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Cardio M PC - User manual 2012 rev3 2

1. Mod with short PQ atrial origin P wave VR AR unusual P axis probable accelerated junctional rhythm unusual P axis probable junctional bradycardia tachycardia accelerated junctional rhythm junctional bradycardia tachycardia atrial flutter with slow ventricular response with normal ventricular frequency with rapid ventricular response irregular atrial function with slow ventricular response with normal ventricular frequency with rapid ventricular response kk atrial fibrillation with slow ventricular response with normal ventricular frequency with rapid ventricular response accelerated ventricular rhythm ventricular bradycardia tachycardia undetermined rhythm first degree AV block Long PQ 2nd degree AV block Wenckebach periodicity 2nd degree AV block Mobitz Il type higher degree AV block complete heart block unifocal multifocal premature ventricular complexes n pair of consecutive sequence of consecutive premature Rev 3 1 11 04 2012 63 Medical Econet GmbH CARDIO M PC ECG Ventricular complex es n premature ventricular complex es or aberrantly conducted n premature sinus atrial complex es Mod with QRS widening n pair of consecutive sequence of consecutive premature junctional complex es Mod
2. Examples of using this function e Ifa patient s ECG is mistakenly recorded twice it is possible to unite the two recordings into one and delete the unnecessary record e f recordings of a common type are to be examined for example myocardial infarction patients it is possible to create a record called Myocardial Infarction and collect the recordings in that card 8 4 Exporting and importing files Cardio M can export the measurements in several file formats most of them are commonly used in the medical industry like SCP HL7 or DICOM Menu Transfer From the patient list or from the record list the selected items or the actual item can be exported using the Transfer menu in the following formats e SCP With the File export SCP function a directory browsing dialog opens and after selecting or creating the desired destination directory the concerned recordings are written as SCP files containing patient data too Concerned recordings are all the rest or stress ECG records of the selected patients or if none is selected only of the actual one If the function is selected in the record list of a patient concerned recordings are the selected actual rest or stress ECG records File names are generated from the creation time of the recordings and have the extension scp e HL7 With the HL7 export function a confirmation window pops up and after selecting OK the concerned recordings see a
3. On the server side having the agent already running and right clicking it s icon on the tray a local menu pops up where under the Set new password opens a dialog for entering a new name password pair to have access to the server The usernames with password are stored in the pass dat file at the same directoryCardio M PC is located default place is C Crx EXE Administering deleting users adding multiple users quickly changing passwords can be done by editing this text file where the syntax is one comma separated lt user_name gt lt password gt pair by one line The listening TCP port of the server can be modified by editing theCardio M PC ini file in the NetCenter section by specifying listening_port 1234 where 1234 is the desired port number Rev 3 1 11 04 2012 62 Medical Econet GmbH CARDIO M PC ECG 13 Appendix 13 1 Appendix A Diagnosis Normal ECG The analyzed part of the ECG sec beats shows no signs of abnormality for one of the patient s age Pathological abnormalities short PQ sinus bradycardia tachycardia sinus bradyarrhythmia arrhythmia tachyarrhythmia Mod with short PQ sinus origin P wave VR AR kk atrial bradycardia rhythm tachycardia kk atrial bradyarrhythmia arrhythmia tachyarrhythmia low right atrial bradycardia rhythm tachycardia left atrial bradycardia rhythm tachycardia
4. 200 BP mmHg 18 m eae 130790 150 ian 39 176 00 13 100 H an 06 13 50 r 50 z min min 5 10 15 20 25 5 1 15 20 25 95 ree Median 50 mm s STJ Simulated ECG Not from the patient 25 mvs 10 mvi 10 1 Recording the stress test Monitoring begins with a resting ECG recording You can begin the workload stages as following t Menu Stress test Start Rev 3 1 11 04 2012 47 Medical Econet GmbH CARDIO M PC ECG Hotkey F9 The ergometer bicycle will begin with the initial workload and the storing of the full 12 channel ECG recording will also start The duration of workload stages will be that chosen in the Settings menu At the end of each stage an ECG is stored and the workload will be increased for the next stage The monitor window displays the following data e blood pressure or in case of automatic measuring the word display e time of blood pressure measurement e stage time and total test time in sec e actual load measured in W or in case of a treadmill speed and rise Test breakpoints If any one of the test breakpoints is reached the program enters the recovery phase However you can choose to continue the test at the current workload by pressing F3 within 15 seconds On the screen display below the test time indicators you can see the actual value of the workload measured in watts for th
5. ECG window of the Setup e Free select 6 leads can be set in the ECG window of the Setup e 12 leads Il Il aVR aVL aVF V1 V6 e Cabrera Precordial aVL aVR Il aVF Ill V1 V6 The indication of the stored recording is Precordial 3 Frank placement of 10 electrodes the first four plus e Frank X Y Z The stored recording is indicated as Frank Rev 3 1 11 04 2012 31 Medical Econet GmbH CARDIO M PC ECG 5 4 Storing the ECG recording B Mode Save Hotkey F9 You can use this function to save the immediately preceding 8 16 or 32 sec of ECG tracing that you have been monitoring The ECG curves are always stored without the 35 Hz filtration The length of the ECG to be stored can be specified by Menu Set Record length 8 16 32 Hotkey F8 Pressing F8 repeatedly will cycle through the three options It is also possible to continuously save the whole ECG curve forward in time To activate Menu Mode Continuous save This will cause the actually displayed curves to be stored continuously on the storage device The timer on the right side of the screen shows the length of the ECG recording that has already been saved by the program Saving can be terminated any time by pressing the Stop green square button or by exiting the monitoring window The ECG records saved in this fashion will have the name Longtime in the list of ECG recordings regardless of the lead confi
6. amp inferior location Rev 3 1 11 04 2012 64 Medical Econet GmbH CARDIO M PC ECG kk myocardial ischemia or digitalis effect in anterior amp septal amp lateral amp linferior location prolonged QT Possible pathological abnormalities 2nd degree AV block kk left posterior fascicular block Wolff Parkinson White pattern type A type B right left atrial enlargement biatrial enlargement right left ventricular hypertrophy with repol abn with possible repol abn biventricular hypertrophy with repol abn with possible repol abn Mod with QRS widening myocardial infarction in anterior amp septal amp lateral amp inferior amp posterior location subendocardial injury in anterior amp septal amp lateral amp linferior location acute pericarditis myocardial ischemia in anterior amp septal amp lateral amp linferior location myocardial ischemia or digitalis effect in anterior amp septal amp lateral amp linferior location ST abnormality probably digitalis effect prolonged QT Unspecified undetermined variations QRS left axis deviation kk QRS superior axis deviation QRS right axis deviation QRS right superior axis deviation abnormal QRS T angle nonspecific intraventricular block ST elevation
7. multiple selection possible speed and amplitude of the recording can be selected Specifying given seconds results one page of ECG curve printout at each given time points With the special sign three dots periodicity can be defined e g 100 means every 100 second Parts of the interpretation can also be separately included in the printing The Single lead box gives additional printout of the whole record with the corresponding speed and amplitude settings Rev 3 1 11 04 2012 21 Medical Econet GmbH CARDIO M PC ECG The Ergometry sub category allows the following report items of the stress test to be printed besides the ECG properties on the ECG tab that are also available independently from rest ECG settings in the previous sub category Likewise the ead selections speed amplitude settings and single lead parameters are also independent of the rest ECG settings ECG List of records a ST Level E Graphs B Conconi a ST Trend E Median of phases r Rev 3 1 11 04 2012 22 Medical Econet GmbH CARDIO M PC ECG 3 4 Setting the size and color of the Monitor window You can customize here the general appearance of the windows monitor ECG ruler medians inCardio M PC Preferences Categories Colors ECG device Background Default ECG n Print Grid Blue ECG Ergometry View of monitor and di Line Ergometry SS Ergometer program Text Treadmill program Blood pressure Pierre Langua
8. notebook for mobile use TheCardio M PC system can also be interfaced with medical database systems Rev 3 1 11 04 2012 5 Medical Econet GmbH CARDIO M PC ECG 1 2 Main system components The main parts of the system are e CARDIO M ECG recorder CARDIO M U USB Cardio M PC W both USB WiFiconnection e USB cable for connection to PC A mini B e Cardio M PC software Together these cooperating components are referred to as theCardio M PC PC system Minimal computer requirements A personal computer configuration desktop or notebook or netbook optionally equipped with inkjet or laser printer with installed and working operating system from the following list Windows XP Windows Vista Windows 7 Note the computer has to meet the requirements of the standard for business machines EN 60950 1 3 General instructions The equipment is designed for use by qualified medical personnel only Please read this User s Manual thoroughly before using the equipment Safe operation and accurate results can be achieved only when theCardio M PC system is used according to this User s Manual Only Medical Econet GmbH approved accessories should be used with the equipment 1 Instructions for storing and transporting Do not operate or store this equipment in places with high humidity in places with extreme atmospheric pressures or temperatures in any place where it can contact water or where poor ventilation dust or
