Omron HEM-7530T-E3 Instruction Manual

Omron HEM-7530T-E3 Instruction Manual

Automatic upper arm blood pressure monitor + ecg complete
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Automatic Upper Arm Blood Pressure Monitor + ECG
Complete (HEM-7530T-E3)
Instruction Manual
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Summary of Contents for Omron HEM-7530T-E3

  • Page 1 Automatic Upper Arm Blood Pressure Monitor + ECG Complete (HEM-7530T-E3) Instruction Manual...
  • Page 2: Table Of Contents

    Table of Contents Introduction ..............EN2 7. Taking a Blood Pressure Measurement Manually ..............EN40 Safety Instructions ............. EN2 8. Other Settings of the Monitor........EN41 Intended Use ..............EN3 Receiving and Inspection ..........EN3 8.1 Disabling/Enabling Bluetooth........EN41 Important Safety Information .......... EN4 8.2 Restoring Your Monitor to the Default Settings ..
  • Page 3: Introduction

    The “OMRON connect” app also provides analysis results of the recorded ECG to evaluate whether the heart rhythm is normal or if possible atrial fibrillation, bradycardia and tachycardia are detected. ECG software and technology powered by AliveCor is embedded on the OMRON connect app and is integral part of OMRON Complete blood pressure monitor + ECG system.
  • Page 4: Intended Use

    Receiving and Inspection Remove this monitor and other components from the packaging and inspect for damage. If this monitor or any other components are damaged, DO NOT USE and contact your OMRON retail outlet or distributor.
  • Page 5: Important Safety Information

    Important Safety Information Read the Important Safety Information in this instruction manual before using this monitor. Follow this instruction manual thoroughly for your safety. Keep for future reference. For specific information about your own blood pressure and heart related conditions, CONSULT WITH YOUR PHYSICIAN.
  • Page 6 Important Safety Information • Keep components out of the reach of infants, toddlers and children. This product contains small parts that may cause a choking hazard if swallowed by infants, toddlers and children. • DO NOT record an ECG with a cardiac pacemaker, Implantable Cardioverter Defibrillators, or other implanted electronic devices.
  • Page 7 Important Safety Information • When the monitor malfunctions, it may get hot. DO NOT touch the monitor if it occurs. • DO NOT use this monitor for any purpose other than measuring blood pressure and/or recording an ECG. • During a blood pressure measurement and/or an ECG recording, make sure that no mobile device or any other electrical device that emits electromagnetic fields, other than the smartphone to be used with the monitor, is within 30 cm of this monitor.
  • Page 8 • OMRON makes no warranty for any data or information that is collected erroneously by the monitor, or misuse or malfunction as a result of abuse, accidents, alteration, misuse, neglect, or failure to maintain the product as instructed.
  • Page 9 Consult with your physician. • OMRON does not guarantee that you are not experiencing an arrhythmia or other health conditions when labeling an ECG as normal. You should notify your physician for possible changes in your health.
  • Page 10 • Make sure the battery compartment is securely closed with the battery cover when recording an ECG. If the battery cover is not in place, recording an ECG may not be successful. If you have lost the battery cover, contact your OMRON retail outlet...
  • Page 11: Know Your Monitor

    1. Know Your Monitor 1.1 Contents Monitor, arm cuff (HEM-RML31), storage case, 4 “AA” alkaline batteries, instruction manual, setup instructions, blood pressure diary 1.2 Monitor and Arm Cuff Smartphone stand Top electrodes Side electrode (both sides) [Connection] button BP reading display* BP [START/STOP] button* Battery compartment Air jack...
  • Page 12: Bp Reading Display And Symbols On The Monitor

    1. Know Your Monitor 1.3 BP Reading Display and Symbols on the Monitor Heartbeat symbol Flashes while taking a blood pressure measurement. Movement error symbol Appears along with a blood pressure reading when your body is moving during a blood pressure measurement. If it appears, remove the arm cuff, and wait for 2 to 3 minutes.
  • Page 13 1. Know Your Monitor Systolic blood pressure reading Diastolic blood pressure reading Pulse display Pulse rate appears after the blood pressure measurement. OK symbol Flashes when your monitor is connected to your smartphone or readings are transferred successfully. Bluetooth ON symbol Appears when your blood pressure readings are being transferred.
  • Page 14: 2018 Esh/Esc** Guidelines For The Management Of Arterial Hypertension

