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InstantCheck ECG User Manual

1. 12 V 2 4 PRODUCT 65 00 0 0 1 13 READMYHEART SOFTWARE 14 3 1 SYSTEM REQUIREMENTS 14 3 2 00000 1 14 3 9 TRANSMIT 15 3 4 SOFTWARE INTERFACE niens 18 3 5 USER MANAGEMENT 2ceccccececcececcccacecccceccceacsceaeacseavsnees 19 3 5 1 Add a New 2 101 0 20 3 5 2 Display or Change User s Information 21 3 5 3 Search for SOR dado 22 3 5 4 Move file to other User folder 22 3 5 5 Delete E mail Save Preview and Print a File 23 o o D Del eO HH DIDI C IU HA 23 3 5 7 Review ECG Trace and Parameters 25 3 5 8 Redefine ECG 26 3 5 9 Reading the Grapn 27 3 5 10 ECG Waves and Parameters 28 FREQUENTLY ASKED QUESTIONS 30 1 c S 34 REFERENCES j ccccscsccnencncnsecccscncncnsenenencnsecccscsenessunenenensecenccses 36 CONTACT INFORMATION 2 37 VI
2. afe S N Dail rag Chungi 320 Ti awan Ace 100 RMH4 0 Made in Taiwan Two 1 5V AAA size batteries Parts Descriptions A Power on off button Turns the power on and off B 9 Start button Press to start measuring LUN s Description of device information External electrode cable Insert external electrode cable in this Socket Socket Protection mechanism to make sure L Sliding socket cover USB cable and external electrode cable is NOT used at the same time Only Insert USB cable provided by Note Only use USB cable provided by manufacturer Other USB cables will cause serious damage to device Please visit www dcbiomed com to re order USB cable 2 1 2 Product Package Standard Package N 4 AW Auxiliary Electrode Cable InstantCheck InstantCheck Software CD InstantCheck User s Manual Carrying Case USB Cable Not Included 2 1 3 Product Label Attention consult ACCOMPANYING ally Gale S N DOCUMENT 25 3 Ji Lin RD i Chungli 320 Taiw td Model 4 0 Made in Taiwan Two 1 5V size batteries DailyCare BioMedical Inc x 1 x 1 x 1 x 1 x 1 x 1 Manufactured by Lor _ _ 1 Electrode gel pad These pads can purchased at qualified local drug stores 2 AAA alkaline battery operate
3. 3 When the USB connection detected it will be indicated on the bottom left corner of the software screen Only use USB cable provided by manufacturer to transmit data 24 4 Press until G Transmit Data is highlighted Then press OK to transmit data to PC Arrow gt will appear on the LCD panel indicating the transferring of data Data transmission progress window will pop up on the monitor User name DCBM Total records Received record 1 Receiving data please keep connecting Please confirm select the right user before the transmitted data save to the PC The user confirm window as below F Transmit data to you sure want to tranzmit data to this user fe Yes Nn Select other user After data files have been successfully transferred to the PC and when you start your next measurement InstantCheck hardware will erase its memory automatically 25 The default file name is the time stamp of the reading clicking the selected file name the user can change the name hes OE Eri If gt flashes after pressing 4 or during file transfer it means the connection between InstantCheck and the PC has failed Please close and start the software again and or reconnect the USB cable 3 4 Software Interface InstantCheck 4 0 ECG Analysis Software AHK File Help 2 1x2 2 Amy 01012000 000 0701
4. What is ReadMyHeart ReadMyHeart is a personalized home care heart monitoring device The main function of ReadMyHeart 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 ReadMyHeart 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 ReadMyHeart 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 detailed operating procedure please refer to P 9 of the User s Manual What are some of the factors that may affect the measurement by ReadMyHeart Besides the factors mentioned in Q2 the followings are some of the factors that may also affect measurements 1 Thumbs be greasy which may affect the transmission of signals Please use clean water to clean thumbs 2 Thumbs be too dry DO NOT use cream Please use external auxiliary electrode cable am
5. 2 Set and Adjust Backlight Brightness The default brightness has been pre set in the optimal operation for both visual check battery power consumption Keep the default brightness is strongly recommended a Press again until brightness is highlighted Data amp Time b The scale will be changed when brightness is changed Press to decrease the brightness Press 4 to increase the brightness Press to go back to setting menu c Press to go back to menu 3 Set and Adjust Backlight Contrast The default contrast has been pre set in the optimal operation for both visual check and battery power consumption Keep the default contrast is strongly recommended a Press E again until contrast is highlighted Data amp Time 3 Brightness Contrast b The scale will be changed when contrast is changed Press gt to decrease the contrast Press to increase the contrast Press E to go back to setting menu c Press to go back to menu 2 4 5 Erase all ECG Data You have the option to erase and clear all ECG readings stored This will permanently delete all data a Press E to enter menu selection b Press again until Erase All Data is highlighted Transmit Data Continuous Mode Heview ECG System Setting Erase All Data Attention c Press to enter Message will show to confirm if you want to erase all readings Press to select Yes or No Press to confir
6. 3 5 5 Delete E mail Save Preview and Print a File 1 Select the files first Multiple files can be selected 4 InstantCheck 4 0 ECG Analysis Software PEE 2 Click delete email save preview or print function 3 5 6 Set Heport Header 1 Select function key The information window will appear as shown below 2 Enter header information Click on Save and the header information will show on the top of the ECG report 31 3 5 7 Review ECG Trace and Parameters InstantCheck 4 0 ECG Analysis Software File Help f 3 bd ll User Information 11 9 ec OG 01012000 0009 002 01012000 0000 001 File Information Date 01 01 2000 Time 00 09 HR 35 bpm ST 031 QRS 0 06 sec Result Regular Heart Rate B D i 1 Select a user and click on a file 2 A 30 seconds trace will be shown on the right side of the screen in quadrant 1 Q1 NOTE If you stop ECG measurement in less than 30 seconds you will not have the full 30 seconds trace 32 3 The average ECG parameters HR PR QRS QT QTc ST
7. 1 3 Variables QRS Complex R ST S Figure 1 Normal ECG Waveform Lead I Figure 1 is a presentation of a normal ECG waveform from Lead I InstantCheck uses patented algorithms to identify and compute parameters in the table listed below Table 1 is a list of ECG parameters measured by InstantCheck Table 1 InstantCheck Output Parameters Parameters Reference Range Average Heart Rate HR 60 lt HR 100 bpm SI Segment ST 2 lt ST lt 2 QRS Interval QRS 0 08 sec 5 lt 0 12 sec PH Interval 0 12 0 20 sec QT QTc 0 32 0 44 sec 0 41 0 44 sec The hardware only shows HR ST and QRS The PR and QT QTc will be provided in analysis software provided on your computer Table 2 InstantCheck Display Messages 1 Regular Heart Rate Heart rhythm is REGULAR Fast Heart Rate f heart rate is too fast HR 100 bpm it will be indicated Slow Heart Rate f heart rate is too slow lt 60 bpm it will be indicated High ST Value If ST value is too high ST gt 2 mm it will be indicated Low ST Value If ST value is too low ST lt 2 mm it will be indicated High QRS Value If QRS value is too high QRS gt 0 12 sec it will be indicated 2 Irregular Heart Rate Heart rhythm is IRREGULAR If this warning appears frequently regardless if you have any uncomf
