4, LABTECH ECG Holter System Cardiospy® User Manual for EC-2H; EC-3H; EC-12H; EC-3H/ABP recorder LABTECH LID. medical@labtech.hu Fax +36-52-412-023 LABTECH LTD. MADE IN HUNGARYINTRODUCTION ECG HOLTER SYSTEM 1 Introduction Dear Customer! Thank you for purchasing our Cardiospy ECG Holter System. We sincerely hope that our product will help you with your diagnostic and therapeutic work. To be able to use Holter System and computer programs appropriately, please read the manuals carefully A basic knowledge of computers and Windows based applications are required. We appreciate any comment you might have on the use of the System. Please, turn to us with confidence: our colleagues and representatives will be pleased to help you, even in person if need be. What is a Holter? A Holter is a non-invasive, long-term ambulatory ECG device that is capable of recording up to 24 (or even 48-72) hours of ECG signals. How to use Holter monitoring? The Holter recorder is worn by the patient for 24 hours, and records during normal daily activities, including sleep periods. After 24 hours, the readings are downloaded to a computer for analysis, where a qualified expert reviews and, if necessary, edits the data. What is the main idea of Holter Monitoring? Holter monitoring is a tool in the evaluation of patients with symptoms of various forms of heart disease, or in situations where the physician suspects cardiac pathology in the absence of symptoms. Holter monitoring is an ideal test because the patient assumes normal daily activities, increasing the likelihood that he or she will experience the precise situations that can trigger symptoms or cardiac events. This allows correlation of any rhythm problems or abnormalities with activities and/or symptoms. In the opposite sense, Holter monitoring can also be used to "rule out" cardiac causes of patients! symptoms. 2 V5.03_2014_11 LABTECH LTD.ECG HOLTER SYSTEM INTRODUCTION Does this system have any quality certifications? The CE mark indicates that the product meets the essential Cc € requirements of European Council Directive 93/42/EEC 0120 concerning medical devices. Labtech Ltd. also operates a quality system certified to ISO ‘© 'g 9001:2008 and ISO 13485:2003. Made in Hungary by ‘'scs > sos Labtech Ltd. We wish you success in using our ECG Holter Systems! Should you have any questions, ideas, partnership suggestions please contact us: LABTECH LID. E-mail medical@labtech.hu Fax +36-52-412-023 LABTECH LTD. V5.03_2014.11 3TABLE OF CONTENTS ECG HOLTER SYSTEM 2 Table of contents 1 INTRODUCTION... 2. TABLE OF CONTENTS. 3 PREPARATIONS FOR USING THE HOLTER SYSTEM. 3.1 List of accessories for EC-2H: EC-3H: EC-12H * 7 3.2 List of accessories for EC-3H/ABDP........ 3.3. Principles of Operation... 3.4 Warnings and Contraindications of using Holter System, 4 INSTRUCTIONS FOR STARTING HOLTER MONITORING... 4.1 Recorder Components (EC-2H; EC-3H; EC-12H)... 16 42 Recorder components (EC-3H/ABP)...... 17 4.1.1 Signs and alarms of EC-3H/ABP....... oosean seteueonasosneee esosonees 18 43 Database management interface 21 4.1.2 Toolbar 21 4.1.3. List of patients... 25 4.14 — Records toolbar 26 4.1.5 List of records... 27 4.1.6 Selected System.. 27 4.1.7 Filters . evasessenesesesonsssamnscane se oussanecsonrerase seases teu 28 4.1.8 Search. 28 4.1.9 Database information... 28 How to start a New Recording?.... 29 4.1.10 Patient preparation... 29 4.1.11 ‘New Recording 40 4.1.12 Holter monitoring settings . 41 4.1.13 Starting a recording from the computer .........:.0-ssessseeeeeseeeneenee 41 4.1.14 Starting a recording without a computer... 3B 4.1.15 Patient’s event log printing .... 44 4 V5.03_2014_11 LABTECH LTD.ECG HOLTER SYSTEM TABLE OF CONTENTS Reading a Record 5 ANALYSIS WITH THE CARDIOSPY SOFTWARE Views 5.1.1 Main window. 46 5.1.2 ECG window — large Window.......cccsscssnecnsnmnennennneinneneen SO 5.13 Templates window 52 5.14 HRV window. 54 5.1.5 QT Summary window 58 5.1.6 3.1.6 Pacemaker window... 59 5.1.7 Ectopic Trends Window .. 61 5.1.8 Summary window... tose : 62 5.1.9 Vectoreardiography’ ...c..ccsssssissssusetsniannninnneneneineesemsiee 63 5.1.10 BP (EC-3H/ABP) 63 67 5.1.11 Database... 67 5.1.12 ECG leads. 67 5.1.13 Report. 68 5.1.14 Sequence of tasks 68 S.L15 Print....... 5.1.16 Printing of sereen section... 5.1.17 Export... 69 5.1.18 Export Current Samples .. 69 5.1.19 Settings....... 69 5.1.20 Automatic report . 73 5.1.21 Print and export settings . se eee we we weet 4 Editing and measuring options 15 5.1.22 Automatic and manual analysis... Ss 5.1.23 Sequence of tasks . west asesnees se oo os 76 LABTECH LTD. V5.03_2014_11 5TABLE OF CONTENTS ECG HOLTER SYSTEM 5.1.24 Template window ... 76 5.1.25 ECG window 80 5.1.26 Event window......... 81 3.1.27 HRV Window... cece soe oosean oseeasesseesen esesensers SS S128 ST, QT, QTe graph cece cescecssssssnveseeseennennieiseninenseinenuenntesenee 86 5.1.29 AF graph. 87 5.1.30 Deleting T alternans sections..... 8s 5.1.31 Noise window .. . 89 Calculation and Evaluation methods - EKG........ 90 Calculation and Evaluation methods - BP 96 6 TROUBLESHOOTING AND MAINTENANCE 7 TECHNICAL SPECIFICATIONS. 109 Specification table of holter recorders (EC-2H; EC-3H; EC-12H).........+ sesweee LOD Specification table of holter recorders (EC-3H/ABP) 110 Recording time..... Basic functions of different holter systems ... Additional functions of different holter systems... 8 PATIENT DIARY... 6 V5.03_2014_11 LABTECH LTD.ECG HOLTER SYSTEM PREPARATIONS FOR USING THE HOLTER SYSTEM 3 Preparations for using the Holter System NOTE: BEFORE STARTING TO USE THE HOLTER SYSTEM YOU ARE EXPECTED TO FOLLOW LaABIECH L1D.’s INSTALLATION AND UPDATE GUIDE, WHICH PROVIDES GUIDANCE ON ‘THE INSTALLATION OF THE SYSTEM. 3.4 List of accessories for EC-2H; EC-3H; EC-12H * Please check the listed units and accessories before installing the ECG Holter System Ore se EC- EC- EC- : Ne Serer ce pacity CAS- . 00000. | sHvs.o1 | Ce forholding |) | . | the systems ol y ACC- . oswep- | sHvs02 | CD with 1)x |x or installation software DEV- USB-02 ouspp- | #5 Bluetooth ris |x 02 interface unit DEV- | 3uvs.o4. | EC-2HECG 02HLC- c 1 |x 05 A recorder unit DEV- EC-3HECG osHLc- | HVS | Holter Recorder | 1 x 05 (Bluetooth) eo. DEV- | ssays.oa. EC-12H ECG — a 12HLC- c. ~ holter recorder 1 x 05 unit (BT) LABTECH LTD. V5.03_2014_11 7PREPARATIONS FOR USING THE HOLTER SYSTEM ECG HOLTER SYSTEM a tenors Gan mh Stier trio Butcorsy Recorder bag BAG (EC-2-3-12H 0012H- | 3HVS-05 1] x |x] x 01 V5, attachable to patient's waistbelt) bac. ese o012H- | suvs-os | C23 1 x x x 02 V5, attachable to patient's neck) CHA- 0002X- | 3HVS-07 | Batterycharger | 1 | x | x | x ol MINI BAT- Lov 00000- | 3HV5-08 - 2 x x x OL Rechargeable batteries (AAA) 2 CH bipolar ore 3HV5-09- | patient cable ils 06 B (HDML-Snap, 45cm) CABS | srvs-to. potent ble ne B (HDML-Snap, | ! x 45cm) CAB "ation cable oor 32- SHVSL | Ep MAt Snap 1 x ~ connector) 8 V5.03_2014.11 LABTECH LTD.ECG HOLTER SYSTEM PREPARATIONS FOR USING THE HOLTER SYSTEM Blog Old code EC) EC EC a ah Se a nr oe ee bates ‘NEHB patient ooLNE- | V1 | cable HDMI- | 1 06 Snap, 45cm) CAB- . Extension cable oousB- | srivs.i3 | Fasnsion cable | ol CAB- Data transfer OOREC- SAVE | becuspa- | | HDMI) USR- ooo00- | YS! | Installation and | 1 o1 Update Guide USR- | 35-15. | User manual for 00000- 1 B holter recorders 02 ELE- Single-use oo000- | AYS1 | elecwodes(d | 1 | x | x |g ol pack / 30 pes) PAD- 00000- | 3HVS-18 | Mouse pad 1} x] x ol LABTECH LTD. V5.03_2014_11 9PREPARATIONS FOR USING THE HOLTER SYSTEM ECG HOLTER SYSTEM *The manufacturer reserves the right to change prices at any time. **The accessories highlighted in grey in the chart will be given as accessories for the recorders as well. 3.2 List of accessories for EC-3H/ABP Coes CAS. OOABP. | sHacvs.o1 | _€2s2 for holding the Ol recorder and accessories ACC. oSWCD- | 3HA-V5-02 | CD with installation ol software USB-02/B DEV- | sra.vs-03- | Bluetooth Interface Unit OUSBB- a B (monitoring and 02 " evaluation) DEV- EC-3H/ABP ECG and 3HABP- | 3HA-VS-04 | ABPM recorder unit 1 x 0s (BT) BAG- Recorder bag (EC-ABP 3HABP- | 3HA-V5-05 | VS, EC-3H/ABP V5, 1 x 02 attachable to patient’s waistbelt) 10 V5.03_2014_11 LABTECH LTD.ECG HOLTER SYSTEM PREPARATIONS FOR USING THE HOLTER SYSTEM Paeeeta Battery charger MAXT ol BAT- 00000- | 3HA-vs.07 | 1.2V Rechargeable 02 batteries (AA) CAB- 3 CH bipolar patient ooLos- | FAY | cable (HDMI-Snap. 06 45cm) CAB- O0USB- | 3HA-VS-09 | Extension