AED HeartPlus NT-180 User Manual & Warranty Registration
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AED HeartPlus NT-180 User Manual & Warranty Registration

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HeartPlus
User Manual & Warranty Registration
©2016 NANOOMTECH CO., LTD All rights are reserved. It is prohibited to reproduce or
duplicate, in any form, this manual or any part thereof without permission of NANOOMTECH
CO., LTD.
This user manual may be changed without prior notice to users for functional improvements. If
more than two (2) years have elapsed since the revision date (listed on the bottom of this
page), please contact NANOOMTECH CO., LTD or your local distributor to determine whether
additional product information updates are available.
HeartPlus
is a trademark of NANOOMTECH CO., LTD
™
EM0101-2 (1810-REV06)
Publisher: NANOOMTECH CO.,
This issue date for the HeartPlus™ User Guide, Rev. 6, is Oct 2018.
Device manufacturer
NANOOMTECH CO.,LTD.
Address: 57, Cheomdan venture so-ro, Bukgu, Gwangju, 61003, Rep. of Korea.
Authorized EU Representative
CMC Medical Devices & Drugs S.L.
C/ Horacio Lengo Nº 18, CP 29006, Málaga, Spain
Tel: +34951214054 / Fax: +34952330100 / E-Mail: info@cmcmedicaldevices.com
™
LTD.
i

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Summary of Contents for AED HeartPlus NT-180

  • Page 1 HeartPlus ™ User Manual & Warranty Registration ©2016 NANOOMTECH CO., LTD All rights are reserved. It is prohibited to reproduce or duplicate, in any form, this manual or any part thereof without permission of NANOOMTECH CO., LTD. This user manual may be changed without prior notice to users for functional improvements. If more than two (2) years have elapsed since the revision date (listed on the bottom of this page), please contact NANOOMTECH CO., LTD or your local distributor to determine whether additional product information updates are available.
  • Page 2 Intentionally Blank...

  • Page 3: Table Of Contents

    Table of Contents HeartPlus - User Manual & Warranty Registration ™ ......................1 BSTRACT CPR....................2 IMPLIFIED SECTION I - PRODUCT INTRODUCTION .......... 3 ................... 4 ONTRAINDICATIONS ..................5 RODUCT INFORMATION ............6 RODUCT SPECIFICATION AND FUNCTION .................... 9 ET CONFIGURATION ................
  • Page 4 ....................34 ATTERY CHECK ..................35 COMMUNICATION SECTION III - GUIDELINES ............... 37 ................38 HECK PRIOR TO USE .............. 41 USE PRODUCT MANAGEMENT ..................43 TORAGE GUIDELINES ................. 44 AUTIONS FOR BATTERY PACK ................... 46 LOSSARY OF SYMBOLS SECTION IV - APPENDIX ..............49 ................

  • Page 5: Abstract

    Abstract HeartPlus (NT-180) is an Automated External defibrillator which restores ™ a normal heartbeat in patients with SCA (sudden cardiac arrest). HeartPlus (NT-180) is an emergency medical device. ™ Before using this product, please read carefully the safety precautions and instructions for proper usage.

  • Page 6: Simplified Cpr

    Simplified CPR OHCA Chains of Survival  The recommended compression rate is at least 100 compressions per minute.  Be sure to achieve the full compression depth of at least 5cm (2 inches) for adult patients.  For children, be sure to achieve the full compression depth, which should be at least 1/3 of chest anteroposterior diameter of approximately 4cm (1.5inch) for infants and approx.

  • Page 7: Section I - Product Introduction

    Section I Product Introduction...

  • Page 8: Contraindications

    (attaching electrode pad, shock or no shock, CPR). Contraindications None known. Product User HeartPlus should be used by a person who has been educated on the ™ use of AED (Automated External Defibrillator) and CPR (Cardiopulmonary Resuscitation).

  • Page 9: Product Information

    Section I- Product Introduction Product Information Product Name: Brand Name: HeartPlus ™ Model Name: NT-180, NT-180Y, NT-180B, NT-180G Product Appearance: Size: 293mm(W) X 291mm(L) X 71mm(H)  Weight: 1.9kg (Incl. cartridge) ...

  • Page 10: Product Specification And Function

    50J (for infant, load impedance of 50) Defibrillator Patient Insulation: BF Type   Charging period: Less than 13 seconds after pads attachment. Operation Mode: AED (automated external  defibrillator), which can analyze ventricular fibrillation Change Method to Pediatric Mode: Power on device ...
  • Page 11 Section I- Product Introduction Electrode pads.  Composition: Composed of two electrodes  Type: Non-rechargeable Lithium-ion battery Battery DC 21V (1,400mAh) DC 9V (1,400mAh)  Type: Non-chargeable Lithium-ion battery DC 21V (1,400mAh) DC 9V (1,400mAh) Detachable  The number of defibrillation shock can be marked on Type Cartridge the cartridge.
  • Page 12 Section I -Product Introduction  Main unit  Cartridge (all-in-one type) Configuration  Cartridge (detachable type) Electrode pads (detachable type)  In case the electrode pads are not attached to the  patient, device cannot administer defibrillation shock. If defibrillation shock is not executed by way of ...

