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Qardio QardioCore User Manual

Manual is about: WIRELESS ECG MONITOR

Summary of QardioCore

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    Wireless ecg monitor user manual.

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    2 table of contents introduction 4 intended use 6 important safety information 6 features 8 requirements 8 package contents 9 using qardiocore for the first time 10 how to turn on/off qardiocore 12 detailed instructions for the correct fitting of qardiocore 12 wearing qardiocore upside down 14 comfo...

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    3 resetting the pairing 20 accuracy testing and maintenance 20 cautions 21 contraindications 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 specifications 30 disposa...

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    4 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 r...

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    5 qardiocore is the smart way to track your electrocardiogram with contextual information about your physical activity. This device was developed in collaboration with physicians and clinical tests were conducted to prove its measurement accuracy. With its ease of use and accuracy, qardiocore is ide...

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    6 intended use for usa the qardiocore ecg monitor is intended to capture, store, transmit and display electrocardiogram (ecg) information for long term monitoring and evaluation. It is indicated for use on adult patients who may be asymptomatic or who may suffer from transient symptoms such as palpi...

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    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 symptom...

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    8 important safety information • please read the user manual carefully before using the qardiocore ecg monitor. • this device is not to be used by patients who have a pacemaker. If you have an internal electronic device, consult your physician before using an ecg monitor, like qardiocore. • this dev...

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    9 • do not use this device during an mri scan • 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 est...

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    10 features the features for qardiocore include: assessment of symptoms that may be related to arrhythmias assessment of risk in patients with or without symptoms of arrhythmia assessment of efficacy of antiarrhythmic therapy. Qardiocore is intended to record, store and transfer [single-channel] ele...

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    11 package contents you will find in your qardiocore package: a. Qardiocore device b. Three chest straps, to facilitate your everyday use c. Charging cable d. Quick guide e. User manual list of materials 1. Qardiocore cases: acrylonitrile butadiene styrene (abs) and thermoplastic vulcanizates (tpv) ...

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    12 5. Adjust the length of the strap to adapt it for your chest size. 6. Fit the qardiocore to your chest. You should wear qardiocore directly on your skin, just below your sternum. Wear your qardiocore with the qardio logo to the left. All the electrodes should be touching your skin and qardiocore ...

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    13 9. After a few seconds, qardiocore will automatically start recording your electrocardiogram. Your ecg can be affected by the position of qardiocore on your chest and your physiological condition. It is very important that qardiocore is correctly placed. Please read the “detailed instructions for...

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    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 the left side of the strap. When qardiocore is not being worn, if the strap is left attached to the device, qardiocore will remain in a low power mode to pres...

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    15 5. In order to obtain an accurate measurement, it is essential that all of qardiocore’s electrodes remain in contact with your skin at all times. We have designed qardiocore to suit a multitude of body shapes and chest types, allowing for you to make slight modifications to how qardiocore is worn...

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    16 6. Tips to avoid skin irritation, or if you have allergies or skin sensitivities. • keeping your qardiocore and straps—as well as your skin—clean and dry will maximize comfort and prevent long-term damage to the device. This is especially important after workouts or exposure to liquids such as sw...

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    17 wearing qardiocore upside down if you have a more concave chest, or are consistently finding it difficult for the top electrode to remain in contact with the skin, we recommend that you wear qardiocore upside down. Unclip the strap from the left side of qardiocore and flip the device around so th...

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    18 checklist for a correct and accurate ecg/ekg recording • adjust the length of the strap to adapt it for your chest size. Wear your qardiocore with the qardio logo to the left. • fit the qardiocore to your chest. When you connect the strap to the left side of qardiocore you should see a green ligh...

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    19 note: ecg recording viewed or printed at any magnification other than 100% may appear distorted and could lead to misdiagnosis. Note: you will not be able to view your recordings or utilize any of qardiocore’s analytical tools until you are under the care of a physician. To gain access to these f...

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    20 be able to find out if parts of the heart are too large or are overworked. During an ecg, several sensors, called electrodes, capture the electrical activity of the heart. Wearing qardiocore during exercise during exercise the body requires more oxygen. As the level of physical activity increases...

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    21 complex. Each detected qrs complex is tested for valid amplitude, duration and refractory period from previous qrs complex. 2. Rr interval is calculated between two consecutive valid qrs complexes as time difference between its maximal amplitude peaks. Each detected rr intervals is tested for val...

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    22 progress toward your daily steps goal as you move during the day. Intensity minutes to improve your health, organizations such as the world health organization, the u.S. Centers for disease control and prevention, the american heart association recommend at least 150 minutes per week of moderate ...

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    23 • solid green light indicate qardiocore is fully charged. • the green light will blink 3 times to indicate your qardiocore battery is running low and should be charged. Qardio recommends charging your qardiocore battery daily. Resetting the pairing in order to reset the pairing, remove the anchor...

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    24 cautions • self-diagnosis of measurement results and self- treatment are potentially dangerous. You should always consult your doctor. • if you suffer from an irregular heartbeat, measurements taken with this device should be evaluated with your doctor. • this device may only be used for the purp...

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    25 on the cardiograph display or on the printed report. When esd occurs, the cardiograph’s ecg interpretation may be inconsistent with the physician’s interpretation. • qardiocore has features that are only available to those users who are under the care of a physician. These features are available ...

