A SMARTER READ ON BLOOD PRESSURE User Guide DE Bedienungsanleitung -FR Guide d’utilisation -ES Guia del usuario -IT Guida utente NL Gebruikershandleiding -PT Guia do usuário -RU инструкции Download: www.getqardio.
TABLE OF CONTENTS Introduction 4 Intended use 5 Important safety information 5 Package contents 5 Requirements 5 Using QardioArm for the first time Checklist for measuring your blood pressure correctly and reliably 10 The traffic light indicator 10 Selecting multiple measurements averaging 11 Visualizing your historical blood pressure data 11 6 Important facts about blood pressure and selfmeasurement 12 Detailed instructions for correct cuff placement 7 How to evaluate your blood pre
Accuracy testing and maintenance 16 Disposal 25 Contraindications 16 Certifications 25 Cautions 16 FCC statement 26 General use, safety and precautions, cleaning 17 RF statement 27 AAA alkaline batteries usage, storage 18 Irregular Heart Beat Message 18 Customer service contact 19 Limited warranty 19 Error messages and troubleshooting 20 QardioArm technical specifications 24 3
QARDIOARM: WELCOME TO A SMARTER READ ON BLOOD PRESSURE! Your new QardioArm blood pressure monitor is a clinically validated medical device for taking measurements on the upper arm. This device was developed in collaboration with physicians and clinical tests were conducted to prove its measurement accuracy. Every day, we at Qardio put our passion and effort into bringing you products of superior quality, design and technology that can change your life for the better.
INTENDED USE PACKAGE CONTENTS REQUIREMENTS QardioArm is a fully automatic, non-invasive, wireless blood pressure monitor. QardioArm is a blood pressure measurement system intended to measure the systolic and diastolic blood pressures and pulse rate of an adult individual. QardioArm utilizes an inflatable cuff that is wrapped around the upper arm. This device is not intended to be a diagnostic device. Contact your physician if hypertensive values are indicated.
USING QARDIOARM FOR THE FIRST TIME 1. Download the Qardio app: On your mobile phone or tablet go to www.getqardio.com and when prompted, download the app. Alternatively, go on the iTunes App Store or Google Play. The Qardio app is available for free. 6. On the Qardio app, press the green START button to initiate the blood pressure measurement. Blood pressure can be affected by the position of the cuff and your physiologic condition.
DETAILED INSTRUCTIONS FOR CORRECT CUFF PLACEMENT 1. Ideally, remove close-fitting garments from upper arm, and if your roll up your sleeve, ensure it does not cause constriction of the blood flow in your upper arm. 2. Unroll the cuff of your QardioArm, and pull the tab (as indicated in drawing 1 on this page) to open the cuff loop. 3. Insert your arm inside the cuff loop (as indicated in drawing 2 on this page). 4. Pull the cuff to close it around your arm (as indicated in drawing 3 on this page).
BODY POSTURE Note: Blood pressure can be affected by the position of the cuff and your physiologic condition. Sitting During Measurement: Lying Down During Measurement: 1. Be seated with your feet flat on the floor without crossing your legs. 1. Lie on your back. 2. Straighten your arm along the side with your hand palmside up. 2. Place your hand, palm-side up, in front of you on a flat surface such as a desk or a table. 3. The middle of the cuff should be at the level with your heart. 3.
DETAILED INSTRUCTIONS ON TAKING A BLOOD PRESSURE MEASUREMENT Taking a blood pressure measurement with the QardioArm is easy and is done in a few simple steps: until the measurement result is displayed. Breathe normally and do not talk. When the correct pressure is reached, the inflation stops and the pressure gradually decreases. If the required pressure was not reached, the device will automatically inflate additional air into the cuff. 1. Open the Qardio app on your iOS or Android device. 2.
CHECKLIST FOR MEASURING YOUR BLOOD PRESSURE CORRECTLY AND RELIABLY ✓ Avoid activity, eating or smoking immediately before the measurement. ✓ Sit down and relax for a few minutes before the measurement. ✓ Always measure on the same arm (normally left, or as instructed by your doctor). ✓ Ideally, remove close-fitting garments from the upper arm, and, if you roll up your sleeve, ensure it does not cause constriction of the blood flow in your upper arm. Do not place the cuff over thick clothes.
