MIR Cardionica User Manual
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MIR Cardionica User Manual

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Rev 7.1 dated 23.03.2023
ENGLISH (EN)
USER MANUAL
Thank you for choosing
USER MANUAL
Page 1 of 26

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Summary of Contents for MIR Cardionica

  • Page 1 ENGLISH (EN) USER MANUAL Thank you for choosing a MIR - Medical International Research - product Keep the original packaging! If your product has a problem, use the original packaging to ship it back to your local distributor or the manufacturer.
  • Page 2 That’s why MIR reserves to update these user instructions if needed. Please email any suggestions to: mir@spirometry.com. MIR cannot be held responsible for any damage caused by users failing to follow these instructions and/or the warnings contained in this manual.

  • Page 3: Table Of Contents

    9. POSITIONING CARDIONICA ON THE CHEST ................19 10. INDICATORS (ATRIAL FIBRILLATION, NORMAL HEART RATE, NON-INTERPRETABLE RECORDING) ..........................20 11. WHAT TO DO IF CARDIONICA DETECTS ATRIAL FIBRILLATION ..........22 12. DATA SECURITY WARNINGS ....................22 13. DISPOSAL ..........................23 14.

  • Page 4: Content Description

    ENGLISH (EN) 1. CONTENT DESCRIPTION 1 device, 1 CR2032 battery, 2 reusable electrodes, 1 user manual. Description of product Cardionica is a device for detecting atrial fibrillation from a single-lead electrocardiogram (ECG). Cardionica uses a CR2032 battery Cardionica is placed on the chest through an adhesive electrode.

  • Page 5: Indications For Use

    50 beats per minute or above 100 beats per minute. Cardionica can be used by adults as a screening method for atrial fibrillation, people with an atrial fibrillation history, or people with symptoms like palpitations and tachycardia to periodically check the presence of atrial fibrillation.

  • Page 6: Counterindications

    ENGLISH (EN) fibrillation, bradycardia, tachycardia and more. Cardionica can also display the ECG when used in conjunction with a smartphone/tablet. Cardionica is intended for use by healthcare professionals, patients with known or suspected heart disease and health-conscious individuals. The device has not been tested and is not intended for paediatric use.

  • Page 7: Cleaning, Storing, And Servicing The Device

    ENGLISH (EN) 5. CLEANING, STORING, AND SERVICING THE DEVICE Cardionica doesn’t need to be disinfected. Clean Cardionica when needed using a damp cloth and soap. WARNING: do not use the same electrodes on different persons to prevent cross-infection and disease transmission between users Store Cardionica and its accessories in its case, avoiding: •...

  • Page 8: Replacing The Battery

    ENGLISH (EN) 5.1 REPLACING THE BATTERY Replace the battery when you hear the low battery signal upon activation: Remove the battery hatch by rotating it anticlockwise while pressing it firmly Remove the battery and replace it with a new cr2032 3v button battery. Face the positive terminal upwards so you can read the code.

  • Page 9: Warnings

    6. WARNINGS • Cardionica does not provide a complete diagnosis of cardiac conditions. It must never be used as a base for starting or modifying the therapy without consulting the physician. • This device does not analyse all heart rate and cardiac waveform aspects, especially if related to ischemic conditions.

  • Page 10: Using Cardionica

    ENGLISH (EN) WARNING: Cardionica cannot ensure that no arrhythmias or other health problems occur when an ECG is labelled as normal. Immediately inform the physician about your possible health changes. WARNING: Report any serious accident involving the device to the manufacturer and the competent authority where the user/patient is established;...
  • Page 11 ENGLISH (EN) Remove the protective film only after having applied the electrode to Cardionica. Sit down and apply Cardionica to the chest. Rev 7.1 dated 23.03.2023 USER MANUAL Page 11 of 26...
  • Page 12 If necessary, clean the skin using a cloth dampened with ethyl alcohol. To ensure correct positioning, follow the instructions provided in section “Positioning Cardionica on the chest”. Rev 7.1 dated 23.03.2023 USER MANUAL Page 12 of 26...
  • Page 13 ENGLISH (EN) Press the button and wait for the exam to be complete. Rev 7.1 dated 23.03.2023 USER MANUAL Page 13 of 26...
  • Page 14 Remove Cardionica from the chest when you hear the buzzer. Watch the light indicators . 10. Apply the protective film on the electrode and and place Cardionica back into its case. It is not necessary to remove the electrode from Cardionica WARNING: Use only the electrodes indicated in this manual (see section 14.
  • Page 15 ATTENTION: replace the battery if you hear a sound that gradually fades when you press the button. WARNING: Do not use Cardionica in the presence of signs of damage. It can cause electrical discharges or reduce the quality of the acoustic signals.