8. Amplitude Indicator Heart rate Display ECG trace Timer Date Time Messages HH oT QRS Data Stored Descriptions ECG scale Calibration Mark Unit amplitude 1mV Display Heart rate during measurement ECG waveform display during measuring and review mode Timer Day Month Year Hour Minute The messages may include Regular Heart Rate Fast Slow Heart Rate High Low ST High QRS Irregular Heart Rate and Please Measure Again mm indicates the battery is normal indicates the battery is low Average Heart Rate Reference range 60 lt HR lt 100 bpm ST segment Reference range 2 lt ST lt 2 mm QRS interval Reference range 0 08 5 0 12 sec Shows how many readings are stored The device has a looping memory and can store up to 100 readings 13 2 4 Menu Press to power on the device then press to enter Menu mode In Menu press menu button to scroll through options Press OK to enter Press to start measurement anytime Below 15 a list of choices in the menu tems Descriptions G Transmit Data Transmit data to PC Continuous Mode Special measuring mode ECG will be continuously displayed on the LCD The user can manually stop measurement Only the last 30 seconds of data will be stored Review Select a file to review the ECG parameters and waveform System Setting Three functions Date amp Time LCD Brightness
9. InstantCheck Real Time ECG Monitor INSTRUCTION MANUAL 1 2010 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 Inc 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 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 Inc MEDICAL DEVICE WARRANTY DailyCare BioMedical Inc warrants each new device to be free from defects in material and workmanship This warranty is not transferable This warranty 15 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 and labor costs when upon examination by the 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 Inc concerning suspected defects and then if so instructed ship the instrument to t
10. 11032009 1730 002 amp 11032009 1730 001 02032009 0200 003 E amp 3 02032009 0200 002 02032009 0159 001 Of Enc 1A mm mV 25 File Information Waveform Analysis Comment Date 03 02 Time 02 00 HR B bpm ST 0 33 mm 085 008 8 1 Select a user and click on file 2 15 seconds trace will be shown on the right side of the screen in quadrant 1 Q1 If you stop ECG measurement in less than 25 seconds you will not have the full 15 seconds ECG trace 3 The average ECG parameters HR PR QRS QT QTc ST will be displayed in quadrant 2 Q2 4 You can also select a particular section of the ECG trace by 25 clicking left click once to start and left click again to end the section in Q1 The selected part of the trace will turn blue The average ECG parameters will be displayed in Q2 accordingly 3 5 8 Redefine ECG Parameters This section is highly recommended for doctors only The power of the device lies in the algorithm which identifies and defines P 5 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 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 interp
11. InstantCheck needs two batteries to PRODUCT BATCH NO CERTIFIED CE MARKING NOTIFIED BODY NO 0197 InstantCheck is TYPE B EQUIPMENT WITH F TYPE APPLIED PART IN EN IEC60601 1 STANDARD 2 2 Taking a Measurement 2 2 1 Dry Thumb Conduction Electrodes Wash and dry your hands before use sure hands are clean of any lotions oit down and place your hands comfortably on a table or on your laps Open the lid and press once to power on the device Press P Start to start measuring Each measurement will take 30 seconds During measurement you can stop it anytime by press 4HOK Simply press again to start the measurement Place right and left thumbs GENTLY the conduction electrodes Calm and relax yourself with regular breathing Do Move and Do during measurement Press for 3 seconds to power off the device manually anytime during measurement Data will NOT be saved The device will power off automatically if left idle for more than 1 minute If measurement is stopped in less than 30 seconds the recorded data is not enough for calculation The ECG parameters will not be display or recorded The hardware and software will only show ECG trace measured 10 2 2 2 Optional External Electrode Cable InstantCheck has optional electrode cable as an alternative way for users to take an ECG reading instead of dry thumb conduction electrode Please only use one
12. INTRODUCTION 1 1 What is ReadMyHeart ReadMyHeart is a non invasive handheld heart monitoring device It allows users to measure and record electrical activities of the heart anywhere and anytime It records and displays real time electrocardiogram ECG Electrical signals of the heart can be obtained using two methods The first method is by placing thumbs on ReadMyHeart s specially designed dry conducting electrodes The second method is by using external electrode cable and adhesive ECG electrode pads ReadMyHeart records 25 seconds of Modified ECG signal for each measurement After measurement the device will instantly display the average of 3 parameters on the LCD panel the average heart rate HR ST segment deviation ST and QRS interval QRS These parameters are not the traditional standard ECG readings but rather a Modified Lead I ECG can transfer all recorded measurements to a personal computer through USB connection for management and analysis of ECG data t ReadMyHeart uses two conducting electrodes to measure cardiac activities unlike traditional ECG device which requires at least 3 electrodes ECG measured by ReadMyHeart is designated as a modified Lead ECG These parameters from ReadMyHeart are for reference only For interpretation of the parameters please consult professional physicians Additional standard 12 lead ECG test may need to be performed 1 1 2 Benefits of Read
13. Trace and Parameters 32 3 5 8 Redefine ECG Parameters 33 3 5 9 Reading the Graph 34 3 5 10 ECG Waves and 35 FREQUENTLY ASKED QUESTIONS 37 GLOSSARY R 41 REFERENCES 43 CONTACT 43 INTRODUCTION 1 1 What is InstantCheck InstantCheck is a non invasive handheld heart monitoring device It allows users to measure and record electrical activities of the heart anywhere and anytime It records and displays real time electrocardiogram ECG Electrical signals of the heart can be obtained using two methods The first method is by placing thumbs on InstantCheck s specially designed dry conducting electrodes The second method is by using external electrode cable and adhesive ECG electrode pads InstantCheck records 30 seconds of Modified signal for each measurement After measurement the device will instantly display the average of 3 parameters on the LCD panel the average heart rate HR ST segment deviation ST and QRS interval QRS These parameters are not the traditional standard ECG readings but rather a Modified Lead I ECG Ins
14. and LCD Contrast can be adjusted Erase All Data Erase all readings stored in memory P Attention Attention to using the device NOTE Please set the Date amp Time before use 2 4 1 Transmit Data a Press to enter menu selection when the device is b Press to send data to PC NOTE Make sure the USB cable is connected to the device and the PC Make sure the software shows connected 14 Transmit Data Continuous Mode Heview ECG System Setting Erase All Data Attention 2 4 2 Continuous Mode This is an alternative recording mode Selecting this mode will allow you to measure and display your ECG waveform continuously for up to 2 hours You can choose to stop anytime or manual stop anytime Only the last 30 seconds will be recorded and stored in memory a Press to enter menu selection when the device is on b Continuous mode will be highlighted Transmit Data Continuous Mode Review ECG System Setting Erase All Data Attention c Press to start measuring and displaying ECG waveform on LCD Press again when you want to manually stop device will record the last 30 seconds of data 2 4 3 Review ECG Data a Press to enter menu selection when the device Is on b Press again until Review ECG is highlighted Transmit Data Continuous Mode System Setting Erase All Data Attention c Press to enter Review ECG mode d newest ECG dat
