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CARDIO 24 Mobile ECG unit Ver. 12/2009 - davita
Contents
1. I INTRODUCTION Rete 1 T BASIC FUNCTION OF THE HEART tentat ht visco esit ters tia ta mter Sec etes 1 1 2 CONDUCTION SYSTEM OF THE HEART 000cceseeccseeeceeeeseeeeceeeeceeesasees 1 15 MATIS CARDIO Cre camus tetE p ER PME CUM UMEN MURUS MEE 2 ipae GV iic M 3 1 5 BENEFITS OF O7 c18 0 guerre err erent art emmy dI M UEM sae ME 4 1 6 COMMON CAUSES OF ABNORMAL ECG TRACINGS eeeeeeeeees 4 PRODUCT DESCRIPTION wescesssesccuvosisucicactcbeeussesheseeeceoracale i EE IE EI c GU 5 2o E PRODUCT DESIGN Mcr PV 5 2 Vl POOUCE Ir ACK AGC nc 5 2e r OJU EIDE iyers E E E 5 2 159 E XOHOP DESIO korni utat des eaibersencedeatin sett eut NASCE 6 2 2 OPEBATINGIGABDIO oe eteteisat derent depo cendo ertet area tede 7 2 2 1 PTOCOGLIGaemcinistenui aae Dame daddvatace da qeu MD U EA 7 2 8 2 GOBIFOFBUHODS vcnessaderensubeesate ev etx QR D Xd n qU Drs Eo TOV ES YF EE RPE OM EHE tei 9 22 LEOD LDS rea E A 10 2 2 4 LCD Display Description eeeeeeeeseeeeeeeeeeeeeee 11 2 3 PHODUCT SPECIFIOATIONS s suscetetxsdsta pvisGgenen cedes uoce teet dax sen tenus dece 12 CARDIO SOFTWARE eere eseecec seran enean ases nam sana Dates assa mama ieia 13 3 1 SYSTEM REQUIREMENTS ine qucaE sr Ut UN Seen ISO cbabe Ru SUAE Etude 13 3 2 INSTALLA TON T E 13 Oe SO IPILE RANG Fe Re ticccteteitewsneieneannccioaiaiatiaaesaseacgtescenccend E 14
2. 3 6 4 Print Files 1 Click the box beside the file s to print More than one file can be selected to be printed at one time Figure 22 File Information UserName 0001 FileName Date Time 000100001 01701 00 00 000100000 01701 00 00 User Preview a Delete Prim Save Figure 22 Steps to Print Selected Files 2 Select and printer selection window will appear 3 Choose printer and print options accordingly After printing the window will close and return to the main page 96 Cardio 3 6 5 Save Files 1 Click the box beside the file s to save More than one file can be selected to be saved at one time Figure 23 f File Information UserName 0001 FileName Date Time i O00100001 0101 00 00 INooninnonon 01 01 00 00 Figure 23 Steps to Save Selected Files 2 Select There are 2 options Figure 24 gt Save to Default directory Click on the button to the left Selected files will be saved in BMP format at the default path Any compatible image program can be used to open and edit BMP files gt Save to Followed directory where the user can specify the specific folder in which to save files Defeul directory gt CECGOUBTIT 2 Save ag Tadlaeed directory I Cancel l OK Figure 24 Save ECG File 97 Cardio 3 6 6 File Review and Remarks Cardia T File lafosmation UserMame Cardin 24 I
3. Figure 32 Single ECG Parameters Display Steps to redefine ECG waves 1 Display either the Single or Average Parameter display as shown in Figure 32 2 PR QRS and QT interval will be calculated automatically 3 The software will automatically recalculate the parameters if you click and move the vertical bars shown in the parameter box Figure 32 4 Deselect the bar by left clicking on it again 35 Cardio FREQUENTLY ASKED QUESTI ONS Q1 A1 Q2 A2 Q3 A3 What is Cardio Cardio is a personalized home care heart monitoring device The main function of Cardio is to record ECG tracings anywhere and anytime Using uniquely designed dry electrodes users only need to place both thumbs on the electrodes and their ECG will be recorded The parameters measured will be displayed on the LCD screen Together with the software users can transfer data files to PC for the management of data Why does Noise appear during measurement Cardio measures the electrical activities emitted by the heart The Noise is the interference with the recording of these signals due to poor contact between the thumbs and the electrodes excessive movement of the body and other the environment etc When using Cardio it is recommended that users take a stable sitting position with their feet insulated from the ground Please measure again when Noise appears on LCD screen after the device finishes recording For
4. Wiill the measurement be correct Yes ECG can be recorded after exercise During measurement please remain in a stable position to avoid noise interference Can Cardio be used during commuting During commuting if user is able to keep a stable position Cardio can be used to measure ECG Usage of Cardio is not recommended during the operation of any vehicle Can conducting gel or other fluids be used when using Cardio Cardio is designed to be operated without any conducting gel or other fluids Please do not apply any conducting gel or other fluids to avoid damaging the thumb electrodes and the device 39 Cardio GLOSSARY Aorta The main trunk of the systemic arteries carrying blood from the left side of the heart to the arteries of all limbs and organs except the lungs Arrhythmia Irregularity in the force or rhythm of the heart beat Atrioventricular AV Node A small mass of specialized cardiac muscle fibers located in the wall of the right atrium of the heart that receives heartbeat impulses from the sinoatrial node and directs them to the walls of the ventricles Bundle of His A slender bundle of modified cardiac muscle that passes from the atrioventricular node in the right atrium to the right and left ventricles by way of the septum and that maintains the normal sequence of the heartbeat by conducting the wave of excitation from the right atrium to the ventricles called also atrioven