9. this password in the Password field then the new options will be available 3 8 Password protection for usingCardio M PC In the settings of the Advanced main category you can prevent the unauthorized usage of the program by creating an optional entry password After giving the new password you have to re type it to Rev 3 1 11 04 2012 24 Medical Econet GmbH CARDIO M PC ECG confirm If the new password and the confirmed password are not identical a warning message appears and the password is not changed When you next start the program the system will ask for the new password Checking Backup on exit ensures a backup process to happen at program termination for saving any new data into a given directory 3 9 Mail settings See in the chapter 8 Transfer functions for details 3 10 NetCenter See in the chapter 12 Network operation multi user features for details 3 11 Auto backup Hospital specific application 3 12 Security groups Hospital specific application Rev 3 1 11 04 2012 25 Medical Econet GmbH CARDIO M PC ECG 4 Using the Card File inCardio M PC When you start the program the Cardio M PC system displays the Card File window The right hand side of the window contains the Patient List the left hand side of the window shows the Patient Card of the patient selected from the list The Patient List contains the name code birth date and the date of the last ECG record The width of the columns c
10. with QRS widening n aberrantly conducted complex es n other form complex es n ventricular escape complex es n sinus atrial junctional escape complex es Mod with QRS widening bigeminy pattern dextrocardia Wolff Parkinson White pattern type A type B low voltage QRS right left atrial enlargement biatrial enlargement incomplete right bundle branch block with repol abn with possible repol abn incomplete right bundle branch block plus right ventricular enlargement with repol abn with possible repol abn right bundle branch block with repol abn with possible repol abn right bundle branch block plus right ventricular enlargement with repol abn with possible repol abn incomplete left bundle branch block left bundle branch block left anterior fascicular block right left ventricular hypertrophy with repol abn with possible repol abn biventricular hypertrophy with repol abn with possible repol abn Mod with QRS widening myocardial infarction in anterior amp septal amp lateral amp inferior amp posterior location myocardial injury in anterior amp septal amp lateral amp inferior location acute pericarditis wk myocardial ischemia in anterior amp septal amp lateral
11. M allows you to collect an unlimited number of ECG recordings from a patient and store up to 99 resting ECG recordings and 30 stress test ECG recordings in one patient card Select the appropriate field in the Record menu item to make a new ECG recording to replay evaluate delete or copy a stored ECG recording or to compare the ECG recordings and the medians Rev 3 1 11 04 2012 27 Medical Econet GmbH CARDIO M PC ECG Deleting an ECG recording Record Delete Hotkey Dell After selecting this function you have to confirm your decision The deleted recordings cannot be recovered Selecting ECG You can select one or more recordings by F3 from the stored ECG curves Select a recording in order to replay or evaluate it or select several recordings to compare the ECGs and or their medians or to copy or print the ECGs You can also create the inverse of the selection The selection is valid until you cancel it or until you quit the patient card Copying ECG Menu Record ECG Copy Patient records can be copied to other patient s records This could be useful if you are trying to merge the mistakenly twice registered patient s distinct records into one or if you just want to see records of different patients in one listing After selecting the records to copy you have to select the target patient in the patient list and enter his her records Menu Record ECG insert After you have confirmed your operation the records
12. ST elevation because of early repolarization ST depression probably digitalis effect junctional ST depression T wave abnormality probably digitalis effect ST and T abnormality probably digitalis effect only in pediatric diagnose Rev 3 1 11 04 2012 65 Medical Econet GmbH CARDIO M PC ECG only in adult diagnose or amp and Rev 3 1 11 04 2012 66 Medical Econet GmbH CARDIO M PC ECG 13 2 Appendix B Electrode placements and lead calculations Extremal and Precordial rest test recordings Recordings with Frank arrangement Stress test recordings I L R ll F R Ill F L aVR R F L 2 aVL L F R 2 aVF F L R 2 V1 C1 F L R 3 V2 C2 F L R 3 V3 C3 F L R 3 V4 C4 F L R 3 V5 C5 F L R 3 V6 C6 F L R 3 X 0 78 0 78 A 0 22 C I Y 0 35 M 0 65 F H Z 0 87 0 15 A 0 85 M 0 30 1 0 43 E 0 27 C I C1 E C2 C C3 A C4 M C5 H C6 Leads and calculation are the same as described in the Precordial type Rev 3 1 11 04 2012 67 Medical Econet GmbH CARDIO M PC ECG International Sales amp Service Medical Econet GmbH Mainstr 6 c d 45768 Marl Germany www medical econet com Medical Econet GmbH Rev 3 1 11 04 2012 68
13. any chemical pollution or industrial gas is present This equipment must be stored on a flat surface It should be protected against dropping vibration shaking and extreme mechanical forces both during storage and transportation This equipment complies with IEC 601 1 type class Il shock protection therefore the computer must always be operated with its supplied shock protected voltage connector Connect the computer s Rev 3 1 11 04 2012 6 Medical Econet GmbH CARDIO M PC ECG voltage connector as specified taking care to match the voltage and frequency of the network with the voltage and frequency of the device Grounding the equipment is achieved through the network shock protection connector Cardio M may be used safely in patients with pacemakers or other implanted devices Like any ECG the pacemaker or other device will not disrupt or be influenced by the operation of Cardio M PC However equipment operators and supervising physicians should be aware of the presence of pacemakers or other devices The Cardio M PC system is designed for external skin surface ECG recordings only It must not be used for intracardiac recordings and must never be directly connected to the pericardium with internal electrodes 2 Using a defibrillator Although the ECG input is protected against electric discharge the electrodes must not connect with or otherwise contact the defibrillator pads or paddles To avoid injury the patient
14. for the stress test is not listed or if it cannot be controlled by a computer then choose Ergometer or Treadmill without PC connection When using the Treadmill you have the option to choose the units of speed measurement km h or mph Use the Check button to test the connection If successfully connected then a RS 232 control message appears If the program is unable to control the device the warning message No RS 232 connection appears There are several possible reasons for this warning message e the device is not connected properly e the device is turned off e the selected device is not identical with the connected device e the appropriate COM port has not been chosen e the COM port is not set up correctly e the serial cable is not appropriate or it is broken With the Command test button the individual control commands can be tested 9 2 Load program Ergometer Treadmill The workload scheduling can be given here When using a cycle ergometer bicycle you can select a protocol or define a new one by giving a name and pressing New button The parameters Beginning of load Increase of load and Load interval are self explanatory The First recovery phase can be differentiated by Rev 3 1 11 04 2012 44 Medical Econet GmbH CARDIO M PC ECG assigning specific load and interval values to it This can be useful when the patient reached high load e g sportsmen and the doctor intends
15. mailbox Name of POP server POP user id POP password POP port Mail check Cancel inbound mails into the local inbox Rev 3 1 11 04 2012 42 Medical Econet GmbH CARDIO M PC ECG The sending procedure e select the patient cards ECG recordings to be send F3 e select the Transfer Send by mail function F11 e input or select previous recipient address in the pop up window Mail sending can be initiated from inside an ECG recording while viewing in the monitor window by pressing key F11 The receiving procedure The program checks automatically in the specified intervals for inbound mails New ones are downloaded and added to theCardio M PC database automatically accompanied by a notification window Checking for new mail can be initiated anytime using the menu Transfer Receive by mail or by pressing key F12 Rev 3 1 11 04 2012 43 Medical Econet GmbH CARDIO M PC ECG 9 Settings for the stress test Menu Setup Ergometry In the main category Ergometry the device can be selected while in the following two subcategories the workload parameters can be set In the third subcategory the blood pressure device can be selected and enabled 9 1 Ergometer bicycle blood pressure measurement and RS232 control Before beginning the stress test select the serial port Port item and the type name of the connected device If the type of bicycle or treadmill used
16. program will create one but a unique name selection is important in the network environment In network operation ECG recording on a workstation is possible only after enabling the option with a password For these workstations the Network database option must be bought as well as other options that are needed on the workstation see chapter 3 7 Options Network operation introduces some limits only one user can access a patient s card at a time and a card cannot be deleted when more than one user is accessing the database This kind of operation is available not only on Local Area Network but also on other compatible remote networks e g Virtual Private Network 12 2 Remote monitoring Remote monitoring is a feature that allows a workstation runningCardio M PC to monitor the ECG recording process running simultaneously on another workstation in the local network The ECG recording is done on workstation A while workstation B wants to monitor the curve being recorded In the Setup menu under the ECG device category of A the Allow remote monitoring must be checked Rev 3 1 11 04 2012 54 Medical Econet GmbH CARDIO M PC ECG Preferences Categories ECG device Ee eeue ECG on USB Ergometry View of monitor and di Ergometry Ergometer program Treadmill program Blood pressure User d Options Advanced Vv Vv l Remote ECG monitoring Directory for temporary file
