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ATsens AT-PATCH ATP-C130 User Manual

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Document No.
UM-C-002-EN
User Manual
Date of Revision
2020.10.30
Revision No.
0
User Manual
AT-PATCH ECG Analysis System
MODEL ATP-C130
ATsens Co.,Ltd.
Page 1 / 123

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Summary of Contents for ATsens AT-PATCH ATP-C130

  • Page 1 Document No. UM-C-002-EN User Manual Date of Revision 2020.10.30 Revision No. User Manual AT-PATCH ECG Analysis System MODEL ATP-C130 ATsens Co.,Ltd. Page 1 / 123...
  • Page 2 Document No. UM-C-002-EN User Manual Date of Revision 2020.10.30 Revision No. ※ Revision History Version Revision Date Revision Details 2020.10.30 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. Page 2 / 123...
  • Page 3 Document No. UM-C-002-EN User Manual Date of Revision 2020.10.30 Revision No. 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.

  • Page 4: Table Of Contents

    Document No. UM-C-002-EN User Manual Date of Revision 2020.10.30 Revision No. 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 14.2 Storage conditions 15.
  • Page 5 1) Common Name: AT-Patch ECG Analysis System 2) Product Name (Model Name): AT-Patch ECG Analysis System (ATP-C130) 3) Manufacturer: ATsens Co.,Ltd. 4) Address: No.806, Point Town, 11 Gumi-ro, Bundang-gu, Seongnam-si, Gyeonggi-do, Korea 5) Contact: Tel. +82-70-5220-0738 / Fax. +82-70-8270-0738 6) U.S Representative...
  • Page 6 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 Store 2) Download app 3) Register before entering symptoms * Supported on Android 5.0+ or iOS 12.0+ * See User manual 12 How to Install the App (ATN-C130) for details.
  • Page 7 Document No. UM-C-002-EN User Manual Date of Revision 2020.10.30 Revision No. 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.
  • Page 8 Document No. UM-C-002-EN User Manual Date of Revision 2020.10.30 Revision No. 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.
  • Page 9 Document No. UM-C-002-EN User Manual Date of Revision 2020.10.30 Revision No. 3. Symbol Guide 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.
  • Page 10 Document No. UM-C-002-EN User Manual Date of Revision 2020.10.30 Revision No. 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.
  • Page 11 Document No. UM-C-002-EN User Manual Date of Revision 2020.10.30 Revision No. [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.
  • Page 12 Document No. UM-C-002-EN User Manual Date of Revision 2020.10.30 Revision No. 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.
  • Page 13 Document No. UM-C-002-EN User Manual Date of Revision 2020.10.30 Revision No. the result processed by the controller Sensor Accelerometer The part that senses the movement of the device Part ECG Sensor The part that senses electrocardiographic signal Control Digital ADC The part that converts the input signal to a digital signal Part The part that signal processing and various control...
  • Page 14 Document No. UM-C-002-EN User Manual Date of Revision 2020.10.30 Revision No. 4.3 Device and accessories 4.3.1 Device 4.3.2 Accessories Component Description Picture After using the device (14 days), after installing the diagnostic S/W on Dedicated Cable the recommended PC, the device and PC only can get the ECG record of the device through this cable.
  • Page 15 Document No. UM-C-002-EN User Manual Date of Revision 2020.10.30 Revision No. 4.3.3 S/W App (ATN-C130) PC S/W (ATR-C130) Ver 1.3.0.0 / Android 5.x or iOS Ver 1.3.0.0 / Window10(64bit) 12.x or later 5. Critical Component List Object / Manufacturer/ Mark(s) of Type / model Technical data Standard...
  • Page 16 Document No. UM-C-002-EN User Manual Date of Revision 2020.10.30 Revision No. 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.
  • Page 17 Body Body Patch Patch Total Weight width(W) length(L1) length(L2) thickness(T) height(H) Width(W2) 39 mm 31 mm 95 mm 52.6 mm 0.5 mm 8.3 mm 12.6(g) Front View Rear View 2) Dedicated cable length: 1 (m) QF-001 ATsens Co., Ltd. 17/123...
  • Page 18 It uses medical grade tape and adheres to the skin surface. Patch Ass'y It is located between the ECG electrode and the skin, and it has ⑤ Hydrogel a function that allows constant measurement of ECG signals. ⑥ Electrodes ECG electrode ⑦ Coin Battery/CR2032 Battery QF-001 ATsens Co., Ltd. 18/123...
  • Page 19 2020.08.30 Revision No. 8. Insulation Insulation is designed according to IEC 60601-1: Secondary Circuits Main Control CR2032 Electrode Unit Primary Lithium Battery Plastic Enclosure Entire enclosure of device is regarded as BF type applied part QF-001 ATsens Co., Ltd. 19/123...
  • Page 20 Intro Screen 3 Intro Screen Contents of the Device Contents of the guide for device connection Connection Guide Screen for Device Connection navigation Screen call button for device connection button QF-001 ATsens Co., Ltd. 20/123...
  • Page 21 Bar to show the progress of the device connection Input PW This is the field to input the PW to use the App. Button to ok When the PW satisfies the condition, it is activated. QF-001 ATsens Co., Ltd. 21/123...