5. Cardio 3 4 SOFTWARE INTERFACE vccssa cescresiccteenncddatunerenidancaseticesisdaatnuceahonecautaaties 17 3 0 USER MANAGEMENT crassana inea dec mas ico p t MR IM MR reM s 18 IoT Add a NEw USE M 19 302 Diele aU SO e 20 2S0 S Man Oe Aa USE r Aaa 20 oxcsalzi eius 21 3 6 1 File Preview and Print eseeeeeeeeeeeeeeeeeeeeeeees 21 GN osos OCG Mai NND T TU 23 30 9 DCICTE FIOS T H 25 Su T I WNC S oana E 26 70 9 DANS mil iN E A 27 3 6 6 File Review and Remarks ccccseccsecceeeeeeeceeeeeeeeaeeeeeeeaeeeas 28 spWwgnib le 29 4 1 SINGLE ECG SIGNAL AND PARAMETERS ccccesccceseceeeeeeeeeeeesaeeeeeeees 29 4 2 AVERAGE ECG SIGNALS AND PARAMETERS cse 31 4 3 UNDERSTANDING ECG PARAMETERS eene nennen nennen nnn nnns 32 4 9 1 Reading the Gables onda omes as RUD E IDEEN EC RANA RUSSIA GS 32 4 3 2 ECG Waves and Parameters esses 33 4 4 REDEFINING ECG WAVES 0scccccsccescsececceececceeeccseeescseeecceeeeseeeeesoees 34 FREQUENTLY ASKED QUESTIONS c cccssssssssssssssseeeeeesseeeeeeeeeeeees 36 GLOSSARY f 40 di g al iie 2t ee 43 CONTACT INFORMATION 5555 bi ndn ER REY Cn MUR irLIS IEEE Cu C Haan n EN DD ru EE us 43 VI Cardio INTRODUCTION 1 1 Basic Function of the Heart The heart has 4 chamber
6. FTP Error Warning Window b Select Email by clicking on the circle to the left Type in email address of Sender From Receiver To Subject and Body Text Refer to Figure 17 to send files through email User must use an email account and server set up with Microsoft Outlook or Outlook Express These files will be converted to BMP format and sent to the receiver If an error is made a warning window will appear as shown below Warning Message Please setup your Email Server Microsoft Outlook or Outlook Express and try again Figure 19 Email Account Error Warning Window 3 Click on Send Repeat the above steps to send another file Note that you can send multiple files at one time 24 Cardio 3 6 3 Delete Files 1 Under File Management select the files by clicking on the box beside the file name A check sign V will appear as shown below File Information UserName 0001 Sept i FileName Date Time gm 01 01 00 00 000100000 01701 00 00 Step user Review Send T mmm Figure 20 Steps to Delete Files 2 Select and a confirmation warning window will appear as shown Warming Message Figure 21 Confirm Deletion of Selected Files 3 Select to delete the checked files Window will close automatically Select to cancel the deletion 4 Users can repeat above steps to select more files for deletion Click again to deselect the files 25 Cardio
7. conduction electrodes and or external auxiliary electrodes USB interface 1 5V AAA X 2 12 x8 x2 cm 134 g Not including batteries 4 F 122 20 C 50 C 50 F 104 F 10 C 40 C 25 i 95 45 to 180 bpm 3 to 3 mm lt 0 20 sec Cardio Cardio SOFTWARE 3 1 System Requirements Operating System Windows 98 98SE 2000 XP Hardware Requirements gt CPU Pentium Ill and above Memory 100MB and above Hard Disk capacity 100MB and above Data transmission media Universal Serial Bus USB DPI of Screen 1024 x 768 3 2 Installation uh AD daily Cate Tl a Sainya Insrali aran Eiai Si errn am Ad amm nbi ame Homepize F Exbi Figure 3 Cardio Software Main Page Insert Cardio software CD into the CD ROM Select Software Installation from the main page and setup will run automatically If ds Cardio auto installation does not start double click on the autorun exe application file in the CD to install manually Follow the Setup Wizard instruction on the screen 3 3 File Transfer Overview of File Transfer 1 Cardio uses USB 2 After pressing content of cable to connect to data files will be transferred and PC displayed on the monitor All data files recorded in Cardio can be transferred to PC for analysis through the USB port on the left side of Cardio shown in Figure 4 Figure 4 Cardio USB port 14 Cardi
8. detailed operating procedure please refer to P 7 of the User s Manual What are some of the factors that may affect the measurement by Cardio Besides the factors mentioned in Q2 the followings are some of the factors that may also affect measurements 1 Thumbs may be greasy which may affect the transmission of signals Please use clean water or alcohol to clean thumbs 2 Thumbs may be too dry DO NOT use cream Please use external auxiliary electrode cable amp sticky electrode pad 3 Contact pressure between the thumbs and the electrodes may be too strong Please place the ball of the thumbs on the electrodes gently Even when users have followed the regular procedure described in the User s Manual to operate Cardio the user may still experience a weak signal Please contact the distributor retailer or visit DailyCare BioMedical s website www dcbiomed com 36 Q4 AA Q5 Ab Q6 A6 Q7 AT Q8 A8 Q9 A9 Cardio How do you use the optional auxiliary electrodes The optional auxiliary electrodes are for users who cannot hold Cardio steadily without shaking or users whose thumbs are too dry For detailed instructions please follow the steps described in P 8 of the User s Manual Please note that the electrode pads are NOT included Please buy the electrode pads from a medical device store Can Cardio be stopped or powered off in the middle of the measurement During the 30 se