    1. Know Your Monitor 1.4 2018 ESH/ESC** Guidelines for the management of arterial hypertension Definitions of hypertension by office and home blood pressure levels Office Home Systolic Blood Pressure 140 mmHg 135 mmHg Diastolic Blood Pressure 90 mmHg 85 mmHg These ranges are from statistical values for blood pressure.
  • Page 15: Reading Your Ecg Result

    1. Know Your Monitor 1.5 Reading Your ECG Result When the ECG recording is finished, the results are displayed on the downloaded “OMRON connect” app as: Possible Afib (possible atrial fibrillation), Bradycardia, Tachycardia, Normal, Unreadable or Unclassified. Note • Other than Possible Afib, Bradycardia, Tachycardia, Normal, Unclassified and Unreadable, ECG error messages may appear on the app due to some reasons such as a shortage of recording time, too noisy to interpret or etc.
  • Page 16 1. Know Your Monitor The most common presenting symptoms of atrial fibrillation are palpitations, dizziness, fast heart rate, irregularly irregular rhythm, an abnormal heart sound (S1), chest pain, chronic shortness of breath, abnormal jugular venous pressure, fatigue, and impaired exercise tolerance. Other symptoms related to TIAs and strokes may be the initial symptoms of atrial fibrillation. Some of the most common causes of atrial fibrillation are long-standing hypertension, congestive heart disease, cardiac valvular lesions, myocardial infarctions, history of coronary artery bypass grafts, hyperthyroidism, alcohol abuse, smoking, diabetes mellitus, and electrolyte imbalances.
  • Page 17 1. Know Your Monitor Normal means that the heart rate is between 50 and 100 beats per minute, there are no or very few abnormal beats, and the shape, timing and duration of each beat is considered normal sinus rhythm. It is important to remember that there is a wide range of normal variability among different individuals.
  • Page 18 • After ECG analysis, the app may incorrectly identify ventricular flutter, ventricular bigeminy, and ventricular trigeminy heart conditions as unreadable. Consult with your physician. • OMRON does not guarantee that you are not experiencing an arrhythmia or other health conditions when labeling an ECG as normal. You should notify your physician for possible changes in your health.
  • Page 19: Distinction Between Pulse Rate And Heart Rate

    1. Know Your Monitor 1.6 Distinction between Pulse Rate and Heart Rate The pulse rate on blood pressure measurement and the heart rate on ECG recording are calculated differently as follows. There may be a difference between both values. Pulse rate on blood pressure measurements Start Deflate...
  • Page 20: Preparation

    2. Preparation 2.1 Installing Batteries 1. Insert a thin object such as the tip of a pen or thin screwdriver, in the hole of the battery cover hook. Push the hook horizontally, then pull it upward as shown in the image. Note •...
  • Page 21 • Make sure the battery compartment is securely closed with the battery cover when recording an ECG. If the battery cover is not in place, recording an ECG may not be successful. If you have lost the battery cover, contact your OMRON retail outlet or distributor.
  • Page 22: Pairing Your Monitor With A Smartphone

    Any devices and operating systems not listed on our website are not supported. 1. Enable Bluetooth on your smartphone. 2. Download and install the free “OMRON connect” app onto your smartphone. If you already have this app and have created your account, open the app and add your new monitor.
  • Page 23 • Please be aware that OMRON will not be responsible for the loss of data and/or information in the app. • “OMRON connect” is the only app that we recommend to use with your monitor to transfer your blood pressure readings and record and view your ECG results correctly.
  • Page 24: Blood Pressure Measurement/Ecg Recording Tips

    Please use the included Blood Pressure Diary to keep records of several readings over a certain period of time. To download the PDF files of the Blood Pressure Diary or Blood Pressure Pass, visit www.omron-healthcare.com. Caution •...
  • Page 25: Taking A Blood Pressure Measurement And Recording An Ecg

    “Note” located at the end of this sub-section. • The blood pressure can differ between the right arm and the left arm, and the measured blood pressure readings can be different. OMRON recommends to always use the same arm for measurement.
  • Page 26: Taking A Blood Pressure Measurement And Recording An Ecg

