User Manual Document No. UM-C-002-EN Date of Revision 2020.10.30 Revision No. 0 User Manual AT-PATCH ECG Analysis System MODEL ATP-C130 ATsens Co.,Ltd.
User Manual ※ Revision History No Version Revision Date 1 0.0 2020.10.30 Document No. UM-C-002-EN Date of Revision 2020.10.30 Revision No. 0 Revision Details Initial release UM-C-002-User Manual_ATP-C130_Ver 0.0 _ 2020/10/30 Disposable Medical Device (Do Not Reuse) “This product is a medical device.” The warranty period of this product is 12 months from the date of manufacture.
User Manual Document No. UM-C-002-EN Date of Revision 2020.10.30 Revision No. 0 1. Product Introduction --------------------------------------------------------------------------------------------5 1.1 Intended Purpose 1.2 Packaging Information 2. Caution -------------------------------------------------------------------------------------------------------------7 2.1 Contraindications 2.2 Precautions 2.3 Device and App 2.4 S/W 2.5 Usage and Storage Conditions 2.6 Warning 3.
User Manual Document No. UM-C-002-EN Date of Revision 2020.10.30 Revision No. 0 11.1 How to Use and Attach the Device (ATP-C130) 12. How to Install the App (ATN-C130) ---------------------------------------------------------------------114 13. Specifications -------------------------------------------------------------------------------------------------116 14. Usage and Storage Condition -----------------------------------------------------------------------------116 14.1 Conditions of Use 14.
User Manual Document No. UM-C-002-EN Date of Revision 2020.10.30 Revision No. 0 1. Product Introduction It is a device that attaches electrodes to certain parts of the potential difference that occurs when myocardial activity is transmitted to the body surface, which detects signals and uses radio signals to display this ECG data. If you connect the App after turning on the power of the device, you can see the ECG signal through the App.
User Manual Document No. UM-C-002-EN Date of Revision 2020.10.30 Revision No. 0 1.2 Packaging Information 1.2.1 Components (Device) 1) Basic 2) Accessories & PC S/W(ATR-C130) Refer to User Manual 4.3.2 1.2.2 App Android market: Google play (https://play.google.com/store) iOS market: App Store(https://www.apple.com/ios/app-store) 1) Search for ‘AT note, ATsens, ATreport’ in the Google Play™ Store or App StoreSM 2) Download app 3) Register before entering symptoms * Supported on Android 5.
User Manual Document No. UM-C-002-EN Date of Revision 2020.10.30 Revision No. 0 2. Caution ATP-C130 is intended for direct use by the patient and the patiens is an intended operator. 2.1 Contraindications 1) If there are current symptoms or history of skin cancer, rash, skin disease, keloid, or injury, do not use our product. 2) Do not use our product for patients with symptomatic events where instance variations in cardiac performance could result in immediate danger to the patient.
User Manual Document No. UM-C-002-EN Date of Revision 2020.10.30 Revision No. 0 10) If the patch appears to be floating or falling off, apply medical tape to prevent the patch from falling off. 11) When connecting multiple BLEs (more than 2), the App does not work properly. Please stop using BLE as much as possible while using the AT-note App. 12) When take a shower, be careful not to get soap, etc. on the patch as much as possible.
User Manual Document No. UM-C-002-EN Date of Revision 2020.10.30 Revision No. 0 3. Symbol Guide No. 1 2 3 4 5 6 Symbol Descriptions The serial number that identifies the object Date of manufacture For European Authorised Representative Keep dry Prevents dust-proof dust from entering the interior. Even a slight intrusion of dust does not impede normal operation.
User Manual Document No. UM-C-002-EN Date of Revision 2020.10.30 Revision No. 0 4. Device description 4.1 Operation principles This device is a patch-type electrocardiogram device that senses a signal by attaching an electrode to a certain part of the potential difference generated when the action potentials generated when the myocardium is active is transferred to the surface of the body. 4.1.1 What is ECG? Like the figure 3.
User Manual Document No. UM-C-002-EN Date of Revision 2020.10.30 Revision No. 0 [Fig 4.2 ECG waveform and action potential of the heart] 4.1.2 ATP-C130 ECG measurement process [Fig 4.3 ATP-C130 system configuration] 1) Sensor: It detects the ECG signal and receives it in a stable form, reducing the fluidity of the ECG signal for the movement of the human body. However, offset voltage caused by electrodes occurs, and this part is removed from 3 IN-AMP & RLD(Amplifier).
User Manual Document No. UM-C-002-EN Date of Revision 2020.10.30 Revision No. 0 6)Time conversion ADC: Using the IC, It plays the role of converting analog signals into digital signals more accurately and precisely by using internal digital filters (primary / secondary) and algorithms for charging/discharging signals.
User Manual 3 4 5 6 7 8 9 10 11 12 13 Accelerometer Sensor Part ECG Sensor Digital ADC Control Part MCU Communication BLE Part Record part Antenna part Battery Patch Ass’y F/W Software 14 Page 13 / 123 App PC/SW Document No. UM-C-002-EN Date of Revision 2020.10.30 Revision No.
User Manual Document No. UM-C-002-EN Date of Revision 2020.10.30 Revision No. 0 4.3 Device and accessories 4.3.1 Device 4.3.2 Accessories Component Description Dedicated Cable After using the device (14 days), after installing the diagnostic S/W on the recommended PC, the device and PC only can get the ECG record of the device through this cable.
User Manual Document No. UM-C-002-EN Date of Revision 2020.10.30 Revision No. 0 4.3.3 S/W App (ATN-C130) Ver 1.3.0.0 / Android 5.x or iOS 12.x or later PC S/W (ATR-C130) Ver 1.3.0.0 / Window10(64bit) 5. Critical Component List Object / Manufacturer/ Type / model part No. trademark Technical data ISUEXABOAR D CO LTD, PCB MD1-A2-003 Flammability, V-0 Elim electronics Ind.
