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1. a MH Xx vi File Management Function Keys Description User management Add new user Display and change user s information Delete selected user Search for user Move ECG file to other user folder Delete selected file Kies D D E Email ECG data 26 Ri Save ECG waveform as graphic file Preview ECG report for printing Print ECG report x1 x 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 function key The Create new user window will appear as shown below Create Dew user User Information NAME SEE Male Female ID WEIGHT DOH o HEIGHT 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 on and a new user will be added to the patient information user list Name of user must be keyed Otherwise 21 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 AHA e bb 2 Select fp function key The user s information will appear as shown below Modify User Information User Information NAME Amy 3 You can modify the values on the table after click Modify Then click Save al
2. below E Transmit data to Ave you sure want to transnut data to this user Amy fe Yes f No 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 24 The default file name is the time stamp of the reading By clicking the selected file name the user can change the name si 01012000 0005 007 CIS OG Enc If gt flashes after pressing 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 KI BR File Help PORNO x1 x2 CAT L ef Amy Ston 2000 0009 O O reg 2000 0009 002 O Reg 01012000_0000_001 OG Enc 10mmmYyY 25mm sec J File Information Date 01 01 2000 2 bu Aime 00 09 c Nu 75 bpm ST 031 QRS 0 06 Waveform Analysis Commen InstantCheck Software User Interface 25 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 ECG 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 gt Instant heck 4 0 ECG Analysis Software
3. e The digit to be changed will be highlighted Press to go to next digit to change Press to increase the number f When time is set device will go back to main 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 5 to enter menu selection b Press E again until Erase All Data is highlighted Continuous Mode Review ECG Transmit Data Date amp Time Attention c Press to enter Message will show to confirm if you want to erase all readings Press to select Yes or No Press 4 to confirm 2 4 6 Attention a Press 5 to enter menu selection d Press again until Attention is highlighted 18 Continuous Mode Review ECG Transmit Data Date amp Time Erase All Data e Press to enter and the following message will show The device will not tell if you have heart problems Only your physician can do that NOTE 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 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 R
4. 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 Steps for file transfer Please follow the following steps 1 Start the InstantCheck software by selecting DailyCare BioMedical Inc 3 InstantCheck from the File Menu or by clicking on the AP on your desktop 2 A Disconnected status will be shown initially on the bottom 22 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 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 23 4 Press EI until G Transmit Data is highlighted Then press 4 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 DCEM Total records IB Received record 1 Hecelving data please keep connecting Please confirm select the right user before the transmitted data save to the PC The user confirm window as
5. Save and the header information will show on the top of the ECG report 30 EF Report title patani check 4 0 BOG Analyse Software Eue Help nma N BEARS wa FF H Si Electra i i 1 Select a user and click on a file 2 A 30 seconds ECG trace will be shown on the right side of the screen in quadrant 1 Q1 If you stop ECG measurement in less than 30 seconds you will not have the full 30 seconds ECG trace 31 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 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 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 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 i
6. ST QRS and a 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 readings 25 09 2008 HR 072 24 09 2008 ST 40 15 23 09 2008 QRS 0 12 21 09 2008 Regular 21 09 2008 100 e Press to go to next file f Press to play ECG waveform of highlighted file g To speed up press and hold EI Release EI to return to normal speed h To exit press i To stop press il To start again press HY j Press to magnify playback x 2 Press again to return to normal size 2 4 3 Transmit Data a Press 5 to enter menu selection when the device is on b Press 5 until Transmit Data is highlighted Continuous Mode Review ECG Transmit Data Date 8 Time Erase All Data Attention c 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 2 4 4 Set and Adjust Date and Time Please make sure you set the right date and time before using the device Adjust the date and time when needed The date and time are important information of an ECG data file a Press 6 to power on the device b Press 5 to enter menu selection c Press again until Date and Time option is highlighted Continuous Mode Review ECG Transmit Data Date amp Time Erase All Data Attention d Press to enter adjustment mode 17
7. during measurement Data wili 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 method at a time Follow the steps below when using the auxiliary electrodes Slide 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 t
8. 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 40 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 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
9. 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 InstantCheck to drop to a normal operating temperature before making any measurements Can the parameters measured by InstantCheck be used for clinical diagnosis 37 A9 Q10 A10 Q11 A11 Q12 A12 Q13 A13 Q14 A14 The 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 per