    3. Taking a Blood Pressure Measurement and Recording an ECG 2. Place your hand through the cuff loop. Pull the cuff until it reaches your upper left arm. Note • The bottom edge of the arm cuff should be 1 to 2 cm above the inside elbow. The air tube is on the inside of your arm and aligned with your middle finger.
  • Page 27 3. Taking a Blood Pressure Measurement and Recording an ECG 3.2 Sitting Correctly To take a blood pressure measurement and record an ECG, you need to be relaxed and comfortably seated in a quiet room with a comfortable temperature. • Sit in a comfortable chair with your back and arms supported. •...
  • Page 28 ECG may not be recorded successfully. 1. Open the “OMRON connect” app on your smartphone. 2. Follow the instructions to start an ECG recording on your smartphone. Refer to “Help”...
  • Page 29 3. Taking a Blood Pressure Measurement and Recording an ECG 3. Place your smartphone on the smartphone stand of your monitor. Note • Make sure to sit correctly. Refer to sub-section 3.2. 4. Press the BP [START/STOP] button to take a blood pressure measurement. All symbols appear on the BP reading display of the monitor before starting.
  • Page 30 3. Taking a Blood Pressure Measurement and Recording an ECG 5. Touch 4 electrodes as shown in the image. Top electrodes Relax your hands. Put your thumbs on the top electrodes, and 2 or more Side electrode fingers on each of the side electrodes to record your ECG. (both sides) Once fingers are placed on the electrodes, an ECG recording will automatically start.
  • Page 31 3. Taking a Blood Pressure Measurement and Recording an ECG Blood pressure measurement BP reading display 1) The “ ” symbol flashes at every heartbeat. for blood pressure measurement START Note • The “ ” symbol appears if the arm cuff is wrapped around the arm correctly.
  • Page 32 3. Taking a Blood Pressure Measurement and Recording an ECG ECG recording 1) The app starts a 30-second countdown and shows the ECG wave on your smartphone. Normal Normal mmHg mmHg mmHg mmHg 2) After completion of an ECG recording, an ECG analysis result (Possible Afib, Bradycardia, Tachycardia, Normal, Unreadable, Unclassified or other messages) appears on your smartphone screen.
  • Page 33 3. Taking a Blood Pressure Measurement and Recording an ECG 7. Release both of your hands from the electrodes and remove the arm cuff. Note • After taking a blood pressure measurement and recording an ECG, you can promptly add tags such as symptoms, activities or personalized notes on the app.
  • Page 34: Taking Only A Blood Pressure Measurement

    4. Taking Only a Blood Pressure Measurement Note • You can take a blood pressure measurement without pairing to a smartphone. To pair your monitor with your smartphone, refer to sub-section 2.2. • When taking a blood pressure measurement and recording an ECG simultaneously, refer to section 3. •...
  • Page 35 Note • If your monitor has not been paired with your smartphone, skip following steps 3) and 4). 3) As soon as your measurement is complete, open the “OMRON connect” app on your smartphone to transfer your blood pressure readings.
  • Page 36 4. Taking Only a Blood Pressure Measurement 6. Press the BP [START/STOP] button to turn your monitor off. Note • Your monitor will automatically turn off after 2 minutes. • Wait 2-3 minutes between blood pressure measurements. The wait time allows the arteries to decompress and return to their premeasurement state.
  • Page 37: Recording Only An Ecg

    1. Sit correctly. Refer to sub-section 3.2. 2. Open the “OMRON connect” app on your smartphone. 3. Follow the instructions to start an ECG recording on your smartphone. Refer to “Help” section on the app for more detail.
  • Page 38 5. Recording Only an ECG 4. Place your smartphone on the smartphone stand of your monitor. 5. Touch 4 electrodes as shown in the image. Top electrodes Relax your hands. Put your thumbs on the top electrodes, and 2 or more fingers on each of the side electrodes to record your ECG.
  • Page 39 5. Recording Only an ECG 6. Remain still until the entire recording process is complete. 1) The app starts a 30-second countdown and shows the ECG wave on your smartphone. 2) After completion of an ECG recording, an ECG analysis result (Possible Afib, Bradycardia, Tachycardia, Normal, Unreadable, Unclassified or other messages) will appear on your smartphone.
  • Page 40: Transferring Your Blood Pressure Readings Manually

