Tecno-gaz TECNOHEART plus User Manual
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Tecno-gaz TECNOHEART plus User Manual

Automated external defibrillator
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ENGLISH
Defibrillator
Defibrillatore
DAE
User Manual
0Z12I0008_REV_2
15/06/2021

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Summary of Contents for Tecno-gaz TECNOHEART plus

  • Page 1 ENGLISH Defibrillator Defibrillatore User Manual 0Z12I0008_REV_2 15/06/2021...
  • Page 2 Tel: (82) 2 542 3375 (82) 33 742 5400 Fax: (82) 2 542 7447 (82) 33 742 5483 Sold in Private Label by TECNO-GAZ S.p.A. a single-member company Strada Cavalli n.4 – 43038 – Sala Baganza – Parma – Italy Tel. +39 0521 8380 Fax: +39 0521 833391...
  • Page 3 TECNO-GAZ. Damage – caused by unsuitable and/or improper use – is the responsibility of the user.  The use of parts for maintenance that are not recommended by TECNO-GAZ, for repairs  and maintenance.

  • Page 4: Table Of Contents

    2010 CPR GUIDELINES ........................22 Pre-defibrillation Action ........................23 Turn the AED on ..........................23 TECNOHEART plus operation ......................24 AHA 2010 provisions ........................... 26 Notes on how to perform CPR......................27 Notes on User and Bystander Safety (anyone surrounding the rescuer and the patient) ....27 MAINTENANCE .........................
  • Page 5 ILLUSTRATIONS Figure 1. TECNOHEART plus ....................7 Figure 2. TECNOHEART plus: Parts of the Top and Right Panel ......... 7 Figure 3. Parts of the Rear Panel ................... 8 Figure 4. Changing the handle/battery -Right panel ............... 15 Figure 5. Changing the handle/battery -Top Panel ..............16 Figure 6.

  • Page 6: Safety Warnings

    The warnings identify the danger of potentially dangerous situations (death, injury or adverse events), damaging the patient or the user. WARNING: It is essential that all of the users of an AED notify TECNO-GAZ of any accidents when the AED is suspected of having caused death, serious injury or disease. If you have any concerns that a similar case has occurred, you are required to notify TECNO-GAZ directly or through your authorised TECNO-GAZ supplier.
  • Page 7 Do not use the AED on patients who are under 1 year of age. WARNING: Correct electrode positioning is crucial. It is essential to follow the electrode positioning instructions carefully, provided on the labels and during training. It is necessary to make sure that the electrodes adhere well to the patient's skin.

  • Page 8: Attention

    Attention: Situations of alert are marked by the ATTENTION symbol illustrated above. Attention signs identify conditions or actions that could cause damage to the equipment or to property. ATTENTION: The AED may not operate correctly if it is activated or stored in conditions that differ from those set forth herein ATTENTION: The AED is resistant and reliable in various conditions of use.

  • Page 10: Introduction

    INTRODUCTION TECNO-GAZ offers a completely configurable AED designed to actuate the suitable protocol in case of sudden cardiac arrest (SCA). The current AED is designed to operate in compliance with the 2010 version of the guidelines established by the AHA/ERC regarding Cardiopulmonary Resuscitation (CPR) and Emergency Cardiovascular Care (ECC).

  • Page 11: Information On The Manual

    AED. Configuration Reference N. Description TECNOHEART plus AE001Z12 Standard AED (4 action icons) Note: The alphabet “E” can be added as the last digit of reference number in accor dance with the region.

  • Page 12: Description Of The Aed

    DESCRIPTION OF THE AED Parts of the Top and Right Panel Figure 1. TECNOHEART plus Figure 2. TECNOHEART plus: Parts of the Top and Right Panel...

  • Page 13: Parts Of The Rear Panel

    Table 1. Parts of the Top and Right Panel The cover is designed to protect the action icons, patient mode Cover button and shock button. The status indicator indicates the status of the unit, the Status indicator temperature and the battery level. Electrode connector The electrode connector is used to connect the electrodes.

  • Page 14: Symbols And Labels

    Symbols and Labels The following symbols can be used herein, in the relative documents, or appear on system parts or packaging. Table 2. Symbols used on the Panel and Labels Symbols Description Symbols Description Attention, consult the Ready for use attached documents Not ready for use CE Marking...