17. resolution 3 5 Stress test setup See the chapter 9 Settings for the Stress test for details 3 6 User Institute Set the data of the institute This will appear in the header of every printed page Doctors The first column of the table is for the doctor s initials the second for his her full name Initials are used on the Patient Card to indicate which doctor the patient belongs to In printing only the full name appears 3 7 Upgrade options You can see information about the version numbers ECG device Software and the list of possible options An option is enabled if it is checked in the list Options are the following e Network database to use the software over a local area network Recording is possible using the server software running on the computer with the ECG device connected The created database can be viewed on all workstations e Stress test if the stress test option is enabled then the device can automatically control the ergometer bicycle as well as save and store stress test 12 lead ECGs e Remote monitoring online observation of ECG monitoring over a network This function is useful for example during stress tests when an observing doctor is able to view the ECG curves on another computer If you want to purchase a new option Send the device number of your system and the list of requested options to yourCardio M PC distributor You will receive a new password Enter
18. the program does not perform the automatic evaluation 7 1 Manual evaluation in the ECG ruler es Menu Mode Interpretation Hotkey F8 The median calculation determines the most characteristic beat in each lead and displays these median beats for all 12 leads It also calculates the time and amplitude values necessary for the rhythm and contour analysis draws the rhythm curve and displays a table of the diagnostically important parameters 7 2 Median calculation The Interpretation window displays the most characteristic averaged or median beat for each lead The bottom part of the screen shows the rhythm curve Select one lead as the rhythm curve in the Setup ECG menu The medians appear in 50 mm sec time resolution and with 10 mm mV amplitude The parameters of the rhythm curve 8 sec 25 mm sec and 5 mm mV The upper table on the right shows the global parameters relating to the whole of the analyzed curve whereas the lower table displays the more specific parameters relating to the selected lead You can click with the mouse on any selected median cell in order to enlarge it The corresponding median curve will appear in the graphic part of the screen in magnification with 20 mm mV amplitude and 200 mm sec time resolution On the magnified median markers show the interval related calculation points for all of the usual projection points on the ECG curve These points are the same for every lead as shown in the table
19. there The patient list splits into two In the upper part the Client in the lower the Server database can be seen This function is useful for copying and comparing data between two databases e Sending a patient s data to the Server The patient to be sent is selected in the patient list The Send to function under Transfer menu is selected Connection is established as described previously The patient file is transferred into the IMPORT directory on the Server default is C CRX IMPORT from there it must be imported into the server program later This function is useful only if one patient s data must be transferred and there is no need for the Server s database to appear on the Client that would take significantly more time Rev 3 1 11 04 2012 58 Medical Econet GmbH CARDIO M PC ECG 12 5Cardio M PC NetCenter Operation Users run theCardio M PC program on local workstations in client mode These workstations connect to the central database using TCP IP network protocol Connection can be made on a LAN or on the Internet The locally stored recordings are copied onto the database of the specified central server The workstations connected to the server see only their own local database while their database is continually synchronizing with the central database When the user adds a new patient or views the card of an existing one the client checks if the patient is already available on the server If s
20. will be inserted into the list in the correct chronological order 4 6 Comment block operations Besides this you can edit a comment line for each ECG recording which can be up to 20 characters in length Menu Record Comment to recording Hotkey F4 You can attach a comment block for each patient Menu Patient Comment block Hotkey F2 Rev 3 1 11 04 2012 28 Medical Econet GmbH CARDIO M PC ECG Rev 3 1 11 04 2012 29 Medical Econet GmbH CARDIO M PC ECG 5 ECG recording 5 1 Monitoring You can monitor the ECG with theCardio M PC system if you have a connected and enabledCardio M PC device During monitoring the ECG curve is displayed on the screen and you can save selected temporal segments of data You can turn on off the tremor filter the sound of the QRS detector or change the lead system the number of the displayed channels paper speed time resolution amplitude gain and the length of the recording to be stored If the device selected in the Setup is not available the following is displayed ECG driver ECG device not found 3 Start the monitoring Record ECG record Hotkey F9 Note First you should select your device in the Setup ECG menu If the default Demo no ECG is selected you will get a simulated recording 5 2 Time resolution amplitude gain QRS sound and filter The time and amplitude resolution of the ECG recording starts with the parameters selected in the Setup
21. 0 25 mm sec 7 Print Diagnosis ECG Possible i sian a Unspec iew of monitor and di 7 m Ergometry v pa parame enraneg Record length Ergometer program BSH M Baseline filter 16 sec x Treadmill program M 50Hz M 100Hz M 200Hz Blood pressure l 60Hz M 120Hz User M Emergency ECG Options gency Advanced Amplitude 10 mm m Electrode placement Precordial Leads 2x6 leads Rhythm ll Free selected 3 IWW2 V5 Free selected 6 IaVF V2 V4 V5 3D reconstruction Inverse Dower e The Leads monitoring Speed and the Amplitude parameters can also be changed during the recording With every new recording the same default values set here will be used until they are changed by the user e Diagnosis when switched on the automatic diagnosis function can be accessed otherwise it is disabled The categories can be enabled selectively e Filters 35Hz muscle noise filter 50Hz 100Hz 200Hz or 60Hz and 120Hz mains filter it is advisable to have these turned on 0 1Hz baseline fluctuation reduction filter Le Lej let Let let Ls Rev 3 1 11 04 2012 18 Medical Econet GmbH CARDIO M PC ECG e Sound state of QRS complex detection signaling e Speaker use the system speaker for QRS signaling e Recording length the length of the stored ECG segment 8 16 or 32 sec e J 60 80 the method of calculating the end of the ST segment for more in
22. 1 Medical Econet GmbH CARDIO M PC ECG Cardio M can import files in its own CRC format The function can be invoked by selecting Import from file CRC under the Transfer menu Then a directory browser opens for selecting the place where the files to be imported are located All the patient cards and ECG recordings in the directory will be imported Upon successful import the files are deleted This function is only accessible in the patient list window 8 5 Send receive by mail Patient cards and ECG recordings can be transmitted by e mail with an appropriate Internet connection Required settings must be given previously in the Setup menu under the Advanced Mail category The address of the remote and local mailboxes are to be filled implicitly The SMTP and POP server names can be obtained from the mailer client if set or from the Internet provider Some servers may require secure connection this can be set by checking SSL The ports are also need to be obtained from the service provider Preferences Categories ECG device ECG Print Address of remote mailbox ECG Ergometry View of monitor and di Ergometry Ergometer program Treadmill program Blood pressure User Options Advanced NetCenter Auto backup Security Groups A non zero value for the Mail check field provides automatic checking of Name of SMTP server SMTP user id SMTP password SMTP port Address of local
23. Avoid reusing disposable electrodes or using mixed types of electrodes 5 During usage Do not touch the electrodes and take care that neither the patient nor the electrodes connect with conducting objects e g metal parts of the examining bed equipment holding tripods etc If one or more electrodes become loose disconnected or are inexpertly placed an error message will occur on the computer monitor during ECG recording Replace these electrodes If required for patient safety switch off the device and disconnect the electrodes 6 After using the device Immediately after use disconnect the lead wires from the electrodes then remove and dispose the electrodes Non disposable electrodes if used should be properly cleaned after each use with alcohol of appropriate clearing materials If needed the lead wires may also be cleaned as appropriate 7 Maintenance and checking TheCardio M PC system and any accessories should be checked regularly monthly by visual inspection If the system has been stored or not used for a long period of time 6 month all components accessories must be checked carefully before using it again The device must be powered off before cleaning and disinfection The device must not be modified or altered any way TheCardio M PC system is calibrated by the manufacturer prior to delivery No additional calibration or scheduled maintenance needed under normal operation In cas
24. Cardio M PC User Manual C 0123 oe3oos cee e N e o o o o o o o o ooog e o o oop Medical Econet GmbH CARDIO M PC ECG Contents Introduction 1 1 Features 1 2 Main system components 1 3 General instructions 1 4 Security instructions 1 5 Electromagnetic Compatibility 1 7 Explanation of symbols on machine Installation 2 1 Hardware installation 2 2 Software installation Setting the default parameters 3 1 ECG device 3 2 ECG 3 3 Print 3 4 Setting the size and color of the Monitor window 3 5 Stress test setup 3 6 User 3 7 Upgrade options 3 8 Password protection for usingCardio M PC 3 9 Mail settings 3 10 NetCenter 3 11 Auto backup 3 12 Security groups Using the Card File inCardio M PC 4 1 Adding a new patient 4 2 Editing a patient card 4 3 Deleting from the patient list 4 4 Selecting card files 4 5 Findings list of stored ECG recordings 4 6 Comment block operations Rev 3 1 11 04 2012 2 eeen eevee geeeen e o o o o eo Medical Econet GmbH CARDIO M PC ECG ECG recording 5 1 Monitoring 5 2 Time resolution amplitude gain QRS sound and filter 5 3 Selecting a lead system 5 4 Storing the ECG recording Stored ECG recordings 6 1 Recording display in the ECG ruler 6 2 Comparison of recordings medians 6 3 The Frank ECG vector 6 4 Replay of recordings 6 5 Data export to MS ExcelP 6 6 Longtime recordings Evaluation of the ECG