cable for o USB-02 CAB- OOREC- | 3HA-VS-10 | Data transfer cable 05 (USB A - HDMI) USR- : 00000. | 3HVvs-15-A Installation and Update Guide ol USR- coo. | aHvs.is.3 | User manual for holter DD recorders ELE- 00000. | s1ivs-ié-a. | Single-use electrodes (1 OL pack / 30 pes) ELE- ; 00000. | sHa-vs.12 | Single-use electrodes 02 for cuff fixing LABTECH LTD. V5.03_2014_11 11PREPARATIONS FOR USING THE HOLTER SYSTEM ECG HOLTER SYSTEM a EC : Spreitetcr ee baron’ BEL- 00000- 3HA-V5-13 Waist belt 1 x ol CUF- 1 cost. | SHAWS-14 | ABPM cuff, Adult (23- | x e B 33cm) 02 A PAD- 00000- | 3HA-V5-15 Mouse pad 1 x ol *The manufacturer reserves the right to change prices at any time. **The accessories highlighted in grey in the chart will be given as accessories for the recorders as well. 12 V5.03_2014_11 LABTECH LTD.ECG HOLTER SYSTEM PREPARATIONS FOR USING THE HOLTER SYSTEM 3.3 Principles of Operation Holter monitoring is a tool in the evaluation of patients with symptoms of various forms of heart disease, or in situations where the physician suspects cardiac pathology in the absence of symptoms. Symptoms such as lightheadedness, palpitations, or fainting may be caused by disturbances in the electrical signals that control the heart muscle contractions. These disturbances can be random, spontaneous, sleep-related, emotion- or stress-induced. Holter monitoring is an ideal test because the patient assumes normal daily activities, increasing the likelihood that he or she will experience the precise situations that can trigger symptoms or cardiac events. This allows correlation of any rhythm problems or abnormalities with activities and/or symptoms. In the opposite sense, Holter monitoring can also be used to "rule out" cardiac causes of patients’ symptoms. LABTECH LTD. V5.03_2014_11 13PREPARATIONS FOR USING THE HOLTER SYSTEM ECG HOLTER SYSTEM 3.4 Warnings and Contraindications of using Holter System AM Never use the recorder: ~ in wet conditions (the recorder is not waterproof) ~ in strong heat - in explosive surroundings - in strong electrostatic field - in the presence of flammable anaesthetics - Do NOT remove recorder covers - Do NOT immerse the recorder in any fluid - the Holter is not defibrillator-protected, do not use with not-implanted defibrillator Usage with other devices: Holters may be used safely in patients with pacemakers, Implanted Cardiac Defibrillator (ICD) or other implanted devices. The implanted devices will not disrupt or be influenced by the operation of the recorder, as well as the recorder will not be influenced by the operation of the above devi The recorder may be used simultaneously with a high frequency surgical device, in this case make sure that the ECG electrodes are placed as far as possible away from the surgical field A\ Environmental conditions of storage and operation: Temperature-range: -10-50°C Relative humidity: 10-95% non-condensing Air pressure-range: 700-1060 hPa To achieve good and safe connection, to take care of the patient’s skin and to avoid infection use only good quality single-use electrodes that are marked with the CE sign. Do not use electrodes with expired warranty or dry or used ones from old, previously opened packages because it will result in bad recording quality. As in all Holter systems, noise and artefact may produce false positive ECG events Therefore, patient data must be reviewed and edited by a qualified technician. Opening the enclosure by unauthorized person may invalidate warranty. Modification of the ME equipment can only be performed by the manufacturer. In case of problems contact a professional repair shop. NOTE: IF ANY ABNORMALITY OCCURS IN THE UNIT, SUSPEND THE OPERATION IMMEDIATELY AND DISCONNECT THE UNIT FROM THE PATIENT. 14 V5.03_2014_11 LABTECH LTD.ECG HOLTER SYSTEM PREPARATIONS FOR USING THE HOLTER SYSTEM Symbols: cE 0120 ps4 MDD Ila Fy) v “) | This equipment meets the requirements of Directive 93/42/EEC Annex II (excluding section 4) Do not dispose of this product and batteries as unsorted municipal waste. Prepare this product for reuse or separate collection as specified by Directive 2002/96/EC of the European Parliament and the Council of the European Union on Waste Electronic and ElectricalEquipment (WEEE). MDD classification Ila. EMC class B. EMC group 1. Bluetooth Wireless Communication Technology Not ionizing radiation — Device including Bluetooth based RF transmitter. Pay special attention to the part, marked with the exclamation mark. CF type on patient’s side Date of manufacturing Manufacturer LABTECH LTD. V5.03_2014_11 15INSTRUCTIONS FOR STARTING HOLTER MONITORING ECG HOLTER SYSTEM 4 Instructions for starting Holter Monitoring 4.1 Recorder Components (EC-2H; EC-3H; EC-12H) FRONT VIEW LCD Display Record reading indicator lamp REAR VIEW 16 “| - Easy to replace - Patient cable Battery Cover V5.03_2014_11 Event Button - Use this button for patient events - Recorder Configuration type Patient Cable LABTECH LTD.ECG HOLTER SYSTEM INSTRUCTIONS FOR STARTING HOLTER MONITORING 4.2. Recorder components (EC-3H/ABP) FRONT VIEW Patient cable Pneumatic tube - Easy to replace - Event LED Event Button LABTECH LTD. V5.03_2014_11 17INSTRUCTIONS FOR STARTING HOLTER MONITORING ECG HOLTER SYSTEM 4.1.1 Signs and alarms of EC-3H/ABP The recorder contains a single RGB LED with which you can indicate several colours aad hues. Light signal The LED light is red. Bieter Hardware error RE Ry After detecting the hardware error it waits a few seconds and restarts automatically. If it’s not then you should restart the recorder by removing the batteries and taking them back. If the problem still occurs it requires repair. The LED is red and flashing. The battery has run out. Battery exchange required. The LED light is green, The recorder connects to the PC through the USB data transfer cable and it works properly. The green LED light flashes quickly. The recorder connects to the PC through the USB data transfer cable and and there is data transfer between. the PC and the recorder. The rythm of the flashing is syneronized with the rythm of data transfer. The green LED seldom flashes 18 The recorder is ready to start recording (doesn’t contain any unread records, the self-test and V5.03_2014_11 LABTECH LTD.ECG HOLTER SYSTEM INSTRUCTIONS FOR STARTING HOLTER MONITORING Ree CR Cy initialization was successfully completed). The yellow LED The device is - flashes. recording. Accrimson LED The recorder contains | You should read the last record from the flashes unread record. recorder, otherwise you cannot start the next record and the device won’t turn on the Bluetooth modul. Blue LED seldom There is Bluetooth - recorder. flashes connection between the PC and recorder. Blue LED flashes | There is data transfer | - quickly between the PC and The recorders include a zimmer which can operate in different frequencies. By this the recorders are able to display the different statuses and errors. Status description One high-pitched long beep One high-pitched short beep . Push-button event on the recorder or on the PC (Start/Stop BP). One short beep in deep voice ° The device was removed from the USB. e Start of recording. Stop of recording. The recorder beeps for some seconds on a high-pitched voice. Hardware error. LABTECH LTD. V5.03_2014_11 19INSTRUCTIONS FOR STARTING HOLTER MONITORING ECG HOLTER SYSTEM Seung Ca) Two high-pitched short beep Cannot start recording (no patient data). Push-button event, but there is no function related to pushing the Push-button in the current state of the recorder (for example: the recorder connects to the USB). Two short beep with descending melody Two short beep in deep voice 00 The device was connected to USB. Two short beep with rising melody Oo Bluetooth connection was created. 70 Bluetooth connection was broken. Three high-pitched short beep After the battery was put in the initialization, selftest was sucessfully completed. Four high-pitched short beep sees Discharged battery. 