Mediana HeartOn A15 Operator'S Manual Download Page 1

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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

Summary of Contents for HeartOn A15

Page 1: ...S S A Bd G n ral 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: ...d 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 n...

Page 3: ...ed communication port 17 Setting up the AED 18 Temperature status 18 BATTERY OPERATION 21 Operating the AED on Battery Power 21 Battery Status Indication 23 Self Test 24 USING THE AED 27 AHA ERC guide...

Page 4: ...on Icon Step 6 33 Figure 15 HeartOn A15 Action Icon Step 7 34 Figure 16 HeartOn A15 Action Icon Step 8 34 Figure 17 HeartOn A15 G4 Pad disconnect icon 35 Figure 18 HeartOn A15 G4 Action icon Step 1 36...

Page 5: ...rical Code Articles 500 503 In accordance with the IEC EN 60601 1 Classifications the AED is not to be used in the presence of flammable substance air mixtures The AED has been designed to work on unr...

Page 6: ...e heart Pay attention to possibility of contact with conduction part of electrode lead line cable connector other patient installation part for patient safety Do not use this AED near or within puddle...

Page 7: ...r stacked with other equipment verify proper operation prior to use Handling or transporting the patient during ECG analysis can cause incorrect or delayed diagnosis If the AED gives a SHOCK ADVISED p...

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Page 9: ...oads including the pavement public squares parks subway station government buildings beaches public libraries privately owned buildings or property opened to public visible from sidewalks and any shar...

Page 10: ...Standard 8 Action Icons HeartOn A15 G4 A15M G4 0 E AED Standard 4 Action Icons Note The alphabet E can be added as the last digit of reference number in accordance with the region Features for the AE...

Page 11: ...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 1 2 3 4 5 6 7 9 10 8 2 3 4 5 6 7 1 9 10...

Page 12: ...de between adult and pediatric infant child patient mode by pushing the patient mode switch 6 Shock button When preparation for electric shock is completed the shock button will flash Push the Shock b...

Page 13: ...mark Battery status Environmental shipping storage atmospheric pressure limitations Temperature status Environmental shipping storage humidity limitations Contains no latex Environmental shipping sto...

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Page 15: ...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...

Page 16: ...the SD card into the SD card port 4 Close the SD card port cover 5 If necessary to update the AED through SD card turn on the AED by pushing Slide button to the right 6 After complete the update autom...

Page 17: ...d could be used for further clinical assessment Please make sure that event data are securely saved in any of storage format when event data is accessed by the HeartOn AED Event Review Software or is...

Page 18: ...value for environmental operation condition for long time it will be longer than usual to recognize the temperature It is recommended that AED should be stored in environmental operation condition de...

Page 19: ...he voice prompt Unit ok and then check the AED is turned off Install 3 Place the AED into its Soft Carry Case Install 4 Put into a storage or safe visible location Note Storage differs in some countri...

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Page 21: ...carded batteries may explode during incineration Dispose used batteries properly Do not dispose of batteries in refuse containers Check battery capacity regularly Replace the new battery if you need E...

Page 22: ...le battery by using the hook as shown in the first figure of the Figure 6 4 With the handle battery being connected to the AED by hook connect handle battery connector and hook of the AED as shown in...

Page 23: ...fe time specified in above Note After 200 times of shock the voice prompt Low battery insert fresh battery will be emitted Note Due to the physical dimensions of the battery compartment only batteries...

Page 24: ...er 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 B...

Page 25: ...icator displays X If the AED does not function properly do not use the AED Instead contact qualified service personnel or your local supplier You can also skip the battery insertion self test try foll...

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Page 27: ...ealth care 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 AHA ERC guidelines Re...

Page 28: ...er should call for help before checking for breathing and trained rescuers are encouraged to simultaneously perform checking for pulse step After call for help Send for AED Person not responsive Not b...

Page 29: ...ation 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 To apply the pads to p...

Page 30: ...switched to right Pediatric pads If the pad is not inserted you will hear the voice prompt Plug in pads Insert connector firmly Figure 7 Patient mode switch Note The patient mode can switch even if an...