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    26 the user of the product shall have the sole responsibility for any malfunction, which results from improper use, faulty maintenance, damage or alteration. General use, safety and precautions, cleaning • this device is not to be used by patients who have a pacemaker. If you have an internal electr...

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    27 • do not expose qardiocore to temperatures outside the storage or operating range. • do not expose qardiocore to direct sunlight for extended periods of time. • do not disassemble, modify, remanufacture, puncture or damage qardiocore. • do not immerse or expose qardiocore to liquids, fire, explos...

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    28 qardiocore dust and water resistance your qardiocore is dust resistant and splash and water resistant, but not waterproof (qardiocore has a water resistance rating of ip65 under iec standard 60529). For example, you may wear and use your qardiocore during exercise (exposure to sweat is ok), or wh...

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    29 • keep your qardiocore clean and dry. A soft toothbrush or a nonabrasive, lint-free cloth to scrub it with a weak solution of fresh water and a mild neutral detergent. • the bacteria and odor resistant qardiocore straps protect against odor generated by the formation of bacteria from sweat, which...

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    30 customer service contact qardio customer service contact is available at support.Getqardio.Com. Limited warranty this device is covered by a one year limited warranty from the date of purchase. Each strap has a functional warranty (elasticity) for one year, while battery and other wearing parts a...

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    31 and/or implied terms may last, so the limitations described above may not apply to you. In no event shall qardio be liable for (a) any losses that were not caused by our breach of this limited warranty; (b) any incidental, special, indirect or consequential damages, whether resulting from use, mi...

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    32 error messages and troubleshooting lead quality problems the following table describes different lead quality problems and possible actions to try to resolve this: condition possible causes actions bad signal • poor electrode contact with skin • not all electrodes are touching • make sure qardioc...

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    33 condition possible causes actions muscle tremor interference (random irregular voltage superimposed on the waveforms). May resemble or coincide with ac interference • user is uncomfortable, tense, nervous. • user is cold and shivering. • qardiocore strap is too tight • not all electrodes are touc...

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    34 qardiocore technical specifications chest size 27.5 - 43 in (70 - 109 cm) memory practically unlimited, when connected to smartphone or 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...

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    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 3-a...

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    36 power source the device is powered by a built-in, 3.7v lithium-ion battery that you can charge using the charging cable supplied in the product package battery life 24 hours of continuous recording, when fully charged battery charge time about 3 hours to 100%. Charge time depends on environmental...

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    37 storage conditions -20c to 40c (-4f to 104f) temperature, 45% to 85% (non condensing) 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 obligati...

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    38 disposal actuation of european directives 2002/95/ec, 2002/96/ec and 2003/108/ec, for reduction in use of dangerous substances in the electric and electronic device and for garbage disposal. The symbol applied on the device or its packaging means that at the end of its useful life the product mus...

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    39 3. Fcc part b 15b:2013 electromagnetic compatibility 4. Fcc rule part: 15.247 cat: dss (bluetooth) fcc rule part: 15.247 cat: dts (bt4.0) 5. En iso 10993-1:2009/ac:2010 biological evaluation of medical devices-part 1: evaluation and testing within a risk management process (iso 10993- 1:2009) 6. ...

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    40 14. En301489-17 v2.2.1:2012 electromagnetic compatibility and radio spectrum matters (erm); electromagnetic compatibility (emc) standard for radio equipment; part 17: specific conditions for broadband data transmission systems 15. Iec 62133:2012 rlv: secondary cells and batteries containing alkal...

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    41 equipment generates, uses and can radiate radio frequency energy and, if not installed and used in accordance with the instructions, may cause harmful interference to radio communications. However, there is no guarantee that interference will not occur in a particular installation. If this equipm...

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    42 le présent appareil est conforme aux cnr d’industrie canada applicables aux appareils radio exempts de license. L’explotation est autorisée aux deux conditions suivantes: 1) il ne doit pas produire de brouillage et 2) l’utilizateur du dispositif doit étre prêt à recepter tout brouillage radioélec...

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    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 equ...

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    44 rf statement medical electrical equipment needs special precautions regarding emc and needs to be installed and put into service according to the emc information provided in the following section. Interference may occur in the vicinity of equipment marked with the following symbol . Portable and ...

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    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 d...

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    46 guidance and manufacturer’s declaration-electromagnetic emissions 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 envi...

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    47 us importer eu importer designed by and manufactured for qardio, inc. California, usa. For us and international www.Getqardio.Com kahl handelsvertretung add.: isarstr.33 40699 erkrath, germany type bf applied part 2018 ya horng electronic co., ltd. No. 35, shalun, anding dist., tainan city 745, t...

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    48 designed by and manufactured for qardio, inc. California, usa. For canada www.Getqardio.Com kahl handelsvertretung add.: isarstr.33 40699 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 5...

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    49 declaration – electromagnetic emissions and immunity for equipment and systems that are not life-supporting and are specified for use only in a shielded location the qardiocore wireless ecg monitor system declaration-electromagnetic immunity the qardiocore wireless ecg monitor system is intended ...

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    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. Immunity test iec ...

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    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...

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    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 ...