20 V5.03_2014_11 LABTECH LTD.ECG HOLTER SYSTEM INSTRUCTIONS FOR STARTING HOLTER MONITORING 4.3. Database management interface ‘The database management interface enables us to add physicians and patients by name and ID number (e.g., social security number), which can be sorted and filtered according to different criteria. The interface also offers a search option by name or ID. The database management interface displays the list of patients and the pertaining number of records, Here we can view previous records and start new recordings as well. 4.1.2 Toolbar The toolbar contains buttons which provide access to the most often used functions in the software. New patient: Here you can add new patients to the list. Patient’s first and last names, birth dates and patient IDs are fields which need to be filled in. The D neercten software allows only unique patient IDs to be entered into the database which is the reason why it is recommended to use this field for entering the social security number of each patient (or any other code which uniquely identifies a person). Entering address and height is optional when registering a patient. Modify: Patient data can be edited by clicking on the Modify button. The interface Modity allows every field to be edited except patient ID (social security number) LABTECH LTD. V5.03_2014.11 21INSTRUCTIONS FOR STARTING HOLTER MONITORING ECG HOLTER SYSTEM Medical record: This function gives a summary about the medical record. This summary can be edited and we can also add explanations and Z Medical record + y ~ observations. Delete: Click on the Delete button for deleting patients. When patient is deleted, all of PA ove 8 cowtesponding records are deleted as well. After deleting, there is 0 way to restore data. Settings: - Select physician: In this menu the physician performing the current test can login to the software, and also select to Select physician view the records of other physicians whose records are not Change password. password protected. Administration. - a - Change password: By selecting this option, the physician Select database. 5 performing the current test can change his/her password. File names as Input Devices - Administration: Selecting this menu point, we can see FTP settings. names of Test Physicians. Other names can be added to the Communication list in this menu point by clicking on “New” button; data of 7) Compress record flee existing physicians can be edited by clicking on “Modify”, and “Delete” serves to delete the physician (a physician can only be removed if there are no records relegated to his/her name). Security settings and administrator rights can be set under this menu point. Further information on modifying user authorization can be found in Cardiospy Installation and Update Guide. To INSERT YOUR OWN INSTITUTION’ LOGO INTO THE PRINTED REPORT, ADD THE DESIRED LOGO UNDER SETTINGS / ADMINISTRATION TO THE DOCTOR YOU WISH TO USE IT WITH. EACH THE LOGO HAS TO BE ADDED TO EACH DOCTOR WE WISH TO USE THE LOGO WITH, ONE BY ONE. - Select database: In this menu, you can choose to create a new database or to use a different one. These databases operate independently of each other, so a patient created in one does not appear in another. The software always uses the database set for the previous operation. 22 V5.03_2014_11 LABTECH LTD.ECG HOLTER SYSTEM Ctopay 00a INSTRUCTIONS FOR STARTING HOLTER MONITORING Clicking on the Add bution creates a new database. If you need to work with a different one, select it and click on OK. There are three possible ways to create a database: Local database folder: The database is stored in a local directory on your computer. Network drives are not supported. Optimal for single computer usage. Select the directory for the database and it is ready. Network mode- Microsoft SOL Server SEE DESCRIPTION IN INSTALLATION AND UPDATE GUIDE’S CHAPTER 4.3. SQLite database: SEE _DESCRIPTION_IN INSTALLATION AND UPDATE GUIDE'S CHAPTER 4.2. - File names as: The order of first and last name can be set in this menu. - Input devices: Barcode readers and magnetic card readers can be set here. - FTP settings: SEE DESCRIPTION IN INSTALLATION AND UPDATE GUIDE’S CHAPTER 5.1. - Communication: HL7 communication protocol can be started here. LABTECH LTD. V5.03_2014_11 23INSTRUCTIONS FOR STARTING HOLTER MONITORING ECG HOLTER SYSTEM - Select systems: Here you can select the ECG systems you wish to use. Inactive systems will not appear in the field of Selected Systems. A system is inactivated by removing the green tick from the box to its left. Help Heb | - User manual: Choose the system in the Select systems . panel (further description in point 2.2.5). Once you click on Insiiston and updote guide User marwal User manual button, the user manual of the currently Whats new selected system will appear. Lanovegee >|. Installation and update guide: The guide on software Mutangvage transistor installation and system configuration also contains a poms description of the software update process. - What’s new: The novelties of the current software version can be found in this option. - Languages: The software offers a choice of several languages, from which you can select the one you wish to work in. - Multilanguage translator: This function enables the user to translate each term appearing in the software into the desired target language. A password is necessary to enter this menu point. In case you would like to use this function, turn to your distributor for a password. - About: Information on sofware version, the operational system and copyrights can be found here. 24 V5.03_2014_11 LABTECH LTD.ECG HOLTER SYSTEM INSTRUCTIONS FOR STARTING HOLTER MONITORING ECG Device Connection Status Indicator: This indicator shows the current connection status of the devices (the USB-02 interface, the ECG recorder, the blood pressure monitor and the stress device). The ECG Device Connection Status Indicator has three types: the first one is used with the Holter, ABP and Resting Test systems. The second type is used with the Stress Test systems, and the third type with the Continuous ECG systems. 1, Status of Bluetooth or direct connection 2. Status of connection with Holter ECG recorder /ABP recorder / Resting ECG recorder / Test ECG recorder 3. Status of connection with blood pressure monitor 4, Status of connection with loading machine 5. Status of connection with Pulse Oximeter (this section is only available when Pulse Oximeter is activated under System Configuration menu) Colour codes for the ECG Devices Connection Status Window: HHBBB - The device is properly connected Yell6W - Manual operation, the device is not connected to the computer HB— No connection with the device 18y — No connection is needed for recording 4.1.3 List of patients This menu point lists the patients in the database. Clicking on the appropriate tab of the header sorts the available data by patient's first or last name. date of birth, ID number, or date of the last record. LABTECH LTD. V5.03_2014_11 25INSTRUCTIONS FOR STARTING HOLTER MONITORING ECG HOLTER SYSTEM 4.1.4 Records toolbar This is a toolbar for managing existing records. By Load record: Opens the selected record from the list. Once the record fae is open we can edit, analyze or print it. Import / export: In this menu point we can save the current record to the directory of our choice. This directory can be on a network drive or on a portable drive (e.g. USB stick). The name of the exported record will include the first and last name of the patient, the date of recording and patient ID, separated by low lines. We can also import any previously saved (exported) record from Gessenentostistrntostens. any directory. The imported record is automatically saved to Usioad FTP ae the current database. Bomar A omens —s - Import selected records: With this function we can import ror sample data records from a directory of our choice. Should you need to import more records at a time, select records while holding the CTRL key, then press Import selected records. = Import records by date: Imports all the records of a selected directory which were recorded in a given interval - Download from FTP: We can download records from the given FTP server. We can see all the available directories and Cardiospy files in the appearing window, the left side column is for navigation among folders. the right one is for Cardiospy files. The files can be arranged according to their Names, IDs, Record dates and Upload dates, and a search bar is also available to help find the necessary record. Holding the Ctrl button enables highlighting and downloading multiple records at a time. Records can be deleted by pressing the Delete button, and triggering the “Delete downloaded records” automatically erases all records after downloading them. 26 V5.03_2014_11 LABTECH LTD.ECG HOLTER SYSTEM INSTRUCTIONS FOR STARTING HOLTER MONITORING - Export selected records: With this function we can export records