15. method at a time Follow the steps below when using the auxiliary electrodes olide the socket cover to expose the optional electrode cable socket and connect one end of the cable to the device Connect the split ends of the cable to the adhesive ECG electrode pads Users can buy qualified electrode pads from qualified medical device and pharmacy stores Place the RED electrode on the right arm and the BLUE electrode on the left arm as shown Do NOT put your thumbs on the dry conduction electrodes when using this method Start the measurement by pressing Start NOTE Both auxiliary electrode and USB sockets on the device are to be used only with the standard accessories provided Warranty will NOT cover damages that result from failure to comply with these instructions Visit www dcbiomed com to order replacement parts 2 3 Display Panel InstantCheck has a large LCD panel to display operating steps results of ECG measurements date time settings and playback 2 3 1 LCD Display A dH Stp 072 BPM 030 LCD Display Panel During measuring 2 2006 01 01 12 00 Regular Heart Rate HR 082 1 High ST Value ST 0 00 J High ORS Value QRS 0 08 K Irregular Heart Rate Impossible to Analyze Please measure 1 0 0 u L again LCD Display Panel After measuring 12 gt 2 3 2 LCD Display Description Item Scale Indicator
16. seconds of measurement avoid talking and keep a steady but gentle contact of the thumbs to the conduction electrodes HeadMyHeart can store up to a maximum of 30 data files The device will stop recording If you want to do the next measurement you need to transfer data to PC or erase the memory Record number will start to flash at 26 gata files to remind you that memory is almost full Three parameters of the measured results will be displayed on the LCD screen To start another measurement simply press again Please note that ReadMyHeart cannot be powered off during recording Hold 5 for 3 seconds to power off the device ReadMyHeart will be powered off automatically if left idle for more than 2 minutes to save power 2 2 2 Optional External Electrode Cable ReadMyHeart has optional auxiliary electrodes as an alternative way for users to take ECG readings 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 ReadMyHeart accordingly Please connect the RED electrode on the right arm and the BLUE electrode on the left arm as shown in figure on the right otart the measurement as described above Section 2 2 1 Both auxiliary electrode
17. small using dry electrodes For detailed instructions please follow the steps described in P 11 of the User s Manual Please buy extra adhesive ECG electrode pads from a qualified medical device store Can InstantCheck be stopped or powered off in the middle of the measurement During the 30 seconds measurement InstantCheck can be stopped or powered off The measured data will be saved if you stop in the middle of the measurement If you power off the device in the middle of the measurement the data will not be saved Will static electricity affect the measurement of InstantCheck InstantCheck is CE certified and has passed electromagnetic interference and compatibility tests Under normal circumstances static electricity will not affect the operation of InstantCheck However strong EMI Electromagnetic Interference may affect the operation of the device How do you manage ECG signals if multiple people use a single InstantCheck device Data cannot be managed on the InstantCheck device directly If there is more than one user please use the software provided for data management Why does the temperature of InstantCheck rise after the batteries are inserted The rise in temperature is caused by the improper direction polarities of the poles of the batteries when inserted Please remove the batteries quickly and then reinsert the batteries correctly Please allow the InstantCheckto drop to a normal operating temperature before
18. that exceeds these might indicate atria hypertrophy i e enlargement gt PR Interval interval is measured from the start of the P wave to the start of Q wave t represents the duration of atria depolarization Normal duration is from 28 0 12 to 0 20 seconds f the PH interval is greater than 0 20 seconds then an AV block might be present QRS Duration The QRS duration is measured from the start of wave to the end of S wave It represents the 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 gt QT QT The QT 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 ventricular muscle This duration varies inversely with the heart rate The normal QT is approximately 0 41 seconds it is corrected with the heart rate with the following formula to get QTc QT sqrt RR RR is interval between H to R peak gt ST Segment The ST segment is measured from end of 5 wave J point to the start of T wave This segment is important in identifying pathology such as myocardial infarction elevation and ischemia depression To learn more about the analysis of ECG parameters please refer to the list of references provided in the Reference Section 29 FREQUENTLY ASKED QUESTIONS Q1 A1 Q2 A2 Q3 A3
19. will be displayed in quadrant 2 Q2 4 You can also select a particular section of the ECG trace by clicking left click once to start and left click again to end the section in Q1 The selected part of the trace will turn blue The average ECG parameters will be displayed in Q2 accordingly 3 5 8 Redefine ECG Parameters This section is highly recommended for doctors only The power of the device lies in the algorithm which identifies and defines P 5 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 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 33 Waveform Analysis bpm mm ms Ims Ims Steps to redefine ECG waves 1 ECG parameters will be calculated automatically 2 If you click on the vertical bars on the ECG waveform it will change to a red bar Use the left and right arrow key to move it The software will automatically recalculate the parameters 3 Left click on the ECG waveform after you have finish adjusting the bar 3 5 9 Reading the Graph Y axis r
20. 01012000 0009 002 C pes 01012000 0000 001 305 10 25mmv sec ile Information Date 01 01 2000 00 09 InstantCheck Software User Interface 26 InstantCheck has a simple analysis interface This analysis and database management system is divided into four main parts 1 User and file management 2 Average parameters display and remarks 3 Connection status of ECG to PC 4 ECG diagram analysis display Maximum of 30 seconds 3 5 User and File Management S InstantCheck 4 0 ECG Analysis Software Sel S B4 E x 2 File Management Function Keys Description User management Add new user Display and change user s information Delete selected user Search for user Move file to other user folder Delete selected file E i Dg 5 Email ECG data 27 Save ECG waveform as graphic file 14 Preview ECG report for printing Print ECG report x1 2 View between 10mm mV or 20mm mV Set ECG report header Detailed descriptions of Function Keys are as follows 3 5 1 Add New User 1 To add a new user click on f amp function key The Create new user window will appear as shown below Create new user User Information NAME SEX WEIGHT HEIGHT Cancel 2 Enter user information such as name sex ID weight date of birth DOB and height NOTE Name has to be keyed to create a new user 3 Click
21. 20 sec QT QTc 0 32 0 44 sec 0 41 0 44 sec The hardware only shows HR ST and QRS The PR and QT QTc will be provided in analysis software provided on your computer 1 4 Common Causes of Abnormal ECG Tracings Abnormal ECG tracings may be caused by many different factors including e Coronary artery disease e Electrolyte imbalances in your blood such as sodium or potassium e Changes in your heart muscle e Injury from a heart attack e Healing process after heart surgery Please consult your physician if you are concerned about your ECG recording and symptoms to get more information about your condition 1 5 Basic Function of the Heart The heart has 4 chambers that act together to pump blood throughout the body 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 18 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 pressure that the left ventricle exerts to keep the blood moving throughout the whole body is the blood pressure 1 6 Conduction Sys
