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Qardio QardioCore User Manual

Wireless ecg monitor
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WIRELESS ECG MONITOR
USER MANUAL

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Summary of Contents for Qardio QardioCore

  • Page 1 WIRELESS ECG MONITOR USER MANUAL...

  • Page 2: Table Of Contents

    Checklist for a correct and accurate ECG/EKG recording Requirements Visualizing your ECG/EKG data Package contents Important facts about ECG/EKG and Using QardioCore for the first time self-measurement How to turn on/off QardioCore Activity tracking Detailed instructions for the correct fitting of QardioCore...
  • Page 3 QardioCore technical specifications Resetting the pairing Disposal Accuracy testing and maintenance Certifications Cautions FCC Statement Contraindications RF Statement User Responsibility General use, safety and precautions, cleaning Customer service contact Limited warranty Error messages and troubleshooting...

  • Page 4: Introduction

    INTRODUCTION Qardio offers a better way of tracking heart health that fits effortlessly into your life. Our devices are powerful and smart, have a beautiful design with a delightful user experience so you can use them anytime, anywhere. QardioCore is a clinical-quality wearable electrocardiogram recorder.
  • Page 5 With its ease of use and accuracy, QardioCore is ideal for monitoring your ECG trace throughout the day. With this system, you can record your ECG over extensive periods of time.

  • Page 6: Intended Use

    INTENDED USE For USA For EU The QardioCore ECG monitor is intended to capture, The QardioCore wireless ECG monitor is intended store, transmit and display electrocardiogram (ECG) to record, store and transmit single-channel information for long term monitoring and evaluation.
  • Page 7 For CANADA The QardioCore ECG monitor is a smartphone/tablet enabled device intended to capture, store, transmit and display electrocardiogram (ECG) information for monitoring and evaluation. It is indicated for use on adult patients who may be asymptomatic or who may suffer from transient...

  • Page 8: Important Safety Information

    • Please read the User Manual carefully before using especially those related to ischemic heart the QardioCore ECG monitor. conditions. • This device is not to be used by patients who have • Do not attempt self-diagnosis or self-treatment a pacemaker.
  • Page 9 • Our device will not be performing any measurements that require validation through ANSI/AAMI EC 57 • QardioCore relies on sensors that track your movement and other metrics. The data and information provided by this device is intended to be a close estimation of your activity and metrics tracked, but may not be completely accurate, including step, distance, and calorie data.

  • Page 10: Features

    (when prescribed • Must download the free Qardio App from the or used under the care of a physician). QardioCore Apple App Store, or go to www.getqardio.com is intended for use by healthcare professionals, individuals with known or suspected heart conditions •...

  • Page 11: Package Contents

    PACKAGE CONTENTS You will find in your QardioCore package: List of materials a. QardioCore device 1. QardioCore Cases: Acrylonitrile butadiene styrene b. Three chest straps, to facilitate your everyday use (ABS) and Thermoplastic vulcanizates (TPV) c. Charging cable d. Quick guide 2.

  • Page 12: Using Qardiocore For The First Time

    FIRST TIME for your chest size. 1. Download the free Qardio App: On your mobile 6. Fit the QardioCore to your chest. You should wear phone or tablet go to www.getqardio.com/ QardioCore directly on your skin, just below your download and when prompted, download the app.
  • Page 13 9. After a few seconds, QardioCore will automatically start recording your electrocardiogram. Your ECG Adjust length of strap can be affected by the position of QardioCore on QardioCore should be snug your chest and your physiological condition. It is enough to stay in place during your movement.

  • Page 14: How To Turn On/Off Qardiocore

    QardioCore turns itself on when you attach the chest strap to its left side and it turns off when you unclip 1. Wearing your QardioCore with the right fit will keep the left side of the strap. When QardioCore is not...
  • Page 15 Wrap the strap around your body and connect it to 5. In order to obtain an accurate measurement, it is the left side of QardioCore. All of the electrodes essential that all of QardioCore’s electrodes remain should be touching your skin and QardioCore in contact with your skin at all times.
  • Page 16 QardioCore and likely if found between QardioCore and your straps particularly clean. skin. • If you have known allergies or sensitivities to substances like metals or plastics, check the materials in QardioCore and its straps on support.getqardio.com.

  • Page 17: Wearing Qardiocore Upside Down

    QardioCore and removing it from the chest. COMFORTABLE FIT FOR FEMALES QardioCore should be worn underneath the bra for an accurate reading. To ensure the most comfortable fit, QardioCore should be used with a wire-free bra or a sport bra.

  • Page 18: Checklist For A Correct And Accurate Ecg/Ekg Recording

    Press the ECG button while in the QardioCore section that QardioCore has switched on. of Qardio App to see your ECG trace and heart rate data to see your ECG trace and heart rate data. • You should wear QardioCore directly on your skin, just below your sternum.