selected in the list of records. Should you need to export more records at a time, select records while holding the CTRL key, then press Export selected records, - Export records by date: Exports all the records which were recorded in a given interval. - Export records of selected patients: Holding CTRL while clicking on several patients enables the multiple selections of patients. This option saves all the records of the selected patients. - Upload to FTP: We can select multiple records from a single patient and upload them to the given FTP server. - Upload to FIP by date: Every record is uploaded which fits to all the criteria given and was recorded within a given period. - Upload to Labtech: In case you have any problem with the interpretation of a record, or you face any difficulties you can upload the record to the Labtech server. - Print rest records by date: Prints every rest record which was made with the given conditions and recorded in a given interval. - Import sample data: In case a CD was used for installing the Cardiospy software and there are no sample records in the database, you can import them by pressing this button. Delete selected record: This buttons deletes every selected record from the database. Fcaisessetesecos After deleting, there is no way to restore data. Should you need to delete more records at a time, select records while holding the CTRL key, then press Delete selected records. Delete records by date: Deletes every record recorded in the Deeawes| > ‘ KX brdste given interval according to the criteria selected. 4.1.5 List of records Displays the records of the patient selected in List of patients (point 2.2.2). Here you can search among the records. Should you need to select more records at a time, you can. do so while holding the CTRL key. 4.1.6 Selected System Here you can select the ECG systems you wish to use, configure systems, add new recorders before you start recording. You can also start Demo recording in this field. Please keep in mind that a demo recording can only be started if the USB-02 device is not connected to the PC. LABTECH LTD. V5.03_2014_11 27INSTRUCTIONS FOR STARTING HOLTER MONITORING ECG HOLTER SYSTEM 4.1.7 Filters This field provides a number of filters which enable the filtering of records by different criteria. Once the database is filtered, List of patients displays only those who fit the criteria, ‘You can filter records by: - Physician: When this filter is used, List of patients displays those patients whose records have been made by the doctor selected. - Date: When this filter is used, List of patients displays those patients who have records made today / in the last 2 days / in the last 7 days / this month / this year. - Status: When this filter is used, List of patients displays those patients who have temporary / pre-evaluated / evaluated / approved records. - Record type: When this filter is used, we can view all types of records or only those pertaining to the system currently selected in Select system field. - Pacemaker: When this filter is used, we can view patients who have and those who do not have a pacemaker in separate lists. 4.1.8 Search The Search (name or ID) field is used for narrowing down the list of patients displayed. Once we enter a letter or a number in the field, List of patients will only display patients whose first or last name, or the ID begins with the pertinent letter or number. The more letters we type in the field, the more we narrow down the number of patients appearing in the list. Clicking on the Reset button cancels the filtration and the default List of patients will appear, where every patient and every record is displayed. 4.1.9 Database information This field contains general information about the database, such as access path, number and size of records contained, etc 28 V5.03_2014_11 LABTECH LTD.ECG HOLTER SYSTEM INSTRUCTIONS FOR STARTING HOLTER MONITORING How to start a New Recording? NOTE: A NOISE-FREE RECORD CAN BE OBTAINED ONLY IF ALL THE STEPS OF PATIENT PREPARATION HAVE BEEN FOLLOWED ACCORDING TO THE INSTRUCTIONS. DO NOT START THE RECORDING IF ECG SIGN IS NOISY. 4.1.10 Patient preparation Step 1: Place the case of the recorder unit on the right side of the patient and fix it on the belt on his/her waist. Although the case is washable, it is recommended to avoid skin-contact. Step 2: Clean the surface of the skin thoroughly using: razor /in case it is necessary/ - abrasive preparation pad and = alcohol swab The Holter System is designed for external skin-surface ECG recording. The electrodes can be applied only on injury-free skin. Step 3: Attach the single-use electrodes as it is indicated below and by keeping to the instructions shown on the electrode’s package. Step 4: Connect the patient cable to the attached electrodes. Step 5: Secure the cables below the electrodes one by one by making a loop on each of the cables and secure them to the skin by adhesive plaster. LABTECH LTD. V5.03_2014_11 29INSTRUCTIONS FOR STARTING HOLTER MONITORING ECG HOLTER SYSTEM 3 lead placement (1 CH) Standard 1 AHA Label | IEC Label BOTT CB arte fortes 6th intercostal space at the anterior axillary's line Corer Right clavicle, lateral to the mid-claviele line My Lowest rib on right side of chest 30 V5.03_2014_11 LABTECH LTD.ECG HOLTER SYSTEM INSTRUCTIONS FOR STARTING HOLTER MONITORING 5 lead placement (2 CH) Standard 1 AHA Label —_ IEC Label parC Rao 6th intercostal space at the anterior axillary’s line CH1- Right clavicle, lateral to the mid-clavicle line Approximately | inch right of Xiphoid Process on the rib Left clavicle, lateral of sternum border Lowest rib on right side of chest LABTECH LTD. V5.03_2014_11 31INSTRUCTIONS FOR STARTING HOLTER MONITORING ECG HOLTER SYSTEM 5 lead placement (2 CH) Standard 2 7 NCO OT OR Mon R aro tog 32 V5.03_2014_11 LABTECH LTD.ECG HOLTER SYSTEM INSTRUCTIONS FOR STARTING HOLTER MONITORING 5 lead placement (2 CH) Orthogonal AHA Label —_ IEC Label CHI LABTECH LTD. V5.03_2014_11 33INSTRUCTIONS FOR STARTING HOLTER MONITORING ECG HOLTER SYSTEM 7 lead placement (3 CH) Standard 1 PUG 6) le 1 Oe PO aU 6th intercostal space at the anterior axillary’s line Corre Right clavicle, lateral to the mid-clavicle line Approximately | inch right of Xiphoid Process on the rib. Left clavicle, lateral of sternum border 6th intercostal space on left midelavicular line Nt Lowest rib on right side of chest 34 V5.03_2014_11 LABTECH LTD.ECG HOLTER SYSTEM INSTRUCTIONS FOR STARTING HOLTER MONITORING 7 lead placement (3 CH) Standard 2 [A Label TEC Label PAC Bae 5 LABTECH LTD. V5.03_2014_11 35INSTRUCTIONS FOR STARTING HOLTER MONITORING ECG HOLTER SYSTEM 7 lead placement (3 CH) Orthogonal PU POP 1 meee ot Bower rib. fork Sth intercostal space at the center of the back, - opposite the CH3+ electrode i Lowest rib on right side of chest 36 V5.03_2014_11 LABTECH LTD.ECG HOLTER SYSTEM INSTRUCTIONS FOR STARTING HOLTER MONITORING 10 lead placement (12 CH) Standard 1 AHA Label IEC Label BoB art d BI ost ine ove ne ic | a Lower edge of the rib cage. or at the level of the umbilicus at the left and right mid-clavicular lines. LABTECH LTD. V5.03_2014_11 37INSTRUCTIONS FOR STARTING HOLTER MONITORING ECG HOLTER SYSTEM NEHB placement Standard 1 FSCO Es imple ete Electrode Placement Slightly below left clavicle. | Slightly below the right clavicle Lower edge of the rib cage, or at the level of the umbilicus at the left and right mid-clavicular lines. 38 V5.03_2014_11 LABTECH LTD.ECG HOLTER SYSTEM INSTRUCTIONS FOR STARTING HOLTER MONITORING NEHB placement Standard 2 AHA Label IEC Label Dea ete Nst — 2nd rib at the right sternal border Nax - 5th intercostal space on the left posterior Nap- Sth intercostal space mid-clavieular line (cardiac apex) equates to (V4 / C4) On the middle line of midaxillary, on the position of ribcage LABTECH LTD. V5.03_2014_11 39INSTRUCTIONS FOR STARTING HOLTER MONITORING ECG HOLTER SYSTEM 4.1.11 New Recording Before starting a new recording, you have to add the recorder you wish to record with. Please follow the steps below: 1/ Press the System configuration icon to add a new recorder. Press the Add new recorder button. 2/ Connect the recorder via USB cable to your PC, if the connection is stable, you will see the following window: 3/ Disconnect the recorder from your PC, connect a patient cable to the recorder, choose from the list the serial number of the recorder you wish to use and press Start monitoring with the selected recorder. When you have added a new recorder or chosen a registered one, you may start the recording in one of two ways: - from the computer. when starting the recording from the computer, it is possible to check the ECG signal before the start. 