22. 3 9 1 Add a New User To add a new user click on f amp function key The Create new user window will appear as shown below f Create new user User Information ID DOB Enter user information such as name sex ID weight date of birth DOB and height Click on and a new user will be added to the user information list Name of user must be keyed Otherwise a 20 warning window will appear Repeat step 1 and 2 to add more new users Click on to close the user management window 3 5 2 Display or Change User s Information Select a file user first amp bL Patient Information amp mw Ex DOE Mei Step 1 Step 2 oelect 5 function key The user s information will appear as shown below Modify User Information Information Step3 You can modify the values on the table after click Modify Then click Save all the modified values will be saved automatically Click Exit The values will NOT be changed 21 3 5 3 Search for User 1 Select function key A window will appear You can search by User Name or by ID Please type in your search characters in the String field Field ser Name string search Name DOB BM Weight Height 2 Select to start finding If the user is found the name will be highlighted 3 5 4 Move ECG file to other User folder 1 Select the files f
23. Conduction Electrodes 10 2 2 2 Optional External Electrode Cable 11 LGB SEN 12 12 2 3 2 LCD Display 13 ZEN N 14 2 4 1 Transmit 14 2 4 2 Continuous 15 2 4 3 REVIEW Data 16 2 4 4 System 17 2 4 5 Erase all ECG 24 19 2 4 6 Attention nem mn mnnera 20 2 5 PRODUCT 5 21 INSTANTCHECK SOFTWARE 22 3 1 SYSTEM REQUIREMENT 22 3 2 INSTAELATIONS 5 godes 22 3 3 TRANSMIT DATA 23 3 4 SOFTWARE 26 3 5 USER AND FILE MANAGEMENT enm Immer 27 3 5 1 Add New 28 3 5 2 Display or Change User s Information 29 3 5 3 Search for USOE cocco mE Eee REFER ee EN 30 3 5 4 Move ECG File to Other 30 3 5 5 Delete E mail Save Preview and Print a File 31 9 5 0 9 31 3 5 7 Review ECG
24. MyHeart ReadMyHeart is a recording device used to monitor or spot check the electrical activities of the heart anytime and anywhere It is designed to be small portable and easy to use With ReadMyHeart you can e The New Vital Sign ReadMyHeart enables qualified medical personnel to quickly spot check for irregular heart beat during primary assessment e Take measurements anytime anywhere HeadMyHeart s compact design allows the user to carry device anywhere anytime for periodic monitoring of his her heart throughout the day e Manage ECG recordings over time software allows users to manage ECG recording with a time stamped record e Patient to Physician Data generated by the ReadMyHeart can be printed faxed or emailed using the accompanying software ReadMyHeart also stores up to 30 records 1 3 ECG Variables PR QT Figure 1 Normal ECG Waveform Lead 1 Figure 1 is a presentation of a normal ECG waveform from Lead I ReadMyHeart uses patented algorithms to identify and compute parameters in the table listed below Table 1 is a list of ECG parameters measured by ReadMyHeart Table 1 ReadMyHeart Output Parameters Parameters Reference Range Average Heart Rate 60 lt HR 100 bpm SI Segment ST 2 lt ST lt 2 QRS Interval QRS 0 08 sec QRS 0 12 sec PH Interval 0 12 0
25. XXX XX XXXXX dos 5 Sliding Socket t3 SIE Model RMH2 0 Cover Made in Taiwan Two 1 5V AAA size batteries USB Cable Socket Product abel 2 1 2 Control Buttons Control Button Descriptions Buttons Descriptions On Off Start Button Press once to power on and start measurement Hold for seconds to power off Button 1 After measuring press again to start another measurement Data Recall button Data Clearance Press once to enter data recall mode The latest data recorded will be displayed Press again to recall other recorded data starting from the first Button 2 Hold for 3 seconds or press any other button to leave data recall mode Hold together for 3 seconds to manually clear all stored data Data Transfer Button Data Clearance Connect ReadMyHeart to PC with USB cable and press once to start transferring of stored data Button 3 Hold and together for 3 seconds to manually clear all stored data Time Setting When the device is on press once to set the right time Hidden Button Press Button 2 to select month date time Press Button to adjust value Only use USB cable provided by manufacturer Other USB cables will cause serious damage to device Please visit www InstantCheck com to re order USB cable 2 1 3 Product Package Standard Package HeadMyHeart device x 1 Softwa
26. a file will be placed at the top and highlighted The highlighted file will display the calculated ECG parameters HR ST QRS and message will be displayed on the right side of the screen The file number will be displayed at the bottom right corner Note The device can store up to 100 data e Press to go to next file f Press 4 to play ECG waveform of highlighted file 01 01 2010 072 08 01 2010 ST 0 15 15 01 2010 QRS 0 12 22 01 2010 Regular 29 01 2010 100 g To speed up press and hold EJ Release to return to normal speed h To exit press 0 i To stop press To start again press 2 4 4 System Setting Please make sure you have set the right date and time before using the device Adjust the date and time when needed date and time are important information of an ECG data a Press 6 to power on the device b Press E to enter menu selection c Press 5 again until System setting is highlighted Transmit Data Continuous Mode Heview ECG System Setting Erase All Data Attention d Press to enter setting menu selection 1 Set and Adjust Date and Time a Press to enter Date amp Time adjustment mode amp Brightness b The digit to be changed will be highlighted Press to go to next digit to change Press to increase the number c When time is set device will go back to setting menu d Press to go back to menu
27. an 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 ReadMyHeart 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 ReadMyHeart to drop to a normal operating temperature before making any measurements Can the parameters measured by ReadMyHeart be used for clinical diagnosis The ECG tracings recorded by ReadMyHeart 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 31 10 A10 Q11 A11 Q12 A12 Q13 A13 Q14 A14 Q15 A15 Why does the data recorded in the ReadMyHeart disappear after batteries are replaced Data will remain in the memory for approximately 2 minutes 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 ReadMyHeart not match ReadMyHeart can store up to 30 data files in its memory only Please remember to transfer data files to the PC or erase the memory if you want to make the next measurement his is to make sure that you record and transfer all important ECG data to the PC fo
28. and USB sockets on the device are to be used only with the standard accessories provided Warranty will NOT cover damages that result from failure to comply with these instructions 10 2 3 Display Panel 2 3 1 LCD Display gt of JE WU Bg 3 5 QRS LI HH Figure 2 LCD Display Panel Reference Range of Measured Results memo _ oem _ Attention The information above is for reference ONLY If the measured parameters fall within the reference range and user feels any discomfort user should contact a physician Measured data by RMH may be provided to a physician for reference monitoring or further analysis Search 4 4 Send Total Number Data File Number Battery Condition HR oT QRS Date Time 2 3 2 LCD Display Description Descriptions Displays when ReadMyHeart is searching for signals Takes around 3 5 seconds Flashes when measurement Is in progress Flashing stops when measurement is completed Displays when ReadMyHeart is in data recall mode Displays when ReadMyHeart 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 indicates the battery is low Noise is displayed aft
