Mediana HeartOn A16 Series Operator's Manual
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Mediana HeartOn A16 Series Operator's Manual

Automated external defibrillator
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OPERATOR'S MANUAL
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: 2020-01
Part Number-Revision: A7659-0
Copyright © 2020 All rights reserved.
MEDIANA
HEARTON
AED A16
Automated External Defibrillator
HeartOn A16
OPERATORS
MANUAL

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  • Page 1 MANUAL 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 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.

  • Page 3: Table Of Contents

    MEDIANA HEARTON AED A16 Automated External Defibrillator CONTENTS CONTENTS ..............................i SAFETY INFORMATION ..........................1 General Safety Information ........................1 Warning ..............................1 Cautions ..............................3 INTRODUCTION ............................5 Intended Use for the AED ........................5 Where can it be used? .......................... 5 Who can use it? .............................
  • Page 4 MEDIANA HEARTON AED A16 Automated External Defibrillator ECG ..............................49 Indication ............................. 49 Physical ............................... 49 Environmental Conditions........................50 Self Test ............................... 50 Data Backup and Communication ....................... 50 Expected Service Life .......................... 50 Accessories Specifications ........................51 Defibrillation waveform ........................52 ECG Analysis Performance .........................

  • 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 AED can cause death or injury. Do not use or place the AED in service if the status indicator of AED displays “X”. Contact your local distributor or Mediana service team. Keep batteries dry and away from any heat sources (including direct sunlight).

  • Page 7: Cautions

    MEDIANA HEARTON AED A16 Automated External Defibrillator 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.
  • Page 8 MEDIANA HEARTON AED A16 Automated External Defibrillator...

  • Page 9: Introduction

    Automated External Defibrillator 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

    If the person expecting to use the AED is not trained in the above, please contact your local distributor or Mediana who can provide the training. Information on authorized local training organizations can also be found in relevant departments of the government.

  • Page 11: Identifying The Aed Configurations

    MEDIANA HEARTON AED A16 Automated External Defibrillator Identifying the AED Configurations The following table identifies the AED configurations and how they are indicated. The Reference number and serial number are located on the bottom of the AED. Model Name Reference No.
  • Page 12 MEDIANA HEARTON AED A16 Automated External Defibrillator Features for the AED Physical/Mechanical The AED is an automated external defibrillator (AED) used for the fast delivery of defibrillation electric shock therapy which can be battery-operated. Electrical The AED has a battery which is detachable and non-rechargeable.

  • Page 13: Description Of The Aed

    MEDIANA HEARTON AED A16 Automated External Defibrillator DESCRIPTION OF THE AED Top and Right Panel Components <Chest Type ∙ A16-DS, A16-DF> <Icon Type ∙ A16-GS, A16-GF> Figure 1. HeartOn A16: Top and Right Panel Components...

  • Page 14: Rear Panel Components

    MEDIANA HEARTON AED A16 Automated External Defibrillator Rear Panel Components <With a Battery> <Without a Battery> Figure 2. HeartOn A16: Rear Panel Components Table 1. HeartOn A16 Panel Components Select language User can select the desired language among three different button languages by pushing the select language button.

  • Page 15: Symbols And Labels

    MEDIANA HEARTON AED A16 Automated External Defibrillator 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...
  • Page 16 MEDIANA HEARTON AED A16 Automated External Defibrillator...

  • Page 17: Setting Up The Aed

    MEDIANA HEARTON AED A16 Automated External Defibrillator SETTING UP THE AED To ensure accurate performance and prevent AED failure, do not expose the AED to extreme moisture, including direct exposure to rain. Such exposure may cause inaccurate performance or AED failure. Refer to Specification section.

  • Page 18: Soft Carry Case

    6. After complete the update, automatically turn off itself. Close the cover again. Note: Only micro SD cards supplied by Mediana should be used. Event Data The event data are stored in the SD card. The event data can be read by HeartOn AED Event Review Software.

  • Page 19: Infrared Communication Port

    5. Copy the carried out ‘Import Internal Data.txt’ file into the ‘Update’ directory folder. 6. Remove the battery from the AED and insert the SD card supplied by Mediana to SD card port which is located at bottom side of the AED.