40 V5.03_2014_11 LABTECH LTD.ECG HOLTER SYSTEM INSTRUCTIONS FOR STARTING HOLTER MONITORING - by pressing the button on the recorder: it is more convenient when the patient cannot go to a computer, e.g., in case of a bed-ridden patient. 4.1.12 Holter monitoring settings Patient tab: When start of ABP recording there is an opportunity in the program to enter the name of the doctor who requested the examination and the medication and symptoms of the patient. The information will be put in the record and will be available if you scan it on another PC. If you import automatic report then the symptoms and medication field’s content will be imported to the report, as well. The doctor’s name will be imported to every report's letterhead. At the Measurement tab you can find the setting of waking period you can modify it after the record was read, as well. You can also set the frequency of the BP measurement the maximum pressure of the cuff and right after the output of the recorder it is able to measure. Miscellaneous tab: Here you can find the miscellaneous settings. Monitoring and reading (Loading record after reading: If you connect the recorder to the PC the record will be imported to the database and automatically loads in.) Length of recording (Here you can set the length of record). QRS signal: the program sign the QRS beat arrival with sound signal during the monitoring process. Recording (setup of the length of the record, frequency of sampling, see detailed in Chapter 7.2) Filters (base line and muscle contraction filtering are switched on during the monitoring process). 4.1.13 Starting a recording from the computer Please follow the steps below: a) Select the patient from the database whom you wish to make a record of. b) Click on the Holter ECG icon in the Selected System menu point. c) Click on Start Recording button to start monitoring. LABTECH LTD. V5.03_2014_11 41INSTRUCTIONS FOR STARTING HOLTER MONITORING ECGHOLTER SYSTEM - The USB-02 Bluetooth interface unit should be connected to your PC. d) Check the quality of the ECG signal. ¢) Start a test record with the Start BP command in the right bottom coraer £) If you find it acceptable, start monitoring by clicking on YES, START Recording indicated on the screen. You will see a confirmation that the recording has been started succesfully: 42 V5.03_2014_11 LABTECH LTD.ECG HOLTER SYSTEM INSTRUCTIONS FOR STARTING HOLTER MONITORING 4.1.14 Starting a recording without a computer Use this method oaly in situatioas when patient is limited in his/her movement (e.g., due to his/her illness) a) Select the patient from the database whom you wish to make a record of. b) In case you have not done so yet, disconnect the USB-02 interface device from PC. c) Connect the recorder to theh USB reader cable. ‘Connect a recorder via USH to startrecording without PC oF an USH-G2 Key © start mentoring! ls) d) Click the Start without PC bution to start recording. As soon as it starts, the recorder saves the patient's data and the parameters of the recorder. If the procedure is successful you will see the following window. d) Take the recorder to the patient place the electrodes as it was shown before. Push the event button until you hear a long beep signal (approximately 3 sec.) to start recording. The program saves the starting and ending times as well as the duration of the monitoring. LABTECH LTD. V5.03_2014_11 43INSTRUCTIONS FOR STARTING HOLTER MONITORING ECG HOLTER SYSTEM 4.1.15 Patient’s event log printing After pressing ‘start record’ button the pop up window offer the printing of the patient’s event log. The verification of Personal data is possible or making modification if needs. The printed out event log can be hand out to the patient for making notes about his/her complaint, uncommon activities and medication. 44 V5.03_2014_11 LABTECH LTD.ECG HOLTER SYSTEM INSTRUCTIONS FOR STARTING HOLTER MONITORING Reading a Record The recording stops automatically after 8-24-48-72-168 hours or when the batteries go flat or when they are removed Continuous record: During recording it is possible to replace flat batteries so longer recording can be made (IN CHAPTER 6 IN SPECIFICATIONS TABLE it is shown how many batteries are needed for one recording) , the patient cable can be detached as well during recording: when reattached recording continues automatically It is advisable to remove the batteries first and then the cables from the electrodes. Otherwise the end of the recording cannot be analyzed because of lead-off error. For reading a record, please follow the steps below: a) Remove the batteries from the recorder unit (this ends the recording, if the preset time has not expired yet, otherwise the recording automatically stops at the preset time b) Take off the recorder-case from the patient and remove the electrodes from him/her. ¢) Start the Cardiospy program on the computer. Then select the holter system. d) Attach the recorder to the USB reader cable. Then reading starts automatically. BEFORE READING THE RECORDING YOU HAVE THE OPTION TO SET THE AUTOMATIC SENDING OF RECORDING TO THE FTP SERVER IN THE SYSTEM CONFIGURATON WINDOW UNDER THE SETTINGS TAB. THIS WAY, AFTER READING THE RECORD IS AUTOMATICALLY UPLOADED TO THE PRESET FTP SERVER. LABTECH LTD. V5.03_2014_11 45ANALYSIS WITH THE CARDIOSPY SOFTWARE ECG HOLTER SYSTEM 5 Analysis with the Cardiospy Software Views We can view the recorded ECG curve and its calculated parameters in several forms. The following chapter is dedicated to listing these views in the order they appear in the software interface 5.1.1 Main window The Main window has three fields, all of which vary according to the tab selected at the left side. The graphs are colour-coded, which means that areas suspected to be pathological are highlighted in different colours. Eero HR, BP, ACL The uppermost section of the Main window displays the heart rate graph, which shows us heart rate calculated from the ECG signal (for the definition of Avg Hr, go to chapter 3.4), motion intensity, and in case the recorder comes with an integrated ABPM component. this graph shows blood pressure values as well. With the two arrows below the tabs this component can be removed. giving more space to the middle part. The heart rate graph is able to display the time distribution of events selected in Events menu. The temporal occurrence of individual events is indicated by small vertical lines. Customisation of the upper HR graph is possible at the Holter record investigation 46 V5.03_2014_11 LABTECH LTD.ECG HOLTER SYSTEM ANALYSIS WITH THE CARDIOSPY SOFTWARE which makes more visible of the HR graph: - Default (0-200) ordinary enlargement - Optimized: enlarging the range between the minimum and maximum value ~ 50-150 range display - 50-200 range display Quist The algorithm calculates ST and QT values from normal beats and right- or left bundle branch blocks. The displayed valve is calculated from the averages of beats within a ten-second range of the given ruler position. In case a section of ECG does not contain any right- or left bundle branch blocks, then ST is not calculated or displayed. The ST level is calculated from the J+ point (see Settings/Parameters/ECG-ST). We can also edit QT, QTc and ST values in the software (see chapter 3.3) jae The scaling of the ST chart (the ST levels) can be changed with the zoom button found in the upper menu, if the ST level does not fit into the 1X range then you can set it to 0.5X range, and if the ST levels are too small v - you can set it to 2X range to zoom in. REG Events By selecting Events from the tabs on the left side, we can see a summary containing events of the entire record. The graph has three columns: the left column contains Event types; the second column displays their time distribution and the third one, on the right side, shows the aggregate number of each event. Each type of event can be selected by a single left-click of the mouse, which changes background color and broadens the selected line. You can edit the list of events (e.g. delete a single or a group of events. See also chapter 3.3). Under the menu of Settings / Events it can be configurated. You can set the order of events, can place events into and out