  • Page 19: Important Facts About Ecg/Ekg And Self-Measurement

    What is an electrocardiogram? NOTE: You will not be able to view your recordings or utilize any of QardioCore’s analytical tools until you are An electrocardiogram – often abbreviated as ECG under the care of a physician. To gain access to these or EKG –...
  • Page 20 During an ECG, several sensors, called electrodes, capture the electrical activity of the heart. While using QardioCore, the Qardio App displays the current heart rate and the target heart rate Wearing QardioCore during exercise during recording, in the overview area.

  • Page 21: Activity Tracking

    The minimum overall heart rate Heart Activity goal Rates The average overall heart rate QardioCore sets automatically a goal of 10,000 steps per day. You can change your daily steps goal in the Qardio App settings. The Qardio App shows your...

  • Page 22: Charging Qardiocore

    Move in at least 10 charging cable to the device and connecting the consecutive minutes of moderate to vigorous intensity cable to a USB power source. QardioCore will not activities to work toward achieving your weekly work until the battery has enough power.

  • Page 23: Resetting The Pairing

    2 years or after mechanical impact In order to reset the pairing, remove the anchor from (e.g. being dropped). Please contact Qardio the QardioCore and use a paper clip to press the customerservice at support.getqardio.com button on the pinhole on the QardioCore. You should to arrange the test.

  • Page 24: Cautions

    CAUTIONS evaluated before the equipment is operated as they may seriously degrade performance. • Self-diagnosis of measurement results and self- • This device is susceptible to interference from treatment are potentially dangerous. You should RF energy sources (lowered RF immunity) which always consult your doctor.

  • Page 25: Contraindications

    MRI. • QardioCore has features that are only available to • Do not use in case of known skin allergies those users who are under the care of a physician.

  • Page 26: General Use, Safety And Precautions, Cleaning

    QardioCore while recharging. GENERAL USE, SAFETY AND PRECAUTIONS, CLEANING • Do not use QardioCore for any purpose other than as specified in this User Manual. • This device is not to be used by patients who have a pacemaker.
  • Page 27 OF EMERGENCY. IN CASE OF EMERGENCY, IMMEDIATELY CONTACT YOUR LOCAL • Do not expose QardioCore to direct sunlight for EMERGENCY SERVICES. extended periods of time. • Certain services may give you ability to request •...
  • Page 28 OK), or while it is raining, but is not suitable for diving, outside of its operating or storage range swimming, or otherwise submerging in water • Wearing your QardioCore in a sauna or steam QardioCore should not be immersed in water. room.
  • Page 29 QardioCore and the straps clean. cloth. • Cleaning products, and abrasive materials 4. To clean the QardioCore strap, wash it by hand or shouldn’t be used on your QardioCore. washing machine with a mild soap and cold water.

  • Page 30: Customer Service Contact

    If a defect arises during the warranty period, Qardio, at its option and to the extent permitted by law will LIMITED WARRANTY (1) repair the product at no charge, using new parts or...
  • Page 31 To obtain warranty service, an original or copy of the sales receipt from the original In no event shall Qardio be liable for (a) any losses retailer is required. Qardio will not replace missing that were not caused by our breach of this limited components from any package purchased through an warranty;...

  • Page 32: Error Messages And Troubleshooting

    Possible Causes Actions Bad signal • Poor electrode contact with skin • Make sure QardioCore is fitting tightly and • Not all electrodes are touching that all electrodes are touching the skin Wandering baseline • Electrodes that are dirty, loose, or •...
  • Page 33 • User is cold and shivering. the skin. superimposed on • QardioCore strap is too tight • If interference still persists, the problem the waveforms). May • Not all electrodes are touching. is probably electrical in nature. See the...

  • Page 34: Qardiocore Technical Specifications

    QardioCore Technical Specifications Chest Size 27.5 - 43 in (70 - 109 cm) Practically unlimited, when connected to smartphone or tablet. Up to Memory 48 hours data storage when not connected to smartphone or tablet, depending on usage conditions. ECG Data Compression No data compression.
  • Page 35 Differential Range +/-5mV ECG Amplitude resolution 0.8 μV ECG Signal bandwidth 0.05 to 40 Hz ECG A/D Sampling rate 600 samples per second, internal sampling rate ECG Sampling resolution 16 bit ECG Common Mode Rejection 60dB ECG Input impedance >100M Ω ECG Calibration Automatic Movement sensor...
  • Page 36 The device is powered by a built-in, 3.7V lithium-ion battery that you can Power source charge using the charging cable supplied in the product package Battery life 24 hours of continuous recording, when fully charged About 3 hours to 100%. Charge time depends on environmental factors; Battery charge time actual results will vary.
  • Page 37 -20C to 40C (-4F to 104F) temperature, 45% to 85% (non condensing) Storage conditions relative maximum humidity, atmospheric pressure 86~106kpa, maximum altitude: 3000m (9,842 ft). Shelf life Estimated 2 years. Specifications and features are subject to change without prior notice or any obligation for the manufacturer, and may not be available in all regions or all languages.

