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Qardio QardioCore, User Manual

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Qardio QardioCore User Manual Download Page 52

Qardio, QardioArm, QardioBase, QardioCore, QardioMD and their 
respective logos are either registered trademarks or trademarks of 
Qardio, Inc. in the United States and/or other countries.

iPhone, iPad, iPod are trademarks of Apple Inc., registered in the U.S. 
and other countries. 

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. Patents assigned and pending.

Model number: C100 
Copyright © 2018 Qardio, Inc. All rights reserved.

Version 1.02 - Eng

Summary of Contents for QardioCore

Page 1: ...WIRELESS ECG MONITOR USER MANUAL...

Page 2: ...urn on off QardioCore 12 Detailed instructions for the correct fitting of QardioCore 12 Wearing QardioCore upside down 14 Comfortable fit for females 15 Taking an ECG EKG recording 15 Checklist for a...

Page 3: ...ntraindications 22 User Responsibility 22 General use safety and precautions cleaning 22 Customer service contact 26 Limited warranty 26 Error messages and troubleshooting 28 QardioCore technical spec...

Page 4: ...iogram recorder It records electrocardiogram ECG EKG and physical activity Health conscious individuals or patients with known or suspected heart conditions can use QardioCore to record everyday ECGs...

Page 5: ...traces accompanying intermittent or infrequent symptoms difficult to capture with conventional ECG and Holter systems Please read through these instructions carefully so you understand all functions...

Page 6: ...n to render a diagnosis based on clinical judgment and experience Caution Federal law restricts this device to sale by or on the order of a physician For EU The QardioCore wireless ECG monitor is inte...

Page 7: ...atients who may be asymptomatic or who may suffer from transient symptoms such as palpitations shortness of breath dizziness light headedness pre syncope syncope fatigue or anxiety The device is not i...

Page 8: ...sician before you begin or modify any exercise program This device does not detect or measure all heart rate heart rhythm and heart waveform changes especially those related to ischemic heart conditio...

Page 9: ...nt 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 distan...

Page 10: ...care professionals individuals with known or suspected heart conditions and health conscious individuals The device has not been tested for and it is not intended for pediatric use QardioCore has feat...

Page 11: ...e e User manual List of materials 1 QardioCore Cases Acrylonitrile butadiene styrene ABS and Thermoplastic vulcanizates TPV 2 Connectors Electrodes Silver plated brass 3 Strap 20 Nylon Wooly 44 Spande...

Page 12: ...th your phone or tablet When prompted accept the pairing request The green light on your QardioCore will blink while the device is pairing and the Qardio App will indicate your QardioCore has successf...

Page 13: ...ect and Accurate ECG EKG Recording sections on the User Manual with particular care 10 The ECG recording can be stopped at any time by detaching the left clip from QardioCore and removing it from the...

Page 14: ...INSTRUCTIONS FOR THE CORRECT FITTING OF QARDIOCORE 1 Wearing your QardioCore with the right fit will keep you comfortable the device should be snug but comfortable and it should remain in place during...

Page 15: ...ing on the device Avoid wearing sunscreen under the device Wear the device below your sternum bone The device should be snug but comfortable You can try wearing the device lower on your chest Wrap the...

Page 16: ...en QardioCore and your 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 If you experien...

Page 17: ...vement in recording quality 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 fr...

Page 18: ...ough to stay in place during your movement Ensure the Qardio App is running on your iOS device You can stop the recording at any time by pressing the clip and detaching QardioCore from your chest The...

Page 19: ...ance if you are suffering from any medical problem IMPORTANT FACTS ABOUT ECG EKG AND SELF MEASUREMENT What is an electrocardiogram An electrocardiogram often abbreviated as ECG or EKG is a test that m...

Page 20: ...n or other symptoms Normally you should maintain your heart rate below your target level 85 of a predicted maximum heart rate based on your age and your any known medical conditions You should consult...

Page 21: ...ll Rhythm Heart Rates Max The maximum overall heart rate Min The minimum overall heart rate Avg The average overall heart rate Pause determination Pause is defined as an RR interval greater than 3 sec...

Page 22: ...es of moderate to vigorous intensity activities to work toward achieving your weekly intensity minutes goal You should consult your doctor before undertaking intensity minutes CHARGING QARDIOCORE Firs...

Page 23: ...e the pairing has been reset If necessary go into the Settings of your phone or tablet select the QardioCore and select Forget this device ACCURACY TESTING AND MAINTENANCE QardioCore comprises sensiti...

Page 24: ...the cardiograph should be evaluated before the equipment is operated as they may seriously degrade performance This device is susceptible to interference from RF energy sources lowered RF immunity whi...