User Manual Document No. UM-C-002-EN Date of Revision 2020.10.30 Revision No. 0 Object / Manufacturer/ Mark(s) of Type / model Technical data Standard part No. trademark conformity1) Supplementary information: 1) Indicates a mark which assures the agreed level of surveillance. See Licenses and Certificates of Conformity for verification. 6.
User Manual Document No. UM-C-002-EN Date of Revision 2020.08.30 Revision No. 0 7. Photograph and/or Drawing of the Device 7.1 External Shape 1) Device (Model: ATP-C130) Body Body Patch Patch Patch Total width(W) length(L1) length(L2) Width(W2) thickness(T) height(H) 39 mm 31 mm 95 mm 52.6 mm 0.5 mm 8.3 mm Weight Front View 12.6(g) Rear View 2) Dedicated cable length: 1 (m) QF-001 ATsens Co., Ltd.
User Manual Document No. UM-C-002-EN Date of Revision 2020.08.30 Revision No. 0 7.2 Interface Description QF-001 No. Name Description ① Case Top ② Case BTM ③ Power Button / LED ④ Patch Ass'y ⑤ Hydrogel It is located between the ECG electrode and the skin, and it has a function that allows constant measurement of ECG signals. ⑥ Electrodes ECG electrode ⑦ Battery The power button is assembled, and the company logo and S/N of the device are printed on the surface.
User Manual Document No. UM-C-002-EN Date of Revision 2020.08.30 Revision No. 0 8. Insulation Insulation is designed according to IEC 60601-1: B Secondary Circuits Main Control CR2032 Unit Electrode Primary Lithium Battery A Plastic Enclosure Entire enclosure of device is regarded as BF type applied part QF-001 ATsens Co., Ltd.
User Manual Document No. UM-C-002-EN Date of Revision 2020.08.30 Revision No. 0 9. How to use (Device, App & PC S/W) 9.1 App (ATN-C130) Icon Screen and Initial Launch Screen Figure 9.1 AT-note App Icon Figure 9.2 Intro Screen 1 Figure 9.3 Intro Screen 2 Figure 9.4 Intro Screen 3 Table 9.1.
User Manual Document No. UM-C-002-EN Date of Revision 2020.08.30 Revision No. 0 9.2 Device Connection Window Figure 9.5 AT-patch Connecting Screen Figure 9.6 AT-patch Connecting Screen Figure 9.9 AT-patch PW input Screen3 Figure 9.7 AT-patch PW input Screen Figure 9.8 AT-patch PW input Screen2 Figure 9.10 AT-patch PW input Screen4 Table 9.2 No Item Description Button to cancel the device Pressing the button cancels the device connection and switches to connection the [Figure 9.5] screen.
User Manual Document No. UM-C-002-EN Date of Revision 2020.08.30 Revision No. 0 9.3 Screen for 5 consecutive login failures If 5 consecutive logins fail, a message appears on the screen like [Fig 9.11], and you cannot log in for 30 minutes. Figure 9.11 Recorded ECG/3axis Data Viewer 9.
User Manual Document No. UM-C-002-EN Date of Revision 2020.08.30 Revision No. 0 Table 9.3 No Item Description 1 Input PW This is the field to input the PW to use the App. 2 Button to ok When the PW satisfies the condition, it is activated. 9.5 Main Screen Figure 9.14 AT-note Main Screen Table 9.
User Manual Document No. UM-C-002-EN Date of Revision 2020.08.30 Revision No. 0 9.6 LIVE Display Screen Figure 9.15 Live ECG Screen Figure 9.16 Live 3axis Zoom-in Table 9.
User Manual Document No. UM-C-002-EN Date of Revision 2020.08.30 Revision No.
User Manual Document No. UM-C-002-EN Date of Revision 2020.08.30 Revision No. 0 Figure 9.18 Symptom Note Procedure Table 9.
User Manual Document No. UM-C-002-EN Date of Revision 2020.08.30 Revision No. 0 shown by the red square area. If you touch the 'Later' button, the number of symptom notes registered on the main page will be increased but the screen will not switch. But if you touch 'Create Symptom’, the screen will return to the initial screen of symptom note registration. Figure 9.19 Symptom Note by AT-patch trigger buttion 9.9 Screens for Detailed View of Symptom Notes 9.9.
User Manual Document No. UM-C-002-EN Date of Revision 2020.08.30 Revision No. 0 Table 9.
User Manual Document No. UM-C-002-EN Date of Revision 2020.08.30 Revision No. 0 9.10 View Details of Symptom Notes registered with the Device (ATP-C130) When the symptom note is registered with the device, the event time is displayed only as the start time of symptoms as shown in the red square of [Figure 9.21], and the other contents are not set. Since the registration of symptom notes is not completed, the indication of whether symptom notes registration is completed is shown in black.
User Manual Document No. UM-C-002-EN Date of Revision 2020.08.30 Revision No. 0 9.11 Screen to Correct Symptom Notes The upper left screen of [Figure 9.21] below is the detailed view screen of one symptom note and shows the edit button or correct button area for each item. When touching each edit button or edit button area, the values of the selected items are displayed on the screen.
User Manual Document No. UM-C-002-EN Date of Revision 2020.08.30 Revision No. 0 Table 9.
User Manual Document No. UM-C-002-EN Date of Revision 2020.08.30 Revision No.
User Manual Document No. UM-C-002-EN Date of Revision 2020.08.30 Revision No. 0 10. How to Use S/W (ATR-C130 AT-Report PC S/W) 10.1 Overview of AT-Report S/W 1) AT-Report S/W (ATR-C130) is obtained from ATP-C130 device. The S/W is a program that can read ECG data c Windows based OS, show file of device user saved by ATN-C130 (Android / IOS) App on PC of Microsoft○ ECG rhythm waveform and analyze ECG Data.
User Manual Document No. UM-C-002-EN Date of Revision 2020.08.30 Revision No. 0 Figure 10.2 Icon and File Name of the ATR-C130 (AT-Report S/W) Installation File 2) When the installation file is executed, as shown in [Figure 10.3], a language selection dialog box is displayed. Select the language to be installed and click OK. Figure 10.3 Language Selection Screen for Installation Figure 10.4 Initial Installation Screen of ATR-C130 (AT-Report S/W) QF-001 ATsens Co., Ltd.