SELECTING MULTIPLE MEASUREMENTS AVERAGING Because blood pressure constantly fluctuates, a result determined with multiple measurements is more reliable than one produced by a single measurement. To activate the Multiple Measurement Averaging, press the Q menu button (on the top left of the screen), then press the Settings button. On the Settings screen you can select the number of measurements and the pause between measurements (which is set at 30 seconds by default).
IMPORTANT FACTS ABOUT BLOOD PRESSURE AND SELF-MEASUREMENT QardioArm measures your blood pressure. Blood pressure is the pressure of the blood flowing in the arteries generated by the pumping of the heart. Two values, the systolic (upper) value and the diastolic (lower) value, are always measured. You should never alter the dosages of any medications prescribed by your doctor.
When you detect unusually high readings during pregnancy, you should measure again after at least four hours. If the reading is still too high, consult your doctor or obstetrician. BLOOD PRESSURE CLASSIFICATION Physical activity including eating, drinking, and smoking as well as excitement, stress, and many other factors can influence blood pressure results.
REPLACING THE BATTERIES When the batteries are approximately 25% full the battery symbol will appear on the Qardio app blood pressure measurement screen. Although the QardioArm will continue to measure reliably, you should obtain replacement batteries. If the empty battery symbol appears on the Qardio app, your QardioArm batteries are depleted and it’s time to replace them. You cannot take any further measurements and must replace the batteries. To replace batteries: 1.
RESETTING THE PAIRING In order to reset the pairing, unwrap the cuff from around the QardioArm to switch on the device and use a paper clip to press the button on the pinhole on the battery compartment hatch. You should see a green light shining through. If necessary, go into the Settings of your phone or tablet, select the QardioArm and select “Forget this device”.
ACCURACY TESTING AND MAINTENANCE CAUTIONS QardioArm comprises sensitive components and must be treated with caution. Observe the storage and operating conditions described in the “Technical Specifications” section. Self-diagnosis of measurement results and self-treatment are potentially dangerous. You should always consult your doctor.
QardioArm is not suitable for checking the frequency of heart pacemakers. • Do not wrap the cuff inside-out. • Do not apply strong shocks and vibrations to the QardioArm blood pressure monitor, as this may result in damage to the device. GENERAL USAGE, SAFETY AND PRECAUTIONS, CLEANING • Do not drop the QardioArm blood pressure monitor. • Do not expose the cuff and/or the QardioArm blood pressure monitor to temperatures outside the storage or operating range.
• Do not disassemble the QardioArm blood pressure monitor. • Always replace all four AAA alkaline batteries at the same time: do not use new and old AAA alkaline batteries together. • Do not use an alcohol-based or solvent agent to clean the device. Clean the device only with a soft, dry cloth. Clean the cuff carefully with a damp cloth and soap. Do not submerse any part of the QardioArm in water at any time.
CUSTOMER SERVICE CONTACT charge, using new parts or parts that are equivalent to new in performance and reliability, (2) exchange the product with a functionally equivalent product that is new or equivalent to new in performance and reliability, or (3) refund the original purchase price. This warranty excludes damage resulting from abuse, accident, modifications or other causes that are not defects in materials and workmanship. Qardio customer service is available on www.getqardio.com.
ERROR MESSAGES AND TROUBLESHOOTING PROBLEM CAUSE REMEDY START button is gray, not green. QardioArm is not connected to your smartphone or tablet. Possible solutions: 1) Close the QardioArm cuff and reopen it again. 2) Ensure that Bluetooth is enabled on your phone or tablet and the QardioArm is nearby your phone or tablet. 3) Replace the batteries of the QardioArm. 4) Reset the pairing. Measurement could not be performed.
PROBLEM CAUSE REMEDY No pressure in the cuff. An adequate pressure cannot be generated in the cuff. A leak may have occurred. 1) Check that the cuff is correctly positioned and fit to the arm. 2) Replace the batteries, if necessary. Repeat the measurement. If the problem occurs again, contact customer service. Abnormal result. The measuring signals are inaccurate therefore no result can be displayed.