Page 31: ...apy Note If you hear following voice prompt when the AED is turned on you should perform the following actions Low battery insert fresh battery After replace the new battery open the door case to turn...

Page 32: ...actly 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 When the p...

Page 33: ...ice prompt will be emitted 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 Note The AED performs th...

Page 34: ...de is changed has been occurred 3 times the AED is performing the CPR process Note If Shock button not pressed the AED will move to step 8 which demonstrate CPR process directly Step 8 It is safe to t...

Page 35: ...en the AED is turned on you should perform the following actions Low battery insert fresh battery After replace the new battery open the door case to turn on the AED and after complete the power on se...

Page 36: ...area where the pads are about to be applied 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...

Page 37: ...ure 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 Note The AED performs the Step 2 directly when i...

Page 38: ...een occurred 3 times the AED is performing the CPR process Note If Shock button not pressed the AED will move to step 4 which demonstrate CPR process directly Step 4 It is safe to touch the patient Be...

Page 39: ...he recommended compression rate is 100 120 beats per minute the recommended compression depth is at least 2 inches 5 cm but not more than 2 4 inches 6 cm the recommended compression ventilation ratio...

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Page 41: ...tteries or Li ion batteries together as they might leak electrolyte heat or explode Do not mistreat the battery or use the battery in applications not recommended by Mediana Keep the battery out of re...

Page 42: ...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 yo...

Page 43: ...ay need to replace the battery with a 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 indica...

Page 44: ...r replacements Figure 23 Use by date of Pads 3 Check the 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 e...

Page 45: ...ng 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 opening the cover of the AED A CPU module may b...

Page 46: ...ectrical 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 The AED is designed for...

Page 47: ...gnals 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 ventricula...

Page 48: ...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 ar...

Page 49: ...equal to 0 2 mV V T Adult greater than or equal to 150 bpm Pediatric Infant Child greater than or equal to 180bpm Lead connection Confirm the connection and emit voice prompt Filter 0 5 to 30 Hz Indi...

Page 50: ...IEC60529 Note The Standby condition indicates that the self test periodically runs with installed battery in the AED Storage in shipping container Temperature 20 to 60 C 4 to 140 F Relative Humidity 5...

Page 51: ...to 109 4 F Relative Humidity 5 to 95 RH Non condensing Battery Battery Type LiMnO2 Disposable Long Life Primary Cell Voltage Capacity 15V 4200 mAh Shelf Life in the original packaging 2 years from man...

Page 52: ...ld defibrillation Load Resistance Pulse width 1 ms Pulse width 2 ms Delivered 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 47 200 11 7...

Page 53: ...81 82 Non shockable TN 32291 17518 1267 7062 58138 Non shockable FP 0 2 8 33 43 Specificity 100 00 99 99 99 37 99 53 99 93 Positive Predictive Value 100 00 91 67 97 24 97 99 100 00 98 55 Database for...

Page 54: ...ty engineering to Medical devices IEC60601 1 9 2007 A1 2013 EN 60601 1 9 2008 A1 2013 Medical electrical equipment Part 1 9 General requirements for basic safety and essential performance Collateral S...

Page 55: ...ronic instructions for use of medical devices eIFU Hazardous Substance 2015 863 EU Restriction of the use of Hazardous Substances in electrical and electronic equipment lll RoHS lll EC 1907 2006 Regis...

Page 56: ...energy in order to perform its intended function Nearby electronic equipment may be affected RF emissions CISPR 11 Class B The AED is suitable for use in all establishments Table 6 Electromagnetic Im...

Page 57: ...e 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 guidelin...

Page 58: ...wer of Transmitter in watt Separation distance according to frequency of transmitter in meter 80 MHz to 800 MHz d 1 2 P 800 MHz to 2 5GHz 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...

Page 59: ...Band 7 Pulse Modulation 217 Hz 2 1 28 5240 5500 5785 5100 5800 WLAN 802 11 a n Pulse Modulation 217 Hz 0 2 1 9 Note If necessary to achieve the IMMUNITY TEST LEVEL the distance between the transmitti...

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