User Manual Document No. UM-C-002-EN Date of Revision 2020.08.30 Revision No. 0 Figure 10.5 ATR-C130 (AT-Report S/W) installation password input screen Figure 10.6 License Agreement Screen for ATR-C130 (AT-Report S/W) QF-001 ATsens Co., Ltd.
User Manual Document No. UM-C-002-EN Date of Revision 2020.08.30 Revision No. 0 Figure 10.7 Screen for Selecting Installation Location of ATR-C130 (AT-Report S/W) 3) It converts to the installation location selection screen, and the default value can be changed by selecting “C:\Program Files\ATsens\ATReport” or the installation location. Figure 10.8 Installation Screen when installing ATR-C130 (AT-Report S/W) (Copying files) Figure 10.
User Manual Document No. UM-C-002-EN Date of Revision 2020.08.30 Revision No. 0 Figure 10.10 Uninstall icon under “ATSens” in Start menu 2) When confirming the program deletion, the language selection (Korean or English) and the removal guide window are displayed. If you select'Yes (Y)' and'OK' in the information window, ATR-C130 S/W is deleted. Figure 10.
User Manual Document No. UM-C-002-EN Date of Revision 2020.08.30 Revision No. 0 Figure 10.12 Confirmation message of ATR-C130 (AT-Report S/W) program removal 10.4 How to obtain S/W License 1) How to set a password for first access ①Upon initial login, a warning window as shown in [Fig. 10.13] appears, and the initial password must be reset. QF-001 ATsens Co., Ltd.
User Manual Document No. UM-C-002-EN Date of Revision 2020.08.30 Revision No. 0 Figure 10.13 ATR-C130(AT-Report S/W) initial password reset warning screen ② [Fig 10.14] Enter the initial password “0000” and the password to reset. Password must be at least 8 characters in combination of lowercase letters, uppercase letters, number and special characters. Figure 10.
User Manual Document No. UM-C-002-EN Date of Revision 2020.08.30 Revision No. 0 Figure 10.15 ATR-C130 (AT-Report S/W) login screen 3) When the initial program is executed, it is executed in the demo version, and in the demo version, only the recording and region tabs are displayed. [Fig 10.16] click the setup icon on the uuper right of the initial screen to display the setup dialog box. Figure 10.16ATR-C130 (AT-Report S/W) login screen QF-001 ATsens Co., Ltd.
User Manual Document No. UM-C-002-EN Date of Revision 2020.08.30 Revision No. 0 Figure 10.17 Setup dialog box 4) Copy the ID from the license item and inform the software manufacturer ATSense Co. [Figure 10.18]. As shown in ①, if you click theClipboard icon nex to the ID, the ID value is copied to the Clipboard. Figure 10.18 The clipboard icon to copy the registration screen and ID 5) When you receive the serial number corresponding to the ID as shown in [Figure 10.
User Manual Document No. UM-C-002-EN Date of Revision 2020.08.30 Revision No. 0 Figure 10.19 Registration version serial number input result screen 6) In the case of Registered Version, as shown in [Figure 10.20], all tabs are displayed. Figure 10.20 In case of Registered version, initial screen of ATR-C130 (AT-Report S/W) 7) License types are Demo/ Evaluation / Registered/ Illegal/ Clear version Demo Only limited use is possible. Evaluation Can only be used for a fixed period of time.
User Manual Document No. UM-C-002-EN Date of Revision 2020.08.30 Revision No. 0 10.5 AT-Report (ATR-C130) PC S/W Title Bar 10.5.1 Title Bar Menu Figure 10.21 Title Bar Menu Figure 10.22 Display status of Title Bar with patient data loaded 10.5.2 Start {Fig10.21 Title Bar Menu ①} 10.5.2.1 New Patient data 1) This is a screen for registering patient and modifying information, and moves to the screen by pressing the [Start] button. Figure 10.
User Manual Document No. UM-C-002-EN Date of Revision 2020.08.30 Revision No. 0 check and input new Patient ID (Chart no) Please input correct PSN When SN (Serial Number) is not 10 digits when clicking (PSN can only be input alphabet and numeric. Hookup. (SN is 10 letters and numbers.) Drag error. The file with these file extensions When importing by dragging a file that does not match the cannot be processed extension Figure 10.24 New patient data screen and input items 10.5.2.
User Manual Document No. UM-C-002-EN Date of Revision 2020.08.30 Revision No. 0 Figure 10.26 Patient Data Import Screen 1) You can change existing registered patient information in the Patient Data Box of the Patient List. [Fig 10.26 - -①] 2) AT-Patch Data and AT-Note Data can be imported (imported) from the Patient List. [Fig 10.
User Manual Document No. UM-C-002-EN Date of Revision 2020.08.30 Revision No. 0 Figure 10.27 AT-Patch Import Process 7) Error message according to user actions in ECG Data USB download and import Error Message Detail USB download error When the dedicated cable connection is unstable during USB Failed open a FT4222 device. download please check USB cable connection. USB download error When the dedicated cable is not connected during USB Not found a FT4222 device.
User Manual Document No. UM-C-002-EN Date of Revision 2020.08.30 Revision No. 0 please reconnect the patch and retry again. USB download error The connection is disconnected during the download. When the AT-Patch and the dedicated cable are disconnected during USB download please reconnect the patch and retry again. When ECG Data Import cannot be performed for an ECG Import error unknown reason (reconnect AT-Patch, turn on the power and try again.) 10.5.2.
User Manual Document No. UM-C-002-EN Date of Revision 2020.08.30 Revision No. 0 Figure 10.29 Hookup location 2) Error message according to user action in hook-up Error message Detail Hookup connection error not found serial port. Error message according to user action in hook-up please check BLE dongle connection. Hookup connection error When a problem occurs in setting the BLE dongle can not open serial port.