25. ECG device is connected to the computer using a standard USB cable shipped with the device The cable has two different connectors one that fits into the device and the other into the computer The operating system of the computer automatically recognizes the ECG whereupon the yellow LED on the device lights up and starts blinking When the online monitoring is started in theCardio M PC program the LED will light continuously due to the data transmission The standard ECG electrodes can be ordered optionally must be attached to the patient as regular see appendix 13 2 B 2 2 Software installation e Turn on the computer e After starting Windows place the installation CD labeledCardio M PC into the CD drive e f the automatic insert notification is enabled the Cardio M PC installer will auto start Otherwise browse to the root folder of the CD ROM and execute the installer shown with the following icon G a e Choose the destination directory If there is a previous version already installed we recommend that the new version be installed to the same directory In this case the new version will automatically use the previous database Choose the language After successful installation Cardio M PC can be started by clicking on the following icon on the desktop or by launching wincrx32 exe Rev 3 1 11 04 2012 16 Medical Econet GmbH CARDIO M PC ECG 3 Setting the default parameters Default parameters concerning the functio
26. PC ECG Crx Server OFFLINE Received Command Command Status isen Password Next the Listen function must be started and the network port can be set if necessary If the port number is appropriate the Continue button places the server program into communication ready state Starting the Client program We have three possibilities to connect to a remote Server s database e The Server holds the whole database patient list From the Transfer menu the Remote database function must be selected Then the following window appears Choose Communication Device Cancel Using the Setup button the IP address and the listening port of the server can be set These values are remembered in new sessions after exiting Rev 3 1 11 04 2012 57 Medical Econet GmbH CARDIO M PC ECG the program but can be modified if the server changes Port 200 IP address Cancel By clicking the Connect button the program asks the password for accessing the Server After given the correct password the Client program connects to the Server and the patient list of the remote database appears e The Server as the second card file From the Transfer menu the Open 2 card file function is selected A window opens and the Remote button on it s upper side must be clicked that opens the same window mentioned in the previous point Connection is established as described
27. above and to the right of the medians e PB PE beginning end of the P wave Rev 3 1 11 04 2012 37 Medical Econet GmbH CARDIO M PC ECG e B J beginning end of the QRS complex e STE end of the ST segment e TE end of the T wave The parameters within the table beneath and to the right of the medians are calculated on a lead by lead basis The calculation of the ST attributes can be done in two different ways press F5 to toggle it The calculation of the end of the ST segment is different e STE the middle point of the interval between the global cusp of the T wave and the J point e J80 J60 80 msec from the J point or in case of HR gt 100 60 msec from the J point 7 3 Parameters Menu Mode Diagnosis The Parameters item displays the parameters of every lead system in a comprehensive table The upper part of the table contains the global parameters relating to the whole of the recording the lower part contains the specific parameters of each lead system The Automatic diagnosis provides a suggested rhythm and clinical diagnosis based on the evaluation of the morphology of the recorded ECG to assist in interpretation by the physician ANY FINAL DIAGNOSIS MUST ALWAYS BE MADE BY A QUALIFIED PHYSICIAN The physician s diagnosis can be added by opening the Edit diagnosis item where the suggested Automatic diagnosis text will be displayed Patient AGE must be entered by the user for the Automatic diag
28. an be adjusted or even hidden with the mouse by grabbing the delimiter in the table header The default order of the patients is alphabetical which can be changed by clicking on the header of the desired column code born last ECG The easiest way to find a patient is to enter the starting letters of the patient s name The cursor jumps automatically to the first line where letters are identical with the entered letters You can move in the patient list with the Up and Down keys PgUp and PgDn are for the bigger jumps pages Jumping to the beginning end of list Home End 4 1 Adding a new patient a Menu Patient New patient Hotkey Insert You can start to start fill out the patient card The patient card includes the following fields name code birth date sex height weight doctor diagnosis The entered dates can be stored by pressing Enter or by clicking on OK 4 2 Editing a patient card The patient card can be modified any time Menu Patient Patient card Hotkey Tab The last three lines of the patient card contain read only information e number of stored rest or stress test ECG recordings e indicator of the patient s comment block e date of the last ECG recording Rev 3 1 11 04 2012 26 Medical Econet GmbH CARDIO M PC ECG 4 3 Deleting from the patient list BD vrenu Patient Delete Hotkey Del All data for the patient including ECG recordings will be deleted Important the dele
29. ardio M PC program for normal recording e g Setup ECG device ECG on USB The program must be started with the parameter netdevice This wayCardio M PC at A starts monitoring immediately the user has nothing to do expect supplying the IP address of A to B This address appears on the lower side of the monitoring window Practically a communication channel should be established between A and B chat skype telephone since operations must be synchronised and patient data is also entered by B At place B in the Setup ECG device must be selected as TCP IP ECG device and the IP address of A must be supplied Afterwards theCardio M PC program can be used as regular for recording the signal coming from of A 12 4 Server Client remote database operation In this operational mode theCardio M PC program running on a local computer Client connects to the database of aCardio M PC running on a remote computer Server using TCP IP protocol Starting the server program is possible from the Transfer menu by selecting Start server When starting for the first time a password must be given by clicking the Password button on the window just appeared This button can be used later as well if the password needs to be changed This same password given on the server side has to be used on the Client side when connecting Rev 3 1 11 04 2012 56 Medical Econet GmbH CARDIO M
30. bove are written in HL7 format files into the EXPORT directory ofCardio M PC default is C Crx EXPORT There is a setting in the initialization file default isCardio M PC ini that enables the ECG curve data to be written into the HL7 file as well The setting is under the hI7 section as wave 1 File names are generated from the creation time of the recordings and have the extension rep e DICOM With the DICOM wave export function a directory browsing dialog opens and after selecting or creating the desired Rev 3 1 11 04 2012 40 Medical Econet GmbH CARDIO M PC ECG destination directory the concerned recordings see above are written as DICOM files with waveform data containing patient data too File names are generated from the creation time of the recordings and have the extension dcm e CRC It can be created with the File export CRC function It is a proprietary format and can contain the records of a patient so when more patients are selected when exporting a directory browser opens for selecting the destination of multiple files one for each patient while if a record or selected records from a single patient are involved a file selection dialog opens where the name can be specified too Else a random name is used Extension of the file is cre additional files may be created with the same name but with random extension the crc file needs them e CRN It can be created with the Patient name ex
31. but these can be changed during the recording Time resolution di gt did Menu Set Time resolution Hotkeys Speed can be 25 50 100 or 200 mm s Amplitude a v oo Y Menu Set Amplitude Hotkeys Up Down Amplitude can be 5 10 or 20 mm mV It is possible to toggle on off the beat detection sound the 35 Hz tremor filter and the baseline wander spline filter Rev 3 1 11 04 2012 30 Medical Econet GmbH CARDIO M PC ECG Sound gt Menu Set Sound Hotkey F6 Filter Menu Set Filter Hotkey F7 Besides the 35Hz tremor and baseline wander spline filters there are also other filters available Enabling and disabling these is done through the Setup ECG menu The average pulse HR beats per minute and the time between the last two R waves RR msec can be seen in the top right corner of the screen 5 3 Selecting a lead system The system supports three types of electrode placement from which the following lead combinations can be displayed see also Appendix C 1 Placing only the limb electrodes e Limb 1 Il Ill aVR aVL aVF e Cabrera aVL aVR II aVF III e Standard II III e Unipolar aVR aVL aVF The stored recording is indicated as Extremal 2 Standard placement of all 10 electrodes the previous four plus e Precordial V1 V2 V3 V4 V5 V6 e Precordial 1 3 V1 V2 V3 e Precordial 4 6 V4 V5 V6 e Free select 3 leads can be set in the
32. copy from one to the other Menu Transfer Copy Hotkey F5 Patient records that have been selected will be copied If no records are highlighted as selections the single record at the cursor will be copied All data including ECG recordings is copied Re archive Menu Transfer Re archive Previous versions ofCardio M PC allowed a group of patients to be archived to smaller capacity media floppy disc for backup This feature is dismissed due to the great increase in disk capacities though the re archiving of previously archived data is supported through this command 8 2 Backup Menu Transfer Backup Backup can easily be done with this function to create a duplicate mirror database When Backup is invoked the program will automatically select and copy patient records that do not already exist in the duplicate mirror database or that are newer than existing records 8 3 Copying and inserting ECG recordings Menu Record ECG copy Record ECG insert It is easy to copy individual ECG recordings as follows e Select the recordings to be copied on the Findings screen F3 Rev 3 1 11 04 2012 39 Medical Econet GmbH CARDIO M PC ECG e Use the Record ECG copy function to copy the selected recordings The program will store which recordings have been selected e Select the patient s card file where the selected ECG recordings are to be copied then use the Record ECG insert function to insert them in the list