29. art of the Q wave to the end of T wave QT interval represents the duration of activation and recovery of the ventricular muscle This duration varies inversely with the heart rate The normal QT is approximately 0 41 seconds it is corrected with the heart rate with the following formula to get QTc QT sqrt RR RR is interval between H to R peak gt ST Segment The ST segment is measured from end of 5 wave J point to the start of T wave This segment is important in identifying pathology such as myocardial infarction elevation and ischemia depression To learn more about the analysis of ECG parameters please refer to the list of references provided in the Reference Section 36 FREQUENTLY ASKED QUESTIONS Q1 1 Q2 A2 Q3 A3 What is InstantCheck InstantCheck is a handheld ECG monitor The main function of InstantCheck is to record ECG tracings anywhere and anytime 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 analysis and management of data Why does Noise appear Why does P wave sometimes disappear during measurement InstantCheck measures the micro electrical activities emitted by the heart Noise means there is the interference with the recording of these signals due to poor contact between the thumbs and the elect
30. ase consult your physicians immediately Table of Contents IMPORTANT NOTIGE uieciniuets MEDICAL DEVICE WARRANTY LIMITATIONS AND EXCLUSIONS I ATTENTION Ii INTRODUCTION eem XX 1 1 1 WHAT TIS READMYEIEARBT rl esto rd rts 1 1 2 BENEFITS OF 2 1 3 2 VARIABLE S utet ua 3 1 4 COMMON CAUSES OF ABNORMAL ECG TRACINGS 4 1 5 BASIC FUNCTION OF THE 4 1 6 CONDUCTION SYSTEM OF THE 5 PRODUCT 6 PRODUCT BC MEER 6 2 1 1 Main 6 2 1 2 Control 7 2 1 ol 010 8 61M are CKA gt eee E 8 2 1 4 Product Labe 8 2 2 TAKING A MEASUREMENT 9 2 2 1 Dry Thumb Conduction Electrodes 9 2 2 2 Optional External Electrode Cable 10 2 9 DISPLAY e 11 rcm 11 2 3 2 LCD Display
31. ashes after pressing or during file transfer it means the connection between ReadMyHeart and the PC has failed Please close and then re start the software again and or reconnect the USB cable 3 4 Software Interface 72 ReadMyHeart 2 0 ECG Analysis Software Sec File Help 6 6 6 f D 7 10 25 File Information Waveform Analysis 1 HR bpm 2 ST mm PR ms QRS ms QT ms _ QTc ms Figure 4 ReadMyHeart Software and Database Interface Details 18 ReadMyHeart has a simple analysis interface as shown in Figure 4 This analysis and database management system is divided into four main parts 1 User and file management 2 Average parameters display and remarks 3 Connection status of ReadMyHeart to PC 4 waveform diaplay Maximum of 15 seconds 3 5 User Management DailyCare BioMedical Real M yHeart 2 0 Analysi S b E amp 077 ld User management File Management Function Keys Description Add a new user Display and change user s information Delete selected user Search for user Move file to other user folder E gu 5 Delete selected file 19 Email ECG data mi Save ECG waveform as graphic file Preview ECG report for printing amp Print ECG report View between 10mm mvV or 2 20mm mV Set report s header Detailed descriptions of Function Keys are as follows
32. 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 6 Conduction System of the Heart The chambers of the heart pump with the automatic discharge of electricity from the sinoatrial node a group of specialized cells in the right atrium 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 15 propagated across the AV node causes both ventricles to contract and pump blood normal delay between the atrium and ventricle contractions is 0 12 to 0 20 seconds studying the electrical activity that results when heart muscle cells contract we gain insight to the health and workings of the heart These electrical activities can be detected recorded and studied with ECG monitoring device for example InstantCheck superior vena cava aorta pulmonary artery SA node left atrium right atrium mitral valve AV node tricuspid valve left ventricle right ventricle cardiac muscle interior vena cava PRODUCT DESCRIPTION 2 1 Product Design 2 1 1 Main Unit Manufactured by Lor XXXXX XX XXXXX
33. ctrodes and Do NOT move and talk during measurement You may choose to use external electrode cable and ECG pads for better ECG trace measurement Can InstantCheck 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 InstantCheck is able to record ECG signals correctly After exercising can ECG be measured using InstantCheck Will the measurement be correct Yes ECG can be recorded after exercise During measurement please remain in a stable position to avoid noise interference Can InstantCheck be used during commuting During commuting if user is able to keep a stable position InstantCheck can be used to measure ECG The usage of InstantCheck is not recommended during the operation of any vehicle Can conducting gel or other fluids be used when using InstantCheck InstantCheck 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 40 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 heart rhythm Atrioventricular AV Node A small mass of specialized cardiac conducting tis
34. e 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 33 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 atrioventricular 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
35. ency 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 You may use other fingers other than the thumbs for measurment using ReadMyHeart Please make sure you place the fingers gently on the electrodes and Do NOT move and talk during measurement You may choose to use external electrode cable and ECG pads for better ECG trace measurement Can ReadMyHeart 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 ReadMyHeart is able to record ECG signals correctly After exercising can ECG be measured using ReadMyHeart 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 ReadMyHeart be used during commuting During commuting if user is able to keep a stable position HeadMyHeart can be used to measure ECG Usage of ReadMyHeart is not recommended during the operation of any vehicle Can conducting gel or other fluids be used when using ReadMyHeart ReadMyHeart is designed to b
36. epresents voltage in mV bar indicated below represents 1millivolt mV This denotes the electrical strength of the signal Therefore each big square represent 0 5 mV and each small square represent 0 1 The X axis represents time in seconds Each big square represents 0 2 seconds Therefore each small square represents 0 04 seconds 34 Waveform Analysis bpm mim 0 2 seconds graph 3 5 10 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 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 enlargement gt PR Interval interval is measured from the start of the P wave to the start of Q wave t represents the duration of atria depolarization Normal duration is from 0 12 to 0 20 seconds f the PH 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 wave to the end of S wave It represents the 35 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 gt QT QT The QT QT is measured from the st
37. er measurement when noisy signals are detected more than 5 times during measurement PLEASE MEASURE AGAIN 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 12 2 4 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 13 gt 10 M Ohm 2 mV 0 15 40 Hz gt 60 db 12 bit 250 samples sec 25 seconds First 10 seconds is to search for Signals LCD display panel Dry conduction electrodes and or external auxiliary electrodes USB interface 1 5V AAA X 2 12 x 8x 2cm 134 9 Not including batteries 49 122 F 20 C 50 50 F 104 F 10 40 25 95 45 to 180 bpm to 3 mm 0 20 sec ReadMyHeart SOFTWARE 3 1 System Requirements Operating System Windows 98 985 E 2000 XP V
38. ericanheart org 2 National Heart Lung and Blood Institute www nhlbi nih gov 3 ECG Library www ecglibrary com 4 eMedicine www emedicine com 5 HeartCenterOnline www heartcenteronline com 6 Arrhythmia Alliance www heartrhythmcharity org uk CONTACT INFORMATION Manufacturer DailyCare BioMedical Inc 8F 25 3 Ji Lin Rd Chungli 320 Taiwan ROC 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 ReadMyHeart Handheld ECG Monitor INSTRUCTION MANUAL IMPORTANT NOTICE 2009 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 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 Inc MEDICAL DEVICE WARRANTY DailyCare Biomedical Inc warrants each new device to be free from defects in mater