User Manual Document No. UM-C-002-EN Date of Revision 2020.08.30 Revision No. 0 User User setting User addition, removal, password change, etc. Analyze Analysis setting Analysis, parameter setting etc. Report Report setting Selection etc. including report More Etc. setting Other options such as save/password 10.5.3.2 About screen This is the screen for checking S/W information and setting the program of AT-Report (ATR-C130). Press the [Setup] button to move to the screen.
User Manual Document No. UM-C-002-EN Date of Revision 2020.08.30 Revision No. 0 10.5.3.4 Storage screen 1) On the Storage screen, you can check and change the data storage location and check the folder storage capacity. Figure 10.32 Storage screen 2) In the Database category, the Database Type can be selected from SQLite / PostgresSQL / ODBC, and the DB File Path shows the path where the Database file is saved.
User Manual Document No. UM-C-002-EN Date of Revision 2020.08.30 Revision No. 0 1) Add User – This is a menu to add a user to AT-Report. As shown in [Fig 10.34], you can add users by setting User Name/Password/Repeat Password. Figure 10.34 Add New User screen Only Admin account can add new user account. When re-login AT-Report SW as an added user, the user's screen displayed in Setup-User does not display the Admin account as shown in [Fig 10.35], but only the added user account.
User Manual Document No. UM-C-002-EN Date of Revision 2020.08.30 Revision No. 0 3) Change Password-This is the function to change the password for the user selected in the User screen. Since the changed password is encrypted and stored, it cannot be restored, so be careful when entering the password. Only the Admin account can change the password of other accounts, and only the password of the own account can be changed for accounts other than Admin. Figure 10.
User Manual Document No. UM-C-002-EN Date of Revision 2020.08.30 Revision No. 0 The Analyze screen of [Figure 10.38] is a screen where you can configure each event used in the AT-Report Events Tab. 1) R-R Pause duration – This is a value that allows you to set 'R-R Pause' in the Events Tab. 2) N-N Pause duration – This is a value that allows you to set'N-N Pause' in the Events Tab. 3) N-N Delay duration – This is a value that allows you to set'N-N Delay' of the Events Tab.
User Manual Document No. UM-C-002-EN Date of Revision 2020.08.30 Revision No. 0 1) Save The 'Save' option is an option that allows the user to select a method to save the modified information when various modifications occur while using the AT-Report SW. - Auto Save-When this option is selected, it is an option to automatically save the modified work while the user proceeds with the modification work using AT-Report SW.
User Manual Document No. UM-C-002-EN Date of Revision 2020.08.30 Revision No. 0 5) Password Strength When creating a password for a user account with this option, you can set the password strength. - Upper-When selected, the password must contain at least one uppercase letter. - Lower-When selected, the password must contain at least one lowercase letter. - Number-When selected, the password must contain at least one number. - Symbol-When selected, the password must contain at least one symbol.
User Manual Document No. UM-C-002-EN Date of Revision 2020.08.30 Revision No. 0 Figure 10.45 History List - User QRS Label change time information-This is the part that displays information about the time when the user modified each QRS Label. - User QRS Label Change History-This is the part that displays the change history of the user directly adding, deleting, modifying, moving, or deleting a QRS Label.
User Manual Document No. UM-C-002-EN Date of Revision 2020.08.30 Revision No. 0 - Refresh – This is a button to refresh the details of the History Graph Plot. - History Graph – History Graph shows the revision history of QRS Label by user's date as a graph. - Select History-This is an option button to select the history you want to see in the current History Graph Plot.
User Manual Document No. UM-C-002-EN Date of Revision 2020.08.30 Revision No. 0 10.6.1.2 List search [Figure 10.50 Recording Tab screen ①] List Search is a function that allows users to search and select the data in the Recording List by the desired item. Click…” Input text to search. And press the “Search” button to search for the entered content and appear in the Recording List. The categories of searchable items are “All / Patient ID / Name / Physicians” as shown in [Figure 10.51 Search].
User Manual Document No. UM-C-002-EN Date of Revision 2020.08.30 Revision No. 0 Figure 10.54 Window that appears when performing back-up after selecting patient data 3) Delete Record – This is a function to delete patient data in the Recording List. After selecting the patient data to be deleted from the Recording List with the mouse, press the Delete Recording button ( ) to proceed with deletion. Figure 10.
User Manual Document No. UM-C-002-EN Date of Revision 2020.08.30 Revision No. 0 5) Restore Back-up-This function restores the list in the Back-up List back to the Recording List. It is executed by clicking the Restore back-up button ( ) with the left mouse button, and clicking the “OK” button in the dialog box as shown in [Figure 10.58 Restore Back-up] proceeds to the execution window and restore is completed. Figure 10.
User Manual Document No. UM-C-002-EN Date of Revision 2020.08.30 Revision No. 0 8) Export back-up-This is a function to export patient data from the Back-up List to an external storage device. After selecting the data to be exported from the patient data in the back-up list, click the export back-up button ( ) to execute the export. Figure 10.61 Export Back-up 9) Recording List – The Recording List button is to go back to the screen with the Recording List from the current Back-up List screen. 10.
User Manual Document No. UM-C-002-EN Date of Revision 2020.08.30 Revision No. 0 10.63 Resize Column width to contents before operation]. If you select and click the pop-up box, the Recording List automatically sorted according to each column appears. Figure 10.63 Resize column width to contents before operation Figure 10.64 Resize column width to contents after operation - Edit Patient Data & Reanalyze : This function is for modifying patient information and patient data.
User Manual Document No. UM-C-002-EN Date of Revision 2020.08.30 Revision No. 0 - Reanalyze : This function allows the user to revert the revised data in the Recording List to the initial patient data that was first imported. If you select Reanalyze, a pop-up box appears asking if you want to proceed as shown in the figure below. Reanalyze starts when you click the “OK” button in the pop-up box. Figure 10.67 Reanalyze function - List Number Information : 【Figure 10.