  • Page 20: Setting Up The Aed

    HEARTON AED A16 Automated External Defibrillator 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 21 MEDIANA HEARTON AED A16 Automated External Defibrillator Install 1 1. Install the battery to the AED. 2. The status indicator of the AED will display “X” and then operate the battery insertion self test. 3. When the battery insertion self test is completed normally, voice prompt “Unit ok” will be emitted and the status indicator will be changed from “X”...
  • Page 22 MEDIANA HEARTON AED A16 Automated External Defibrillator Install 2 Check that the AED is working optimally. 1. (option) Connect the CPR Feedback sensor to the AED. 2. Turn on the AED by pushing the power button, ensure that you can hear the voice prompt.

  • Page 23: Battery Operation

    MEDIANA HEARTON AED A16 Automated External Defibrillator 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.

  • Page 24: Figure 4. Inserting The Battery

    MEDIANA HEARTON AED A16 Automated External Defibrillator Hook Battery Battery release button Figure 4. Inserting the battery Pull down the battery while pushing the battery release button, then disconnect the battery as shown in the Figure 3. Prepare the new battery, then connect the battery and AED by using the hook as shown in the second figure of the Figure 4.

  • Page 25: 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.

  • Page 26: Self Test

    MEDIANA HEARTON AED A16 Automated External Defibrillator 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.
  • Page 27 MEDIANA HEARTON AED A16 Automated External Defibrillator Note: When the battery is discharged, the status indicator will display “X”. Even if the new battery is replaced, the status indicator still displays “X”. Please contact qualified service personnel or your local supplier.
  • Page 28 MEDIANA HEARTON AED A16 Automated External Defibrillator...

  • Page 29: Cpr Feedback Module Operation

    CPR Feedback Module is connected to the AED, please contact the local distributor or Mediana service team immediately. Note: If user has a CPR Feedback Module, it is recommended that user keep the CPR Feedback Module connected to the AED with the adhesive pad as preparation for emergency circumstances.

  • Page 30: Figure 7. Replacing The Cpr Feedback Module

    MEDIANA HEARTON AED A16 Automated External Defibrillator Replacing the CPR Feedback Module Figure 7. Replacing the CPR Feedback Module 1. Loosen the CPR Feedback Module connector and separate the pads and CPR Feedback Module. 2. Push the new CPR Feedback Module into the CPR Feedback Module connection socket of the pads fully inserted and tighten the connection.

  • Page 31: Using The Aed

    AHA/ERC Guidelines for Resuscitation and Emergency Cardiac Care. Please contact your Mediana service representative for more information.
  • Page 32 MEDIANA HEARTON AED A16 Automated External Defibrillator 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 33: Pre Defibrillation Action

    MEDIANA HEARTON AED A16 Automated External Defibrillator 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.

  • Page 34: Figure 8. Patient Mode Switch Button

    Automated External Defibrillator material touching the patient during ECG analysis or defibrillation. Note: Only pads supplied by Mediana should be used. Using other types of pads may result in damage to the patient and the AED. Note: When the voice prompt, “Replace pads.”, is played, ignoring the guidance and using the same pads can cause the fail of the deliver the energy that AED assured.

  • Page 35: Figure 9. Pads Disconnect Icon (Chest Type∙A16-Ds, A16-Df)

    MEDIANA HEARTON AED A16 Automated External Defibrillator If the pad is not inserted, you will hear the voice prompt:  “Plug in pads. Insert connector firmly.” Figure 9. Pads disconnect icon (Chest type∙A16-DS, A16-DF) Figure 10. Pads disconnect icon (Icon type∙A16-GS, A16-GF)

  • Page 36: Operation Of Hearton A16

    MEDIANA HEARTON AED A16 Automated External Defibrillator Operation of HeartOn A16 Note: The AED with CPR First option turned on starts with step 4. The CPR First option can be set via service mode. It is applied to the chest type, A16-DS and A16-DF, only.

  • Page 37: (Left: Chest Type∙A16-Ds, A16-Df(Ⓒ), Right: Icon Type∙A16-Gs, A16-Gf (Ⓒ)

    MEDIANA HEARTON AED A16 Automated External Defibrillator Step 2 When the pads are attached correctly to the patient you will hear the voice prompts:  “Do not touch the patient.”  “Analyzing and Charging”  “Shock advised.”  “Do not touch the patient.”...

  • Page 38: Figure 14. Action Icon - Step 3

    MEDIANA HEARTON AED A16 Automated External Defibrillator Step 3 Semi-Auto  “Press the flashing button now.”  “Shock delivered.”  “Press the flashing button now.”  “Shock button not pressed.” When the ECG rhythm is changed to a non-shockable rhythm before the shock button...

  • Page 39: Figure 15. Action Icon - Step 4

    MEDIANA HEARTON AED A16 Automated External Defibrillator 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 and when the electric shock will be delivered.