  • Page 16: Configuring The Aed

    Disposable razor - to shave the chest if hair makes good contact with the impossible electrodes Pocket mask or face protection-to protect the user An absorbent cloth or pad- to dry the victim's skin for good electrode contact TECNO-GAZ can provide a complete kit with all of the above accessories 1Z12A0009...

  • Page 17: Soft Case

    Soft case WARNING: Do not use the AED on patients that react to stimuli or who are breathing normally. The soft case is designed to stop the AED from moving inside the case, using the device's handle. The user can view the AED status indicator without having to open the case. The contact information sheet for the nearest emergency medical services can be placed inside the transparent cover.

  • Page 18: Configuring The Aed

    Configuring the AED WARNING: Only use parts, accessories, optional parts, materials and components that are approved and specified by TECNO-GAZ. The use of unauthorised accessories can cause the device to fail and provide false readings. Follow all of the instructions provided on the defibrillation electrode and battery labels.

  • Page 19: Installation Step 2

    Installation step 2 Make sure the AED is working correctly. 1. Change the patient mode by moving the Scrolling button to the right or to the left, depending on whether it is an adult or paediatric patient. 2. Turn the AED on by moving the Scrolling button to the right and opening the cover, making sure that it is possible to hear the voice messages.

  • Page 20: Battery Operation

    BATTERY OPERATION WARNING: Test the battery on a regular basis, when the battery voltage is very low. A battery that does not pass the test could suddenly stop working. WARNING: Do not use batteries that are damaged, wet or leaking. WARNING: Do not use or store batteries that may have been exposed to high temperatures.

  • Page 21: Figure 5. Changing The Handle/Battery -Top Panel

    To disconnect the battery To connect the battery 1. AED connector 2. Hook 3. Handle/battery connector Figure 5. Changing the handle/battery -Top Panel To disconnect the battery: Press the handle/battery removal button, pull upwards, then disconnect the handle/battery. To connect the battery: Tilt the handle/battery and hold the handle/battery removal button and the AED connector perpendicular, as illustrated in Figure 5.

  • Page 22: Battery Status Reading

    10 hours of operation at an ambient temperature of 20 °C. TECNO-GAZ suggests replacing the used battery, even if it has only been used once. Notes: After 200 electrical shocks, a voice message will play ““Low battery, insert fresh battery”...

  • Page 23: Self-Test

    Self-test Before using the AED, make sure that the AED is working correctly and that it is safe to use, as described below. WARNING: If the self-test is not carried out correctly, do not attempt to use the AED. ATTENTION: When the power supply is connected, the AED automatically runs the self-test, which checks the AED circuits and functions.

  • Page 24: Self-Test When The Batteries Are Inserted

    Self-test when the Batteries are Inserted When the battery is installed or changed, the AED automatically runs the battery insertion self-test. Once the battery insertion self-test is complete, the AED will play the “Unità ok (unit ok)” voice message, the status indicator will display “O” and the AED will automatically switch off.

  • Page 26: Aed Operation

    AED OPERATION WARNING: Do not use the AED on patients that react to stimuli or who are breathing normally. WARNING: Do not use the electrodes if the gel is dry or damaged. WARNING: Before defibrillation, disconnect the patient from other medical equipment.

  • Page 27: 2010 Cpr Guidelines

    2010 CPR GUIDELINES This "Guideline summary" summarises the 2010 Guidelines of the American Health Association (AHA) for Cardiopulmonary Resuscitation (CPR) and Emergency Cardiovascular care (ECC) of the American Heart Association and the European Emergency Association. This reference material is simple for lay rescuers as well as medical attendants.

  • Page 28: Pre-Defibrillation Action

    Make sure no one is touching the patient while the shock is being delivered. Notes: It is only possible to use TECNO-GAZ electrodes. Using other types of electrodes can cause damage to the patient and to the AED.

  • Page 29: Tecnoheart Plus Operation

    Premere forte gli elettrodi sul petto nudo del paziente. (Remove any clothing from the patient's chest. Place the electrodes exactly as illustrated in the figure. Press the electrodes firmly onto the patient's bare chest.)" Figure 7. TECNOHEART plus: Action icon – Step 1...