User Manual Document No. UM-C-002-EN Date of Revision 2020.08.30 Revision No. 0 Figure 10.68 Report preview 10.6.1.5 Error message according to user operation in recording tab Error message Detail Loading error When the imported patient's ECG file cannot be loaded Cannot load ECG file for an unknown reason When the changed QRS label, class, event information, Saving error etc.
User Manual Cannot load & remake analysis from ECG file Cannot reanalyze ECG data Select patient first Cannot load ECG Data Cannot load imported ECG data. Back-up error Document No. UM-C-002-EN Date of Revision 2020.08.30 Revision No.
User Manual Document No. UM-C-002-EN Date of Revision 2020.08.30 Revision No. 0 In the Regions Tab, the Date Tab represents the date you are currently working on in the History Menu. To change the date the user wants, click the left mouse button or use the keyboard hotkey to change the date information. The selected date has a red line below the date as shown in the picture above. 10.6.2.3 Average HR Plot [Figure 10.69 Regions tab screen ②] Figure 10.
User Manual Document No. UM-C-002-EN Date of Revision 2020.08.30 Revision No. 0 3) HR Plot: HR Plot shows the HR Plot for the entire date selected in the Regions Tab. In the HR Plot, information on the Maximum HR Plot / Average HR Plot / Minimum HR can be obtained, and if the user wants to check the noise event of the QRS Label Rate, the noise event can also be obtained. Figure 10.73 HR Plot in Regions Tab Figure 10.74 How to display Noise Event in HR Plot in Regions Tab 10.6.2.
User Manual Document No. UM-C-002-EN Date of Revision 2020.08.30 Revision No. 0 Figure 10.76 Time range box 4) HR number: The HR Number is displayed on the Strips Plot. This HR Number can be displayed by selecting the value of R-R Interval / HR / Average HR / max min HR using the right mouse button. For more information, refer to [10.6.3.5 Seconds Strip Plot ⑩– HR Number Change Function in Seconds Strip Plot]. 10.6.2.5 Seconds Strip Plot [Figure 10.69 Regions tab screen ④] Refer to [10.6.3.
User Manual Document No. UM-C-002-EN Date of Revision 2020.08.30 Revision No. 0 Figure 10.78 Save function in Class tab 2) Date Drop box 3) The current working date information of the Class Tab is displayed in the Data Drop Box. Click (▼) in the Data drop box to select and change the date the user wants.
User Manual Document No. UM-C-002-EN Date of Revision 2020.08.30 Revision No. 0 6) Group Class event card sorting method: First, sorting the QRS label according to the shape of the ECG, and then setting the order of the index, sorting and displaying all class events in the order of the ratio with the event number and event rate large.
User Manual Document No. UM-C-002-EN Date of Revision 2020.08.30 Revision No. 0 ■ Group Ventricular QRS Label - Defined as a non-normal QRS wave pattern based on the QRS wave of ECG ■ Group Artifact QRS Label – This is an abnormal wave pattern that cannot be classified as a group of N/S/V. 10.6.3.5 Seconds Strip Plot – [Figure 10.6.3.1 Class Tab screen ④] Figure 10.81 Seconds Strip Plot - 1 Figure 10.82 Seconds Strip Plot - 2 Figure 10.
User Manual Document No. UM-C-002-EN Date of Revision 2020.08.30 Revision No. 0 If you select “10 sec” in the Range Drop Box as shown in [Figure 10.84 Time information sign of seconds Strip Plot], time information is displayed based on the time selection and the time is displayed in the range of “10 Seconds”. Figure 10.
User Manual Document No. UM-C-002-EN Date of Revision 2020.08.30 Revision No. 0 The calculation method is as follows. [Distance (mm/beat) × Time (sec/square) = RR interval (sec/beat)] 1 beat is a value calculated by 1 second (1 second/beat), and the number of beats per second must be calculated to calculate the heart rate, and to do so, the RR value is 1/RR value. It uses a conversion factor and converts it to a general unit of minutes (beat/min). [1 beat/sec x 60 sec/min = 60 beats/min.
User Manual Document No. UM-C-002-EN Date of Revision 2020.08.30 Revision No. 0 ■ Add Caliper: If you click the Add Caliper button, the Drop-down Menu of Add Horizontal Caliper / Add Vertical Caliper / Add Horizontal / Vertical Caliper appears. Figure 10.90 Add Caliper Figure 10.91 Operation status of Add Caliper When a Caliper is added by clicking the Add Caliper button, the Caliper appears centering on the Indicator Line of the current Seconds Strip Plot.
User Manual Document No. UM-C-002-EN Date of Revision 2020.08.30 Revision No. 0 If you use the Show divider function as shown in [Figure 10.93 Show Right Divider] and, [Figure 10.94 Show Left Divider] a dotted line that is expanded by a multiple of Caliper set to the left and right of the graph area indicated by the ECG of Seconds Strip Plot appears.
User Manual Document No. UM-C-002-EN Date of Revision 2020.08.30 Revision No. 0 In the Events Drop Box, the events specified or specified in the xx Second Strip area are displayed. Events appearing in this section are events included in the Events Graph Plot of the Events Tab. ■ Symptom Memo Box Events Description User Input Users can directly enter events or text Palpitation It is a symptom of a palpitation or discomfort due to an irregular or rapid heartbeat.
User Manual Document No. UM-C-002-EN Date of Revision 2020.08.30 Revision No. 0 9) QRS Label Move button The QRS Label Move button is a function that allows you to change the position of the QRS label of the Seconds Strip Plot. Based on the selected QRS Label, you can move left or right by pressing the PREV Label / NEXT Label button. Figure 10.
User Manual Document No. UM-C-002-EN Date of Revision 2020.08.30 Revision No. 0 Figure 10.102 HR/RR interval/Average HR/max-in HR sign 10.6.4 Sub Class Tab 10.6.4.1 Sub class tab screen Figure 10.103 Sub class Tab screen Figure 10.104 Sub class QRS label Card In [Figure 10.104 Sub-class QRS Label Card], Sub-class QRS Label represents the type of QRS Label of each sub-class, and Sub-class Index is the total number of QRS labels belonging to each Sub-class Event Card. Represents. QF-001 ATsens Co.