39. hat 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 Seconds 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 seconds QT Interval Ventricular refractory time Duration varies according to rate age and sex Right Atrium Top right chamber of the heart Right Ventricle Bottom right chamber of the heart 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 42 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 and REFERENCES 1 American Heart Association www am
40. he designated facility correctly packed in an appropriate shipping container for examination and servicing www dcbiomed com 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 warranted for a period of 30 days and are subject to the limitations and exclusions described in this document DailyCare BioMedical Inc 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 Inc has agreed to and provided a written exception to this policy DailyCare BioMedical Inc assumes no responsibility for any personal injuries or damages sustained by or through use of this product The InstantCheck 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 a diagnostic device It is only an ECG recorder is NOT a substitute for a traditional ECG diagnosis is NOT recommended for users with pacemakers What you should NOT do Do NOT operate InstantCheck while using other electrical devices Do NOT connect InstantCheck to the PC via USB cable when acquiring ECG Do NOT use accessories
41. ial 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 and labor costs when upon examination by the 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 Inc concerning suspected defects and then if so instructed ship the instrument to the designated facility correctly packed in an appropriate shipping container for examination and servicing www dcbiomed com 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 warranted for a period of 30 days and are subject to the limitations and exclusions described in this document DailyCare Biomedical Inc reserves the right to make design changes in its products without incurring the obligation to incorporate these changes products previously delivered This warranty applies unless DailyCare Biomedical Inc has agreed to and provided a written exception to this policy ATTENTION DailyCare Biomedical Inc assumes no responsibility for any personal injuries or damages sustained by or through use of this pr
42. irst Multiple files can be selected Step 1 T Step 2 2 Click function key A window will appear You can move the selected ECG file to other user 22 F Hove file to FileName Test Date 11032009 1732 001 331 17 66 00 11032008 1730 002 30 17 66 00 11032009 1730_001 30 17 files will be moved to this user Delete all files after moving files to the selected user ox 3 5 5 Delete E mail Save Preview and Print a File Select the files first Multiple files can be selected DailyCare BioMedical Real M yHeart 2 0 Analysis Soft Sele File Help fb 6 xix 3 User Information A MEE ug ja 11052009 1720 Ki O 1 02032009 0200 2 Click delete email save preview or print function 3 5 6 Set Heport Header 1 Select function key The information window will appear as shown below 23 E Report Information DailyCare Biomedical B Custom 5 Service Daily Care Biomedical Custom Service Film 0602 Od Tes Dane iii Enter header information Click on Save and the header information will show on the top of the ECG report 24 3 5 7 Review ECG Trace and Parameters DailyCare BioMedical Read MyHeart 2 0 Analysis Software Sele File Help 6 6 6 e b EL S amp amp 11032009 1732 001 amp
43. ista Hardware Hequirements gt CPU Pentium Ill and above Memory 100MB and above gt Hard Disk capacity 100MB and above Data transmission media Universal Serial Bus USB Screen resolution 1024 x 768 3 2 Installation BioMedical Software Installation Read MyHeart Handheld ECG Caring every beat your hea Figure 3 ReadMyHeart Software Main Page Insert ReadMyHeart software CD into the CD ROM Select Software Installation from the main page and setup will run automatically If 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 14 3 3 Transmit Data All data files recorded in ReadMyHeart can be transferred to PC for analysis through the USB port on the left side of ReadMyHeart shown in below Slide the socket cover to expose the USB socket Only use USB cable provided by manufacturer to transmit data USB port ReadMyHeart USB port oteps for file transfer Please follow the following steps 1 Start the ReadMyHeart software by selecting DailyCare Biomedical Inc gt ReadMyHeart from the File Menu or by ck FA clicking on the 41 on your desktop 2 Disconnected status will be shown initially on the bottom left of the main menu Connect one end of the USB cable small to the USB socket on the hardware first A Then c
44. m 2 4 6 Attention a Press E to enter menu selection d Press E again until Attention is highlighted Transmit Data Continuous Mode Heview ECG System Setting Erase All Data Attention e Press 43 to enter and the following message will show The device will not tell if you have heart problems Only your physician can do that This message is to remind that user that if you feel any discomfort regardless of the results of the measurement by the device you should consult your physician 20 2 5 Product Specifications Input impedance Input dynamic range Bandwidth CMRR Common Mode Rejection Ratio A D conversion Sampling Rate 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 gt 20 M Ohm 3 mV 0 1 40 Hz gt 95 12 bit 250 samples sec 30 seconds 240 X 128 Dot matrix LCD display Dry conduction electrodes and or external auxiliary electrodes USB interface 1 5V AAA X 2 124 x 78 x 22 mm 150 g excluding batteries 4 F 122 F 20 C 50 C 50 F 104 F 10 C 40 C 25 95 45 to 180 bpm 3 to 3 mm 0 20 sec 21 InstantCheck SOFTWARE 3 1 System Requirements Operating System Windows 98 98SE 2000 XP Vista Hardware Hequirements gt CPU Pentium Ill and above Mem
45. making any measurements Can the parameters measured by InstantCheck be used for clinical diagnosis 38 A9 Q10 A10 Q11 A11 Q12 A12 Q13 13 014 14 ECG tracings recorded by InstantCheck 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 Why does the data recorded in the InstantCheck disappear after batteries are replaced Data will remain in the memory for approximately 2 minutes only during battery replacement Thus please replace batteries as quickly as possible to preserve data What is the maximum memory of InstantCheck hardware InstantCheck can store up to 100 data files in its memory only When the 100 files limit is exceeded InstantCheck has a looping memory and will delete the oldest data and save the newest data Please try to transfer data files to the PC regularly It is important to save all ECG data for personal health management How do you transfer InstantCheck s ECG data files by internet ECG report can be saved as JPG file using the software You can send the report as an attached file to your physician for reference using your regular email account How do you maintain InstantCheck When the dry conduction electrodes on InstantCheck are used regularly grease and dirt may accumulate which may affect the recording of signal Please use a clean wiping cloth to remove g
46. oduct ReadMyHeart 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 a diagnostic device It is only an ECG recorder is NOT a substitute for a traditional ECG diagnosis is NOT recommended for users with pacemakers What you should not do Do NOT operate ReadMyHeart while using other electrical devices Do NOT connect ReadMyHeart to the PC via USB cable when acquiring ECG Do NOT use accessories other than those provided by the manufacturer Do NOT use USB cable other than that Supplied by 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 use with any lotions Do NOT place the device and Its accessories under direct sunlight and harsh environments Do NOT disassemble ReadMyHeart It may cause device malfunction device failure or damage and you will loose all warranty ATTENTION Please use the device properly by following standard operating procedure Please refer to Section 2 2 Page 9 Improper use of the device will cause inaccurate representation of measured results 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 ple