  • Page 38: Disposal

    DISPOSAL compliance with current standard. The device and its parts is made with regard to disposal, as appropriate, Actuation of European directives 2002/95/EC, in accordance with national or regional regulations. 2002/96/EC and 2003/108/EC, for reduction in use of This product complies with RoHS Directive 2011/65/ dangerous substances in the electric and electronic EU and Amendment (EU) 2015/863.
  • Page 39 3. FCC part B 15B:2013 Electromagnetic Compatibility basic safety and essential performance – Collateral Standard: Electromagnetic disturbances 4. FCC Rule Part: 15.247 Cat: DSS (Bluetooth) FCC Rule Part: 15.247 Cat: DTS (BT4.0) 10. IEC 60601-2-47 Ambulatory electrocardiographic monitors 5. EN ISO 10993-1:2009/AC:2010 Biological evaluation of medical devices-Part 1: Evaluation and testing 11.

  • Page 40: Fcc Statement

    14. EN301489-17 V2.2.1:2012 Electromagnetic 19. IEC 62304:2006 Medical device software - Software compatibility and Radio spectrum Matters (ERM); life cycle process ElectroMagnetic Compatibility (EMC) standard for A full declaration of conformity (DoC) may be radio equipment; Part 17: Specific conditions for consulted at: www.getqardio.com/conformity.
  • Page 41 equipment generates, uses and can radiate radio Operation is subject to the following two conditions: frequency energy and, if not installed and used in 1) This device may not cause harmful interference and accordance with the instructions, may cause harmful interference to radio communications.
  • Page 42 Le présent appareil est conforme aux CNR d’Industrie for satisfying RF exposure compliance. This transmitter Canada applicables aux appareils radio exempts de must not be co-located or operating in conjunction license. L’explotation est autorisée aux deux conditions with any other antenna or transmitter. suivantes: IC Radiation Exposure Statement / IC Déclaration sur 1) il ne doit pas produire de brouillage et...
  • Page 43 Under Industry Canada regulations, this radio transmitter may only operate using an antenna of a type and maximum (or lesser) gain approved for the transmitter by Industry Canada. To reduce potential radio interference to other users, the antenna type and its gain should be so chosen that the equivalent isotropically radiated power (e.i.r.p.) is not more than that necessary for successful communication.

  • Page 44: Rf Statement

    RF STATEMENT network that supplies buildings used for domestic purposes. Medical Electrical Equipment needs special Portable and mobile RF communications equipment precautions regarding EMC and needs to be should be used no closer to any part of the device, installed and put into service according to the EMC including cables, than the recommended separation information provided in the following section.
  • Page 45 installed and put into service according to the EMC information provided in the following. Portable and mobile RF communication equipment (e.g. cell phones) can affect Medical Electrical Equipment. The use of accessories and cables other than those specified may result in increased emissions or decreased immunity of the unit.
  • Page 46 The QardioCore Wireless ECG Monitor system is intended for use in the electromagnetic environment specified below. The customer or the user of the QardioCore Wireless ECG Monitor system should ensure that it is used in such an environment. Emissions test...
  • Page 47 Designed by and manufactured for Qardio, Inc. California, USA. FOR US AND INTERNATIONAL www.getqardio.com YA HORNG ELECTRONIC CO., LTD. No. 35, Shalun, Anding Dist., Tainan City 745, Taiwan Type BF Applied Part 2460 2460 FCC ID: 2ABF2-888CORE 2460 2460 2018...
  • Page 48 Designed by and manufactured for Qardio, Inc. California, USA. FOR CANADA www.getqardio.com ATTEN ELECTRONIC (DONGGUAN) CO., LTD. No.34 Gao Yu Nan Road, Tang Xia Town, Dong Guan, Type BF Applied Part Guang Dong 523728 China 2460 2460 FCC ID: 2ABF2-888CORE...
  • Page 49 The QardioCore Wireless ECG Monitor system declaration-electromagnetic immunity The QardioCore Wireless ECG Monitor system is intended for use in the electromagnetic environment specified below. The customer or the user of the QardioCore Wireless ECG Monitor system should ensure that it is used in such an environment. Compliance...
  • Page 50 Declaration – electromagnetic immunity The QardioCore Wireless ECG Monitor system is intended for use in the electromagnetic environment specified below. The customer or the user of the QardioCore Wireless ECG Monitor system should ensure that it is used in such an environment.
  • Page 51 Information in this document is subject to change without notice. All changes will be in compliance with regulations governing manufacture of medical equipment. Qardio reserves the right to change or improve its products and to make changes in the content of its User Manuals without obligation to notify any person or organization of any such changes or improvements.
  • Page 52 The Bluetooth® word mark and logos are registered trademarks owned by Bluetooth SIG, Inc. and any use of such marks by Qardio, Inc. is under license. All other trademarks are properties of their respected owners. Qardio products should be only used in conjunction with professional medical advice for diagnosis or treatment, and not as a substitute or replacement of it.

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