9. mV and each small square represent 0 1mV The X axis represents time in seconds Each big square represent 0 2 seconds Therefore each small square represents 0 04 seconds 32 Cardio single Lj lt 4 Show ECG Parameters Average 0 2 seconds Figure 31 ECG graph 4 3 2 ECG Waves and Parameters The following is a summary of the ECG wave morphologies and parameters that users can use as a guide to interpret their ECG recordings For more technical information please refer to the reference section gt P wave The P wave results from atria contraction P wave is generally about 1 box wide or 1 box tall P wave that exceeds these might indicate atria hypertrophy 1 e enlargement gt PR Interval The PR interval is measured from the start of the P wave to the start of Q wave It represents the duration of atria depolarization Normal duration is from 0 12 to 0 20 seconds f the PR interval is greater than 0 20 seconds then an AV block might be present gt QRS Duration The QRS duration is measured from the start of Q wave to the end of S wave It represents the soos Cardio duration of ventricle depolarization Normal duration is from 0 08 0 12 seconds f duration is longer it might indicate presence of bundle branch blocks or WPW gt QT QT The Q T QT is measured from the start of the Q wave to the end of T wave QT interval represents the duration of activation and recovery of the vent
10. only during battery replacement Thus please replace batteries as quickly as possible to preserve data Why does the transferred files to PC and the number of times measured on Cardio not match Cardio can store up to 30 data files in its memory only When the 30 files limit is exceeded Cardio s system will automatically clear all the recorded data and start recording from file serial number 1 Please remember to transfer data files to the PC before or when the 30 maximum files are reached The purpose of this setup is to remind users to regulary transfer ECG data files to the PC for personal health management How do you transfer Cardio s ECG data files by internet User needs to SAVE the data files first using Cardio s exclusive software before sending the files by e mail FTP For the detailed procedures please refer to the software instruction manual How do you maintain Cardio When the dry conduction electrodes on Cardio are used regularly grease and dirt may accumulate which may affect the recording of signal Please use a clean wiping cloth to remove grease and dirt Please DO NOT use any cleaning solutions or organic solvents to prevent damaging the device Can Cardio use other external power supply No Cardio is to be operated by two replaceable 1 5V AAA alkaline batteries Please do not use other external power supply which may be hazardous and may damage the system and the device Can Cardio us
11. stored data Button 3 When the device is on hold button for 3 seconds to manually clear all stored data Time Setting When the device is on press once to set the right time Hidden T Press Button 2 M to select month date time Button Press Button 3 9 to adjust value Cardio 2 2 3 LCD Display Search sena t O28 co 3335 D Figure 2 LCD Display Panel Q9 OO Q9 9 Reference Range of Measured Results a Menem m momwes n Deme essere mn Attention The information above is for reference ONLY In case Irregular Heart Beats are detected measurement made with this device should only be evaluated after consulting a doctor If the measured parameters fall within the reference range and NO Irregular Heart Beats are detected and the user still feels any discomforts please consult an appropriate physician Measured data by Cardio may be provided for a physician for reference and further analysis 10 JD Item Search oy aU x Record Send Total Number Data File Number Battery Condition HR ol QRS Date Time Cardio 2 2 4 LCD Display Description Descriptions Displays when Cardio is searching for signals Takes around 3 5 seconds Flashes right after measurement when Irregular Heart Beats are detected Note Please consult your physician if Irregular Heart Beats are detected on a regular basis Displays when Cardio is in dat
12. the health and workings of the heart These electrical activities can be detected recorded and studied with an electrocardiograph for example Cardio 1 3 What is Cardio Cardio is a personalized non invasive handheld heart monitoring device designed especially for individual and family use It is not diagnostic in nature but only for recording It alows users to measure and record electrical activities of the heart anywhere and any time he electrical signals from the heart are obtained by placing thumbs on Cardio s specially designed conducting plates without using any complicated wires or conducting gel Cardio takes 30 seconds for each measurement The device will record 15 seconds of the Modified ECG signal and instantly display the average of 3 parameters on the LCD display the average heart rate HR ST segment and QRS interval These parameters are not the traditional standard ECG readings but rather a Modified Lead I ECG Cardio can transfer all recorded measurements to a personal computer through USB connection for easy viewing managing and printing of ECG recordings 1 Cardio uses two conducting electrode plates to measure cardiac activities unlike traditional ECG device which requires at least 3 electrodes ECG measured by Cardio is designated as a modified Lead ECG These parameters from Cardio are only for user reference For interpretation of the parameters please consult professional phy
13. 05759 Email cardio24 dcbiomed com European Authorized Representative Obelis S A Avenue de Tervueren 34 bte 44 B 1040 Brussels Belgium Tel 32 0 2 732 59 54 Fax 32 0 2 732 60 03 Website www obelis net 43