Page 25: ...ribed Do not use in combination with external cardiac defibrillator or high frequency surgical equipment or near strong magnetic fields or devices such as MRI Do not use in case of known skin allergie...

Page 26: ...Core is not intended to diagnose cure or prevent any disease or medical condition QardioCore is not intended to be a replacement for a 12 lead ECG While you wear the QardioCore the recharging function...

Page 27: ...nder the care of a physician These features are available to prescription users only and may not be available in all regions or all languages QARDIOCORE SHOULD NOT BE USED IN CASE OF EMERGENCY IN CASE...

Page 28: ...nce of your QardioCore and should be avoided Dropping or bending your QardioCore or subjecting it to other impacts Submerging your QardioCore in water for long periods of time Swimming or bathing with...

Page 29: ...roducts and abrasive materials shouldn t be used on your QardioCore Compressed air and external heat sources like hair dryers can cause damage Direct sunlight high temperatures and humid conditions ca...

Page 30: ...over damage caused by improper handling discharged batteries accidents or non compliance with the operating instructions and normal wearing of parts If a defect arises during the warranty period Qardi...

Page 31: ...ine Auction Purchases Products purchased through online auctions are not eligible for rebates or other special offers from Qardio warranty coverage Online auction confirmations are not accepted for wa...

Page 32: ...at all electrodes are touching the skin Wandering baseline an upward and downward fluctuation of the waveforms Electrodes that are dirty loose or positioned on a bony area Oily skin or body lotions Ri...

Page 33: ...r voltage superimposed on the waveforms May resemble or coincide with muscle tremor interference Electrodes that are dirty loose or positioned on a bony area Patient touching any metal objects Electri...

Page 34: ...tablet Up to 48 hours data storage when not connected to smartphone or tablet depending on usage conditions ECG Data Compression No data compression All data is stored and transmitted in raw format E...

Page 35: ...V 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 ECG Cali...

Page 36: ...depends on environmental factors actual results will vary Water resistance Water resistance rating of IP65 under IEC standard 60529 Weight including strap 130g 0 29lb including the battery Dimensions...

Page 37: ...heric 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...

Page 38: ...t s made up in order to obtain an important saving of energy and resources and to avoid negative effects to the environment and health In case of abusive disposal of device by the user will be applied...

Page 39: ...methods of measurement 9 IEC60601 1 2 Part 1 2 General requirements for basic safety and essential performance Collateral Standard Electromagnetic disturbances 10 IEC 60601 2 47 Ambulatory electrocar...

Page 40: ...sability engineering to medical devices 18 IEC 60601 1 6 Medical electrical equipment Part 1 6 General requirements for basic safety and essential performance Collateral standard Usability 19 IEC 6230...

Page 41: ...technician for help A This device complies with Part 15 of the FCC Rules Industry Canada license exempt RSS standard s Operation is subject to the following two conditions 1 This device may not cause...

Page 42: ...ting instructions for satisfying RF exposure compliance This transmitter must not be co located or operating in conjunction with any other antenna or transmitter IC Radiation Exposure Statement IC D c...

Page 43: ...power e i r p is not more than that necessary for successful communication En vertu de la r glementation de l Industrie du Canada cet metteur de radio ne peuvent fonctionner en utilisant une antenne...

Page 44: ...luding domestic establishments and those directly connected to the public low voltage power supply network that supplies buildings used for domestic purposes Portable and mobile RF communications equi...

Page 45: ...tion 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 r...

Page 46: ...Group 1 The QardioCore Wireless ECG Monitor uses RF energy only for its internal function Therefore its RF emissions are very low and are not likely to cause any interference in nearby electronic equ...

Page 47: ...9 Erkrath Germany Type BF Applied Part 2018 YA HORNG ELECTRONIC CO LTD No 35 Shalun Anding Dist Tainan City 745 Taiwan Read this manual before use 2460 2460 2460 2460 2460 FCC ID 2ABF2 888CORE IC 1188...

Page 48: ...Erkrath Germany Type BF Applied Part WEEE 2018 US Importer ATTEN ELECTRONIC DONGGUAN CO LTD No 34 Gao Yu Nan Road Tang Xia Town Dong Guan Guang Dong 523728 China 2460 2460 2460 2460 2460 2460 2460 FCC...

Page 49: ...uld ensure that it is used in such an environment Immunity test IEC 60601 test level Compliance level Electromagnetic environment guidance Conducted RF IEC 61000 4 6 3 Vrms 150 kHz to 80 MHz 3V Portab...

Page 50: ...be that of a typical commercial or hospital environment Surge IEC 61000 4 5 1 kV differential mode 2 kV common mode N A Mains power quality should be that of a typical commercial or hospital environme...

Page 51: ...rdio 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 improvem...

Page 52: ...e 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 own...

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