    6. Transferring Your Blood Pressure Readings Manually As soon as a blood pressure measurement is complete, open the “OMRON connect” app on your smartphone to transfer your blood pressure readings. If you need to transfer the blood pressure readings later, try transferring them manually.
  • Page 41: Taking A Blood Pressure Measurement Manually

    7. Taking a Blood Pressure Measurement Manually If your systolic blood pressure is more than 210 mmHg, take a blood pressure measurement manually. Prepare for taking a blood pressure measurement by referring to sub-sections 3.1 and 3.2. And press the BP [START/STOP] button. After the arm cuff starts to inflate, press and hold the BP [START/STOP] button until the monitor inflates 30 to 40 mmHg higher than your expected systolic blood pressure.
  • Page 42: Other Settings Of The Monitor

    8. Other Settings of the Monitor 8.1 Disabling/Enabling Bluetooth Disable Bluetooth in your monitor in the following areas where use of wireless equipment is prohibited. • On aircraft • In hospitals • While abroad Bluetooth is enabled as default. 1. When your monitor is off, press and hold the button on the monitor for more than 10 seconds.
  • Page 43 8. Other Settings of the Monitor 8.2 Restoring Your Monitor to the Default Settings To delete all the information stored in your monitor, follow the instructions below. Make sure that your monitor is turned off. 1. While holding the button down, press and hold the BP [START/STOP] button for more than 10 seconds.
  • Page 44: Tracking Your Memory In The App

    2. Tap the ECG recording you wish to view. Note • The “OMRON connect” app has the function of emailing, printing and deleting ECG recordings. When you use these functions, refer to the guidance on the app. 9.2 Tracking Your Blood Pressure Readings Note •...
  • Page 45: Ecg Settings And Adjustments In The App

    10. ECG Settings and Adjustments in the App For settings and adjustments, open the “OMRON connect” app and follow instructions. 10.1 Recording Review Adjustments Enhanced Filter The Enhanced filter suppresses noise in the ECG. From the ECG review screen, tap the graph, then change the filter setting.
  • Page 46: Error Messages And Troubleshooting

    The arm cuff is not applied correctly. the arm cuff does not Refer to sub-section 3.1. inflate. Replace the arm cuff with a new one. Air is leaking from the arm cuff. Contact your OMRON retail outlet or distributor. EN45...
  • Page 47 11. Error Messages and Troubleshooting BP reading display / Possible Cause Solution Problem You move or talk during a measurement and the arm cuff does not inflate Remain still and do not talk during a blood pressure sufficiently. measurement. If “E2” appears repeatedly, inflate the arm cuff appears manually until the systolic pressure is 30 to 40 mmHg above your previous blood pressure readings.
  • Page 48 Refer to sub-section 3.1. Remain still and sit correctly during a measurement. appears does not flash during a measurement. Press the BP [START/STOP] button again. If “Er” still appears, The monitor has malfunctioned. contact your OMRON retail outlet or distributor. appears EN47...
  • Page 49 Possible Cause Solution Problem The monitor cannot connect to a Follow the instructions shown in the “OMRON connect” app. If smartphone or transmit blood pressure the “Err” symbol still appears after checking the app, contact your readings correctly. OMRON retail outlet or distributor.
  • Page 50 Press the BP [START/STOP] button to turn the monitor off, then press it again to take a blood pressure Any other problems measurement. If the problem continues, remove all batteries and wait for 30 seconds. Then, reinstall batteries. occur. If the problem still persists, contact your OMRON retail outlet or distributor. EN49...
  • Page 51 Problem Solution Ensure that the “OMRON connect” app has access to the microphone of the smartphone. Open the settings of your smartphone, and enable the microphone of the app. Try the following tips for acquiring the best quality ECG recording: I have a lot of artifact, •...
  • Page 52: Maintenance