33. d for Not Applicable domestic purposes Voltage fluctuations flicker emissions IEC 61000 3 3 Rev 3 1 11 04 2012 10 Medical Econet GmbH CARDIO M PC ECG Electromagnetic Immunity TheCardio M PC ECG is intended for use in the electromagnetic environment specified below The customer or the user of theCardio M PC ECG should assure that it is used in such an environment Immunity test IEC 60601 1993 test level Compliance level Electromagnetic environment guidance Electrostatic discharge ESD IEC 61000 4 2 4 kV contact 8 kV air 4 kV contact 8 kV air Floors should be wood concrete or ceramic tile If floors are covered with synthetic material the relative humidity should be at least 30 Electrical fast 2 kV for power Mains power quality should be that of a transient burst supply lines Not Applicable typical commercial or 1 kV for hospital environment IEC 61000 4 4 input output lines Mains power quality Surge 1 kV differential should be that of a mode Not Applicable typical commercial or IEC 61000 4 5 2 kV common mode hospital environment Voltage dips short interruptions and voltage variations on power supply input lines IEC 61000 4 11 lt 5 UT gt 95 dip in UT for 0 5 cycle 40 UT 60 dip in UT for 5 cycles 70 UT 30 dip in UT for 25 cycles lt 5 UT gt 95 dip in UT for 5 sec Not App
34. diagram displaying the trend of the Double product 1000 as a function of oxygen consumption 11 3 ST evaluation ST Trend The screen displays the ST diagrams of the 12 standard leads as a function of time Press F5 to toggle the STJ STM and STE values With Up and Down keys can you change the amplitude gain ST List The ST list is a comprehensive table of heart rates and ST values of the standard 12 leads Press F5 to toggle the STJ STM and STE values The STE STM and STJ values are replaced with J80 J60 J40 J30 STJ values if the program used the J 80 60 msec to determine the end of the ST segment Setup ECG U 60 80 ON Rev 3 1 11 04 2012 53 Medical Econet GmbH CARDIO M PC ECG 12 Network operation multi user features 12 1 Local network operation In case of using the program in a network configuration the software must be installed only to the server computer It can be executed on each workstation that uses the common database located on the server A patient s card can be accessed from several places this way and possible changes can be tracked from those places without intervention The parameters set in the Setup menu are valid for each workstation When a user wishes to use custom configuration the program can be started with the i option and the name e g stationO1 of the INI file containing the custom settings wincrx32 exe istation01 If the given file does not exist the
35. e ergometer bicycle and as speed and grade for the treadmill 10 2 Recovery phase At the end of the last workload stage or when any test endpoint is reached the program automatically switches to the recovery phase Menu Stress test Recovery If a limit value is reached the workload can be continued by pressing F3 within 15 seconds and the recovery phase will not begin In the recovery phase the workload is set to zero or to a minimum value and blood pressure measurements continue With ergometer bicycles controlled by the computer the workload is set to a minimum value automatically With ergometer bicycles that are not computer controlled the minimum workload must be set manually 7 Menu Mode Return Hotkey ESC Quits the program Be sure to the test is completed and saved before quitting Rev 3 1 11 04 2012 48 Medical Econet GmbH CARDIO M PC ECG 10 3 Blood pressure measurement Blood pressure BP measurements start automatically at the end of the rest load and recovery phases The blood pressure measurements can be done in two ways In manual BP mode the user types in BP measurements in the following form BP mmHg systole diastole Before the end of each workload stage the program provides a beep signal and a schematic figure of a sphygmomanometer appears under the pulse values The BP measurements are to be entered 40 seconds after the beep tone a white stripe in the schematic figure indicates the t
36. e of malfunction manufacturer or distributor should be informed and the system should be taken out of service and labeled with visually prominent notice to prevent continued use Repair must be carried out by the manufacturer or a qualified agent of the manufacturer Rev 3 1 11 04 2012 8 Medical Econet GmbH CARDIO M PC ECG 1 4 Security instructions This device complies with IEC601 1 2 international standards for electric medical devices and electromagnetic tolerance of devices If the electromagnetic environment exceeds limits specified in IEC601 1 2 the device could be disturbed such that malfunction or failure could occur Therefore to prevent malfunction or failure nearby interference or noise should be eliminated before operating the device Here are some of the common sources of interference and steps to prevent them The device is not grounded is not connected to a potential equalizer Remedy Connect the potential equalizer switch of the device with the one in the examination room with a potential equalizer cable Strong electromagnetic noise produced by nearby noise source e g mobile phone or radio station Remedy Eliminate the nearby noise source or if the source cannot be eliminated install the Cardio M PC system in another location Radio frequency noise produced by another device through the power supply of the system Remedy Search for the source of the noise and eliminate it if possible A
37. e program displays in the case of a 6 channel recording a maximum of 7 and in the case of a 3 channel lead a maximum of4 median recordings at a time If you have selected several recordings use the PgUp and PgDown keys to scroll forward or backward The median cells display Rev 3 1 11 04 2012 33 Medical Econet GmbH CARDIO M PC ECG the average beat of the recordings The header of the columns contains the heart rate HR calculated from the given curve the date of the recording and for stress tests the serial information related to load phases and time values You can magnify the median cells with the mouse click Above the magnified picture the program displays the global parameters and besides those the parameters characteristic to the individual lead You can analyze and compare the medians in a much more vividly descriptive way by viewing them all together Cardio M PC can put together the related medians in a 3D figure Medians from different recordings appear one after another It is easy to see the differences in the length of the QRS complex the T wave etc Medians from every lead can be examined this way a Menu Mode 3D median compare The picture below illustrates a 3D median from the V1 lead Rev 3 1 11 04 2012 34 Medical Econet GmbH CARDIO M PC ECG 6 3 The Frank ECG vector a Menu Mode Vector TheCardio M PC program can display the vector ECG from the Frank ECG recording You need the spec
38. formation see the Stress test chapter e Electrode placement the actual placement of electrodes Important for storing and evaluation of ECG recordings e Leads the lead combination by which the ECG curves will be represented e Rhythm You can select any of the 12 leads to be the rhythm strip on the median screen e Free selected It is possible to monitor any 3 or 6 channels in the recording Here you can select which 3 or 6 you want to see 3D reconstruction Conversion method for vector ECG from normal 12 lead ECG Rev 3 1 11 04 2012 19 Medical Econet GmbH CARDIO M PC ECG 3 3 Print General ECG printout setting can be modified in this Setup category In case of color printers the color of the curves the grid the lines and the texts can be selected separately or well established default schemes can be selected The background can not be modified it will be always white Preferences Categories Printer colors ECG device Default Grid Blue Ergometry _ ewe View of monitor and di Ergometry Ergometer program Treadmill program Blood pressure Grid User Options New Style Step Advanced Old Style Point size Line Text Draw Grid First M Default Picture Export Picture size 3488 X 2500 Portrait pic export I Print 3x4 leads r Diagnosis in header B Ok Cancel In some cases especially with high resolution laser printers t
39. ge User Hoes dt English GB date Options C Thick ECG curve Advanced Curve F Medians in longtime monitor window Always on top Fontsize M Multiple monitor windows Automatic 12 User interface timeout min l English measures Colours can be set separately for the elements of graphs by clicking its button and selecting from the upcoming dialog or you can choose from three presets Default By selecting Shrink heigh the monitor window s height will change proportionally to the number of channels displayed It can be useful when other running programs also need to be seen on the display Thick ECG curve provides better visibility on the screen Medians in longtime monitor window displays the online calculated medians together with the curves Always on top ensures that the monitor window is always seen above other running applications When Multiple monitor windows is checked each ECG record appears in its own individual window e g for comparison Language can be selected for the program interface if changed the program restarts Fontsize determines the used font size in allCardio M PC windows Note Rev 3 1 11 04 2012 23 Medical Econet GmbH CARDIO M PC ECG that other operating system dependent fonts like in menus and on system messageboxes cannot be changed here It is advised to choose the maximum size that fits your display
40. guration you are using Rev 3 1 11 04 2012 32 Medical Econet GmbH CARDIO M PC ECG 6 Stored ECG recordings 6 1 Recording display in the ECG ruler The curves are displayed with baseline correction If the baseline correction could not be performed for example because the recording was too noisy incomplete or possibly because the patient had a pacemaker and an error message will appear Baseline correction failed You can perform measurements on the curve displayed in the ECG rulers with the help of the markers The top right hand side of the window displays the average heart rate HR below it the time interval between the markers in msec and the heart rate that you would get if you regard this time interval as the RR distance Using Frank placement 2D and 3D vectorgraphs are also available Filter 1 Menu Set Filter Hotkey F7 The filter of the ECG can be turned on off see also Monitoring 6 2 Comparison of recordings medians To compare recordings select from the list with the key F3 There are two possible ways of comparison 1 Compare of ECG curves 2 Record Compare You can compare the specific leads of up to 6 rest or stress test recordings If there are more recordings selected only the first 6 will appear in the comparison The program displays the same lead of the selected records Select another type of lead from the Leads menu 2 Median comparison EB ten Record Compare Th