of the view. LABTECH LTD. V5.03_2014_11 47ANALYSIS WITH THE CARDIOSPY SOFTWARE ECG HOLTER SYSTEM Full View In this menu we can overview a longer section of the ECG curve. The window displays the number of ECG channels selected in the ECG field. Depending on the ECG paper speed, ECG intervals of either 30 seconds or 60 seconds can be displayed here. The ECG field in the lower section displays the sub-section which we select in the middle section by left-clicking the mouse. If you turn off the channels and set the amplitude in the upper menu, and remove the HR chart with the two arrows then you will see a longer section of ECG on your screen oo La PACER Atrial Fibrillation This tab displays the graph of NN Intervals, which helps us check the correct detection of Atrial Fibrillation. You can edit the AF intervals (e.g., insert AF intervals, delete a single or a group of AF intervals. See also chapter 3.3) T T 7m Noise The significance of this function is that it enables us to mark any section as noise, either from the HR or ECG field. Conversely, sections of noise can also be marked as normal in this function, (See chapter 3.3) Apart from this, the intervals marked as noise by the software's automatic noise detector are indicated by a different background colour. ECG — normal window The ECG field displays the selected channels in the desired degree of magnification. Clicking on Median button in the lower left comer displays the median pertaining to the 48 V5.03_2014_11 LABTECH LTD.ECG HOLTER SYSTEM ANALYSIS WITH THE CARDIOSPY SOFTWARE selected ECG section. Both the median and the ECG curve can be measured in terms of time and amplitude. Editing is enabled in the ECG field (e.g,, insert, delete or classify QRS. SEE ALSO CHAPTER EDITING AND MEASURING OPTIONS) The Service field illustrates the technical details of the recording. It displays the lead-on and lead-off intervals of each electrode, and the state of battery. You can see here what version of recorder was used for the loaded recording. LABTECH LTD. V5.03_2014.11 49ANALYSIS WITH THE CARDIOSPY SOFTWARE ECG HOLTER SYSTEM 5.1.2. ECG window — large window The ECG window displays the ECG curve in a larger screen-space. You can view the ECGs in two columns. 3 ‘RHEE FH iE iH { Beet ae You can edit in the ECG field (e.g., insert, delete or classify QRS. SEF ALSO CHAPTER EDITING AND MEASURING OPTIONS) T alternans Sra a OR eee 50 V5.03_2014_11 LABTECH LTD.ECG HOLTER SYSTEM ANALYSIS WITH THE CARDIOSPY SOFTWARE In the HR field the time interval is marked with red lined, where the SW detected T alternans. The detection is completed for each holter channel, that is why the event line belongs to that channel, which was chosen in the ECG field. To T alternans events the amplitude belongs as well, which shows the alternans’s amplitude size in the uV. The SW offers the editing possibility as well: deleting of T alternans intervals (SEE ALSO CHAPTER EDITING AND MEASURING OPTIONS) The meaning of alternans’s amplitude: On the picture the QRS with even indexes are marked with blue, the odd ones are marked VV! XV] ith red. LABTECH LTD. V5.03_2014_11 51ANALYSIS WITH THE CARDIOSPY SOFTWARE ECG HOLTER SYSTEM 5.1.3 Templates window ae - [poor pueorrat Tey aoe 28 The analysis software classifies each heartbeat (N, S, V) and clusters similar formations. Filter templates by function in the upper right corner serves to display QRS complexes of different types altogether or individually. 52 V5.03_2014_11 LABTECH LTD.ECG HOLTER SYSTEM ANALYSIS WITH THE CARDIOSPY SOFTWARE Meaning of the information on cluster pictures: Number of beats Beat type Cluster cleanness Cluster vooA4 validation Cluster cleanness measuring circle (homogeneity) Clean cluster Somewhat mixed cluster Extremely mixed cluster Ifa cluster is marked with green circle, it means that the QRS complexes belonging to the cluster show very similar forms to the cluster QRS shape. The red area in a circle signifies the pereentage of non-similar QRS shapes. The validation of a type of cluster means the affirmation of the type. If you click on a template the program automatically puts a yellow check mark as a default setting. This is good to see in which template you have already been. You can switch off the automatic check mark under the menu of Settings (Automatic check mark, choosing form). If you want to confirm the automatic checking you can click on the yellow check mark which will turn green as proof of that the template has been searched thoroughly. Not validated type. J Automatic marking JV Validated type by user SEE ALSO CHAPTER EDITING AND MEASURING OPTIONS LABTECH LTD. V5.03_2014_11 53ANALYSIS WITH THE CARDIOSPY SOFTWARE ECG HOLTER SYSTEM 5.1.4 HRV window The HRV window provides detailed information on time and frequency parameters of RR variability. Time Distribution Three graphs are displayed in this section: RR Intervals, RR Differences and Lorenz plots. We can also edit data in the RR Intervals graph, for example we can validate or revalidate the intervals (see chapter 3.2).Data edition is convenient, because the ECG pertaining to each selected interval is displayed immediately in a lower section. Next to the ECG-display we can see the Patient Risk graph, which is calculated from the HRV parameters. To check the exact meaning of each parameter, CALCULATION AND EVALUATION METHODS oer A vag OCs fete ee Ra [Gomer RUSE TONST [Tr ave 6 5] i To check data edition possibilities, SEE ALSO CHAPTER EDITING AND MEASURING OPTIONS 54 V5.03_2014_11 LABTECH LTD.ECG HOLTER SYSTEM ANALYSIS WITH THE CARDIOSPY SOFTWARE Histogram and Table The first row of this graph displays SDNN values by a 5-minute division, the second one contains SDNN calculated for 1 hour, the last two rows contain rMSSD and PNNS50% values. In the lower part of the screen we can see these values in table format. To check the exact meaning of each parameter, see CALCULATION AND EVALUATION METHODS LABTECH LTD. V5.03_2014_11 55ANALYSIS WITH THE CARDIOSPY SOFTWARE ECG HOLTER SYSTEM ion in 3d. Frequency: In the representation of frequency range, three graphs are displayed: one showing the period when the patient is awake, one when sihe is asleep, one for the total period of the measurement time, represented ina 3D HRV frequency graph, The latter can be represented in a 2D format as well. To check the exact meaning of each parameter, SEE ALSO CHAPTER EDITING AND MEASURING OPTIONS 56 V5.03_2014_11 LABTECH LTD.ECG HOLTER SYSTEM ANALYSIS WITH THE CARDIOSPY SOFTWARE RR Graphs: Here you can see the RR Max and Min ECG views and the diagram shows the distribution of the RR intervals. Dale Dial Hear ORolabie HR Turbulence: This menu point displays the HR turbulence both in graph and table formats. To check the exact method for calculating HRV turbulence SEE ALSO CHAPTER: EDITING AND MEASURING OPTIONS. Be ar OR mmr ar lllte eee [alee LABTECH LTD. V5.03_2014.11 57ANALYSIS WITH THE CARDIOSPY SOFTWARE ECG HOLTER SYSTEM 5.1.5 QT Summary window The values of the QT analysis are shown in the form of a distribution graph and a table. We can choose to display QT or QTe values by selecting one of them at the left side of the distribution graph, while the table displays both values. mI 58 V5.03_2014_11 LABTECH LTD.ECG HOLTER SYSTEM ANALYSIS WITH THE CARDIOSPY SOFTWARE 5.1.6 3.1.6 Pacemaker window Pacemaker Histograms: This menu displays eight graphs according to what follows below: oes Pesan pn a= a-PMI The time distribution between the stimulation of the atrium and the heart beat (induced by the heart on this stimulation). y-PMI The time distribution between the stimulation of the ventricle and the heart beat (induced by the heart on this stimulation). «PMI The time distribution between the stimulation of the atrium and the ventricle and the heart beat (induced by the heart on this stimulation) N-PMI The distribution graph of the normal and PM induced beats. v-PMI The distribution graph of the ventricular and PM induced beats. PMLN The distribution graph of the PM induced and normal beats. The distribution graph of the PM induced and ventricular beats. The distribution graph of consecutive PM induced beats. LABTECH LTD. V5.03_2014_11 59ANALYSIS WITH THE CARDIOSPY SOFTWARE ECG HOLTER SYSTEM Pacemaker Summary Here you can view a table summary of the pacemaker analysis. The number of beats induced by the PM is presented in the table in groups based on the type of the induction in an hourly division. The table shows the failure of electric capture and failure to sense events detected by the program as well. FO Coa aa sel ells The failure to capture (FTC) means that the pacemaker spike appears at the right time. but it is not followed by QRS. The failure to sense (FTS) refers to premature pacemaker stimulation, in which case the pacemaker produces a stimulus, without being stimulated by the patient’s heart. 