14. Cardio NOTI CE 2005 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 the Taiwan R O C 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 This warranty covers parts labor and transportation costs when upon examination by the Cardio manufacturer the device is determined to be in fact defective In order to implement the provisions of warranty repair the purchaser must notify DailyCare BioMedical concerning suspected defects and then if so instructed ship the instrument to the designated facility correctly pac
15. FileHame Dait Time I C 00055 12009 15 55 O u dn 4 1 15 62 O 900053 O dd e gs CO 0000051 O manns 1 Siriaas L7 m nanad O ooooo47 O mua O04 Tz O hooded O mmia O dijana D B Disconnecilan Copyright amp 2006 Daily Care BioMedical Inc Figure 25 Review ECG Parameters File 1 Click once on the file listed under File Management The file selected will be highlighted in blue with its 15 seconds of recording displayed on the right Figure 25 Only one file can be selected for review at one time The ECG recordings window is separated into an upper and a lower section The upper section shows 15 continuous seconds of ECG signals The lower section is separated into two sides The left side shows a single ECG signal The right side shows an average ECG signal 2 Users can enter or edit notes under the Notes section as shown in Figure 25 The notes will be saved automatically 28 Cardio DATA ANALYSIS 4 1 Single ECG Signal and Parameters Linii 4 LioorMene Ceidio 24 FileName Date Time Pr 0000055 1209 1555 I 0000054 12 08 15 52 O 0000053 1551 10000052 li 15 50 OOOO T2703 15 43 0800851 1 15 58 10600050 12 09 15 43 D GEE 1703 1547 0800845 1 15 43 0000047 12 09 1547 Coo 1 15 41 mnad4s 15 41 Dco a i tio O diihi User re Vies r ECG Ietermallon HR Er er c 4 ORS mn IHG
16. a recall mode Displays when Cardio is transferring data During power on mode the number represents the total number of data files recorded In data recall mode the number represents the serial number of data file being displayed indicates the battery is normal C2 indicates the battery is low Noise is displayed after measurement when noisy signals are detected more than 5 times during measurement PLEASE MEASURE AGAIN Note Under above conditions parameters displayed on LCD may not be accurate but will still be stored in the device Average Heart Rate of 15 seconds Flashes right after measurement when the numbers are out of reference range ST segment Flashes right after measurement when the numbers are out of reference range QRS interval Flashes right after measurement when the numbers are out of reference range Month Day Hour Minute LE Cardio 2 3 Product Specifications Input impedance Input dynamic range Bandwidth CMRR Common Mode Rejection Ration A D conversion Sampling frequency Measurement Time Display Input Output Power Supply Size Weight Environmental Conditions Storage temperature Operating temperature Humidity Measurement Range Average heart rate ST segment QRS interval 12 gt 10 M Ohm 2 mV 0 15 40 Hz gt 60 db 12 bit 250 samples sec 30 seconds First 10 seconds is to search for signals LCD display panel Dry
17. aries according to rate age and sex Right Atrium Top right chamber of the heart Right Ventricle Bottom right chamber of the heart 44 Cardio Right Left Bundle Branch Either of the parts of the bundle of His passing respectively to the right and left ventricles Sinoatrial SA Node A small mass of specialized cardiac muscle fibers located in the posterior wall of the right atrium of the heart that acts as a pacemaker by generating at regular intervals the electric impulses of the heartbeat ST Segment ST segment represents the period from the end of ventricular depolarization to the beginning of ventricular repolarization Superior Vena Cava A large vein formed by the union of the two brachiocephalic veins and the azygos vein that receives blood from the head neck upper limbs and chest and empties into the right atrium of the heart T Wave Ventricular Repolarization Usually 0 5mV or less in Lead Il and Ill 42 REFERENCES 1 American Heart Association 2 National Heart Lung and Blood Institute 3 ECG Library 4 eMedicine 5 HeartCenterOnline CONTACT INFORMATION Manufacturer DailyCare BioMedical Inc Cardio www americanheart org www nhlbi nih gov www ecglibrary com www emedicine com www heartcenteronline com 8F 25 3 Ji Lin Rd Chungli 320 Taiwan ROC European Service Center dyvis gmbh ochillerstrasse 19 74889 Sinsheim Germany Fax 49 7261 4
18. conds measurement Cardio cannot be stopped or powered off Will static electricity affect the measurement of Cardio Cardio is CE certified and has passed electromagnetic interference and compatibility tests Under normal circumstances static electricity will not affect the operation of Cardio How do you manage ECG signals if multiple people use a single Cardio device Data cannot be managed on the Cardio device directly If there is more than one user please use the software provided for data management For detailed information please refer to the User s Manual Why does the temperature of Cardio rise after the batteries are inserted The rise in temperature is caused by the improper direction of the poles of the batteries when inserted Please remove the batteries quickly and then reinsert the batteries correctly Please allow the Cardio to drop to a normal operating temperature before making any measurements Can the parameters measured by Cardio be used for clinical diagnosis The ECG tracings recorded by Cardio is not for clinical diagnostic purposes It is only to be used for physician s reference and to be used for personal home care health management OTa Cardio Q10 A10 Q11 A11 Q12 A12 Q13 A13 Q14 A14 Q15 A15 Why does the data recorded in the Cardio disappear after batteries are replaced Data will remain in the memory for approximately 2 minutes