  • Page 30: Figure 10. Tecnoheart Plus: Icon Of Action - Phase 2

     "Scarica non consigliata. (Shock not recommended)" Figure 10. TECNOHEART plus: Action icon – Step 2 Notes: If the voice message plays "Scarica non consigliata (Shock not recommended)", the AED will switch to step 4, which illustrates the CPR process.

  • Page 31: Aha 2010 Provisions

     "Scarica erogata. (Shock delivered)" or "pulsante di Scarica non premuto. (Shock button not pressed)" Figure 11. TECNOHEART plus: Action Icon - Step 3 Notes: The AED will only deliver a shock if necessary. A voice message will tell you when to press the Shock button to administer the defibrillation therapy.

  • Page 32: Notes On How To Perform Cpr

    The rescuers perform 5 cycles of CPR, each cycle is comprised of 30 chest compressions and 2 rescue breaths at intervals of 30 chest compressions every 2 minutes. Or perform the chest compressions without rescue breaths. The AED will stay in CPR mode for 2 minutes or 5 cycles.

  • Page 34: Maintenance

    If the AED is commissioned outside of the range of the ambient conditions, it will not operate correctly. After using the AED, TECNO-GAZ technical support recommends performing the following operations: 1. Use AED Event Review Software to download information on the treatment that was carried out, and store it accordingly.

  • Page 35: Recycling And Disposal

    "Unità ok (Unit ok)" voice message. Turn the AED off. 9. Contact TECNO-GAZ after use. It is important for us to be notified of every occasion that our customers use our products, even if treatment is not carried out in case of an accident.

  • Page 36: Returning The Aed And System Parts

    Returning the AED and System Parts To return the AED and/or its accessories, contact the qualified staff or your local supplier. Assistance The AED does not require any other type of scheduled maintenance other than cleaning, battery maintenance and service activities required by the user's establishment. For further information, consult the AED maintenance manual.

  • Page 37: Aed Maintenance

    AED Maintenance TECNO-GAZ advises users to perform periodic checks. A recommended maintenance check could be. 1. Checking the status indicator. If the status indicator reads “X”, this means it has detected a problem. Consult the troubleshooting section herein. 2. Check the expiration date of the electrodes. If the electrodes have reached their expiration date, remove and change them.

  • Page 38: Troubleshooting

    If the status indicator does not yet read “X” or if you hear a warning message when the AED is on or if, for any reason, you suspect that the AED is not working correctly, contact qualified staff or your local supplier or TECNO-GAZ directly, to receive assistance. (info@TECNO- GAZ.co.kr) 1.

  • Page 39: Emi (Electromagnetic Interference)

    AED maintenance. For technical assistance, please contact the store that invoiced the device, or contact us directly at: TECNO-GAZ S.P.A. Tel. +39 0521 8380 - Fax +39 0521 833391 MEDILINE ITALIA S.r.l. Tel. +39 0522 942997 – Fax +39 0522 944800...

  • Page 40: Glossary

    GLOSSARY Sudden Cardiac Arrest (SCA) Sudden cardiac arrest is a condition in which the heart suddenly stops pumping efficiently due to an electrical malfunction of the heart. Often, the victims of SCA do not present premonitory signals or symptoms. SCA can also occur in individuals with previously diagnosed cardiac conditions.
  • Page 41 AED. Also, AED Event Review Software can be used to configure the AED. Additional Information If you have had the chance to use the AED or if you wish to receive further information on the AED, its accessories or any other product, contact TECNO-GAZ.