47. on and a new user will be added to the patient information user list Name of user must be keyed Otherwise 28 a warning window will appear 4 Repeat step 1 and 2 to add more new users 5 Click on to close the user management window 3 5 2 Display or Change User s Information 1 Select a file user first 2 Select f amp function key The user s information will appear as shown below Modify User Information User Information Amy You can modify the values on the table after click Modify Then click Save all the modified values will be saved automatically Click Exit The values will be changed 29 3 5 3 Search for User 1 Select function key A window will appear You can search by User Name or Please type in your search characters in the String field 2 Select to start finding If the user is found the name will be highlighted 3 5 4 Move ECG File to Other User 1 Select the files first Multiple files can be selected InstantCheck 4 0 ECG Analysis So 2 Click function key A window will appear You can move the selected ECG file to other user 30 F Move file to FileName Test Date Test Time 01012000 0009 002 01 01 2000 00 09 01012000 0000 001 01 01 2000 00 00 files will be moved to thi user Delete all files after moving files to the selected user Cancel
48. onnect the other end of the 15 USB cable to the USB port on the computer B A Connection of USB Cable 3 When the USB connection detected it will be indicated on the bottom left corner of the software screen Only use USB cable provided by manufacturer to transmit data 16 4 Press ReadMyHeart and send will appear on the LCD display indicating a transfer of the data files to the PC The number below sena 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 Status User name Total records B Received record 1 Receiving data please keep connecting Data Transmission Progress Window Please confirm select the right user before the transmitted data save to the PC The user confirm window shown as below Transmit data to you sure want to transmit data to this user fe Yez Select other user After data files have been successfully transferred to the PC and when you start your next measurement ReadMyHeart hardware will erase its memory automatically 17 The default file name is the time stamp of the reading clicking the selected file name the user can change the name 11032008 1730 001 02032009 0200 003 02022009 0200 002 02032009 0159 001 If sena fl
49. ortable symptoms or not please consult your physician 3 Impossible to Analyze Acquired signals CANNOT be analyzed Please measure again Please measure again ATTENTION The parameters and messages provided by the device are for reference ONLY If the user feels any discomfort regardless of the results from the device please consult an appropriate physician immediately Measured data by InstantCheck may be provided to a physician for reference and further analysis 1 4 Common Causes of Abnormal ECG Tracings Abnormal ECG tracings may be caused by many different factors including e Coronary artery disease e Electrolyte imbalances in your blood such as sodium or potassium e Changes in your heart muscle e Injury from a heart attack e Healing process after heart surgery 4 Please consult your physician if you are concerned about your ECG recording and symptoms to get more information about your condition 1 5 Basic Function of the Heart The heart has 4 chambers 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 18 oxygenated blood then comes back into the left
50. ory 100MB and above Hard disk capacity 100MB and above Data transmission media Universal Serial Bus USB Screen resolution 1024 x 768 3 2 Installation D DailyCale Software Installation User s Manual InstantCheck Real Time Display Heart Function Monitor Exit InstantCheck Software Main Page Insert InstantCheck software CD into the CD ROM Select Software Installation from the main page and setup will run automatically If auto installation does not start double click on 22 the autorun exe application file in the CD to install manually Follow the Setup Wizard instruction on the screen 3 3 Transmit Data All data files recorded in InstantCheck can be transferred to PC for analysis through the USB port on the left side of InstantCheck shown as below Slide the socket cover to expose the USB socket Only use USB cable provided by manufacturer to transmit data USB Port InstantCheck USB port oteps for file transfer Please follow the following steps 1 Start the InstantCheck software by selecting DailyCare BioMedical Inc gt InstantCheck from the File Menu or by clicking on the on your desktop 2 Disconnected status will be shown initially on the bottom 23 left of the main menu Connect one end of the USB cable small to the USB socket on the hardware first A Then connect the other end of the USB cable to the USB port on the computer B
51. other than those provided by the manufacturer Do NOT use USB cable other than that supplied by 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 use with any lotions Do NOT place the device and its accessories under direct sunlight and harsh environments Do NOT disassemble InstantCheck It may cause device malfunction device failure or damage and you will loose all warranty Table of Contents 55 ako ax TOWN e 1 Tal WHAT IS INS TANTOHECK 1 1 2 BENEFITS INSTANTCHECK 2 Tes etch iir 3 1 4 COMMON CAUSES OF ABNORMAL ECG TRACINGS 4 1 5 BASIC FUNCTION OF THE 5 1 6 CONDUCTION SYSTEM OF THE 5 PRODUCT 7 2 PRODUCT DESIGN 7 2 1 1 Main enn zd iore 9 2 1 3 Product EBDOlL 9 2 2 TAKING 2 10 2 2 1 Dry Thumb
52. p sticky electrode pad 3 Contact pressure between the thumbs and the electrodes may be too strong Please place thumbs on the electrodes gently Even when users have followed the regular procedure described in the User s Manual to operate ReadMyHeart the user may still experience weak signal Please contact the distributor retailer or visit DailyCare BioMedical s website www dcbiomed com 30 QA A4 Qb5 Ab Q6 Q7 7 Q8 A8 Q9 A9 How do you use the optional auxiliary electrodes The optional auxiliary electrodes are for users who cannot hold ReadMyHeart steadily without shaking or users whose thumbs are too dry For detailed instructions please follow the steps described in P 10 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 ReadMyHeart be stopped or powered off in the middle of the measurement During the 25 seconds measurement ReadMyHeart cannot be stopped or powered off Will static electricity affect the measurement of ReadMyHeart ReadMyHeart is CE certified and has passed electromagnetic interference and compatibility tests Under normal circumstances static electricity will not affect the operation of ReadMyHeart How do you manage signals if multiple people use a single ReadMyHeart device Data cannot be managed on the ReadMyHeart device directly If there is more th
53. r health management How do you transfer ReadMyHeart s ECG data files by internet User needs to SAVE the data files first using ReadMyHeart s exclusive software before sending the files by e mail For the detailed procedures please refer to the software instruction manual P 23 How do you maintain ReadMyHeart When the dry conduction electrodes on ReadMyHeart 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 ReadMyHeart use other external power supply No ReadMyHeart 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 device Can ReadMyHeart use 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 other than the ones provided in the standard package to avoid hazards and subsequent damages to the device and to avoid hazards 32 16 16 Q17 A17 Q18 A18 Q19 A19 Q20 A20 Q21 A21 What to do if the parameters measured by ReadMyHeart do not correspond with the user s condition In case of an emergency physical condition users should contact emerg
