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DailyCare BioMedical ReadMyHeart 100 User Manual

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ReadMyHeart 100
Copyrights and Trademarks Notice
Copyright © 2006 DailyCare BioMedical, Inc. All rights reserved.
No part of this publication may be reproduced in any manner
whatsoever without written permission from the owner.
Proprietary rights of DailyCare BioMedical are involved with the
subject matter of this document and all manufacturing,
reproduction, use, and sales rights pertaining to such subject
matter are expressly reserved. The recipient, by accepting this
document, agrees that the information contained herein will not be
copied or reproduced in whole or in part, nor its contents revealed
in any manner or to any person, except to meet the purpose for
which this document was prepared and delivered without the
express permission of DailyCare BioMedical.
Printed in Taiwan.
I

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Summary of Contents for DailyCare BioMedical ReadMyHeart 100

  • Page 1 ReadMyHeart 100 Copyrights and Trademarks Notice Copyright © 2006 DailyCare BioMedical, Inc. All rights reserved. No part of this publication may be reproduced in any manner whatsoever without written permission from the owner. Proprietary rights of DailyCare BioMedical are involved with the...

  • Page 2: Document Warranty

    ReadMyHeart 100 Document Warranty The information contained in this document is subject to change without notice. DailyCare makes no warranty of any kind with respect to this information. DailyCare SPECIFICALLY DISCLAIMS ANY IMPLIED WARRANTY OF MERCHANTABILITY AND FITNESS FOR ANY PARTICULAR PURPOSE.

  • Page 3: Table Of Contents

    ReadMyHeart 100 Table of Contents Copyrights and Trademarks Notice......... I Document Warranty..............II Chapter 1: Introduction to ReadMyHeart ....... 1 Purpose of the device (Indications for use)......1 Important safety notice ............1 Caution ................... 2 Introduction: what do ECGs do? ..........3 How does ReadMyHeart work? ..........
  • Page 4 ReadMyHeart 100 Chapter 4: Viewing records on ReadMyHeart ..... 17 Recalling Data ..............17 Deleting data ................ 18 Chapter 5: Installing ReadMyHeart software ....... 19 System requirements ............19 Software installation instructions .......... 19 Software registration and upgrade information ....20 Transferring data from ReadMyHeart to a PC......

  • Page 5: Chapter 1: Introduction To Readmyheart

    ReadMyHeart 100 Chapter 1: Introduction to ReadMyHeart Thank you for purchasing ReadMyHeart. This manual provides guidance on how to use this product, as well as reference information on its components. Purpose of the device (Indications for use) ReadMyHeart is intended to record, display, store, recall, and transfer electrical heart activity for home health care use.

  • Page 6: Caution

    ReadMyHeart 100 Caution: Do NOT o perate ReadMyHeart concurrently with other electrical devices. Do N OT connect the device to your computer via USB cable while recording Do N OT record with a dirty or greasy hand surface Do NOT mov...

  • Page 7: Introduction: What Do Ecgs Do

    ReadMyHeart 100 Introduction: what do ECGs do? The function of our heart is so important. It has its own automatic nervous (electrical) system to keep it running independently, without control from the brain. Electrical waves travel through the heart chambers to charge and trigger heartbeats. Each chamber contracts with perfectly synchronized timing to circulate blood effectively.

  • Page 8: Chapter 2: Getting Started

    ReadMyHeart 100 Chapter 2: Getting started Product Package contents ReadMyHeart USB Cable ReadMyHeart Software CD ReadMyHeart User’s Manual External Auxiliary Electrode Cable Note: The following accessories are not included: 1. AAA alkaline batteries: Two batteries are needed to operate ReadMyHeart.

  • Page 9: Product Back View & Side View

    ReadMyHeart 100 Product Back View & Side View Back View Side View Battery cover External Auxiliary Electrode Socket Sliding Socket Cover USB Cable Socket Product Label Product Label Product Lot Attention, consult Serial No. accompanying Certified CE document marking, Notified Body NO.

  • Page 10: Battery Installation

    ReadMyHeart 100 Battery Installation Slide the battery cover open, and insert two AAA alkaline batteries, making sure the poles of the batteries are inserted correctly. Note: If the batteries are inserted incorrectly, it may cause the temperature of ReadMyHeart to rise suddenly. In the event of a sudden rise in device temperature, immediately remove the batteries and reinsert them correctly.

  • Page 11: Lcd Panel Description

    ReadMyHeart 100 LCD panel description (See p. 9 ‘Recording ECG Parameters’ to obtain the screen below) Item LCD Panel Descriptions Search Displayed when detecting heart electrical signals. Flashes when recording is in progress. Flashing stops when recording is completed. NOTE: This is an idealized ECG tracing, NOT a real-time recorded ECG tracing.