User Manual Document No. UM-C-002-EN Date of Revision 2020.08.30 Revision No. 0 Figure 10.105 Selection Sub class QRS label Card [Figure 10.105 Selection Sub-class QRS Label Card] shows how to select Sub-class QRS Label Card. If you select the Sub-class QRS Label Card with the left mouse button, the selected Sub-Class QRS Label Card is changed to gray. Figure 10.106 When Sub-class QRS Label is changed, Index change (Bold font) is displayed 10.6.4.
User Manual Document No. UM-C-002-EN Date of Revision 2020.08.30 Revision No. 0 Figure 10.108 Multi-Selection Sub-class QRS Label Card-2nd 3) 3rd selection guide If you select (①→②) by using the shift ( ) key on the keyboard and the left mouse button together as in [Figure 10.109 Multi-Selection Sub-class Event Card-3rd], click the second on the sub-class QRS Label card you clicked first. All up to one sub-class card can be selected. Figure 10.109 Multi-Selection Sub-class QRS Label Card-3rd 10.6.
User Manual Document No. UM-C-002-EN Date of Revision 2020.08.30 Revision No. 0 Figure 10.111 How to move between Sub-class QRS Label 10.6.4.5 Change Label List – [Figure 10.103 Sub class Tab screen - ①] “Total Sub-class Number” means the number of all labels existing in the created Sub-class QRS Label Tab.
User Manual Document No. UM-C-002-EN Date of Revision 2020.08.30 Revision No. 0 2) Date Drop box The Date Drop Box in the Sub-class QRS Label Tab indicates the date of the Sub-class QRS Label Tab currently being worked on. 10.6.4.7 Sub-class Event Card – [Figure 10.103 Sub-class Tab screen - ③] In this area, all of the sub-class QRS Label Cards currently in the Sub-class QRS Label Tab are displayed, and you can edit and save the Sub-class QRS Label.
User Manual Document No. UM-C-002-EN Date of Revision 2020.08.30 Revision No. 0 The selected date has a red line below the date as shown in the picture above. 10.6.5.3 Average HR Plot – [Figure 10.115 Events Tab screen - ②] Figure 10.116 Average HR Plot 1) Average HR: Average HR represents the heart rate per minute where the indicator line is located. 2) Average HR Plot: This is the average HR graph for the day of the date selected in the Date Tab.
User Manual Document No. UM-C-002-EN Date of Revision 2020.08.30 Revision No. 0 13 SVE Bigeminy Determines whether an event label will be displayed when an SVE occurs every other beat. 14 SVE Trigeminy Determines whether an event label will be displayed when an SVE occurs every third beat. 15 Bradycardia Bradycardia is a slower than normal heart rate. The hearts of adults at rest usually beat between 60 and 100 times a minute.
User Manual Document No. UM-C-002-EN Date of Revision 2020.08.30 Revision No. 0 3) Add Report/Remove Report function in Event Graph Plot This function is a function that the user can add or delete to the report for each event in the Event Graph Plot. Figure 10.119 Add Report/Remove Report function In [Figure 10.
User Manual Document No. UM-C-002-EN Date of Revision 2020.08.30 Revision No. 0 In AT-note Tab, Date Tab indicates the date you are currently working in History Menu. To change the date the user wants, the date information can be changed by clicking the left mouse button or using the keyboard hotkey. The selected date has a red line below the date as shown in the picture above. 2) AT-note Edit button – [Figure 10.
User Manual Document No. UM-C-002-EN Date of Revision 2020.08.30 Revision No. 0 3) AT-Note List – [Figure 10.120 AT-Note Tab screen - ③] AT-note List is a part that displays symptom note data received from AT-patch and symptom note data downloaded from smartphone. This function can be viewed as a function that shows the contents written by ATpatch users while using AT-patch. Figure 10.124 AT-Note List ■ Select: This is a check box used to select the list to be deleted from the AT-note List.
User Manual Document No. UM-C-002-EN Date of Revision 2020.08.30 Revision No. 0 Figure 10.126 Seconds Strip operation when selecting an item in the AT-Note List 5) Seconds Strip Plot – [Figure 10.120 AT-Note Tab screen - ④] Refer to [10.6.3.
User Manual Document No. UM-C-002-EN Date of Revision 2020.08.30 Revision No. 0 10.6.6.2 Date Tab – [Figure 10.127 HR MIN/MAX Tab screen - ①] In HR MIN/MAX Tab, Date Tab indicates the date you are currently working on in the History Menu. To change the date the user wants, click the left mouse button or use the keyboard hotkey to change the date information. The selected date has a red line below the date as shown in the picture above. 10.6.6.3 Average HR Plot – [Figure 10.
User Manual Document No. UM-C-002-EN Date of Revision 2020.08.30 Revision No. 0 4) Minimum/Min: This is a function that finds the lowest Heart Rate per minute value shown in Average HR Plot. In the signal analyzed by AT-report, the point with the lowest heart rate becomes Index 1, and the heart rate increases sequentially, and the index increases. 5) Maximum/Short: This function finds the point where the interval between instantaneous QRS peaks seen in Average HR Plot is the shortest. .
User Manual Document No. UM-C-002-EN Date of Revision 2020.08.30 Revision No. 0 10.6.6.4 Seconds Strip Plot – [Figure 10.127 HR MIN/MAX Tab screen - ③] Refer to [10.6.3.5 Seconds Strip Plot] 10.6.7 Statistics Tab 10.6.7.1 Statistics Tab screen Figure 10.134 Statistics Tab screen 10.6.7.2 Plot Events Tab – [Figure 10.134 Statistics Tab screen - ①] Figure 10.
User Manual Document No. UM-C-002-EN Date of Revision 2020.08.30 Revision No. 0 Figure 10.136 High/Low Graph 10.6.7.4 Analysis – [Figure 10.134 Statistics Tab screen - ③] To view the statistical graph and data for the ECG data in the selected Plot Events, statistical analysis of the ECG data is required, and the Analysis button is to execute it. If you click this button and run it, the graph appears in the graph area. 10.6.8 Full Disclosure Tab 10.6.8.1 Full Disclosure Tab screen Figure 10.
