Mediana A16M-DF-0E Operator'S Manual Download Page 1

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OPERATOR’S MANUAL

HeartOn A16

Automated External Defibrillator

EU representative

OBELIS S.A

Bd. Général Wahis, 53, 1030 Brussels, Belgium

Manufacturer

Mediana Co., Ltd.

132, Donghwagongdan-ro,
Munmak-eup, Wonju-si, Gangwon-do, Korea
Tel: (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

MEDIANA

HEART

AED A16

Automated External Defibrillator

OPERATORS

MANUAL

Summary of Contents for A16M-DF-0E

Page 1: ...ls 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 Rev...

Page 2: ...nded 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 b...

Page 3: ...6 Temperature status 16 Pads status 16 BATTERY OPERATION 19 Operating the AED on Battery Power 19 Battery Status Indication 21 Self Test 22 CPR FEEDBACK MODULE OPERATION 25 Operating the CPR Feedback...

Page 4: ...con type A16 GS A16 GF 31 Figure 11 Action Icon Step 1 Left Chest type A16 DS A16 DF Right Icon type A16 GS A16 GF 32 Figure 12 Pads Placement 32 Figure 13 Action Icon Step 2 Left Chest type A16 DS A1...

Page 5: ...tions as defined in the National Electrical Code Articles 500 503 In accordance with the IEC EN 60601 1 Classifications the AED is not to be used in the presence of flammable substance air mixtures Th...

Page 6: ...t for patient safety Do not use this AED near or within puddles of water Do not reuse electrodes to many patients Use the AED or accessories only as described in this manual Improper use of the AED ca...

Page 7: ...er operation prior to use Handling or transporting the patient during ECG analysis can cause incorrect or delayed diagnosis If the AED gives a SHOCK ADVISED prompt during such handling or transport st...

Page 8: ...MEDIANA HEARTON AED A16 Automated External Defibrillator 4...

Page 9: ...sible to people Roads including the pavement public squares parks subway station government buildings beaches public libraries privately owned buildings or property opened to public visible from sidew...

Page 10: ...age for accurate diagnosis It is also recommended that user be educated or retrained with the latest content in accordance with general retraining or the recommendation of the training institution If...

Page 11: ...Pads quality A16M DF CQ 0E A16 DF Standard Pads quality CPR feedback A16M DF VCQ 0E A16 DF Standard Voice recording Pads quality CPR feedback HeartOn A16 GS A16M GS 0E A16 GS Standard A16M GS VQ 0E A...

Page 12: ...D used for the fast delivery of defibrillation electric shock therapy which can be battery operated Electrical The AED has a battery which is detachable and non rechargeable Display The indication is...

Page 13: ...tomated External Defibrillator 9 9 DESCRIPTION OF THE AED Top and Right Panel Components Chest Type A16 DS A16 DF Icon Type A16 GS A16 GF Figure 1 HeartOn A16 Top and Right Panel Components 3 2 8 7 9...

Page 14: ...the patient mode between adult and pediatric patient mode by pushing the patient mode switch button 5 Indicator LED The indicator LED flashes red LED near the relevant action icon 6 Infrared communica...

Page 15: ...se Not ready to use CE mark Battery status Environmental shipping storage atmospheric pressure limitations Temperature status Environmental shipping storage humidity limitations Contains no latex Envi...

Page 16: ...MEDIANA HEARTON AED A16 Automated External Defibrillator 12...

Page 17: ...if needed Contact qualified service personnel or your local supplier for pricing and ordering information Table 3 Accessories Standard Accessories Qty HeartOn A16 1 Operator s manual 1 Automated Exter...

Page 18: ...Remove the battery from the bottom of the AED 3 Check the proper orientation of the SD card and insert the SD card into the SD card port 4 Reseat the battery in the bottom of the AED 5 If necessary to...

Page 19: ...nize that the SD card is not inserted Note Event data in SD card could be used for further clinical assessment Please make sure that event data are securely saved in any of storage format when event d...

Page 20: ...st is implemented in out of range for environmental operation condition above 5 times the status indicator X will be displayed When the AED with displaying status indicator O is turned on in out of ra...

Page 21: ...t the CPR Feedback sensor to the AED 8 Check the voice prompt Unit ok is emitted and the status indicator is O by pushing the power button 9 Turn off the AED by pushing the power button 10 Close the c...

Page 22: ...AED as preparation for emergency circumstances Note When the battery is replaced with the AED self test will be automatically started After completing the self test ensure that you can hear the voice...

Page 23: ...operating If the battery shows any signs of damage leakage or cracking it must be replaced immediately Discarded batteries may explode during incineration Dispose used batteries properly Do not dispos...

Page 24: ...n into the AED until the click sound is emitted as shown in the third of the Figure 4 The AED uses the non rechargeable battery The AED cannot operate with the battery that has been completely dischar...

Page 25: ...ed in above After installing the new battery in the AED then the AED is on standby at least one day the discharge condition may not meet that mentioned above Note Due to the physical dimensions of the...

Page 26: ...uring POST the status indicator will display X Contact qualified service personnel or your local supplier for assistance 5 Upon successful completion of the POST the AED sounds voice prompt Unit ok an...