41. he ST segment Setup ECG J 60 80 ON Select the ECG menu item to replay measure evaluate compare and delete a recording in the same way as for resting ECG recording Press F3 to select recordings for comparison The evaluation of ECG intervals and segments of the stress test ECG is performed in an identical manner as the evaluation of resting ECG recordings However the automatic interpretation function in the stress test ECG differs in a few ways e the parameters of the P wave do not occur in the parameter tables e if a lead is noisy or cannot be evaluated the program does not calculate the median of this lead but the other medians and their parameter tables are calculated e the program does not propose a diagnosis but you can ask for the reports of the evaluation 11 1 Calculation of maximum exercise performance Maximal HR predicted HR 220 minus age maximal BP and the maximal Rev 3 1 11 04 2012 51 Medical Econet GmbH CARDIO M PC ECG workload achieved are displayed just below the recording list For a ergometer bicycle stress test the right hand side of the screen display shows an evaluation of exercise performance The maximum expected performance from the patient can be calculated according to the weight and the body surface area by the method of DuBois The display also shows achieved performance as a percentage of maximum predicted If the HR during the stress test has reached the limits defined for
42. he grid is too light for this the printing style can be adjusted The Old style setting uses dots for the grid with the given point size while the New style draws lines as the grid using the step size Toggling Draw grid first may help in cases when grid is not printed correctly due to printer driver issues Checking the Print 3x4 leads forces printing in 3x4 lead format always if printing from the monitor regardless of the selected lead selections The selectable Picture size and the orientation is used for GIF and DICOM file exports from the print dialog Rev 3 1 11 04 2012 20 Medical Econet GmbH CARDIO M PC ECG Different prints can be created from the same ECG record The ECG sub category allows the predefinition of print types which can be used at later time printing from the record list view of a patient not from monitor view A Preferences Categories ECG device ECG Print ECG Ergometry Leads Standard Unipolar precordial 1 3 precordial 4 6 12 leads View of monitor and di BAERS Ergometry Ergometer program Treadmill program Blood pressure User Options Advanced Cabr amp Precord 2x6 Cabr amp Precord v At given seconds eg 300 600 ECG Median Diagnosis Speed 50 mm sec 100 mm sec Amplitude 10 mm mYV 20 mm mY Comment Vector HRY Parameters Single lead Lead Speed 50 mm s Amplitude fn x 20 mmm Lead combinations
43. iagnosis window 6 6 Longtime recordings With saved Longtime ECG curves besides the previously mentioned measurement and other functions it is also possible to obtain a view of the whole recording This can be done within the Navigation window Dron Mode Navigation window The Navigation window will display a single channel ECG picture that the user can scroll through Orientation is made easier by the time stamps on the left Using the a lead specific icons at the top it is possible to individually view information from any of 12 leads The arrow symbols control the time and amplitude sampling rate while the lead buttons change the lead to be displayed in the previously mentioned way Navigator 3 Sum I I MlavRavialF Vi V2 V3 V4 V5 V6 Es Rev 3 1 11 04 2012 36 Medical Econet GmbH CARDIO M PC ECG 7 Evaluation of the ECG recordings The Cardio M PC system allows you to evaluate and analyze your stored ECG recordings in an offline fashion subsequent to data collection itself The 12 lead ECG recordings indicated as Precordial can be automatically evaluated The automatic evaluation ECG ruler Interpretation produces the averaged median beats from the recording performs the rhythm and contour analysis and prepares a table of the related parameters If the selected recording is incomplete the ECG sign does not appear on a channel or one of the leads is too noisy an error message appears and
44. ial placement of the precordial electrodes in order to make a Frank ECG recording see Appendix B The Frank recording displays the orthographic projection of the ECG vector in the X Y and Z planes leads The program creates and displays the vector diagram from the segment marked out in the ECG ruler by the markers The left window shows the frontal horizontal and sagittal projection the right window shows the 3 D curve You can rotate the 3D diagram in any direction and toggle on off the 35 Hz filter 6 4 Replay of recordings Mode Playback displays the stored recordings in a form that simulates the monitoring mode All functions valid during monitoring are also valid here except the recording length 6 5 Data export to MS Excel Menu Mode File export Thanks to the file export feature you can display data from your recordings using Microsoft Excel allowing you to make presentations perform statistical analyses etc The exported file is a plain text file with the data cells in the table separated by semicolons You can export all of the following e the recording itself every point of the curve is represented by an Rev 3 1 11 04 2012 35 Medical Econet GmbH CARDIO M PC ECG integer number e medians counted from the curve e result of the diagnostics and the parameter table File export can be started by Mode File export from Ruler and from the window of the Medians or by pressing the Export button in the D
45. ime remaining With an automated BP measurement device connected the computer acquired and stores the data The program displays the last measured BP values It s also possible to take BP measurements more than once in each stage or phase or to leave out BP measurements This option is set in Extra BP measurement lf this field is empty or 0 then each stage or phase will have one BP measurement performed If this field is set to 1 2 3 4 then there will be 2 3 4 or 5 measuring per phase 1 2 3 4 then the 1st 2nd 3rd and 4th phases will not have BP measuements taken Examples e Interval 180 e Extra BP measuring 2 e Time interval for BP measuring 180 1 2 60 e Interval 90 e Extra BP measuring 1 e Time interval for BP measuring 90 1 1 180 At the end of extra BP measurements 40 sec after the beep there will also be an additional ECG saved The measured BP values will be added to this ECG recording 10 4 Manual change of workload It is possible to increase or decrease the pre programmed workload with the value set as the Manual increase of the load in the ergometry Rev 3 1 11 04 2012 49 Medical Econet GmbH CARDIO M PC ECG program settings W increase by the set amount decrease by the set amount Once the desired change in workload set it should be saved by pressing F9 within 10 seconds to store the new workload value It is also possible to hole the workload co
46. ion applicable to the frequency of the transmitter where P is the maximum output power rating of the transmitter in watts W according to the transmitter manufacturer NOTE 1 At 80 MHz and 800 MHz the separation distance for the higher frequency range applies NOTE 2 These guidelines may not apply in all situations Electromagnetic propagation is affected by absorption and reflection from structures objects and people Rev 3 1 11 04 2012 13 Medical Econet GmbH CARDIO M PC ECG 1 6 Technical parameters Patient protection floating common IEC 601 BF type Shock protection Class Il Defibrillator protection 5 kV max 1 kV msec Resolution 2 44 uV bit 12 bit A D Input impedance gt 10 MOhm CMRR gt 120 dB Filters 524 Hz low pass hardware constant 50 100 200 Hz software switchable 60 120 Hz software switchable 35 Hz software tremor filter switchable Time constant 1 6 sec Linearity error lt 0 5 lt 1 2 LSB Polarization voltage 400 mV Leads 12 Standard 3 Frank Power consumption Both models used on USB port 5 V 100 mA CARDIO M W 3 7 V Li Po embedded battery 2000 mAh Printing To normal paper A4 with inkjet or laser printer connected to the computer Display Using the monitor video output of the computer Status indication Both models green LED battery charge leve
47. l status Both models yellow LED slow blinking USB connected solid light ECG monitoring CARDIO M W blue LED solid light active WiFi connection blinking searching WiFi network Computer requirement Windows XP Vista Windows 7 32 or 64 bit operating systems Controls CARDIO M W power on button touch Everything else fromCardio M PC softver Accessories Standard 10 wire ECG cable Standard limb and precordial ECG electrodes optional Standard USB cable A mini B Operation Continuous operation Rev 3 1 11 04 2012 14 Medical Econet GmbH CARDIO M PC ECG Operating temperature 10 C 40 C Storage temperature 0 C 40 C Operating and storage humidity 25 95 Operating and storage pressure range 750 1060 hPa 1 7 Explanation of symbols on machine A Read User s Manual before operating System is BF type protected against defibrillator This device has Class II shock protection Manufacturer m seal anal Date of manufacturing YYYY MM DD Rev 3 1 11 04 2012 15 Medical Econet GmbH CARDIO M PC ECG 2 Installation 2 1 Hardware installation The parts of the system e ECG sampling device connected to a USB port or with WiFi connection e Standard USB cable A mini B max 3 m e Patient cable Operating system Windows XP Windows Vista Windows 7 The
48. licable Mains power quality should be that of a typical commercial or hospital environment If the user of theCardio M PC PC ECG requires continued operation during power mains interruptions it is recommended that theCardio MPC PC ECG be powered from an uninterruptible power supply or a battery Power frequency 50 60 Hz magnetic field IEC 61000 4 8 3 A m 3 A m Power frequency magnetic fields should be at levels characteristic of a typical location in a typical commercial or hospital environment NOTE UT is the a c mains voltage prior to application of the test level Rev 3 1 11 04 2012 11 Medical Econet GmbH CARDIO M PC ECG Electromagnetic Immunity TheCardio M PC ECG is intended for use in the electromagnetic environment specified below The customer or the user of theCardio M PC ECG should assure that it is used in such an environment Immunity test IEC 60601 1993 test level Compliance level Electromagnetic environment guidance Radiated RF IEC 61000 4 3 3 V m 80 MHz to 1 GHz 3 V m Portable and mobile RF communications equipment should be used no closer to any part of theCardio MPC PC ECG including cables than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter Recommended separation distance d 1 2VP 80 to 800 MHz d 2 3 VP 800 MHz to 2 5 GHz