    12. Maintenance 12.1 Maintenance To protect your monitor from damage, follow the directions below: • Changes or modifications not approved by the manufacturer will void the user warranty. Caution • DO NOT disassemble or attempt to repair this monitor or other components. This may cause an inaccurate blood pressure readings and/or ECG recordings.
  • Page 53 12. Maintenance 2. Gently fold the air tube into the arm cuff. Note • Do not bend or crease the air tube excessively. Caution • To unplug the air plug, pull on the plastic air plug at the base of the tube, not the tube itself. 3.
  • Page 54: Cleaning

    • It is generally recommended to have the unit inspected every two years to ensure correct functioning and accuracy. Please consult your authorised OMRON dealer or the OMRON Customer Service at the address given on the packaging or attached literature.
  • Page 55: Optional Accessories

    13. Optional Accessories Arm cuff Arm circumference Arm circumference 17 - 22 cm 22 - 42 cm Model: HEM-CS24 Model: HEM-RML31 • Same as the arm cuff provided with the product. Note • Do not throw the air plug away. The air plug can be applicable to the optional cuff. EN54...
  • Page 56: Specifications

    14. Specifications Product category Electronic Sphygmomanometers with Electrocardiograph function Product description Automatic Upper Arm Blood Pressure Monitor Single lead electrocardiogram Model (code) Complete (HEM-7530T-E3) BP reading display LCD digital display Operation mode Continuous operation IP classification IP 21 Rating DC6 V 4 W Power source 4 “AA”...
  • Page 57 14. Specifications Blood pressure measurement Cuff pressure range 0 to 299 mmHg Blood pressure measurement range SYS: 60 to 260 mmHg DIA: 40 to 215 mmHg Pulse measurement range 40 to 180 beats / min. Accuracy Pressure: ±3 mmHg Pulse: ±...
  • Page 58 14. Specifications Accuracy of Afib algorithm 98% sensitivity and 97% specificity 1. Lau JK, Lowres N, Neubeck L, Brieger DB, Sy RW, Galloway CD, et al. Int J Cardiol. 2013;165(1):193-4 Note • These specifications are subject to change without notice. •...
  • Page 59: Limited Warranty

    15. Limited Warranty Thank you for buying an OMRON product. This product is constructed of high quality materials and great care has been taken in its manufacturing. It is designed to give you a high level of comfort, provided that it is properly operated and maintained as described in the instruction manual.
  • Page 60: Guidance And Manufacturer's Declaration

    Part 1: General Requirements and Part 3: Supplementary requirements for electromechanical blood pressure measuring systems. • Hereby, OMRON HEALTHCARE Co., Ltd., declares that the radio equipment type HEM-7530T-E3 is in compliance with Directive 2014/53/EU. The full text of the EU declaration of conformity is available at the following internet address: www.omron-healthcare.com...
  • Page 61 16. Guidance and Manufacturer’s Declaration Symbols description OMRON’s trademarked technology for Manufacturer’s quality control mark blood pressure measurement Identifier of cuffs compatible for the device Not made with natural rubber latex Cuff positioning indicator for the left arm Arm circumference...
  • Page 62 16. Guidance and Manufacturer’s Declaration Important information regarding Electromagnetic Compatibility (EMC) HEM-7530T-E3 conforms to EN60601-1-2:2015 Electromagnetic Compatibility (EMC) standard. Further documentation in accordance with this EMC standard is available at www.omron-healthcare.com. Refer to the EMC information for HEM-7530T-E3 on the website. EN61...
  • Page 63 Bluetooth SIG, Inc. and any use of such marks by OMRON HEALTHCARE Co., Ltd. is under license. Apple and the Apple logo are trademarks of Apple Inc., registered in the U.S. and other countries and regions. App Store is a service marks of Apple Inc.
  • Page 64 OMRON HEALTHCARE Co., Ltd. Manufacturer Fabricant Hersteller 53, Kunotsubo, Terado-cho, Muko, KYOTO, 617-0002 JAPAN OMRON HEALTHCARE EUROPE B.V. EU-representative Mandataire dans l’UE EU-Repräsentant Scorpius 33, 2132 LR Hoofddorp, THE NETHERLANDS www.omron-healthcare.com Importer in EU Importateur dans l’UE Importeur in der EU OMRON HEALTHCARE Co., Ltd.

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