19. d its accessories under direct sunlight and harsh environments Do NOT disassemble Cardio It may cause device malfunction device failure or damage to the device and you will loose any warranty Cardio ATTENTI ON Appearance of irregular Heart Beat indicator The appearance and flashing of this indicator signifies that ECG irregularities were detected during the 15 second ECG measurement NOTE Please use the device properly by following standard operating procedure Please refer to Section 2 2 Page 7 Improper use of the device will cause inaccurate representation of measured results IHB indicator and or NOISE indicator may appear if the device is not operated correctly If you readings are NOT within the reference range multiple readings are recommended As a rule if you are feeling uncomfortable regardless of the numbers and symbols on the device please consult your physicians immediately If the Irregular Heart Beat indicator appears more frequently for example several times per week on measurements performed daily or if it suddenly appears more often than usual please consult your physicians for medical advices NOTE This device is a Lead Handheld ECG device The accuracy of this device has been clinically validated The device does not replace a cardiac examination but serves to detect Irregular Heart Beats at an early stage Cardio Table of Contents NOTICE srs ATTENTION e
20. e accessories other than the ones provided in the standard package All standard package accessories meet special specifications of medical device regulations Please DO NOT use any other accessories 38 Q16 A16 Q17 A17 Q18 A18 Q19 A19 Q20 A20 Q21 A21 Cardio other than the ones provided in the standard package to avoid hazards and subsequent damages to the device and to avoid hazards What to do if the parameters measured by Cardio do not correspond with the user s condition In case of an emergency physical condition users should contact emergency services immediately or go report immediately to the hospital If the measured parameters do not correspond with user s condition please make sure all standard operating procedures are followed If not please contact a physician for further check up Can any other fingers be used beside the thumbs for measurement of ECG Noise signals may be larger if fingers other than the thumbs are used It is recommended that users choose the optional Auxiliary Electrodes for measurement of ECG Can Cardio be used while the user is standing up sitting down or lying down Will the measurements make any difference Different body positions may affect the cardiac signals slightly However by following the standard operating procedure closely Cardio is able to record ECG signals correctly After exercising can ECG be measured using Cardio
21. eg Haie D jp B Dizcannmectiaen Copyright 2006 Daily Care Bloedic hnc Figure 26 15 Seconds signal recording with Single signal display 1 Start up the Cardio software by clicking on the icon 2 Select a User under File Management Then select a file to view by clicking on it 3 A 15 second recording will be shown on the right side of the screen in quadrant 1 Q1 Figure 26 4 Click on the ECG Parameter Square as shown in Figure 27 This will display the ECG Parameter of the signal with the red flag on top of it The display area would point to the left as shown with the circle Click on the square again to parameter values Figure 28 29 Cardio ECG Parameter Square single Single ECG Parameters Average PR interzal 148 ms Heart Rate 64 bpm 4 QRS duration 84 ms ol level mim Lo QT OTc 388 401 ms Single Average Figure 28 Hide ECG Parameters 5 Move the red flag in quadrant 1 Q1 by clicking on any QRS complex The selected signal will be displayed in quadrant 2 Q2 with its signal parameters gt Single ECG parameters include PR interval QRS duration QT QT and heart rate 30 Cardio 4 2 Average ECG Signals and Parameters goiris isma 15 49 zi mmjs dr gt 14B ii I OAS duration l ma DTIJUTE 3995 40 ms Figure 29 15 second signal recording with average ECG Parameters 1 Start up the Cardio sof
22. have abnormal ECG tracings These include people who smoke who have high cholesterol who are over weighted or who have a family history of heart complications Please consult your physician if you are concerned about your ECG recording and symptoms to get more information about your condition Cardio PRODUCT DESCRI PTI ON 2 1 Product Design 2 1 1 Product Package Standard Package MI X Cardio x 1 M USB Cable x 1 M Cardio Software CD x 1 M Cardio User s Manual x 1 Optional Accessories vi Auxiliary Electrode Cable x 1 Not Included 1 Electrode gel pad These pads can be purchased at local drug stores 2 AAA alkaline battery Cardio needs two to operate 2 1 2 Product Label turae ot LOT XXXXX XX XXXXX PRODUCT BATCH Attention consult Tbyosvcs Eli amen 5 NO pocument Seoc N M Lind acm Getler ina DOCUMENT BF 35 5 Lin AD Cw 120 Tn ieee 0 mn CERTIFIED CE AER H AN Norton mem ANON LR MARKING NOTIFIED CE as TYPE BF RA amp 01987 Model Cardio BODY NO 0197 EQUIPMENT Nam in Tarea Two 1 5 AAA sone barernes Cardio IS TYPE B EQUIPMENT WITH F TYPE APPLIED PART IN EN IEC60601 1 STANDARD Cardio 2 1 3 Exterior Design Front Cover LCD Display Left Thumb Right Thumb Electrode Electrode Date Time On Off Start Button File Transfer Button Data Recall Button External Auxiliary Electrode Socket hai Dy for XXXXX XX XXXXX jarok na S