  • Page 13: Set Configuration

    Section I- Product Introduction Set Configuration The product is composed of a main body, a cartridge, and other components (a towel, a USB cable, etc.) In case of cartridges, there is All-in-one type of cartridges where an electrode pads and a battery are not separated and detachable type of cartridge where a battery and electrode pads are separated.
  • Page 14 Section I -Product Introduction Set Configuration (options) Cartridge (All-in-one type) electrode pads Consumables for a detachable type Cartridge (detachable type) electrode pads (detachable type) Other consumables Towel USB cable(Option)

  • Page 15: Product Characteristics

    Section I- Product Introduction Product Characteristics  User-friendly device management (all-in-one type/detachable type)  Decides if it will give a defibrillation shock to the patient or not after analyzing the patient's ECG automatically. (Defibrillation shock button should be pushed for delivering a defibrillation shock.) ...

  • Page 16: Display Details

    Section I -Product Introduction Display Details Product State LED State Description Adult mode lamp (Blue) Adult Mode The adult LED light is lit when the adult mode is on Pediatric mode lamp (Orange) Pediatric Mode The pediatric LED light is lit when the pediatric mode is normal state...
  • Page 17 Section I- Product Introduction Analyze ECG. During analysis: ECG analysis analysis lamp flashes After completion of analysis: ECG analysis lamp stays on. Cardiopulmonary Commence CPR. (CPR lamp stays flashing) resuscitation...

  • Page 18: Name And Function Of Components

    Section I -Product Introduction Name and Function of Components Name/Shape Function Display  Power button (ON/OFF), separate buttons for either Adult or Pediatric Modes, and lamps ① indicating the current state of device (or which step the user is on). Defibrillation shock button (Red) If the flashing...
  • Page 19 Section I- Product Introduction Name/Shape Function Cartridge cover A cover to open the case, revealing  ⑤ the cartridge beneath. PUSH then lift Cartridge Cover To open the cover, push the hand  ⑤ picture on the right side to release and then lift the cover.
  • Page 20 Section I -Product Introduction Name/Shape Function Speaker  Plays voice prompts to guide user through operation.  Alerts user problem ⑨ occurring during equipment check self-test voice prompt. Handle ⑩ A handle to carry the equipment.  All-in-one type cartridge ...
  • Page 21 Section I- Product Introduction Name/Shape Function Detachable type cartridge It contains only battery without  ⑬ the electrode pads. Electrode pads (detachable type)  It connected ⑭ detachable type cartridge only. Port for electrode pads connector (detachable The disposable electrode pads type) ...
  • Page 22 Section II – Product Use Intentionally Blank...

  • Page 23: Section Ii - Product Use

    Section II Product Use...

  • Page 24: Simple Guide For Use

    Section II – Product Use Simple Guide for Use 1. Press Adult ( ) or Pediatric ( ) power button. Put the electrode pads on the patient’s bare skin by the proper placement guide. 3. Press defibrillation shock button ( ) by voice prompt.

  • Page 25: How To Install A Battery Pack

    Section II - Product Use How to Install a Battery Pack (all-in-one type) 1. To replace an all-in-one type cartridge… (1) Check for all-in-one type cartridge Check the expiration date on the sealing film of an all-in-one cartridge. An expired all-in-one cartridge cannot be used in an emergency.
  • Page 26 Section II – Product Use  Do not get rid of the protection film after installing all-in-one type cartridge until situation where immediate usage is required.  You must take off the cartridge protective film before applying pads to the patient and not a moment sooner.

  • Page 27: How To Install Electrode Pads

    Section II - Product Use How to Install Electrode Pads (detachable) 2. Detachable cartridge installation A) The way to install a detachable cartridge The way to replace a detachable type cartridge is exactly same as the all-in-one type cartridge installation. B) Electrode pads (detachable type) installation Check the expiration date of detachable electrode pads...

