (Infant-Child) Pads (1.8m) Non-rechargeable LiMnO...

  • Page 16: Soft Carry Case

    In case the 50 minutes event data are stored in internal memory during boot up, buzzer will sound 5 times {Repeat twice} and ‘action icon – step 5’ (HeartOn A15) / ‘action icon – step 4’ (HeartOn A15-G4) LED indicator will flash.

  • Page 17: Infrared Communication Port

    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.

  • Page 18: Setting Up The Aed

    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.
  • Page 19 Install 2 Check that the AED is working optimally. 1. Change the Patient mode switch by pushing Slide button to the right or left for distinguish between adult and pediatric (infant-child). 2. Turn on the AED by pushing Slide button to the right and opening the cover, ensure that you can hear the voice prompt.
  • Page 20 This page is intentionally left blank.

  • Page 21: Battery Operation

    BATTERY OPERATION Test battery regularly, when the voltage of battery is very low. A battery that does not pass its test might shut down expectedly. Do not use a battery that is damaged, leaking, or wet. Do not use or store the battery in a place that may be exposed to high temperature.

  • Page 22: Figure 5. Removing The Battery Protection Cap

    Figure 5. Removing the battery protection cap Note: For new batteries, remove the battery protection cap before inserting the battery as shown in the Figure 5. 1. Handle/Battery connector 2. Hook 3. AED connector Figure 6. Replacing the handle/battery – Upper Panel Pull up while pushing the handle/battery detachable button, then disconnect the handle/battery.

  • Page 23: Battery Status Indication

    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 in the status indicator indicates the battery condition.

  • Page 24: Self Test

    Self Test Before using the AED, confirm that the AED is working properly and is safe to use as described below. If the self test is not completed successfully, do not try to use the AED. When power is applied, the AED automatically starts the self test, which tests the AED circuitry and functions.
  • Page 25 Battery Insertion Self test When the battery is installed or replaced, the AED automatically starts the battery insertion self test. After battery insertion self test is completed, the AED sounds voice prompt “Unit ok”, the status indicator displays “O” and power of the AED is automatically turned off.
  • Page 26 This page is intentionally left blank.

  • Page 27: Using The Aed

    AHA/ERC Guidelines for Resuscitation and Emergency Cardiac Care. Please contact your Mediana service representative for more information.
  • Page 28 Summary of CPR Guidelines This “Guidelines Highlights” publication summarizes the AHA/ERC 2015 Guidelines. This is easy reference material for both lay rescuer and healthcare provider. Before installing the AED, it is recommended that the expected AED user should be trained to provide CPR and use the AED.

  • Page 29: Pre Defibrillation Action

    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 the AED.

  • Page 30: Figure 7. Patient Mode Switch

    1. Check the status indicator displays “O”. 2. To open the cover, push the Slide button to the right. 3. Turn on the AED by opening the cover. 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. ...

  • Page 31: Operation Of Hearton A15

    Step 1  “Check for response. Are you all right?” Figure 8. HeartOn A15: Action Icon – Step 1 Step 2  “Call for help.” Figure 9. HeartOn A15: Action Icon – Step 2 Note: ERC 2015 Guidelines recommends that untrained user should call the emergency services.

  • Page 32: Figure 11. Hearton A15: Action Icon - Step 4

    Step 4  “Check breathing.” Figure 11. HeartOn A15: Action Icon – Step 4 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.

  • Page 33: Figure 14. Hearton A15: Action Icon - Step 6

     “Shock cancelled.” Figure 14. HeartOn A15: Action Icon – Step 6 Note: If “No shock advised”, the AED will move to step 8 which demonstrate CPR process directly.

  • Page 34: Figure 15. Hearton A15: Action Icon - Step 7

     “Shock cancelled.” Figure 15. HeartOn A15: Action Icon – Step 7 Note: If the shock cancel (When the patients’ ECG rhythm is changed to a non-shockable rhythm, when the pads are disconnected or when the impedance or mode is changed) has been occurred 3 times, the AED is performing the CPR process.

  • Page 35: Operation Of Hearton A15-G4

     “Adult pads” or “Pediatric pads” Figure 17. HeartOn A15-G4: Pad disconnect icon Note: If the pad connector is not connected in any step except for Step 4 (CPR), the AED will move to Pad connector disconnected icon and the voice prompt “Plug in pads.

  • Page 36: Figure 18. Hearton A15-G4: Action Icon - Step 1

    “Remove clothes from the patient’s chest. Place pad exactly as shown in the picture. Press pads firmly to patient’s bare chest.” Figure 18. HeartOn A15-G4: Action icon – Step 1 Adult: age > 8, weigh ≥ 25kg(55lbs) Pediatric (Infant-Child): age ≤ 8, weigh < 25kg(55lbs)

  • Page 37: Figure 20. Hearton A15-G4: Action Icon -Step 2

     “Shock cancelled.” Figure 20. HeartOn A15-G4: Action icon –Step 2 Note: If “No shock advised” voice prompt is emitted, the AED will move to step 4 which demonstrate the CPR process.