  • Page 12: Turning The Power On

    ReadMyHeart 100 is displayed when signal recorded is noisy or beyond the device’s testing range. Note: Inaccurate parameters will still be displayed on LCD and stored. They will appear in RED on your heart trend when displayed on the software (See Ch.

  • Page 13: Setting Date/Time

    ReadMyHeart 100 Setting Date/Time When the device is showing the main menu: 1. Use a thin pointed object (like a toothpick) to click the indented button. Do NOT use a sharp object as this could damage the device. The number under Month on the LCD panel will start to flash.
  • Page 14 ReadMyHeart 100 5. Press the button to start recording. 6. Immediately place your thumbs gently on the dry electrode pads and make sure that they cover the whole electrode pad. will animate on the LCD panel during the recording. 8. The device will record for around 25 -27 seconds. Do not move, talk, or breathe deeply during recording time.
  • Page 15 ReadMyHeart 100 When it is done if the conductivity is very poor, then the LCD panel will look like this: If the measurement is completed despite disturbed conductivity, the screen will look like this: Note: In the screen above, even though the numbers are displayed, the measurements are inaccurate.

  • Page 16: Heart Function (Ecg) Parameters

    ReadMyHeart 100 Heart Function (ECG) parameters The ReadMyHeart hardware displays 3 heart function (ECG) parameters: the average heart rate (HR), the ST segment (ST), and the QRS interval (QRS), displayed on the LCD after each recording. The reference range of the parameters is shown below.

  • Page 17: Chapter 3: Improving Recording Quality

    ReadMyHeart 100 Chapter 3: Improving Recording Quality “Noise” appears during the recording time If the conductivity is too poor for an accurate reading, the following may apply: • “Noise” appears on the LCD • HR numbers change rapidly/ abruptly during recording •...

  • Page 18: Step By Step Recording Procedures

    ReadMyHeart 100 • your thumbs may be covered by dirt, oil, or layers of residue • the skin of your thumbs may be too dry • the skin on your thumbs may be very thick By washing your hands with soap, you will not only remove any dirt or oil but also moisturize the surface, improving the conductivity of your thumbs.

  • Page 19: How Do I Know If There Was A Conductivity Problem

    ReadMyHeart 100 6. Place your thumbs gently on the dry electrode pads and make sure that they cover the whole electrode pad. 7. Do not move, talk, or breathe deeply during the 25 -27 second period of recording. How do I know if there was a conductivity problem? 1.

  • Page 20: Alternative Recording Method

    ReadMyHeart 100 Alternative recording method The device can take measurements through an external auxiliary electrode cable. This cable and ECG conductive adhesive electrodes (ECG pads) are included, but replacement of ECG pads are optional accessories, available for purchase separately. Note: Use only FDA approved ECG pads.

  • Page 21: Chapter 4: Viewing Records On Readmyheart

    ReadMyHeart 100 Chapter 4: Viewing records on ReadMyHeart Operation of ReadMyHeart hardware only requires the four basic control buttons as described below: Buttons Descriptions Start recording / Power Off Recalling Data Transfer Data / Delete Data Set Date / Time Touch any key to switch power on.

  • Page 22: Deleting Data

    ReadMyHeart 100 seconds, pressing or pressing clears the parameter box on the right hand side of the LCD and return to the main menu (see page 7 to know about the main menu). Note: The ReadMyHeart hardware can store 30 records in its memory.

  • Page 23: Chapter 5: Installing Readmyheart Software

    ReadMyHeart 100 Chapter 5: Installing ReadMyHeart software There are some advanced functions available with the software provided. Before learning about those functions, you will need to install the software onto a PC with CD Rom drive. System requirements To install and use the components of the ReadMyHeart software, your computer system must meet the following requirements: •...

  • Page 24: Software Registration And Upgrade Information

    ReadMyHeart 100 First, check that your PC meets the System requirements (p.19). To install ReadMyHeart software: 1. Exit all open programs. 2. Insert the ReadMyHeart CD-ROM into the computer’s CD-ROM drive. 3. The software should start running automatically. 4. If auto-installation does not start, browse CD Rom drive for the menu and open “autorun.exe”...

  • Page 25: Transferring Data From Readmyheart To A Pc

    Start the ReadMyHeart software by clicking on the ReadMyHeart icon: on your desktop, or use Windows Explorer to locate and run “Program Files\DailyCare BioMedical\ReadMyHeart OTC\ ReadMyHeart.exe” A “Disconnected” status will be shown initially on the bottom left of the software screen on the PC monitor as follows: 1.
  • Page 26 ReadMyHeart 100 2. When the USB connection is detected, this icon will appear on the bottom left corner of the software screen on the PC monitor: 3. Press the button on ReadMyHeart device to transfer data from the hardware to the computer.
  • Page 27 ReadMyHeart 100 means the connection between ReadMyHeart and the PC has failed. Please close and start the software again, and/or reconnect the USB cable. 3. If you have successfully transferred your data to the software, even if you press the button again, the software will not receive and duplicate the same data.