49. llowing icon is placed onto the system tray The client agent may stay loaded after the main program is terminated while it finishes any ongoing synchronization with the server Central side server On the central computer the program must be started with the parameter netserver TheCardio M PC starts the Cardio M Server Agent background progess agent This program runs on the tray and is responsible for the TCP IP data transfer with the clients on the server machine The following icon represents the server agent on the system tray Meanwhile the main program opens a dialog where the queries the status and the error messages are displayed This dialog can be minimized also to the tray and reopened from there Netcenter lt gt Terminating the main program by the Exit button also terminates this agent Rev 3 1 11 04 2012 60 Medical Econet GmbH CARDIO M PC ECG Rev 3 1 11 04 2012 61 Medical Econet GmbH CARDIO M PC ECG Security On the central machine name password pairs must be defined When startingCardio M PC in client mode the client agent opens a dialog for entering user name and password to access the server Then the agent checks the server whether the user has the right to use NetCenter If so the given username password is sent along with all subsequent queries to the server until the client is stopped At restart the username and the password must be given again
50. lternatively try another power supply Direct or indirect effect of electrostatic discharge Remedy Before operating the system make sure that neither the patient nor the user is electrostatically charged The danger of electrostatic discharge can be reduced by suitable humidity and antistatic flooring Rev 3 1 11 04 2012 9 Medical Econet GmbH CARDIO M PC ECG 1 5 Electromagnetic Compatibility TheCardio M PC ECG needs special precautions regarding EMC and needs to be installed and put into service according to the following EMC information provided Portable and mobile RF communications equipment can affect the Cardio MPC ECG Electromagnetic Emissions TheCardio M PC PC EGG is intended for use in the electromagnetic environment specified below The customer or the user of theCardio M PC PC ECG should assure that it is used in such an environment Emissions test Compliance Electromagnetic environment guidance TheCardio MPC ECG uses RF energy only for its internal function Therefore its RF emissions are very RF emissions CISPR 11 Group 1 low and are not likely to cause any interference in nearby electronic equipment RF emissions CISPR 11 Class B TheCardio MPC PC ECG is suitable for use in all establishments including Harmonie missions domestic establishments i and those directl IEC 61000 3 2 SET Appana connected to ihe pubik low voltage power supply network that supplies buildings use
51. m alerts when a specific value is reached Rev 3 1 11 04 2012 45 Medical Econet GmbH CARDIO M PC ECG When using a treadmill first a protocol must be selected or a new one can be created The tables contain the time speed and grade parameters for the phases of the program The stress and recovery programs have individual tables The maximum number of phases can be 12 The following common protocols are predefined 0 BRUCE 1 MODIFIED BRUCE 2 NAUGHTON 3 CORNELL 4 BALKE 5 MODIFIED BALKE 6 ACIP 7 ELLESTAD 8 ELLESTAD II The following stop conditions can be set Max heartrate Max systole diastole Min SoO2 The program alerts when a specific value is reached Rev 3 1 11 04 2012 46 Medical Econet GmbH CARDIO M PC ECG 10 Stress test Menu Record Stress test First in the setting window make sure there is a checkbox next to RS232 connecting If the necessary patient information date of birth sex height weight is not specified on the patient card a warning appears You can continue without supplying the data or return to the PATIENT CARD enter the necessary data and restart the stress test After choosing the appropriate stress program begin monitoring by pressing START or F9 ax test aet EEE Eee x Mode Leads Lead Set Stesstest Help St la www wm Z oua Soh HR 250 JHR fmin 200 workload W Y 69 BP CmrHgJ 4
52. nosis function to operate children 1 15 years adults 16 years Without an entry for patient AGE in the patient card a warning appears The first statement of the diagnosis contains the length of the ECG recording used for analysis the total number of the beats analyzed and statements that refer to the normal non pathological attributes of the ECG Following this is a list of ECG alterations classified as pathological This list also includes findings in which pathological ECG findings are present but in which ECG parameters do not reach threshold values to make a diagnosis The diagnosis also lists non characteristic deviations that cannot be clearly related to a pathological ECG alteration but which should be further evaluated Rev 3 1 11 04 2012 38 Medical Econet GmbH CARDIO M PC ECG 8 Data transfer functions 8 1 Copying patient card Menu Transfer Open 2nd card file This function can be used for copying all patient data to another subdirectory or another drive The target drive and subdirectory where the data should be copied should be specified If a nonexistent directory is specified the program will offer to create it After pressing OK the patient list is divided into two parts The upper panel shows the previous database and the lower panel shows the newly opened database If there is already patient data it will be displayed To change to the new database Menu Transfer Toggle card files Hotkey F6 To
53. ns listed on the left can be adjusted here Menu Setup 3 1 ECG device The user selects the source for the incoming ECG data Preferences Categories ECG device ECG on USB Print Demo simulated ECG ECG ECG on USB ECG on WiFi Ergometry TCP IP ECG device View of monitor and di ECONEt Cardio M device Ergometry Ergometer program Treadmill program Blood pressure User Options Advanced r l Remote ECG monitoring M Allow Remote monitoring Directory for temporary files Browse Demo simulated ECG there is no connected ECG device a simulated not real stored ECG curve is looped to simulate ECG recording ECG on USB USB version device is connected to USB port ECG on WiFi Wireless device on WiFi network TCP IP ECG device Controlling a remote device through TCP IP network Rev 3 1 11 04 2012 17 Medical Econet GmbH CARDIO M PC ECG For supporting previous already not manufactured and serviced but still working products further two types of devices are available by selecting the ECG device category holding the Ctrl key pressed e ECG on LPT1 or LPT2 or LPT3 printer port ECG device is connected to the specified printer port Inner ECG Card Cardio M PC extension card is used which is built into the computer 3 2 ECG Settings for the ECG recording Preferences V Speaker Speed evice ECG F J60 8
54. nstant and cancel the pre programmed increases in workload In this case the workload will remain constant until it is cancelled W With this choice the displayed workload value watts blinks and the workload remains constant until this choice is again selected to cancel Rev 3 1 11 04 2012 50 Medical Econet GmbH CARDIO M PC ECG 11 Evaluation of the Final report The final protocol of a stress test is displayed in the list of recordings and identified as Final report Press Enter or double click to open a Final report for evaluation The Final report consists of 4 main parts List Graphs ST Trend ST List List of workload stages The recording list shows the ECG recordings made during the stress test and parameters of each stage The ECG list of an ergometer bicycle stress test contains the time load blood pressure BP heart rate HR revolutions per minute and ST values of the phases In case of a treadmill stress test the fields for load and the revolutions per minute are replaced with data relating to the speed grade MET values and the Double Product or Cross Product Max HR X Max systolic BP In the last column choose the symbol or press F5 to toggle between the STE STM and STJ amplitudes and press the and keys to toggle between the lead systems The STE STM and STJ values are replaced with J80 J60 J40 J30 ST J values if the program used the option for J 80 60 msec to determine the end of t
55. o it asks for the existing recordings from the server and merges with its local database The short recordings are downloaded instantly For performance reasons the long recordings and stress tests are downloaded only on demand if viewed For patient identification the Code field is used In case a new ECG record is made short long recording stress test the record is placed into an upload queue Uploading is done in the background while the user can work with the program normally without interruption User side client For accessing the central server the address and optional port number of it must be set beforehand by startingCardio M PC normally The required settings are in the Setup menu under the Advanced NetCenter category Categories ECG device surg hosp2 org ECG Print ECG Ergometry View of monitor and di Ergometry Ergometer program Treadmill program Blood pressure User Options Advanced Mail Auto backup Security Groups Ok Cancel Rev 3 1 11 04 2012 59 Medical Econet GmbH CARDIO M PC ECG For NetCenter functionality Cardio M PC must be started with the parameter netclient on the client side At start the program asks for user name and password to the server ThenCardio M PC loads the Cardio M Client Agent background process agent This program runs on the tray and is responsible for the TCP IP data transfer with the server on the client machine The fo
56. port CRN function Also proprietary for informational purposes contains patient data only A file selection dialog opens and the destination file will contain the data of the actual patient regardless of any selection if invoked from the patient list view Extension of the file is crn These export functions are also available in the popup menu of the list views invoked by right mouse clicking on an item or selected items File exporting can be initiated from the monitor window as well Under the Mode menu there is a File export CSV SCP DCM function that opens a file selection dialog to define the destination file and also the export format for the ECG record being viewed For CSV type selection the curve data is not exported see chapter 6 5 Data export to MS Excel for details When initiated from the median view the SCP or DICOM file will contain the medians as the wave data Raster based DICOM files can also be created withCardio M PC Everything that can be sent to the printer inCardio M PC can also be exported as DICOM encapsulated Jpeg images In the lower right corner of the Printing dialog inCardio M PC there are two buttons for picture exporting One is for DICOM the other is for GIF format The DICOM file will contain patient data too while the GIF will have a text file created with ni extension holding the patient and other metadata For available picture settings see chapter 3 3 Print Rev 3 1 11 04 2012 4