  • Page 38: Figure 21. Hearton A15-G4: Action Icon - Step 3

     “Shock cancelled.” Figure 21. HeartOn A15-G4: Action Icon – Step 3 Note: If the shock cancel (When the patients’ ECG rhythm is changed to a non-shockable rhythm, when the pads are disconnected or when the impedance or mode is changed) has been occurred 3 times, the AED is performing the CPR process.

  • Page 39: Performing Cpr

    30:2, the recommended duration is 5 cycles (30:2 x 5 cycles). 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.
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  • Page 41: Maintenance

    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 AED Event Review Software to download information about the therapy performed and store appropriately.

  • Page 42: Recycling And Disposal

    “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.

  • Page 43: Cleaning

    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.

  • Page 44: The Aed Maintenance

    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.

  • Page 45: Troubleshooting

    If the status indicator is still not displaying “X” or a warning message is heard when the 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.

  • Page 46: Emi (Electromagnetic Interference)

    EMI (Electromagnetic Interference) 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.

  • Page 47: Glossary

    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.
  • Page 48 SCA. This may allow the victim's heart to return to a sinus rhythm. HeartOn A15 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.

  • Page 49: Specification

    SPECIFICATION Defibrillation Electric Shock Biphasic Truncated Exponential (BTE) waveform Waveform (impedance compensation) HeartOn A15 / HeartOn A15-G4 Energy Adult: 170 to 195J (±5%) Pediatric (Infant-Child): 44 to 51J (±5%) Operating mode Semi-Auto Lead II (RA, LL) Patient impedance HeartOn A15 / HeartOn A15-G4...
  • Page 50 Environmental Conditions Operation/Standby Temperature 0 to 43°C (32 to 109.4°F) Relative Humidity 5 to 95% RH (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...
  • Page 51 Accessories Specifications Pads Adult / Pediatric (Infant-Child) Pads Refer to pad’s direction for use Shelf life Electrodes Disposable pads Placement Adult: Anterior-lateral Pediatric (Infant-Child): Anterior-posterior Minimum active gel 80 cm +/-5% area Cable length About 1.8 m Environmental Conditions Operation: 0 to 43°C (32 to 109.4°F) Temperature Storage:...
  • Page 52 Defibrillation waveform Defibrillation waveform Waveform parameters are automatically adjusted as a Waveform function of patient defibrillation impedance. In the diagram at parameters 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, I is the peak current, and I the final current.
  • Page 53 ECG Analysis Performance Rhythm class AHA-DB MIT-DB CU-DB VF-DB VT-DB Total number of sample size VF-shockable : TP 2200 VF-shockable : FN VF-shockable : sensitivity(%) 95.74 100.00 97.58 97.53 96.75 Adult mode VT-shockable : TP Adult mode VT-shockable : FN Adult mode 91.40 91.40...
  • Page 54 Compliance Item Standard Description Classification IEC 60601-1:2005+A1:2012 Internally powered (on battery power) EN 60601-1:2006 A1:2013 Type CF – Applied part Type of IEC 60601-1:2005+A1:2012 protection EN 60601-1:2006 A1:2013 Mode of IEC 60601-1:2005+A1:2012 Continuous operation EN 60601-1:2006 A1:2013 Degree of IEC 60529:1989+A1:1999 IP54 (provided by enclosures) protection EN 60529:1991+A1:2000...
  • Page 55 Item Standard Description requirements Labeling EN 1041:2008 Information supplied by the manufacturer with Medical devices 2021/2226/EU Electronic instructions for use of medical devices (eIFU) Hazardous 2015/863/EU Restriction of the use of Hazardous Substance Substances in electrical and electronic equipment lll (RoHS lll) EC/1907/2006 Registration, Evaluation, Authorization and Restriction of Chemicals (REACH)

  • Page 56: Manufacturer's Declaration

    Manufacturer’s Declaration 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.

  • Page 57: Table 7. Electromagnetic Immunity (Iec60601-1-2) (Continued)

    Table 7. 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...

  • Page 58: Table 8. Recommended Separation Distances

    Table 8. 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.

  • Page 59: Table 9. Immunity To Proximity Fields From Rf Wireless Communications Equipment (Iec 60601-1-2)

    Table 9. Immunity to proximity fields from RF wireless communications equipment (IEC 60601-1-2) Test Maximum Immunity Band Modulation Distance frequency Service power test level (MHz) (MHz) (V/m) Pulse 380 - TETRA Modulation: 18 Hz GMRS 430 - + 5Hz 460, deviation FRS 460 1 kHz sine...

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