  • Page 42: Technical Specifications

    TECHNICAL SPECIFICATIONS Electric Defibrillation shock Biphasic Truncated Exponential (BTE) waveform Waveform (impedance compensation) Adult: Between 185 and 200J (±5%) Energy Paediatric: Between 45 and 50J (±5%) Operating mode Semi-Automatic Lead II (RA, LL) Patient impedance Between 25 and 175 Ohm Heart Frequency Between 20 and 300 per minute Precision...
  • Page 43 Ambient Conditions Operation Temperature Between 0 and 43°C (Between 32 and 109.4°F) Relative Humidity Between 5 and 95% R.H. (non-condensing) Altitude Between 0 and 4,475 m Shock Acceleration: 100 G (+/- 10%) Time: 6 msec Number of shocks: 3 times/axis(6 axes (+/- X, Y, Z) Vibration Frequency: Between 10Hz and 2000Hz...
  • Page 44 Accessory Specifications Electrodes Adult/Paediatric Electrodes Battery life 2 years from the date of manufacture Standby Electrodes Disposable electrodes Placement Adult: Front-side Paediatric: Front-rear Minimum gel 80 cm +/-5% adhesion surface Cable length Approximately 1.8 m Ambient conditions Operation: Between 0 and 43°C (Between 32 and Temperature 109.4°F) Storage:...
  • Page 45 Defibrillation Waveform Defibrillation Waveform Parameters of The parameters of the waveform are adjusted automatically the waveform based on the patient's defibrillation impedance. In the diagram on the left, A is the amplitude of beat 1 and B is the amplitude of beat 2 of the waveform, C is the interval between beats, I is the peak current, and I is the final current.
  • Page 46 ECG Performance Analysis Rhythm class AHA-DB MIT-DB CU-DB VF-DB Total number of sample size VF-shockable: TP 1552 VF-shockable: FN VF-shockable: 90.1 100.0 92.4 91.4 91.0 sensitivity(%) (>90) VT-shockable: TP VT-shockable: FN VT-shockable: 86.2 86.2(>75) sensitivity(%) Non-shockable: FP NSR, PVC, APB, 3075 17150 1254...

  • Page 47: Conformity

    Conformity Entry Standard Description Classificatio IEC 60601-1:2005 +A1:2012 Internal power supply (battery-powered) EN 60601-1:2006/ AC2010 Type of IEC 60601-1:2005 +A1:2012 CF type - Applied parts protection EN 60601-1:2006/ AC2010 Operating IEC 60601-1:2005 +A1:2012 Continuous mode EN 60601-1:2006/ AC2010 Protection IEC 60529:2001, IP54 (provided by the casing) rating EN 60529:1991+A1 2000...
  • Page 48 ISO 10993-5:2009 Biological assessment of Medical devices - Part 5: Test methods to assess in vitro cytotoxicity EN ISO 10993-5:2009 ISO 10993-10:2010 Biological assessment of Medical devices - Part 10: Tests for irritation and delayed-type EN ISO 10993-10:2010 hypersensitivity Ambulance EN 1789:2007 +A1:2010 Medical vehicles and equipment - road ambulance...
  • Page 49 labelling and information to be supplied - Part 1: General requirements ISO 15223-2:2010 Symbols to be used with medical device labels, labelling and information to be supplied - Part 2: Symbol development, selection and validation ISO 7000:2012 Symbols to be used in the device index and synopsis EN 50419:2006 Marking of electric and electronic devices, in...

  • Page 50: Manufacturer Declaration

    WARNING: To achieve the best performance from the product and maximu m measuring precision, use the supplied accessories or TECNO-GAZ-recommended accessories only. Use the accessories according to the manufacturer's instructions for use and the standards of your facili ty. The use of accessories, transducers and cables, other than those specif herein, can cause an increase in emissions and/or reduction in AED im munity.

  • Page 51: Table 7. Electromagnetic Immunity (Iec60601-1-2) (Continued From Previous Page)

    Table 7. Electromagnetic Immunity (IEC60601-1-2) (continued from previous page) Immunity IEC60601 Conformity Guide to the Test Test Level Level electromagnetic environment The AED is suitable for use in the magnetic environment specified below. The customer or user of the AED must ensure that the device is used in said environment. Portable and mobile RF communication devices must be used at a distance from any part...

  • Page 52: Table 8. Recommended Safety Distances

    Table 8. Recommended Safety Distances Recommended Safety Distances between Portable and Mobile RF Communication Devices and the AED The AED is intended for use in electromagnetic environments with controlled RF disturbance. The AED customer or user can prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF devices (transmitters) and the AED, set forth below, based on the maximum output power of the communication devices.
  • Page 53 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 Copyright © 2021 All rights reserved.

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