  • Page 28: Chapter 6: Using Readmyheart Software

    ReadMyHeart 100 Chapter 6: Using ReadMyHeart software READMYHEART has a simple displaying interface. This display and data management system is divided into four main sections: Record Management Section Heart Parameter Section Trend Plotting Connection Section Section ReadMyHeart software automatically shows you the past 14...

  • Page 29: Viewing Heart Parameters And Data Files

    ReadMyHeart 100 Viewing Heart Parameters and Data Files To view an individual record, you can: • click on its date, time, or record number on the Record Management section (1) • or you can select one point on the Trend Plotting Section...

  • Page 30: Deleting A Record

    ReadMyHeart 100 Note: Data which showed “noise” during recording or which has parameter values outside of the reference range (see Heart Function (ECG) parameters p.12) will appear in RED on the trend curve. Deleting a Record To Delete a record, simple check the record you wish to delete and click “Delete”.

  • Page 31: Chapter 7: Care And Maintenance

    ReadMyHeart 100 Chapter 7: Care and Maintenance Cleaning the dry electrodes When the dry conduction electrodes on ReadMyHeart are used regularly, grease and dirt may accumulate, possibly affecting the recording of the heart function parameters. Please use a clean wiping cloth to remove grease and dirt. DO NOT use any cleaning solutions or organic solvents as they will damage the device.

  • Page 32: Product Registration, Updates, Newsletters

    ReadMyHeart 100 Product registration, updates, newsletters: For registration and software upgrade please see “Software registration and upgrade information“ on page 20. FDA and Health Canada Licence Numbers USA FDA 510K Clearance: K042814 Health Canada Lic # 66589 Descriptions of the device The ReadMyHeart hardware has an LCD panel protected by an open cover.

  • Page 33: Product Specifications

    ReadMyHeart 100 Product Specifications Input impedance > 10 Mohm Input dynamic range +/- 2 mV Bandwidth 0.15 – 40 Hz CMRR (Common Mode > 60 db Rejection Ration) A/D conversion 12 bit Sampling frequency 250 samples/sec Measurement Time ~25-27 seconds...

  • Page 34: Medical Device Warranty

    ReadMyHeart 100 Medical Device Warranty DailyCare BioMedical warrants each new device to be free from defects in material and workmanship. This warranty is not transferable. This warranty is effective for a continuous period of one year from initial date of shipment against the original order to the original purchaser.
  • Page 35 ReadMyHeart 100 this document. DailyCare BioMedical reserves the right to make design changes in its products without incurring the obligation to incorporate these changes in products previously delivered. This warranty applies unless DailyCare BioMedical has agreed to and provided a written exception to this...

  • Page 36: Chapter 8: User Assistance And Trouble Shooting

    ReadMyHeart 100 Chapter 8: User Assistance and Trouble Shooting Frequently Asked Questions Why does the “Start” button not activate a new recording? 1. If you see that the Record # on the device LCD is blinking (see page 7 for a panel description), then the memory is full.
  • Page 37 ReadMyHeart 100 Will static electricity affect measurement ReadMyHeart? ReadMyHeart certified passed electromagnetic interference and compatibility tests. Under normal circumstances, static electricity will not affect the operation of ReadMyHeart. Can ReadMyHeart use another external power supply? No. READMYHEART is to be operated ONLY by two replaceable 1.5V (AAA) alkaline batteries.
  • Page 38 ReadMyHeart 100 Q11: Can ReadMyHeart be used while standing up, sitting down, or lying down? For optimal accuracy, it is recommended that you be in a stable sitting position to take the recording. Q12: After exercising, can I measure heart parameters? Will the measurement be correct? Yes, heart parameters can be recorded after exercising.

  • Page 39: How To

    ReadMyHeart 100 “How to …?”, “What…?” and “ Where…?” Q15: How to install or change the batteries. See “Battery Installation” page 6 Q16: How to setup the date and time. See “Setting Date/Time” page 9 Q17: How do I install the software? See “Software installation instructions”...

  • Page 40: Contact Dailycare

    ReadMyHeart 100 Contact DailyCare Headquarters contact information DailyCare BioMedical Inc. 8F, 25-3, Ji-Lin Rd, Chungli 32062, Taiwan Email: info@dcbiomed.com Website: www.dcbiomed.com USA contact information DailyCare USA Inc. 44888 Osgood Rd. Fremont CA 94539 Tel: 1-800-970-8620 FAX: 1-510-683-8662 References American Heart Association www.americanheart.org...

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