23. io File transfer is not needed 16 Cardio 3 4 Software Interface BL et roe hh ih LgrEAms Canile 74 ire Fiche imm Figure 9 Cardio Database Software Interface Details Cardio has a simple analysis interface as shown in Figure 9 This analysis and database management system is divided into four main parts 1 User and file management 2 Average ECG parameters display and remarks 3 Connection status of ECG to PC 4 ECG record 15 seconds and diagram analysis display Cardio 3 5 User Management Under File information two rows of function keys are located at the bottom for managing user names and user ECG files as shown in Figure 10 Figure 10 Function keys The function keys are described as follows Function Keys Preview Delete t ave Description Add Delete or Change User Preview File for Printing oend Selected Files Delete Files from Record Print Selected Files save ECG Figures Detailed descriptions of Function Keys are as follows 18 Cardio 3 5 1 Add a new User 1 Click on function key under File Management The user Management Window will appear as shown in Figure 11 Add 7 Change Uger Name UserName DCEM Add Delete Figure 11 User Management Window 2 Enter user name ID and Age 3 Click on and a new user will be added to the table Use only characters and n
24. ked in an appropriate shipping container for examination and servicing LIMITATIONS AND EXCLUSIONS This warranty does not cover repairs necessitated by any damage to equipment caused by mishandling neglect abuse customer modification or failure of the user to follow the published operating instructions Repaired devices are warranted for a period of 30 days and are subject to the limitations and exclusions described in 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 policy Cardio ATTENTION Cardio is NOT a diagnostic device It is only an ECG recorder is NOT a substitute for a traditional ECG diagnosis will NOT tell you if you have heart problems Only your physician can do that You should NOT interpret the measurement results yourself is NOT recommended for users with pacemakers What you should not do Do NOT operate Cardio at the same time with other electrical devices Do NOT connect Cardio to the PC via USB cable when measuring Do NOT use accessories other than those provided by the manufacturer Do NOT subject the device to water and liquid spillage Do NOT clean with alcohol acetones or any other flammable chemical agents Do NOT place the device an
25. lidi S k t c UL Cover a ce Model Cardio Mare ii Thien Two 1 5V AAA sine batien USB Cable socket Product Label ET Cardio 2 2 Operating Cardio 2 2 1 Procedure Open the cover of Press once to start LCD screen will Cardio measuring Allow 30 display the parameters seconds after measurement Wash and dry your hands before use Sit down and place your hands comfortably on a table or on your laps Hold Cardio in your hands steadily Calm and relax yourself with regular breathing Press once and place right and left thumbs gently on the conduction electrodes to start measurement During measurement a timer will be displayed at the right bottom corner of LCD screen During the 30 seconds of measurement avoid talking and keep a steady but gentle contact of the thumbs to the conduction electrodes Cardio can store up to a maximum of 30 data files Memory will be cleared automatically if more than 30 data files are stored Three parameters of the measured results will be displayed on the LCD screen To start another measurement simply press again Please note that Cardio cannot be powered off during recording 2 3 4 Hold for 3 seconds to power off the device Cardio will be powered off automatically if left idle for more than 2 minutes to save power Cardio Optional Method Cardio has optional auxiliary electrodes as an alternative way for users to take ECG reading
26. n Figure 14 File Information UserName 0001 Sei J FileName Date Time 000100001 01 01 00 00 OOO1O0000 01 01 00 00 mE L Figure 14 Steps to Preview Files Cardio 2 Select Preview and a preview window will appear as shown Figure 15 Preview ECG Pattern Parameter for Printout There are 6 function keys in the preview window Select to enlarge pattern diagram Select to reduce pattern diagram Select to page up Select to page down Select to print Select to exit preview window and return to the main page 99 Cardio 3 6 2 Send Files 1 Under File Management select the files by clicking on the box beside the file name A check sign V will appear as shown in Figure 16 File Inform ation UserName 0001 b FileName Date Time N 0001 00001 01 01 00 00 000100000 01701 00 00 Figure 16 Select Files to Send 2 Select Send and a Send Window will appear as shown below in Figure 17 From Mail Tac Subject Figure 17 Select Sending Method 205 Cardio There are 2 options available a Select by clicking on the circle to the left The other option will be grayed out Type in User Name Password and Host address Refer to Figure 17 These files will be the original ECG data files If an error is made a Warning Window will appear as shown below Warning Message Figure 18