54. re CD x 1 HeadMyHeart User s Manual x 1 Carrying Case x 1 USB Cable x 1 Auxiliary Electrode Cable x 1 Not Included 1 Electrode gel pad These pads can be purchased at local drug stores 2 AAA alkaline battery ReadMyHeart needs two to operate 2 1 4 Product Label Attention consult Manufactured by 7 PRODUCT BATCH ACCOMPANYING DOCUMENT DailyCare BioMedical Inc XX BF 25 3 Ji Lin RD ANC amp POTIAS Mod cb j E CERTIFIED CE TYPE BF 0197 oael RMH2 0 MARKING NOTIFIED APPLIED PART MadeinTawan 1 5V AAA size batteries BODY NO 0197 ReadMyHeart is TYPE B EQUIPMENT WITH F TYPE APPLIED PART IN EN IEC60601 1 STANDARD 2 2 Taking a Measurement 2 2 1 Dry Thumb Conduction Electrodes Open the cover of Press once to start LCD screen will ReadMyHeart measuring Allow 30 display the parameters memories after measurement Wash and dry your hands before use Sit down and place your hands comfortably on a table or on your laps Hold ReadMyHeart in your hands steadily Calm and relax yourself with regular breathing Press 0 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 25
55. rease and dirt Please Do NOT use any cleaning solutions or organic solvents to prevent damaging the device Can InstantCheck use other external power supply NO InstantCheck is to be operated by two replaceable 1 5V AAA Q15 A15 alkaline batteries Please Do NOT use other external power supply which may be hazardous and may damage the system and the device Can InstantCheck use 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 other than the ones provided in the standard package to avoid hazards and subsequent damages to the device and to avoid hazards 39 16 A16 Q17 A17 Q18 A18 Q19 A19 Q20 A20 Q21 A21 What to do if the parameters measured by InstantCheck 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 You may use other fingers other than the thumbs for measurment using InstantCheck Please make sure you place the fingers gently on the ele
56. retation Therefore users are strongly advised against performing the function in this section unless under the guidance of a medical professional 26 Waveform Analysis bpm mm ms ms ms ms Steps to redefine ECG waves 1 ECG parameters will be calculated automatically 2 If you click on the vertical bars on the ECG waveform it will change to a red bar Use the left and right arrow key to move it he software will automatically recalculate the parameters 3 Left click on the ECG waveform after you have finish adjusting the bar 3 5 9 Reading the Graph 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 mV and each small square represent 0 1mV 27 The X axis represents time in seconds Each big square represents 0 2 seconds each small square represents 0 04 seconds Waveform Analysis 1 bar HR 76 bpm imV ST 1 18 mm PR 164 ms 0 2 seconds QRS 100 ms OT 344 me QTc ms ECG graph 3 5 10 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
57. rodes excessive movement of the body and other strong environment EMI Electro Magnetic Interference noise etc No P wave or small Lead signal Please try using Lead ll by using the external electrode cable and adhesive ECG pad Please the red end on right arm and the blue end on left leg What are some of the factors that may affect the measurement by InstantCheck Besides the factors mentioned in Q2 the followings are some of the factors that may also affect measurements a Thumbs may be greasy which may affect the transmission of signals Please use clean water to clean the thumbs first b Thumbs may be too dry Do NOT use cream Please use external auxiliary electrode cable amp adhesive ECG electrode pads c Contact pressure between the thumbs and the electrodes may be too strong Please place the thumbs on the electrodes GENTLY Even when users have followed the regular procedure described in the User s Manual to operate InstantCheck the user may still experience a weak signal Please contact the distributor retailer or visit DailyCare BioMedical Inc s website htip www dcbiomed com 37 Q4 4 Q5 5 6 A6 Q7 AT Q8 A8 Q9 Why do you need to use auxiliary electrode cable How do you use the optional auxiliary electrodes The auxiliary electrode cable is for users who cannot hold InstantCheck steadily without shaking or users whose thumbs are too dry or if the signals are too
58. sue 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 conducting tissue 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 atrioventricular 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 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 41 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 t
59. t 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 I REFERENCES 1 American Heart Association www americanheart org 2 National Heart Lung and Blood Institute www nhibi nih gov 3 ECG Library www ecglibrary com 4 eMedicine www emedicine com 5 HeartCenterOnline www heartcenteronline com 36 CONTACT INFORMATION Manufacturer DailyCare BioMedical Inc 8F 25 3 Ji Lin Rd Chungli 320 Taiwan ROC Website www 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 37 59 0R20 0121 A6 38
60. tantCheck can transfer all recorded measurements to a personal computer through USB connection for management and analysis of ECG data t InstantCheck uses two conducting electrodes to measure cardiac activities unlike traditional ECG device which requires at least 3 electrodes ECG measured by InstantCheck is designated as a modified Lead These parameters from InstantCheck are for reference only For interpretation of the parameters please consult professional physicians Additional standard 12 lead ECG test may need to be performed 1 2 Benefits of InstantCheck InstantCheck is a recording device used to monitor or spot check the electrical activities of the heart anytime and anywhere It is designed to be small portable and easy to use With InstantCheck you can e The New Vital Sign InstantCheck enables qualified medical personnel to quickly spot check for irregular heart beat during primary assessment measurements anytime anywhere InstantCheck s compact design allows the user to carry the device anywhere anytime for periodic monitoring of his her heart throughout the day e Manage recordings over time InstantCheck software allows users to manage ECG recording with a time stamped record e Patient to Physician Data generated by the InstantCheck can be printed faxed or emailed using the accompanying software InstantCheck also stores up to 100 records for review using the LCD screen
61. tem 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 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 across the AV node causes both ventricles to contract and pump blood normal delay between the atrium and ventricle contractions is 0 12 to 0 20 seconds studying the electrical activity that results when heart muscle cells contract we gain insight to the health and workings of the heart These electrical activities can be detected recorded and studied with ECG monitoring device for example ReadMyHeart Superior vena Cava aorta pulmonary artery SA node x left atrium right atrium 4 mitral valve AV node y tricuspid valve M left ventricle right ventricle i cardiac muscle interior vena cava PRODUCT DESCRIPTION 2 1 Product Design 2 1 1 Main Unit Front Cover MT CD Display Right Thumb Left Thumb 11 V MIL Electrode Electrode Time setting On Off Start Button Data Transfer Button Data Recall Button External Auxiliary Electrode Socket Lor XX
62. 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 34 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 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 varies according to rate age and Sex Right Atrium Top right chamber of the heart Right Ventricle Bottom right chamber of the heart 35 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 heartbea

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