  • Page 28: Detailed Instructions (Adult)

    Section II – Product Use Detailed Instructions (Adult) 1. Press power button for adult ( Lamp state: Adult mode lamp will be ON.  Adult refers to person older than 8 years (25kg).  After power switch ON, electrode pads attachment lamp ( ) flickers until you attach the electrode pads.
  • Page 29 Section II - Product Use 4. Press PUSH on the cartridge cover to raise the cover. 5-1. All-in-one type cartridge Pull the protruding edge of the film at the edge of the cartridge. Completely remove the cartridge cover film. 5-2. Detachable type electrode pads Take out the electrode pads from the separate electrode pads storage envelope and then remove the protective lining.
  • Page 30 Section II – Product Use  For women, as seen in the picture, check the placement for attaching electrode pads and put them on the patient’s body tightly. The placement of both pads is generally the same as the placement for men, but make sure the left pads (LL) are placed the left breast (not on top).
  • Page 31 Section II - Product Use 9-1. Situation requiring a defibrillation shock  Voice prompt: “Performing an electric shock.” (Charge Beep)  Lamps to indicate the operation state: electrode pads ( ), electrocardiogram ( ) lamps are lit. 9-1-1. After the arrangement of electric shock energy is complete ...
  • Page 32 Section II – Product Use defibrillation shock button, a defibrillation shock will not be applied. Without a moment’s hesitation, move on to the CPR procedure.  Lamps to indicate the operation state: The attachment of the electrode pads ( ) and the electrocardiogram analysis lamp ) are lit.

  • Page 33: Detailed Instructions (Pediatric)

    Section II - Product Use Detailed Instructions (Pediatric) 1. Press power button ( ) for Pediatric mode. Lamp state: Pediatric mode lamp ( ) will be  Ensure to check the electrode pad attachment lamp ( ) is ON.  Pediatric refers to person under 8 years (25kg).
  • Page 34 Section II – Product Use 4. Press PUSH on the cartridge cover to raise the cover. 5-1. All-in-one cartridge After you pull out the arrow portion on the cartridge protective film and then remove film, take out the electrode pads. Remove the protective film on the electrode pads.
  • Page 35 Section II - Product Use 7. Keep away from the patient according to the voice from the product.  Voice prompt: “Stay clear of patient.”  User must stay clear of the patient and the HeartPlus device during analysis of patient's ™...
  • Page 36 Section II – Product Use 9-1-2. Delivering electric shock energy When electric shock button lamp ( ) flicks, the electric shock energy will be delivered to the patient if you press the electric shock button.  Voice prompt: “Electric shock is done.” ...
  • Page 37 Section II - Product Use 10. Cardiopulmonary resuscitation should be performed. 10-1. Cardiopulmonary resuscitation should be performed without delay after a defibrillation shock is delivered.  Voice prompt: “Apply pressure to the chest”, (CPR Beep) 30 chest compressions, 2 rescue breaths (Whoo~Whoo~). ...

  • Page 38: Battery Check

    Section II – Product Use Battery Check 1. There are 2 types of warning for low battery. 1) In case of over about 80% use of the battery  Voice prompt: Before analyzing the patient, it tells you the battery weakness with voice prompt “The battery is low, Change the battery”...

  • Page 39: Pc Communication

    Section II - Product Use PC Communication Make sure the equipment power is off. 2. Push both Adult power button ( ) and the defibrillation shock button ( ) at the same time for one second. Electrode pads attachment, ECG analysis, and CPR lamps are lit together.
  • Page 40 Section III – Guidelines Intentionally Blank...

  • Page 41: Section Iii - Guidelines

    Section III Guidelines...

  • Page 42: Check List - Prior To Use

    1) Electrode pads should be adhered to the patient’s body in the same way as illustrated on the picture on the pads themselves and on the AED’s main panel. 2) If the patient’s body is wet and contaminated, you should put electrode pads on the body after using the supplied towel to clean and dry the patient.
  • Page 43 HeartPlus™ is simple and user-friendly, so there is a good chance of successful use by a layman; however, chances of successful resuscitation increases with first responder’s familiarity with AED operation and CPR administration. 6. The state of HeartPlus™ should be checked periodically.
  • Page 44 Only use HeartPlus™ cartridges (all-in-one type/detachable type) on HeartPlus™ AED and not on the trainer. Also, only use cartridges that are provided by the manufacturer. 14. Potential adverse effects of the device on health  Failure to identify shockable arrhythmia;...

  • Page 45: Post-Use Product Management

    Section III - Guidelines Post-Use Product Management Post-use upkeep You need to inspect the exterior of the equipment to check for damage, dirt or other contamination. If you discover a problem or damage, contact the customer service center for support. You need to clean the product according to the cleaning guideline when the product is stained with dirt or is contaminated.
  • Page 46 Section III - Guidelines  Only all-in-one cartridges that are supplied by NANOOMTECH should be used for our product.mightm  Do not open all-in-one cartridge or detachable electrode pads pouch if you are not going to use them right away. ...

  • Page 47: Storage Guidelines

    Section III - Guidelines Storage Guidelines 1. Store in a dry place.  Do not spill water on HeartPlus™.  This may result in electrocution or defibrillation shocks may not be delivered to patient’s heart. 2. Store in a place not contaminated by airborne dust and salt.