User Manual Document No. UM-C-002-EN Date of Revision 2020.08.30 Revision No. 0 The selected date has a red line below the date as shown in the picture above. 10.6.8.3 Strip item – [Figure10.137 Full Disclosure Tab screen - ②] Figure 10.138 Selection option box in Full Disclosure Tab 1) Amplitude Selection Box: This is a drop box that controls the amplitude of Signal Plot of Full Disclosure. Amplitude can be adjusted by selecting a value between “x0.5 ~ x2.0”. Figure 10.
User Manual Document No. UM-C-002-EN Date of Revision 2020.08.30 Revision No. 0 ■ Time Move button: This is a function that allows the user to directly move the Time Control Bar with the mouse to see the desired time point. ■ Time Input Box: This is a function that allows the user to directly input the desired time in text format and move it to the desired time point. 10.6.8.4 Signal Display option – [Figure 10.137 Full Disclosure Tab screen - ③] Figure 10.
User Manual Document No. UM-C-002-EN Date of Revision 2020.08.30 Revision No. 0 10.6.8.5 Signal Plot – [Figure 10.137 Full Disclosure Tab screen - ④] Signal Plot is an area that expresses the signal selected by the user in the Full Disclosure Tab. In this area, the ECG can be checked in a full screen that is wider and longer than the time range of the existing signal, so it can be useful when viewing the overall signal flow. Figure 10.
User Manual Document No. UM-C-002-EN Date of Revision 2020.08.30 Revision No. 0 10.6.8.6 How to move the time range using the mouse in the signal display area Move the mouse wheel up/down to move the time information forward or backward. 10.6.8.7 How to specify noise in the signal display area In the Full Disclosure Tab, the user can designate an area and set it as a noise section. Figure 10.150 Noise area designation function As shown in the figure at the top of [Fig. 10.
User Manual Document No. UM-C-002-EN Date of Revision 2020.08.30 Revision No. 0 Figure 10.151 Report Tab screen 10.6.9.2 Control button box – [Figure 10.151 Report Tab screen - ①] 1) Export to pdf: This is a button that makes the final report out as a report into pdf. After pressing this button, you can save the folder under the desired name. 2) Print: Used to print the final report out of Report. 3) Save: It is used to save the final report from Report.
User Manual Document No. UM-C-002-EN Date of Revision 2020.08.30 Revision No. 0 Figure 10.152 Report description 8) Report Selector: Report Shows the user's choice for the contents of the report displayed in the final report. Figure 10.153 Report Selector ■ Day Events Summary: Report This is a check box that displays the summary of ECG Events by date when outputting the contents of each ECG event in the final report.
User Manual Document No. UM-C-002-EN Date of Revision 2020.08.30 Revision No. 0 Figure 10.154 Report History If you look at the Report History in [Figure 10.154 Report History], there are History corresponding to “Saved”, “PDF” and “Printed”. The first item corresponding to “Save” is to save the final report like the above History, and the second “PDF” is to save the report final report as a PDF file. The third “Printed” is to save the history of the print operation after printing the final report.
User Manual Document No. UM-C-002-EN Date of Revision 2020.08.30 Revision No. 0 10.7.2 Modification function of Seconds Strip Plot 10.7.2.1 Function to change time in Seconds Strip Plot If you click the left mouse button ( ) while holding down the Shift ( ) key in the Seconds Strip Plot, an indicator line is created in the clicked part, and the time changes. The color of the indicator varies depending on whether the QRS label is selected. Figure 10.
User Manual Document No. UM-C-002-EN Date of Revision 2020.08.30 Revision No. 0 the right mouse button. You can add a QRS Label to an arbitrary area by selecting QRS Label from the pop-up menu that appears with a right-click. Figure 10.159 Add QRS Label function 4) Move Indicator Line If QRS Label is selected at the selected time, the position can be adjusted using the + mouse wheel. 5) The QRS Label icon is changed for the changed QRS Label. Figure 10.
User Manual Document No. UM-C-002-EN Date of Revision 2020.08.30 Revision No. 0 Figure 10.162 Add Event Symptom Figure 10.163 Event Symptom List 10.7.3 Hotkey in Move Seconds Strip Plot The following two methods can be used to move the ECG graph of the Seconds Strip Plot left and right in the Time Domain. Figure 10.164 Time axis movement method in Seconds Strip Plot QF-001 ATsens Co., Ltd.
User Manual Document No. UM-C-002-EN Date of Revision 2020.08.30 Revision No. 0 10.7.4 Moving function of Indicator Line in Average HR Plot of Regions Tab. Figure 10.165 Movement function of Indicator Line In [Figure 10.165 Movement Function of Indicator Line], when the mouse wheel is moved up and down in Average HR Plot, the indicator line moves left and right. 10.7.5 Zoom In/Out function of Average HR Plot Figure 10.
User Manual Document No. UM-C-002-EN Date of Revision 2020.08.30 Revision No. 0 In order to change the sub-class QRS label card with the indicator line in the center as ② of [Fig. 10.167 Subclass QRS Label Card Change Method], [10.7.2.3] of [10.7.2 Seconds Strip Plot Modification]. ① Change QRS Label] function can be referred. After that, when the sub-class QRS Label is changed, it automatically moves to the next Index (Index 1 → Index 2 → Index 3).
User Manual Document No. UM-C-002-EN Date of Revision 2020.08.30 Revision No. 0 As in ②, if you click the left mouse button on the Strips Plot and move the Indicator Line, the Indicator Line of the Strips Plot moves to the location you want. The Indicator Line of the Average HR Plot is the time specified in the Strips Plot, and the Indicator Line of the Seconds Strips Plot Moves to the center Figure 10.170 Time Sync Function of Indicator Line 10.
User Manual , key ( ) Move to graph left . key ( ) Move to graph right Wheel Document No. UM-C-002-EN Date of Revision 2020.08.30 Revision No. 0 Move according to graph wheel motion SHIFT + , key Move to the left of the selected QRS label or Indicator Line ( + ) SHIFT + .
