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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

Содержание A16M-DF-0E

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

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

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

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

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

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

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

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

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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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