27. o Steps for file transfer Please follow the following steps 1 Start Cardio software by clicking on the Cardio icon 43 A Disconnected status will be shown on the bottom left of the main menu Figure 5 Bom Disconnection Figure 5 ECG not connected to PC 2 Slide the socket cover to expose the USB port on Cardio Figure 6 Locate available USB port of computer Connect Cardio as shown below at point A to PC at point B using the USB cable provided Figure 6 Connection of USB Cable 15 Cardio 3 A Connected status will be shown as in Figure 7 Figure 7 ECG connected to PC 4 Press on Cardio and Send will appear on the LCD display indicating a transfer of the data files to the PC The number below Send is the serial number of the data files currently downloading to the PC A transmission window will appear on the PC to show data transmission in progress as shown below Data Transmission Progress Ly Le Figure 8 Data Transmission Progress Window gt Cardio will automatically erase the memory after data files have been transferred to the PC successfully gt If Send flashes after pressing or during file transfer it means that the connection between Cardio and PC has failed Please close and start the software again or reconnect the USB cable gt If number 0 appears below Send after pressing it indicates that there are no more data files in Card
28. ricular muscle This duration varies inversely with the heart rate The normal QT is approximately 0 41 seconds or an accurate measurement it is corrected with the heart rate with the following formula to get QT QT QT 1 75 HR 60 gt ST Segment The ST segment is measured from end of S wave J point to the start of T wave This segment is important in identifying pathology such as myocardial infarctions elevations and ischemia depressions To learn more about the analysis of ECG parameters please refer to the list of references provided in the Reference Section 4 4 Redefining ECG Waves This section is highly recommended for doctors only The power of the device lies in the algorithm which identifies and defines P Q R S and T wave intervals to generate the parameters observed on the file The algorithm is highly precise and accurate which is observed in a correlation study with standard ECG device 34 Cardio In order to present a flexible format the software is developed with the ability to redefine the waves This should only be done by a medical professional who has great experience with ECG analysis and interpretation Therefore users are strongly advised against performing the function in this section unless under the guidance of a medical professional Single Single ECG Parameters Average 4 PA intemal 148 ms Hearn Rate 54 bpm ORS duration 04 ms ST level mm OTe JUHAN ms
29. s Please follow the steps below when using the auxiliary electrodes Place the sticky electrode pad not included on the middle of the inner forearms Users can buy qualified electrode pads from any medical device stores olide the socket cover to expose the optional electrode socket and connect the cable to Cardio accordingly Please connect the RED electrode on the right arm and the BLUE electrode on the left arm as shown on the right otart the measurement as described above Section 2 2 1 The auxiliary electrode socket is located on the left of the device Both auxiliary electrode and USB sockets on the device are only to be used with the standard accessories provided Warranty will NOT cover damages that result from NOT complying with the instructions Cardio 2 2 2 Control Buttons Control Button Descriptions Buttons Descriptions Power On Start Measurement Power Off Press once to power on and start measurement Hold for 3 seconds to power off Button 1 After measuring press again to start another measurement Data Recall Press once to enter data recall mode The latest data recorded will be displayed Press again to recall other recorded data starting from Button 2 the first Hold for 3 seconds or press any other button to leave data recall mode M Data Transfer Data Clearance Connect Cardio to PC with USB cable and press once to start transferring of
30. s that act together to pump blood throughout the body The 2 smaller upper chambers are called atria and the larger lower chambers are called ventricles The right atrium receives oxygen depleted blood coming back from the body via 2 large veins the superior vena cava and inferior vena cava The right atrium pumps this blood into the right ventricle which then pumps the blood into the lungs which is oxygenated The blood then comes back into the left atrium which is then pumped into the left ventricle The left ventricle then pumps the blood back to the circulatory system via the aorta the largest artery in the body The pressure that the left ventricle exerts to keep the blood moving throughout the whole body is the blood pressure 1 2 Conduction System of the Heart The chambers of the heart pump with the automatic discharge of electricity from the sinoatrial SA node a group of specialized cells in the right atrium On average there are 60 to 100 times discharges per minute When the SA node discharges both atria contract and the electrical impulse is relayed to the atrioventricular AV node that is between the 2 ventricles The electrical wave that is propagated at the AV node causes both ventricles to contract and pump blood Ihe normal delay between the atrium and ventricle contractions is 0 12 to 0 20 seconds By studying the electrical activity that results when E Cardio heart muscle cells contract we gain insight to