Page 27: ...lf 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 If the battery insertion sel...

Page 28: ...MEDIANA HEARTON AED A16 Automated External Defibrillator 24...

Page 29: ...f the CPR Feedback Module and press it according to beep sound 4 Perform the CPR according to the voice prompt of the AED Note For more information on performing CPR with voice prompts see the CPR OPE...

Page 30: ...PR Feedback Module connection socket of the pads fully inserted and tighten the connection 3 Keep the adhesive pads with the AED as preparation for emergency circumstances Note When the exchange of th...

Page 31: ...e same time 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 health c...

Page 32: ...recommends that untrained user 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 AE...

Page 33: ...s may produce burns or ineffective energy transfer To apply the pads to patient chest properly shave hair from areas which defibrillation pads are to be applied if necessary Always check the use by da...

Page 34: ...atus 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 pads are inserted alread...

Page 35: ...xcept for Step 4 CPR the AED will move to Pad connector disconnected icon and the voice prompt Plug in pads Insert connector firmly is emitted Note If the pad is disconnected during Step 2 ECG analysi...

Page 36: ...the patient s chest If the patient has an excessively hairy chest shave the area where the pads are about to be applied Ensure that the patient chest is dry If necessary dry chest area Remove clothes...

Page 37: ...Note The AED performs the Step 2 directly when it is turned on after the rescuer attaches the pads to the patient properly Also the Step 2 would be started if the pads are attached to the patient even...

Page 38: ...ing button now the same instruction will be emitted one more time If the shock button is not pressed for more than 20 seconds after the initial instruction the AED performs the CPR process after the v...

Page 39: ...the electric shock is delivered you will hear the voice prompts CPR Feedback option is disabled It is safe to touch the patient Begin CPR CPR Feedback option is enabled It is safe to touch the patient...

Page 40: ...will hear the voice prompts Press slower CPR feedback compression rate is too fast Do chest compression in accordance with the beep sound Press faster CPR feedback compression rate is too slow Do che...

Page 41: ...epending on the setting The AED instructs CPR depending on the setting Perform 2 3 4 5 6 7 8 9 or 10 cycles of CPR each cycle include 15 or 30 times of chest compression and 1 or 2 times of rescue bre...

Page 42: ...ock will be delivered Do not touch the patient 3 2 1 When this voice is played the electric shock is transmitted automatically so look down the entire length of the patient to ensure there is no conta...

Page 43: ...ry 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 elect...

Page 44: ...he 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...

Page 45: ...hocks 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 b...

Page 46: ...fully inserted 4 Turn on the AED 5 Check the status indicator If the pads have been inserted correctly the status Indicator displays O and the voice prompt Unit ok is emitted 6 If the status indicato...

Page 47: ...nel or your local supplier for replacements Figure 17 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 th...

Page 48: ...MEDIANA HEARTON AED A16 Automated External Defibrillator 44...

Page 49: ...ontact qualified service personnel or your local supplier or Mediana directly for support info mediana co kr 1 There is no response to the pushing the power button of the AED A main board may be malfu...

Page 50: ...hones 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 oper...

Page 51: ...called defibrillation The AED is designed to automatically detect ventricular fibrillation VF and perform defibrillation on victims of sudden cardiac arrest Detecting Fibrillation The electrical rhyt...

Page 52: ...fe signs HeartOn AED Event Review Software HeartOn AED 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 vi...

Page 53: ...pm Pediatric greater than or equal to 180bpm Lead connection Confirm the connection and emit voice prompt Filter 0 5 to 30 Hz Indication Controls Standard Power button Shock button Patient mode switch...

Page 54: ...and dust resistance IP55 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...

Page 55: ...age 0 to 43 C 32 to 109 4 F Relative Humidity 5 to 95 RH Non condensing Battery Battery Type LiMnO2 Disposable Long Life Primary Cell Voltage Capacity 15V 3000 mAh Shelf Life in the original packaging...

Page 56: ...ation waveform Defibrillation waveform Waveform parameters Waveform parameters are automatically adjusted as a function of patient defibrillation impedance In the diagram at left A is the width of pul...

Page 57: ...itching power on to ready for discharge at maximum energy Approx 21 seconds Shock Analysis Time 8 seconds typical Note Shock analysis would take about 16 seconds at maximum from the start to the compl...

Page 58: ...nsitivity 81 82 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...

Page 59: ...60601 1 6 2010 Medical electrical equipment Part 1 6 General requirements for basic safety and essential performance Collateral standard Usability IEC 62366 1 2015 EN 62366 1 2015 Medical devices Appl...

Page 60: ...ribed below Table 5 Electromagnetic Emissions IEC60601 1 2 Emission Test Compliance Electromagnetic Environment RF emission CISPR 11 Group 1 The AED must emit electromagnetic energy in order to perfor...

Page 61: ...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...

Page 62: ...ipment Rated Maximum Output Power 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...

Page 63: ...ooth WLAN 802 11 b g n RFID 2450 LTE Band 7 Pulse modulation b 217 Hz 2 0 3 28 5240 5500 5785 5100 5800 WLAN 802 11 a n Pulse modulation b 217 Hz 0 2 0 3 9 NOTE If necessary to achieve the IMMUNITY TE...

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