10. of atria depolarization Normal duration is from 0 12 to 0 20 seconds If 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 34 duration of ventricle depolarization Normal duration is from 0 08 0 12 seconds If 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 QTc QT sart RR RR is interval between R to R peak 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 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 35 FREQUENTLY ASKED QUESTIONS Q1 A1 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 an
11. segment represents the period from the end of ventricular depolarization 41 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 IIl REFERENCES 1 American Heart Association www americanheart 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 59 0R40 0111 A2 42
12. 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 6 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 across the AV node causes both ventricles to contract and pump blood The normal delay between the atrium and ventricle contractions is 0 12 to 0 20 seconds By 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 monito
13. Check 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 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 tissue 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
14. 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 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 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 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 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 exam
15. ange Average heart rate ST segment QRS interval gt 20 M Ohm 3 mV 0 1 40 Hz gt 95 dB 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 4F 122 20 C 50 C 50 F 104 F 10 C 40 C 25 ar 95 45 to 180 bpm 3 to 3 mm lt 0 20 sec 20 I nstantCheck SOFTWARE 3 1 System Requirements Operating System Windows 98 98SE 2000 XP Vista Hardware Requirements gt CPU Pentium lil and above gt Memory 100MB and above gt Hard disk capacity 100MB and above gt Data transmission media Universal Serial Bus USB gt Screen resolution 1024 x 768 3 2 Installation ay v Software Installation be User s Manual InstantCheck Real Time Display Heart Function Monitor q Exit LEH gt E bi De gt DailyCare BioMedical Inc F gt BF 25 3 Ji Lin Rd 5 x Clvang Ld 320 Taiwan R O C Carint r every beat of your heart d Website wwwulcbiamed com 4 gt 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 21 the autorun exe application file in the CD to install manually Follow the Setup Wizard instruction on the screen
16. ay still experience a weak signal Please contact the distributor retailer or visit DailyCare BioMedical Inc s website http www dcbiomed com 36 Q4 A4 Q5 A5 Q6 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 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
17. cceccectecesueeaueueeas 18 2 5 PRODUCT SPECIFICATIONS asaaasaannunnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnn 20 INSTANTCHECK SOFTWARE c ceccccecececsceccncecscscenenceesess 21 3 1 SYSTEM HEOUIDEMENTS 21 3 2 INSTALLATION zwa zwi wwn ziwani nwa waza 21 3 3 TRANSMIT DATA iii EE 22 3 4 GOETWAREINTEREACE 25 3 5 USER AND FILE MANAGEMENT 26 3 5 1 Add New eer 27 3 5 2 Display or Change User s Information 28 3 5 3 Search for Ueer mwan mwai wwa 29 3 5 4 Move ECG File to Other USer w wwanwwanwwana 29 3 5 5 Delete E mail Save Preview and Print a File 30 3 5 6 Set Report Header aa 30 3 5 7 Review ECG Trace and Parameters 31 3 5 8 Redefine ECG Parameters aannannannnnnnnnnnnnnnnnnnnnnn 32 3 5 9 Reading the Granh aaa 33 3 5 10 ECG Waves and Harametere 34 FREQUENTLY ASKED QUESTIONS see EN EN ENN 36 GLOSSARY EEN 40 REFERENCES ee 42 CONTACT INFORMATION 0 cccececececcccccccecscecscsescececenenees 42 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 electrode
18. d 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 electrodes 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 Il 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 m
19. er Press 9 to start measurement anytime Below is a list of choices in the menu bm JL Deeg ch 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 ECG Select a file to review the ECG parameters and waveform NOTE Please set the Date amp Time before use 2 4 1 Continuous Mode This is an alternative recording mode Selecting this mode will allow the user to measure and display ECG waveform continuously for up to 5 minutes You can choose to stop anytime Only the last 30 seconds will be recorded and stored in memory 14 a Press to enter menu selection when the device is on b Continuous mode will be highlighted Continuous Mode Review ECG Transmit Data Date 8 Time Erase All Data Attention c Press to start measuring and displaying ECG waveform on LCD d Press again when you want to manually stop The device will record the last 30 seconds of data 2 4 2 Review ECG Data Q Press to enter menu selection when the device is on b Press EI again until Review ECG is highlighted lp Continuous Mode Review ECG Transmit Data Date amp Time Erase All Data Attention c Press amp to enter Review ECG mode d The newest ECG data file will be placed at the top and highlighted The highlighted file will display the calculated ECG parameters HR
20. ination 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 are 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 ATTENTI ON 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 other than those provided by the manufacturer Do NOT use USB cable other than that supplied by ma
21. l Carrying Case USB Cable Auxiliary Electrode Cable Not Included 2 1 3 Product Label Attention consult ACCOMPANYING Ho allyCale SIN Il DOCUMENT 8F 25 3 Ji Lin RD Chungli 320 Taiw BFF NP KSE TCE Model RMH4 0 Made in Taiwan Two 1 5V AAA size batteries DailyCare BioMedical Inc xX 1 xX 1 xX 1 xX 1 xX 1 xX 1 Manufactured by LOT WORK NON KONO KONO XN 1 Electrode gel pad These pads can be purchased at qualified local drug stores 2 AAA alkaline battery operate 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 Be sure hands are clean of any lotions Sit 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 Start to start measuring Each measurement will take 30 seconds During measurement you can stop it anytime by press HJOK Simply press again to start the next measurement Place right and left thumbs GENTLY on the conduction electrodes Calm and relax yourself with regular breathing Do NOT Move and Do NOT Talk during measurement Press for 3 seconds to power off the device manually anytime