PROBLEM CAUSE REMEDY Irregular heartbeat. Pulse irregularity was detected during measurement, and the blood pressure measurement might not be fully reliable. Repeat the measurement after one hour. If irregular heart beat is detected several times in a day or week, we recommend you to discuss this with your doctor. If irregular heartbeat is detected during the measurement procedure, a message will be displayed.
PROBLEM CAUSE REMEDY Each measurement has significantly different results. Under normal measuring circumstance, the reading at home is different from that of the clinics. The variation is due to the different environments. The blood pressure is changing according to the physiological or psychological status of your body. 1) Relax for a few minutes before each measurement. Try to measure your blood pressure at consistent times and locations. Discuss your blood pressure values with your physician.
QARDIOARM TECHNICAL SPECIFICATIONS Weight 310g (0.68 lb) including batteries. Dimensions 140 x 68 x 38 mm (5.5 x 2.7 x 1.5 in) when closed. Measurement Oscillometric method with automatic inflation and controlled pressure release valve. Measurement Range 40~250 mmHg for blood pressure. 40~200 beats/minute for pulse. Technical Measurement Precision Accuracy ±3mmHg or ±2% of readout value for blood pressure. ±5% of readout for pulse. Measurement Resolution 1mmHg for blood pressure.
EN ISO 13485:2003 /AC: 2009: Medical devices - Quality management systems – Requirements for regulatory purposes (ISO 13485:2003) Reference to standards contd. Specifications are subject to change without prior notice or any obligation on the parts of the manufacturer. Certain features may require purchase of separate services.
Harmonized EN covering the essential requirements of article 3.2 of the R&TTE Directive EN301489-1-3 V1.9.2:2011 Electromagnetic compatibility and Radio spectrum Matters (ERM); ElectroMagnetic Compatibility (EMC) standard for radio equipment and services; Part 1: Common technical requirements EN301489-1-17 V2.2.
This device complies with Part 15 of the FCC Rules. Operation is subject to the following two conditions: The use of accessories and cables other than those specified may result in increased emissions or decreased immunity. 1) This device may not cause harmful interference and The device 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 equipment.
Guidance and manufacturer’s declaration-electromagnetic emissions The Wireless Blood Pressure Monitor is intended for use in the electromagnetic environment specified below. The customer or the user of the Wireless Blood Pressure Monitor should assure that it is used in such an environment.
Manufactured for Qardio, Inc. California, USA. www.getqardio.com YA HORNG ELECTRONIC CO., LTD. Tainan, Taiwan Factory: ATTEN ELECTRONIC (DONGGUAN) CO., LTD. 188 Industrial District, Ping Shan Administrative District, Tang Shia Town, Dongguan, 190, CN, 518055 Type BF Applied Part (cuff) FCC ID: 2ABF2-888ARM 0434 0434 IC: 11885A-888ARM00 0434 0434 0434 0434 2014 0434 US Importer Read this manual before use. WEEE Qardio, Inc. 340 S Lemon Ave #1104F, Walnut, California 91789, USA.
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 QardioArm Wireless Blood Pressure Monitor declaration-electromagnetic immunity The QardioArm Wireless Blood Pressure Monitor system is intended for use in the electromagnetic environment specified below. The customer or the user of the Wireless Blood Pressure Monitor system should assure that it is used in such an environment.
Declaration – electromagnetic immunity The QardioArm Wireless Blood Pressure Monitor system is intended for use in the electromagnetic environment specified below. The customer or the user of the QardioArm Wireless Blood Pressure Monitor system should assure that it is used in such an environment.
Qardio, QardioArm, QardioCore and the Qardio logo are trademarks of Qardio, Inc. Qardio is a registered trademark of Qardio, Inc. in the European Union and other jurisdictions. iPhone, iPad, iPod are trademarks of Apple Inc., registered in the U.S. and other countries. Android and Google Play are trademarks of Google Inc. 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.