  • Page 48: Cautions For Battery Pack

    Section III - Guidelines Cautions for Battery Pack 1. Do not heat battery pack or throw them into fire. Heating the battery pack more than 100 degrees centigrade could increase the internal pressure and electrolyte may boil causing resin parts to melt, resulting in leakage, explosion or fire.
  • Page 49 Section III - Guidelines 4. Guidelines for battery pack. 1) Device administrators discarding spent battery pack should throw them away as nonflammable waste. However, local jurisdictions might have different disposal rules and methods for spent battery packs. 2) Commercial disposal of spent battery packs by contacting a waste disposal company is recommended and may be required by local laws.

  • Page 50: Glossary Of Symbols

    Section III - Guidelines Glossary of Symbols Symbols Definition Consult instructions before use Caution, consult accompanying documents indiscriminately throw cartridge (batteries) away. Its exposure to moisture or external stimulation causing fire or explosion Type and Extent of Protection against electric shock Caution high voltage Compliant to EC Directive 93/42/EEC...
  • Page 51 Section III - Guidelines Symbols Definition Recommended temperature range Fragile, handle with care Keep away from rain Keep away from sunlight Non-rechargeable lithium battery. Do not charge the battery. This equipment is not allowed to be used for training or education. Manufacturer...
  • Page 52 Section III - Guidelines Symbols Definition EU representative Date of manufacture Serial number Power ON/OFF Catalog number Use by date...

  • Page 53: Section Iv - Appendix

    Section IV Appendix...

  • Page 54: Defibrillation Waveform

    Section IV - Appendix Defibrillation Waveform Electric energy output system: Biphasic [Fig1] Biphasic electric energy output waveform [Table1] Adult mode energy discharge time according to the patient impedance Energy output parameter: Energy output time is automatically and adjusted by the impedance of the patient. (Error rate ±...
  • Page 55 Section IV – Appendix [Table2] Pediatric mode energy discharge time according to the patient impedance Energy output parameter: Energy output time is automatically and adjusted by the impedance of the patient. (Error rate ± 10%) Impedance(Ω) Phase 1 duration (ms) Phase 2 duration (ms) Output energy(J) 48.3 49.9 50.8...

  • Page 56: Characteristic Of Ecg Analysis

    Asystole Specificity>95% 96% (n=50) Others 1. American heart Association (AHA) AED Task Force, Subcommittee on AED Safety & Efficacy. Automatic External Defibrillators for Public Access Us: Recommendations for Specifying and Reporting Arrhythmia Analysis Algorithm Performance, Incorporation of New Waveforms, and Enhancing Safety.

  • Page 57: Electromagnetic Compatibility (Emc)

    Section IV – Appendix Electromagnetic Compatibility (EMC) 1) Electromagnetic Emission Emission Test Compliance Electromagnetic environment – Information RF energy is only used for the internal function of HeartPlus ™ Therefore, self-RF emission level is very low; RF(Radio Group 1 in addition, it will not have effect on the Frequency) operation of electronic equipment near it.
  • Page 58 Section IV - Appendix Interference occur in the vicinity of equipment marked with following symbol. NOTE 1 At 80MHz and 800MHz, the higher frequency range applies. NOTE 2 These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects and people.
  • Page 59 Section IV – Appendix HeartPlus can help prevent electromagnetic interference by maintaining a ™ minimum distance between portable and mobile RF communications equipment (transmitters) and the HeartPlus as recommended below, according to the ™ maximum output power of the communications equipment. Separation distance according to frequency of Rated maximum output transmitter (m)

  • Page 60: Voice Prompts

    Section IV - Appendix Voice Prompts 1. Mode “This is the electric shock mode for adult.” “This is the electric shock mode for infant” 2. Pads attachment “Inspect pad placement area, then adhere pad” “Check the pad” 3. ECG analysis “Stay clear of patient”...

  • Page 61: Diagnostics & Troubleshooting

    Section IV – Appendix Diagnostics & Troubleshooting 1. Push adult mode and infant mode power buttons at the same time for at least 1 second. 2. During equipment check, the lamps start to flash in the following order: the electrode pad attachment lamp, the electrocardiogram lamp, the cardiopulmonary resuscitation lamp.
  • Page 62 When you approach a machine with all lights blinking, but you are not certain whether it is a low battery issue or an actually equipment error, push the power button to shut off the AED, then perform the self-test (Step 1 of previous page). ...

  • Page 63: Service & Warranty

    Section IV – Appendix Service & Warranty Paid repair / service charge may apply in the case where…  damage is caused by natural disaster (fire, damage from sea water, gas, earthquake, damage from storm and flood, and etc.) or an act of God. ...

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