22. l the modified values will be saved automatically Click Exit The values will NOT be changed 28 3 5 3 Search for User 1 Select E 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 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 St InstaniCheck 4 0 ECG Analysis So E W lls File Help fh fb KM a MRS vi vi Sel 2 Click function key A window will appear You can move the selected ECG file to other user 29 F Move file to FileName Test Date Test Time O1O12000_ 0009 O02 017017 2000 UU 09 1012000 0000 001 UL 01r 2000 OO 00 DI files will be moved to thi user e Delete all files after moving files to the selected user Cancel ox 3 5 5 Delete E mail Save Preview and Print a File 1 Select the files first Multiple files can be selected S InstantCheck 4 0 ECG Analysis Software E B E Ii bd H IA 3 x1 vi User Information A G Amy aen CT 01012000 0009 003 GO g al 01012000 DUU 001 D Erit 2 Click delete email save preview or print function 3 5 6 Set Report Header 1 Select function key The Report information window will appear as shown below 2 Enter header information Click on
23. lue 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 uncomfortable 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 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
24. n this section unless under the guidance of a medical professional 32 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 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 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 The X axis represents time in seconds Each big square represents 0 2 seconds Therefore each small square represents 0 04 seconds 33 Waveform Analysis bpm mim ma 0 2 seconds 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 that exceeds these might indicate atria hypertrophy Le 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
25. ntact 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 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 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 Instant
26. nufacturer 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 IMPORTANT NOTICE mn AA ATTENTION AA AAP HI INTRODUC TION BEE 1 1 1 WHAT IS INSTANTCHECK a 1 1 2 BENEFITS OF INSTANT CHEGK dana a AA 2 lad OV ARI ABLE gt maa AN AA AA ANA AA 3 1 4 COMMON CAUSES OF ABNORMAL ECG TRACINGS onsin 4 1 5 BASIC FUNCTION OF THE HEART 5 1 6 CONDUCTION SYSTEM OF THE HEART 5 PRODUCT DESCRIPTION bccsotcnewaeutanteccaeennwdencnadeecaveneweuiaabeseaaes 7 GN PRODUCT ADEN 7 a V ANC WT E 2 1 2 Product Package maa NAE AASA ANA 9 Pay GA Produ t LADE AA AA 9 2 2 TAKINGAMEASUDEMENT 10 2 2 1 Dry Thumb Conduction Electrodes 10 2 2 2 Optional External Electrode Cable 11 2S DISPLAY PANE ME 12 Pas EGD DISHI V oea A 12 2 3 2 LCD Display Description aa 13 AN AA AA AA AA 14 2 4 1 CONTINUOUS Mode 14 2 4 2 REVIEW ECO RE AA Aa 15 2 4 3 Transmit Data 2 0 16 2 4 4 Set and Adjust Date and Time 17 2 4 5 Erase all ECG Data 18 2 4 6 Attention ccc ccc ccccccccccccccccccccccceccecce
27. o display operating steps results of ECG measurements date time settings and playback 2 3 1 LCD Display LCD Display Panel During measuring F Se 09 25 2008 08 32 R Past Heart Rate e Sieg EATI Rate HR 082 J High ST Value ST 0 00 High ORS Value QRS 0 08 K Irregular Heart Rate L Impossible to Analyze Please measure 1 0 0 F H again LCD Display Panel After measuring 12 gt 2 3 2 LCD Display Description ltem Scale Indicator Amplitude Indicator Heart rate Display ECG trace Timer Date Time Messages om HR ST 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 deal indicates the battery is normal CT indicates the battery is low Average Heart Rate Reference range 60 lt HR lt 100 bpm ST segment Reference range 2 lt ST lt mm QRS interval Reference range 0 08 lt QRS lt 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 Al OK to ent
28. ring device for example InstantCheck superior vena cava aorta pulmonary artery SA node left atrium 3 mitral valve N left ventricle y right atrium AV node tricuspid valve right ventricle l cardiac muscle interior vena cava PRODUCT DESCRIPTION 2 1 Product Design LOT XXXXX XX XXXXX MT A Chungh 300 Teen AN al ce Model RMH4 0 Made in Taiwan Two 1 54 AAA size batteries Parts Descriptions Items Descriptions A Power on off button Turns the power on and off B D Start button Press to start measuring D Enter OK button Press to select Press to confirm E F Left and right electrodes Dry conduction electrodes for thumbs G Speaker Sound Large LCD panel to display LCD panel parameters and waveform I Battery cover Open cover to insert batteries J Product label 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 M USB socket manufacturer 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 Mi N N N N AW InstantCheck InstantCheck Software CD InstantCheck User s Manua
29. s The second method is by using external electrode cable and adhesive ECG electrode pads InstantCheck records 30 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 InstantCheck 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 ECG 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 e Take measurements anytime anywhere InstantCheck s compact de
30. sign allows the user to carry the device anywhere anytime for periodic monitoring of his her heart throughout the day e Manage ECG 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 8 The InstantCheck also stores up to 100 records for review using the LCD screen 1 3 ECG Variables QRS Complex R wave 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 z100 bom ST Segment ST 2 lt ST lt 2 mm QRS Interval QRS 0 08 sec lt QRS lt 0 12 sec PR 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 QTe 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 If heart rate is too fast HR gt 100 bpm it will be indicated Slow Heart Rate If heart rate is too slow HR lt 60 bpm it will be indicated High ST Va
31. sonal 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 grease 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 38 Q16 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 co

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