31. sicians Additional standard 12 lead ECG may need to be performed mee 1 4 ECG Variables WAVE Complex Wave I Cardio nFEICHETEITI Figure 1 Normal ECG Waveform Lead l Figure 1 is a presentation of a normal ECG waveform from Lead I Cardio has algorithms that will identify and compute parameters in the table listed below Table 1 is a list of ECG parameters measured by Cardio Table 1 Cardio Output Parameters Parameters Average Heart Rate HH SI Segment ST QRS Interval QRS PH Interval QT QT Reference Range 60 lt HR 100 bom 2 lt ST lt 2 Mmm 0 08 s lt QRS lt 0 12 s 0 12 0 205 0 32 0 44 s 0 41 0 44 s Cardio 1 5 Benefits of Cardio Cardio is a recording device used to monitor the electrical activities of the heart anytime anywhere It is designed to be small portable and easy to use With Cardio you can e lake measurements anytime anywhere Cardio is available anytime to periodically monitor the heart throughout the day e Manage ECG recordings over time Cardio software allows users to manage their ECG recording to monitor ECG changes over time e Provide your physicians with these historic data Data generated by Cardio can be used as a reference when diagnosing for conditions in the future 1 6 Common Causes of Abnormal ECG Tracings Individuals with high risk factors might
32. tricular bundle His bundle Electrocardiogram The curve traced by an electrocardiograph Electrocardiograph An instrument used in the detection of heart abnormalities It measures electrical potentials on the body surface and generates a record of the electrical currents associated with heart muscle activity Heart Rate HR The number of heartbeat per unit time usually in minutes Hypertrophy A non tumorous enlargement of an organ or a tissue as a result of an increase in the size rather than number of constituent cells Inferior Vena Cava Large vein formed by the union of the two common iliac veins that receives 40 Cardio blood from the lower limbs and the pelvic and abdominal viscera and empties into the right atrium of the heart Left Atrium Top left chamber of the heart Left Ventricle Bottom left chamber of the heart mm One mm is one small square on the electrocardiograph Myocardial Infarction Formation of an area of tissue that undergo necrosis as a result of obstruction of local blood supply as by a thrombus or embolus P Wave Atrial Depolarization contraction Normal duration is 0 06 0 11 second Parameters A distinguishing characteristic or feature PR Interval Atrial and AV node depolarization Regular duration is 0 12 0 20 seconds QRS Interval Ventricular depolarization Regular duration is no longer than 0 1 second QT Interval Ventricular refractory time Duration v
33. tware by clicking on the icon E 2 Select a User under File Management Then select a file to view by clicking on it 3 A 15 second recording will be shown on the right side of the screen in quadrant 1 Q1 with a red flag in the yellow square in quadrant 2 Q2 Figure 29 4 Click on the ECG Parameter Square This will display the ECG Parameter of the ECG signal with the red flag on top of it 5 To select a range right click once on the graph to mark the beginning of a range and right click again on the graph to mark the end of the range as shown in Figure 29 Red bars denote the range selected gt As a range is selected the display area will point to the right as shown in the red circle in Figure 30 This denotes that the 31 Cardio parameters shown are averages calculated from the range chosen gt Users can switch between single or average views by clicking on the area in Quadrant 2 Q2 or Quadrant 3 Q3 Single Average ECG Parameters ee AWErage PH interval 136 ms Heart Rate B7 hp QRS duration 100 Nms oT hewel 0 0 mm OTfOTc 404 417 mrs S 4 ORTU PR QRS Figure 30 Average ECG Signal and Parameters 4 3 Understanding ECG Parameters 4 3 1 Reading the Graph Figure 31 The Y axis represents voltage in mV The bar indicated below represents 1millivolt mV This denotes the electrical strength of the signal Therefore each big square represent 0 5
34. umbers for user name If the user name is entered inappropriately a warning window will appear as shown Hanoy LEES Tu Please input complete user information L ok Figure 12 User Information Incomplete Window 4 Repeat step 2 and 3 to add more new users 5 Click on or to close the user management window 19 Cardio 3 5 2 Delete a User 1 Click on function key under File Management 2 Select the user to be deleted by clicking on the name 3 Select Delete A warning window will appear as shown below Add Change Der Mame UserName Figure 13 Steps to Delete User 4 Select to delete Select to cancel the deletion 5 Click on or close the window to exit 3 5 9 Change a User oelect a user by clicking on the user name Then close the window to return to main page Alternatively double clicking on the user window will select the user and close the window automatically 20 Cardio 3 6 File Management This section will show users how to manage their files with the menu under File Information At least one file has to be selected to use the following functions PreView Send Delete or Save Users can select one or more files by clicking on the box on the left of the file 3 6 1 File Preview and Print 1 Select one or more files to preview by clicking on the box to the left of the file name A check sign V will appear as shown i
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