60 V5.03_2014_11 LABTECH LTD.ECG HOLTER SYSTEM ANALYSIS WITH THE CARDIOSPY SOFTWARE 5.1.7. Ectopic Trends Window Ventricular: Represents the frequency of events related to V beats on the time axis. The last graph shows the frequency of V episodes (consecutive V beats by length). Ca Oe a ramen | SupraVentricular; Represents the frequency of events related to S beats on the time axis. The last graph shows the frequency of S episodes (consecutive $ beats by length) Tp a Oe Toman] “o] LABTECH LTD. V5.03_2014.11 61ANALYSIS WITH THE CARDIOSPY SOFTWARE ECG HOLTER SYSTEM 5.1.8 Summary window This menu displays the most important findings in the automatic summary of the monitoring in two formats. Meseroe:__ Kao te Sawaya aw “Tedesco crea ma 8 248 har eo 08D 8. = orp rr a cs se aot tt ran ceca 0499 8 a oy eran tes we 3 m2 omar Gees i ww 2 Bs ee : FERRE g 3 sTUPTEEFR Uy ETE TD 62 V5.03_2014_11 LABTECH LTD.ECG HOLTER SYSTEM ANALYSIS WITH THE CARDIOSPY SOFTWARE 5.1.9 Vectorcardiography: Vectorcardiographic display mode is available with records made with EC12H recorders using 3-channel patient cables in orthogonal electrode placement. The medians of the ECGs are displayed in 2D and 3D coordinate systems. Their display is colour-coded which makes it easy to keep track of the QRS in the vectorcardiogram. The assigning of ECG channels to axes is displayed by the software 5.1.10 BP (EC-3EV/ABP) HR, BP graph The graph presents Heart Rate and Blood Pressure measured by the ABPM device LABTECH LTD. V5.03_2014_11 63ANALYSIS WITH THE CARDIOSPY SOFTWARE ECG HOLTER SYSTEM Table The table displays all the BP results in a chronological order. We can validate / invalidate each result by ticking / un-ticking the relevant checkbox in the columa marked “Valid”. We can add short remarks to each measurement in the Comment column (double click). Charts The software represents systole and diastole values in the form of pie-charts. 64 V5.03_2014_11 LABTECH LTD.ECG HOLTER SYSTEM ANALYSIS WITH THE CARDIOSPY SOFTWARE Graphs The software shows BP burdens in the upper graph, while in the secoad graph Systole, Diastole, MAP and HR values are displayed. Histograms In this part Systole, Diastole and Map values are represented in the form of histograms. LABTECH LTD. V5.03_2014_11 65ANALYSIS WITH THE CARDIOSPY SOFTWARE ECG HOLTER SYSTEM Statistics Statistical parameters calculated from the validated Blood Pressure and Heart Rate values are shown in a table format. Scatter In this function, the cohesive systole-HR, diastole-HR and Systole-Diastole points are displayed. 66 V5.03_2014_11 LABTECH LTD.ECG HOLTER SYSTEM Toolbars 5.1.11 Database Gi 5.1.12 ECG leads Millimeter paper setting ANALYSIS WITH THE CARDIOSPY SOFTWARE This function gives you the possibility to go back to database or to complete some operations in the database. It is recommended to use this function in the case of 12-channel es recordings, when only three channels can be displayed in the ECG field. ing: ly splay Here we can select the channels to be displayed. This window is active in stress and holter system, by clicking view menu, Millimetre paper menu. Adjustment of millimetre paper size correlating to the monitor is possible Tt is possible to setup real, 1:1 scale appearance of the millimetre paper on screen. LABTECH LTD. @ _324p0cK9hmn oo 0%) Manual setting: setting manually how many pixels match for 1 mm. Automatic setting: the cube underneath is symbolising the monitor, showing the resolution and display size. The resolution of the monitor is defined by the system setup, but the display size must be set by rolling the cursor above the cube. Finalise the new setting by pressing "Set to recommended" button. Then press the set button, and the program sets the size on 1:1 scale, if the monitor shows 10mm it will be the same size in reality too. V5.03_2014_11 67ANALYSIS WITH THE CARDIOSPY SOFTWARE ECG HOLTER SYSTEM Contrast modification of ECG curves The modification of waves on the monitor is possible, Modify separately the line stickiness of VES, SVES, normal beat curves. The program enables default settings to distinguish each event. Modify the settings in Setting menu, ECG contrast tab 5.1.13 Report When selecting this menu, a movable text-box appears where the _# physician can enter his/her comments. The patient data and the automatic report generated by the program can be copied into this window by clicking on the Import Automatic Report button. You can display any window from the View menu, while the Report text-window is still displayed, which is convenient as you can see your remarks and the necessary information simultaneously. The text written in this window can be printed on a separate page. 5.1.14 Sequence of tasks The status of the record also appears in the database interface, which can be used as a filtering option. See chapter 3.3.1. 5.1.15 Print ‘We can select to print the pages generated by the program in black-and- white or in colour mode. We can also choose from the print settin; More information in chapter 3.2.11 68 V5.03_2014_11 LABTECH LTD.ECG HOLTER SYSTEM ANALYSIS WITH THE CARDIOSPY SOFTWARE 5.1.16 Printing of screen section This function gives you the possibility to print the ECG section, which aM can be seen on the screen. 5.1.17 Export In this menu you can go through the pages completed by the program and wy export separately (JPG, BMP, PDF). We can choose from the print settings as well. More information in chapter 3.2.11. 5.1.18 Export Current Samples ry There is an opportunity to directly export the selected ECG section on the ‘ screen. 5.1.19 Settings In this menu it is possible to set the various parameters of the program, such as parameters relevant to the analysis, colours of the screen, graphs to be displayed in the Main/Events menu. In case we run a new analysis of the record, default settings will be restored, so all previous editing will be lost. Meaning of parameters Time Here we can set asleep and awake periods (related to the ECG and to blood pressure measurement) and add special time intervals (only related to blood pressure measurement). ECG-Riythm Here we can find the settings of the ECG rhythm analysis. For the meaning of each parameter go to chapter 3.3. £CG-ST Here we can set the limits of ischemic burden. ECG-HR turbulence Here we can set the parameters used for calculating turbulence and classifying patient tisk. For the meaning of each parameter go to chapter 3.3. LABTECH LTD. V5.03_2014_11 69ANALYSIS WITH THE CARDIOSPY SOFTWARE ECG HOLTER SYSTEM ECG-Mise Here we can tun ECG filters on and off. A modification triggers the automatic analysis, after which all previous editing will be lost We can also select each channel to be viewed in an inverted position. A modification triggers the automatic analysis, after which all previous editing will be lost. Blood Pressure Here we can set parameters used for statistical calculations and measurement ranges used for automatic pre-filtering. Here you can set the parameters for the analysis of blood pressure measurement. Limits for children and adults can be adjusted separately. Statistical limit: You can set the normal systole and diastole limits in every interval separately. If the patient’s result exceeds this limit the program indicates that it is in a high range (with red colour). Valid measurement range: The program’s analysis accepts BP values within these ranges. If the results of certain measurements are outside of this range the program takes the measurements out of the evaluation. ECG contrast: In this menu you can set the ECG curve’s thickness displayed on the screen, Normal, VES, SVES beats separately Refreshing / method of analysing: You can choose from two methods, if you use an older computer (low memory, weak processor) choose the: Use of refresh button method. In this case the analysis does not run again and again after every editing step, just when changing screens and if you click on the Refresh button displayed on the screen. The other method is “validation of changes immediately’ which means that after each completed editing operation the analysis runs. This is recommended for faster computers. 