User Manual ( / UM-C-002-EN Date of Revision 2020.08.30 Revision No. 0 ) PgUp / PgDn Key ( Document No.
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User Manual Document No. UM-C-002-EN Date of Revision 2020.08.30 Revision No. 0 10.10.3 Related to License Error message Detail AT-report has no license to use caliper. Function When trying to use caliper Detail Plot Please change the AT-report to a registered version AT-report has no license to manage the report. without license authorization When trying to modify a report Report Tab Please change the AT-report to a registered version without license authority 10.10.
User Manual Document No. UM-C-002-EN Date of Revision 2020.08.30 Revision No. 0 You can only export PDF with authority. Authorization to save report as PDF Report tab Please log in as authority and try again QF-001 ATsens Co., Ltd.
User Manual Document No. UM-C-002-EN Date of Revision 2020.08.30 Revision No. 0 11. How to Use the Device (ATP-C130) 11.1 How to Use and Attach the Device (ATP-C130) 11.1.1 How to use Device (ATP-C130) 1) Initial devices (Device, ATP-C130) are packaged in “Sleep Mode” and delivered to customers. For patients who want to attach the device, press the button in device for more than 3 seconds.
User Manual Document No. UM-C-002-EN Date of Revision 2020.08.30 Revision No. 0 Figure 11.1 Attachment Preparation Step In order to output the correct ECG signal, slough off foreign substances such as dead skin cells on the attachment area (ex. Exfoliating products for the human body). First, you should remove dead skin cells and foreign substances and clean the attachment area with alcohol swaps. Then you should dry the skin for at least 1 minute to attach the Device (ATP-C130). QF-001 ATsens Co.
User Manual Document No. UM-C-002-EN Date of Revision 2020.08.30 Revision No. 0 Figure 11.2. How to attach ATP-C130 2) How to Attach to the Human Body After pressing the power button of the device to operate normally, remove the tape to protect the patch as shown in ① of [Figure 11.2]. After attaching the tape removed device to the human body [Figure 11.2] ② As shown in the figure, attach the center part of the clavicle to the body in an inclined direction toward the nipple of the left chest.
User Manual Document No. UM-C-002-EN Date of Revision 2020.08.30 Revision No. 0 12. How to Install the App (ATN-C130) 12.1 Users of Android App (ATN-C130) can be downloaded from Android market: Google play (https://play.google.com/store). If it is as shown in [Figure 12.1], it is normally installed. Figure 12.1 How to install App (ATP-C130) 1) In the search window of Android ™ market Google play ™ (https://play.google.com/store) as shown in the picture ① in [Figure 12.1], “ATnote, ATsens, ATpatch”.
User Manual Document No. UM-C-002-EN Date of Revision 2020.08.30 Revision No. 0 Figure 12.2 How to install App (APK)_iOS 1) In the search term window of IOS Store App StoreSM (https://www.apple.com/ios/app-store/), as shown in ① in [Figure 12.2], “ATnote, ATsens, ATpatch”. 2) As shown in ② in [Figure 12.2], if [AT-Note] is searched, click [Install] to download and install the app. 3) If the installation is completed as shown in ③ in [Figure 12.2], click [Open] to run the app.
User Manual Document No. UM-C-002-EN Date of Revision 2020.08.30 Revision No. 0 13. Specifications 13.1 ATP-C130 Specifications ATP-C130 Item ECG Electrode RF SW Power Requirement Physical Characteristics Description Type BF type Sampling Rate 250sample/sec Input Offset Dynamic Range ±300mV Channel 1 channel ADC Resolution 10 bits Input Impedance ≥10MΩ Frequency Response 0.05Hz to 40Hz AC impedance Less than 3KΩ(10Hz) RF communication 2.4GHz BLE 4.
User Manual Document No. UM-C-002-EN Date of Revision 2020.08.30 Revision No. 0 15. Disposal This product is a disposable medical device and cannot be reused. Disposal of this product and batteries must be in accordance with local waste disposal regulations. If the waste disposal regulations are not followed, it may cause environmental pollution. 16. Maintenance 16.
User Manual Document No. UM-C-002-EN Date of Revision 2020.08.30 Revision No. 0 18. Label QF-001 ATsens Co., Ltd.
User Manual Document No. UM-C-002-EN Date of Revision 2020.08.30 Revision No. 0 19. ANNEX 1 –EMC (Electromagnetic Compatibility) Information Applicable Standards and Test Methods 5.2.1.1 a) The EUT uses RF energy only for its internal function. Therefore, its RF emissions are very low and are not likely to cause any interference in nearby electronic equipment 5.2.1.
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User Manual Document No. UM-C-002-EN Date of Revision 2020.08.30 Revision No. 0 Not applicable 5.2.2.3 / 5.2.2.4 Frequency range: 2 42 MHz ~ 2 480 MHz(LE) Number of channels: 40 ch QF-001 ATsens Co., Ltd.
User Manual Document No. UM-C-002-EN Date of Revision 2020.08.30 Revision No. 0 20. FAQs No. Question 1 This device has FCC certification? Answer This device complies with part 15 of the FCC Rules. We have FCC certification. This device communicates with the App through BLE, and the communicated data is stored in the device.
User Manual Document No. UM-C-002-EN Date of Revision 2020.08.30 Revision No. 0 If the same phenomenon is repeated even after running it again, please contact distributor or us. 1. The battery is discharged. 2. Discharge due to short circuit due to immersion 9 The device does not work during use. 3. Discharge due to other circuit damage This is due to the above causes, so stop using the patch and visit a hospital for replacement after detachment.
FCC Compliance Statement This device complies with part 15 of the FCC rules. Operation is subject to the following two conditions: (1) This device may not cause harmful interference, and (2) this device must accept any interference received, including interference that may cause undesired operation. FCC Caution Any changes or modifications not expressly approved by the party responsible for compliance could void the user's authority to operate this equipment.