  • Page 40: Performing Cpr

    MEDIANA HEARTON AED A16 Automated External Defibrillator Note: If the shock cancel (when the pad connector is disconnected, the patient ECG, impedance, or mode is changed) has been occurred 3 times, the AED is performing the CPR process after the voice prompt “Shock cancelled” is emitted.
  • Page 41 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...

  • Page 42: Note User And Bystander Safety

    MEDIANA HEARTON AED A16 Automated External Defibrillator Note User and Bystander Safety Make sure no one is touching the patient before you press the Shock button (in case of the Semi-Auto). 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.

  • Page 43: 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 44: Recycling And Disposal

    “Unit OK” can be heard. Turn off the AED by pressing the power button. 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 45: Cleaning

    MEDIANA HEARTON AED A16 Automated External Defibrillator Cleaning To clean the AED, wipe the AED with a soft cloth that has been dampened by one of the following:  Quaternary Ammonium (fungicidal, bactericidal and virucidal against enveloped viruses)  Isopropyl alcohol (70% solution).

  • Page 46: Cpr Feedback Module Maintenance

    MEDIANA HEARTON AED A16 Automated External Defibrillator 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 and must be replaced with new pads.)

  • Page 47: The Aed Maintenance

    AED A16 Automated External Defibrillator 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 48 MEDIANA HEARTON AED A16 Automated External Defibrillator...

  • Page 49: 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 50: Emi (Electromagnetic Interference)

    MEDIANA HEARTON AED A16 Automated External Defibrillator 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.

  • Page 51: Glossary

    MEDIANA HEARTON AED A16 Automated External Defibrillator 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.
  • Page 52 MEDIANA HEARTON AED A16 Automated External Defibrillator 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.

  • Page 53: Specification

    MEDIANA HEARTON AED A16 Automated External Defibrillator SPECIFICATION Defibrillation Electric Shock Biphasic Truncated Exponential (BTE) waveform Waveform (impedance compensation) Adult: 170 to 195J (±5%) Energy Pediatric: 44 to 51J (±5%) Operating mode Semi-Auto, Fully-Auto Lead II (RA, LL) Patient impedance...

  • Page 54: Environmental Conditions

    MEDIANA HEARTON AED A16 Automated External Defibrillator 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))

  • Page 55: Accessories Specifications

    MEDIANA HEARTON AED A16 Automated External Defibrillator Accessories Specifications Pads Adult / Pediatric Pads Refer to pad’s direction for use Shelf life Electrodes Disposable pads Placement Adult: Anterior-lateral Pediatric: Anterior-posterior Minimum active gel 80 cm +/-5% area Cable length About 1.8 m...

  • Page 56: Defibrillation Waveform

    MEDIANA HEARTON AED A16 Automated External Defibrillator CPR Feedback Module CPR Feedback Module (option) Dimensions 80 mm diameter Medical device class Environmental Conditions Operation: -5 ~ 50°C (23 ~ 122°F) Temperature Storage: -30 ~ 70°C (-22 ~ 158°F) Relative Humidity...
  • Page 57 MEDIANA HEARTON AED A16 Automated External Defibrillator Pediatric defibrillation Load Pulse width 1 Pulse width 2 Delivered Resistance (Ω) (ms) (ms) Energy (J) 11.3 11.7 11.7 Charging Time < 10 seconds typical (with new battery) Approx. 12 seconds After 6...

  • Page 58: Ecg Analysis Performance

    MEDIANA HEARTON AED A16 Automated External Defibrillator 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...

  • Page 59: Compliance

    MEDIANA HEARTON AED A16 Automated External Defibrillator 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...

  • Page 60: Manufacturer's Declaration

    Automated External Defibrillator 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 61: Table 7. Electromagnetic Immunity (Iec60601-1-2) (Continued)

    MEDIANA HEARTON AED A16 Automated External Defibrillator 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.

  • Page 62: Table 8. Recommended Separation Distances

    MEDIANA HEARTON AED A16 Automated External Defibrillator 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...

  • Page 63: Table 9. Immunity To Proximity Fields From Rf Wireless Communications Equipment (Iec 60601-1-2)

    MEDIANA HEARTON AED A16 Automated External Defibrillator Table 9. Immunity to proximity fields from RF wireless communications equipment (IEC 60601-1-2) Test Maximum Distanc Immunity Band Modulation frequency Service power test level (MHz) (MHz) (V/m) Pulse 360 – TETRA modulation 18 Hz GMRS 430 –...

This manual is also suitable for:

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