70 V5.03_2014_11 LABTECH LTD.ECG HOLTER SYSTEM ANALYSIS WITH THE CARDIOSPY SOFTWARE Basic set events lists Itis possible to make several lists. Thus you need not change the List if you want to differ from the usual event view you only need to set a new group and you will reach it by pressing a button. In the upper toolbar you can step between groups. If you change group, the events under event flap will be altered according to the changed group. You can make 3 basic set event groups. You can include different events into all 3 groups and make different layouts [ seeuos | [Pde enpty event groups Evans on Diplay LABTECH LTD. V5.03_2014_11 71ANALYSIS WITH THE CARDIOSPY SOFTWARE ECG HOLTER SYSTEM Automatical analysing after read-in The automatic analysing read-in method selection is an innovated part of the program. It is possible to select from ‘never’ (no automatic analysing afier read-in), ‘ask me every time’ and ‘always’ (automatic analysing after read-in) options. Standard setting is record automatic analysis. orm Siva R@- B- B- Oar Woke ‘ts Seectedsane. ee eens Speed of Continuous playing It is possible to modify the speed of continuous playing of the Holter ECG records. Setting>continuous playing menu>select the proper speed from | to 9. 72 V5.03_2014_11 LABTECH LTD.ECG HOLTER SYSTEM ANALYSIS WITH THE CARDIOSPY SOFTWARE 5.1.20 Automatic report The selected reports automatic printout/export is possible in Printing/Export Setting menu by clicking Automatic printing button. This function is inactive until activating any of automatic modes in Print preview/Settings menu. Please activate this function in Printing Review>Setting menu>select an automatic mode. Possibilities for printing are: automatic printout, PDF, picture and DICOM export. eta ST LABTECH LTD. V5.03_2014_11 73TOOLBARS ECG HOLTER SYSTEM 5.1.21 Print and export settings ECG drawing: Here we can set the graph paper, the EKG curve. the VES and the SVES curve’s thickness on the print findings. Cutting of noisy ECG: In the whole ECG view the program completely cuts the noisy sections and they do not appear on the finding. Page layout: It is allowed to put a logo in the finding’s headpiece; you can attach the expert's report to the Summary II finding or you can display it as a separate finding. You can take off the automatic expert's report from the finding Summary L Quality: Printer-specific settings. You can select high-resolution or low resolution quality. You can send the findings to the printer in vector graphic or raster graphic modes. The colouring method can be set as black and white or coloured. Furthermore you can change the line smoothing and the contrast here as well for the print findings 74 V5.03_2014_11 LABTECH LTD.ECG HOLTER SYSTEM ANALYSIS WITH THE CARDIOSPY SOFTWARE Editing and measuring options 5.1.22 Automatic and manual analysis This function can be found in Settings menu / Refresh/analysis mode. Apply changes immediately: The software runs the automatic analysis every time we edit the record, this way we'll see the results on the screen immediately. This function is only recommended for modern and fast computers. Use refresh button: The software does not run the automatic analysis each time the record is edited, the analysis only runs when the user presses the refresh button or change the screen. It is recommended for computers with slow CPU or insufficient RAM. Refresh bution can be found in the middle of the screen, next to the horizontal slide. teense ome Siete aCe BR paeenn moe a | wp A F 4 Poll ie LABTECH LTD. V5.03_2014_11 75EDITING AND MEASURING OPTIONS ECG HOLTER SYSTEM The results of the automatic analysis can be edited and checked by means of the program’s editing and measuring options. The program contains all the options with the help of which a record can be quickly and precisely evaluated. 5.1.23 Sequence of tasks Tempo ead sate The current status of the record also appears in the database interface, which can be used as a filtering option. The status of each record can be as follows: Temporary: the recording has been read from the recorder, but no automatic analysis has been performed yet. Pre-evaluated: the recording has been automatically analyzed at least once, and Evaluated by physician still has at least one un- ticked box. Evaluated: automatic analysis has been performed and all boxes in Evaluated by physician are ticked Closed: a record can only be closed when status of record has been evaluated. 5.1.24 Template window Using the Highlight function If this function is on, QRS complex displayed in the ECG window will be marked by a continuous line in the Demix window. 76 cat | ie o_o poe _———<§« — ————=0 Teen . The function is off The function is on V5.03_2014_11 LABTECH LTD.ECG HOLTER SYSTEM ANALYSIS WITH THE CARDIOSPY SOFTWARE Manual demix The purpose of this function is to clear the cluster of the inappropriate QRS complexes and artefacts This function enables us to select one or more QRS complexes in order for them to be moved to a new cluster. Select cluster (it is going to be a parent cluster) Mark a rectangle in Demix window in any channel by pressing left mouse button, All QRS complexes can be moved to a new cluster (it is going to be a child cluster), which has at least one point withia the rectangle. The program automatically modifies and creates the QRS image characteristic of the given cluster. The created child cluster is marked in red. ‘The marking remains on the parent cluster until a new luster is marked. = rare a LABTECH LTD. V5.03_2014_11 7EDITING AND MEASURING OPTIONS ECG HOLTER SYSTEM Auto demix In the Auto Demix function we can “clean” the marked clusters of each channel. If a new cluster is created, the focus moves to the new cluster. The original cluster is marked with a red frame. Tan 3 g oe ae | Edition of Cluster’s type The type of a cluster can be changed by right-clicking the template. The chosen type will automatically appear next to each heartbeat of a cluster. Let Bundle Branch Beck Right Bundle Branch Bleck eM cout om Contraction of Clusters Alll the similar cluster types can be contracted manually or by the drag-and-drop method familiar from Windows. This means that with the left mouse button we mark the cluster and while holding this button just move the marked cluster to the one with which we 78 V5.03_2014_11 LABTECH LTD.ECG HOLTER SYSTEM ANALYSIS WITH THE CARDIOSPY SOFTWARE wish to contract it, then release the button. The program allows contracting only similar types of clusters, e.g. N can be contacted with N, V with V ete. Before completing the contraction, it is advisable to display only one particular type of group in the “Filter templates by” drop-down menu. Cluster group operations We can select all the clusters for group operations by holding the right mouse button, then choosing Select all. We can select the specified multiple clusters for group operations by pressing and holding the Shift button while clicking the lef mouse button at one point and pulling the cursor the desired clusters. The selected clusters can be contracted, or their types can be modified together. The function of the Fix button. By clicking on the Fix button, a certain type of QRS can be fixed in the marked cluster. Marking a new cluster invalidates all the previously set cluster types It is advisable to use this button, if we would like to modify the type of a complex cluster, with the exception of some QRS complexes. Determination of QRS clusters After selecting the desired QRS by right-clicking in the ECG window and clicking on the ’Forms’ tab, the focus will go to the cluster in which there is the appropriate QRS. LABTECH LTD. V5.03_2014_11 79EDITING AND MEASURING OPTIONS ECG HOLTER SYSTEM 5.1.25 ECG window Modification of unique QRS types Right-click the relevant QRS and choose the appropriate QRS type from the list offered by the program. Modification of group QRS types Moving the mouse by holding the left mouse button mark all those QRS, which are found next to each other and the type of which you would like to modify. Ee ace = : ae L LL ae sh pet +4 aati Ce Then by pressing right mouse bution on any of the QRS you can modify the type of all the marked QRS. The marking can be terminated if we click using right mouse button on any of non-marked QRS or if navigate to another time. ptvente Rene HS 80 V5.03_2014_11 LABTECH LTD.