THE SMART BLOOD PRESSURE MONITOR YOU WILL ACTUALLY USE User Manual FR Guide d’utilisation - DE Bedienungsanleitung - IT Guida Utente - ES Guia del Usuario - PT Guia do Usuário DA Brugsvejledning - NL Gebruikershandleiding - NO Brukerveiledning - SV Bruksanvisning - PL Instrukcja Obsługi RU Инструкции - CH (S) 使用手册 - CH (T) 使用手册 - AR دﻟﻴﻞ اﻟﻤﺴﺘﺨﺪم Download: www.getqardio.
TABLE OF CONTENTS Detailed Instructions On Taking a Blood Pressure Measurement Introduction 4 Intended Use 5 Important Safety Information 5 Checklist For Measuring Your Blood Pressure Correctly and Accurately 10 Package Contents 5 The Traffic Light Indicator 10 Requirements 5 Selecting Multiple Measurement Averaging 11 Using QardioArm For The First Time 6 Visualizing Your Historical Blood Pressure Data 11 How To Turn On/Off QardioArm 6 Detailed Instructions For Correct Cuff Placement
Resetting The Pairing On iOS 15 Error Messages and Troubleshooting 21 Resetting The Pairing On Android 16 QardioArm Technical Specifications 25 Accuracy Testing and Maintenance 17 Disposal 26 Contraindications 17 Certifications 26 Cautions 17 FCC Statement 27 General Use, Safety and Precautions, Cleaning 18 RF Statement 29 AAA Alkaline Battery Usage and Storage 19 Irregular Heart Beat Message 19 Customer Service Contact 20 Limited Warranty 20 3
QARDIOARM: THE SMART BLOOD PRESSURE MONITOR QardioArm is a clinically validated, portable blood pressure monitor. QardioArm is the smart way to measure and track your systolic and diastolic blood pressure and heart rate. This device was developed in collaboration with physicians and clinical tests were conducted to prove its measurement accuracy. Qardio offers a better way of tracking heart health that fits effortlessly into your life.
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. The cuff circumference is limited to 8.
USING QARDIOARM FOR THE FIRST TIME 1. Download the free 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. initiate the blood pressure measurement. Blood pressure can be affected by the position of the cuff and your physiological condition. It is very important that the cuff is correctly placed.
DETAILED INSTRUCTIONS FOR CORRECT CUFF PLACEMENT 1. Ideally, remove close-fitting garments from upper arm. If you 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 to open the cuff loop. (As indicated in drawing 1.) 3. Insert your arm inside the cuff loop. (As indicated in drawing 2.) 4. Pull the cuff to close it around your arm.
BODY POSTURE DURING BLOOD PRESSURE MEASUREMENT Note: Blood pressure can be affected by the position of the cuff and your physiological 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 alongside your body with your palm facing up. 2. Place your hand, palm-side up, in front of you on a flat surface such as a desk or a table. 3.
DETAILED INSTRUCTIONS ON TAKING A BLOOD PRESSURE MEASUREMENT 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. Taking a blood pressure measurement with the QardioArm is easy and is done in a few simple steps: 1. Open the Qardio App on your iOS or Android device. 5.
CHECKLIST FOR MEASURING YOUR BLOOD PRESSURE CORRECTLY AND ACCURATELY ✓ Avoid eating, smoking or any activity immediately before taking the measurement. ✓ Sit down and relax for a few minutes before taking the measurement. ✓ Always measure the same arm (normally left, or as instructed by your doctor). ✓ Ideally, remove close-fitting garments from upper arm. 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 MEASUREMENT AVERAGING Blood pressure constantly fluctuates so a result determined by multiple measurements is more reliable and accurate than one produced by a single measurement. To activate the Multiple Measurement Averaging, which is also useful in case of pulse irregularity, press the Q menu button (on the top left of the screen), then press the Settings button.
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 dosage 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 CHART 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 ON iOS 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”.
RESETTING THE PAIRING ON ANDROID 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.
As QardioArm contains magnets, please consult your implantable pacemaker, defibrillator or other device before use. As a general rule, maintain a minimum distance of 6 inches or 15 cm between QardioArm and your implanted devices, or more if so specified by the manufacturer of your implanted device. • Do not inflate the arm cuff when it is not wrapped around your arm. • Do not wrap the cuff inside-out.
• 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 submerge any part of the QardioArm in water at any time.
CUSTOMER SERVICE CONTACT and to the extent permitted by law will (1) repair the product at no 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.
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 fits on 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 circumstances, 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 conditions 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 0.68 lb (310g) including batteries. Cuff Size 8.7 in – 14.6 in circumference (22 cm – 37 cm diameter) Dimensions 5.5 x 2.7 x 1.5 in (140 x 68 x 38 mm) 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.
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. EN ISO 13485:2003 /AC: 2009: Medical devices - Quality management systems – Requirements for regulatory purposes (ISO 13485:2003) Reference to standards contd.
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.
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: appareil numérique de la classe B est conforme à la norme NMB-003 du Canada. FCC RF Radiation Exposure Statement: 1) This device may not cause harmful interference and This equipment complies with FCC radiation exposure limits set forth for an uncontrolled environment.
puissance isotrope rayonnée équivalente (p.i.r.e.) ne dépasse pas ce qui est nécessaire pour la réussite de comunication. The device is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. Any other accessories, transducers and cables may result in increased emissions or decreased immunity and EMC performance.
Guidance and manufacturer’s declaration-electromagnetic emissions The QardioArm Blood Pressure Monitor system is intended for use in the electromagnetic environment specified below. The customer or the user of the QardioArm Blood Pressure Monitor system should ensure that it is used in such an environment.
Designed by and manufactured for Qardio, Inc. California, USA. FOR US AND INTERNATIONAL 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 2016 0434 US Importer Read this manual before use. WEEE Qardio, Inc.
Designed by and manufactured for Qardio, Inc. California, USA. FOR CANADA www.getqardio.com YA HORNG ELECTRONIC CO., LTD. No. 35 Shalun, Anding district, Tainan, Taiwan Factory: ATTEN ELECTRONIC (DONGGUAN) CO., LTD. Type BF Applied Part (cuff) FCC ID: 2ABF2-888ARM 0434 0434 IC: 11885A-888ARM00 0434 0434 0434 0434 2016 US Importer Read this manual before use. WEEE 0434 32 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 system declaration-electromagnetic immunity The QardioArm Blood Pressure Monitor system is intended for use in the electromagnetic environment specified below. The customer or the user of the QardioArm Blood Pressure Monitor system should ensure that it is used in such an environment.
Declaration – electromagnetic immunity The QardioArm Blood Pressure Monitor system is intended for use in the electromagnetic environment specified below. The customer or the user of the QardioArm Blood Pressure Monitor system should ensure that it is used in such an environment.
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. 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.
Copyright (c) 2013-2016 Qardio, Inc. All rights reserved. Version 2.