57. recordings 7 1 Manual evaluation in the ECG ruler 7 2 Median calculation 7 3 Parameters Data transfer functions 8 1 Copying patient card 8 2 Backup 8 3 Copying and inserting ECG recordings 8 4 Exporting and importing files 8 5 Send receive by mail Settings for the stress test 9 1 Ergometer bicycle blood pressure measurement and RS232 control 9 2 Load program Ergometer Treadmill 10 Stress test 10 1 Recording the stress test 10 2 Recovery phase 10 3 Blood pressure measurement 10 4 Manual change of workload 11 Evaluation of the Final report 11 1 Calculation of maximum exercise performance Rev 3 1 11 04 2012 3 Medical Econet GmbH CARDIO M PC ECG 11 2 Stress test graphs 11 3 ST evaluation 12 Network operation multi user features 12 1 Local network operation 12 2 Remote monitoring 12 3 Remote device netdevice operation 12 4 Server Client remote database operation 12 5Cardio M PC NetCenter 13 Appendix 13 1 Appendix A Diagnosis 13 2 Appendix B Electrode placements and lead calculations Rev 3 1 11 04 2012 4 Medical Econet GmbH CARDIO M PC ECG 1 Introduction Cardio M PC is a complete 12 lead electrocardiogram ECG system that is personal computer PC based It provides a full featured portable ECG that has important advantages compared to traditional ECG machines 1 1 Features ECG data is easily collected and stored using the standard 12 lead configuration or u
58. s Browse On the monitoring side the Remote ECG monitoring has to be checked in the same Setup category as above and the IP name or address must be supplied in address field below A starts monitoring and optionally the long time recording or the stress test where long time recording is automatic B also starts monitoring and the curve on A is displayed B can not record this curve only A can This function is also an option and therefore requires a password On the Windows firewall of A the transfer must be enabled and if a router is also involved in the transfer the necessary port forwarding and or firewall settings must be given The default inbound port on A is 7777 B uses it also as default but can be overridden by merging the port number after the address separated by a colon e g office2 hosp org 7697 On A the inbound port number can be modified in theCardio M PC ini file overriding the following entry in the ecg section ecg RemoteMonitorPort 7697 Rev 3 1 11 04 2012 55 Medical Econet GmbH CARDIO M PC ECG 12 3 Remote device netdevice operation Using this function an ECG expert is able to advise a non specialist In another way the expert makes an ECG recording originating the signal from a distant place Let place A be the location where ECG is measured and place B where it is coordinated from At A the user sets up theC
59. s bed the patient and all equipment or devices being used on the patient must not be touched by any personnel during defibrillation 3 Using a high frequency device during surgical procedures When theCardio M PC system is used simultaneously with a high frequency device such as electrocautery make sure that the ECG electrodes are placed as far as possible away from the surgical field to prevent skin injuries that might result from malfunction of the neutral electrodes of the high frequency device Only experienced personnel should place these neutral electrodes and special care must be taken 4 Before using the device Check that the device is in its usual state Verify the correct connection of cables especially the patient electrodes and lead wires Check that the computer must be placed at least 1 5m far away from the patient An mains adapter or an extension cable must not be used Other devices that are not part of the system must not be integrated into it When operating Cardio M PC with other electric devices care must be taken that the devices do not disturb each other and that possibly all devices are connected to the same potential equalizer thus Rev 3 1 11 04 2012 7 Medical Econet GmbH CARDIO M PC ECG reducing the risk of current infiltrating through to other devices To avoid polarization voltage and possible baseline fluctuation all ECG electrodes applied on the skin surface should be of similar type
60. sing the Frank lead configuration In the Frank lead configuration a vector ECG is automatically stored Real time or stored ECG tracings are clearly displayed on a computer monitor and may be printed whenever desired on inexpensive standard printer paper Costly ECG paper is no longer needed Stored ECG data can be accessed at any time Multiple recordings from a single patient can be easily evaluated and compared TheCardio M PC database provides a user friendly interface that can accommodate even the largest clinical and research needs The system is capable of handling 2 million patients each with a maximum of 1000 ECG tracings ECG recordings can be stored and categorized in patient folders or by common features Stored recordings can also be easily copied archived or re analyzed Context sensitive help messages make the system easy to use A built in text editor can be used to create edit store and print notes and comments Automatic evaluation and diagnostics facilitate the physician s diagnoses TheCardio M PC system is also designed to readily interface with commonly used peripheral devices in the Exercise Stress Testing or physiology laboratory The system can automatically control a treadmill or cycle ergometer bicycle while recording the 12 lead ECG TheCardio M PC system can be easily installed on any appropriate PC with a USB interface It can be used in local networks or can be installed on a portable computer
61. ted cards cannot be undeleted All patient data including ECG records will be lost 4 4 Selecting card files Menu Select In the Select menu item you have the option to select only specific cards from the card file You can select names one by one by pressing the F3 key or by groups according to some common feature Use the Select Group window to indicate the aspects of the selecting selection or deselection If the data are indicated with min max the two limit values are also included in the selection In the Code and the Diagnosis field you can search for character strings the Doctor field can be used to search by the initials of the doctor The number of the cards that have been found i e that meet the search criteria appears under the Patient list with the names of the appropriate patients highlighted You can select according to one or more criteria at a time and by specifying another criterion you can extend or reduce the number of the selected cards You can also create the inverse of the selection 4 5 Findings list of stored ECG recordings Entry from the Patient List with Enter or double click The left hand side of the Findings screen shows the card of the selected patient the right hand side displays the list of the stored ECG recordings sorted by date The list of the recordings shows the date and the lead system of the recording Stress test ECG recordings appear as Final report Cardio
62. the PWC calculation 130 150 170 min the program gives the absolute and relative PWC values as well as the normal PWC values according to age and sex in a table For a treadmill stress test the program displays to the right of the table the calculated oxygen consumption VO2 the Double product product of the maximal HR and the maximal systolic BP and MET values 11 2 Stress test graphs HR fmin BP mmHg Sp02 25 min 5 10 15 20 25 You can view the diagrams and tables giving a comprehensive evaluation of the stress test Ergometer Bicycle On the left hand side of the screen the first graph displays the heart rate and if available the SpO2 percentage as a function of time and the blood pressure measurements Predicted HR maximum HR and the maximum GP values shown in the top right corner Beneath this graph the workload is displayed as a function of time On the right you can see the table of the PWC The third graph displays the trend of heart rate as a function of exercise performance with the PWC values marked Treadmill The first two diagrams show the same measurements as in the case of the ergometer bicycle The third figure is the diagram of the calculated Rev 3 1 11 04 2012 52 Medical Econet GmbH CARDIO M PC ECG oxygen consumption as a function of time The right hand side of the screen displays the calculated oxygen consumption and the Double product values Beneath that there is
63. to introduce recovery phase gradually Subsequent recovery phase setting are given at Recovery load usually 25W and Recovery interval The Manual increase of load is used when pressing the W W buttons during stress test Preferences Categories ECG device Ergoline ergometrics 900 ECG Protocol name Default protokol Print ECG New Ergometry F View of monitor and di Continuous increasing of load 5 Conconi test Ergometry Enable automatic BP v Background printing Ergometer prograrr hem s Treadmill program Beginning of load M 40 Increase of load M Blood pressure User Options Manual increase of load M 5 Load interval s Advanced First recovery phase s 60 Recovery interval s First recovery phase W 25 Recovery load W BP measuring interval s 60 Max heartrate bpm Max workload WV 0 Max systole mmHg Max diastole mmHg 0 Min SpO2 Cancel BP measuring interval applies to blood pressure measurement frequency if no extra BP is given This duration cannot be shorter than 60 sec Continuous increasing of load by selecting this option the load will increase linearly during the given interval not abruptly at the end of each one Conconi test special load type frequent in Switzerland By setting any of the stop conditions Max heartrate Max workload Max systole diastole Min SpO2 the progra
64. where P is the maximum output power rating of the transmitter in watts W and d is the recommended separation distance in meters m NOTE 1 At 80 MHz and 800 MHz the higher frequency range applies NOTE 2 These guidelines may not apply in all situations Electromagnetic propagation is affected by absorption and reflection from structures objects and people Rev 3 1 11 04 2012 12 Medical Econet GmbH CARDIO M PC ECG Recommended separation distances between portable and mobile RF communications equipment and theCardio M PC PC ECG TheCardio M PC ECG is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled The customer or the user of theCardio M PC ECG can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment transmitters and the Cardio M PC ECG as recommended below according to the maximum output power of the communications equipment Rated maximum Separation distance according to frequency of transmitter output power of transmitter m Ww 150 KHz to 80 MHz 80 MHz to 800 MHz 800 MHz to 2 5 GHz d 1 2 VP d 1 2VP d 2 3 VP 0 01 0 12 0 12 0 23 0 1 0 37 0 37 0 74 1 1 2 1 2 2 3 10 3 7 3 7 7 4 100 12 12 23 For transmitters rated at a maximum output power not listed above the recommended separation distance din meters m can be estimated using the equat

Cardio M PC - User manual 2012 rev3 2

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