  • Page 16: Using Cardionica Via App

    ENGLISH (EN) 8. USING CARDIONICA VIA APP You can also use Cardionica on your smartphone or tablet. Download the Cardionica app (developed by MIR) from Play Store (Android 5.0 onwards), or Apple Store (iOS 9.0 onwards). You cannot install the app on incompatible devices.
  • Page 17 ENGLISH (EN) The app also allows you to stop the test by scrolling upwards and clicking the “Stop Test” button Once the ECG recording is complete, the app displays the result with the same indicators described in section 8. The test result is also displayed on the device.
  • Page 18 ENGLISH (EN) Another option is to associate a name to the tracings by clicking the settings icon WARNING If the device is used on different persons, it’s important to associate its name to the exam to prevent identification errors. If the device has a low battery, the app displays the “low battery”...

  • Page 19: Positioning Cardionica On The Chest

    ENGLISH (EN) 9. POSITIONING CARDIONICA ON THE CHEST Correctly position Cardionica on the chest to have reliable measurements. Refer to the positions shown below: WARNING: Using Cardionica in different positions from those indicated can affect the test result. Rev 7.1 dated 23.03.2023...

  • Page 20: Indicators (Atrial Fibrillation, Normal Heart Rate, Non-Interpretable Recording)

    10. INDICATORS (ATRIAL FIBRILLATION, NORMAL HEART RATE, NON-INTERPRETABLE RECORDING) Cardionica provides an interpretation of the heart rate through a code and a buzzer, as described below: The red heart indicator lights up if Cardionica detects atrial fibrillation in the ECG...
  • Page 21 When the green indicator lights up, it means that Cardionica has not detected atrial fibrillation. WARNING: Cardionica detects only the presence (or absence) of atrial fibrillation (AF). It does not detect other life-threatening arrhythmias. The green light indicator doesn’t exclude the presence of other arrhythmias or ECG modification.

  • Page 22: What To Do If Cardionica Detects Atrial Fibrillation

    ENGLISH (EN) 11. WHAT TO DO IF CARDIONICA DETECTS ATRIAL FIBRILLATION WARNING: If Cardionica detects atrial fibrillation (red heard indicator), we recommend repeating the measurement after a few minutes. If the result is confirmed, you’re likely experiencing an atrial fibrillation episode.

  • Page 23: Disposal

    ENGLISH (EN) 13. DISPOSAL Never dispose of Cardionica as household waste. Its components must be disposed of correctly and recycled in compliance with the regulations in force. Dispose of Cardionica in compliance with current WEEE (Waste Electrical and Electronic Equipment) regulations 14.

  • Page 24: Technical Specifications

    10%~90% (non-condensing) Operation type Continuous Electrodes Reusable electrodes for personal use (REF 912002) Device class IIa (Regulation (EU) 2017/745 for medical devices) ATTENTION: If stored correctly, Cardionica can last 5 years. Rev 7.1 dated 23.03.2023 USER MANUAL Page 24 of 26...

  • Page 25: Applicable Regulations

    ENGLISH (EN) 16. APPLICABLE REGULATIONS Cardionica meets the following regulations for the parts applicable to it: • EN 60601-2-47:2012 -Medical electrical equipment - Edition 2.0 2012-02 Part 2-47: Particular requirements for the basic safety and essential performance of ambulatory electrocardiographic systems.

  • Page 26: Symbols Used

    ENGLISH (EN) 17. SYMBOLS USED BF type part applied Manufacturer’s name and address Attention Separate disposal. Comply with the local regulations in force for disposing of equipment subject to directive 2012/19/EU Follow the user instructions Storage and transport temperature Medical device CE symbol and Notified Body number 0476...

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