  • Page 22 [Fig 9.12] appears. Enter the PW you set for the first time and press OK to use the app again. Figure 9.12 AT-patch PW input Screen1 Figure 9.13 AT-patch PW input Screen2 QF-001 ATsens Co., Ltd. 22/123...
  • Page 23 Command button for real-time output of ECG and 3-axis data ECG and 3-axis data summed in graph Output area of ECG and 3- Area for real-time output of ECG and 3-axis data summed in axis data graph QF-001 ATsens Co., Ltd. 23/123...
  • Page 24 Zoom out button on ECG Zoom out button on the ECG graph being measured in real time graph Output area of ECG graph Output area of the graph on the enlarged screen of ECG data QF-001 ATsens Co., Ltd. 24/123...
  • Page 25 When registration of symptom notes is completed, a list of symptom notes registered on the main page appears. QF-001 ATsens Co., Ltd. 25/123...
  • Page 26 0.2 seconds, the information is sent to the app by Bluetooth (BLE). Like the screen on the right, the app receives the event information from the device. Then a dialog box appears asking if you want to record the symptom immediately, as QF-001 ATsens Co., Ltd. 26/123...
  • Page 27 Touch the red square to switch to the detailed view of one symptom note. Figure 9.20 Registered Symptom Note QF-001 ATsens Co., Ltd. 27/123...
  • Page 28 End time of symptom onset End time of symptom onset Indication of symptom type Indication of symptom type Indication of activity type Indication of activity type Button to add other descriptions Button to add other descriptions QF-001 ATsens Co., Ltd. 28/123...
  • Page 29 If you touch the red square area and register with the device on the detailed view screen for one symptom note, you can see that other parts except symptom's start time are not set. Figure 9.21 Registered Symptom Note from AT-patch QF-001 ATsens Co., Ltd. 29/123...
  • Page 30 Since the items whose symptom notes are registered with the device do not have values of each item except the start time of symptom occurrence, input must be made by touching the edit button or the edit button area. Figure 9.22 Modifing Registered Symptom Note QF-001 ATsens Co., Ltd. 30/123...
  • Page 31 Command button for going to the main screen of Go button on the main screen symptom notes Back button Button to go back Output area of ECG graph Output area of the graph for ECG Data ECG graph Graph of ECG Data QF-001 ATsens Co., Ltd. 31/123...
  • Page 32 Displays the location time of the file currently playing Displays the end time of data storage of the currently End time of saving data playing file Start and pause command buttons for the file being PLAY / PAUSE played QF-001 ATsens Co., Ltd. 32/123...
  • Page 33 10.2 Installation of AT Report PC S/W (ATR-C130) 1) After connecting the provided USB memory stick to the PC, execute the ATR-C130 (AT-Report S/W) installation file saved as shown in [Figure 10.2]. (However, the file name can be changed.) QF-001 ATsens Co., Ltd. 33/123...
  • Page 34 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. 34/123...
  • Page 35 Document No. UM-C-002-EN User Manual Date of Revision 2020.08.30 Revision No. 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. 35/123...
  • Page 36 Figure 10.9 ATR-C130 (AT-Report S/W) Installation Completed 4) When the program installation is complete, ATsens folder is created in the start menu, and ATReport, ATReport Uninstall, and ATsens Homepage Icon are created in ATsens folder. “ATReport” Icon is created on the desktop.
  • Page 37 2) The user can manually delete all DB data and set values. The path (C: \Users\[Windows user ID] \AppData\Local\ATsens) differs depending on the operating system installed on the PC. QF-001 ATsens Co., Ltd.
  • Page 38 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. 38/123...
  • Page 39 If you select the check box of Save ID/Password, the input ID and PW are saved. When the next S/W is executed, the saved ID/PW is automatically entered and the ID/Password input window does not appear. QF-001 ATsens Co., Ltd. 39/123...
  • Page 40 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. 40/123...
  • Page 41 ID and click the confirmation icon. If the correct serial number is entered, different icons and messages are displayed according to the type of serial number. QF-001 ATsens Co., Ltd. 41/123...
  • Page 42 Illegal activity detected and registered as illegal version. Normal program operation is not possible. 8) License must be issued a serial number for each PC where ATR-C130 (AT-Report S/W) is installed, and if the license is previously installed on another PC, the serial number must be reissued. QF-001 ATsens Co., Ltd. 42/123...
  • Page 43 When patient name is not entered. Patient name corresponds Please input name of patient to required information and must be entered. Patient ID (Chart no) is already exits. Please When the same Patient ID and Patient name exist QF-001 ATsens Co., Ltd. 43/123...
  • Page 44 AT-Patch ECG data and note data recorded in the App are not imported, both AT-Patch and AT- Note data are in 'Empty'. Figure 10.25 Patient List Screen 2) To import patient data, double-click the desired patient to convert to the Import screen. 10.5.2.3 Patient Data QF-001 ATsens Co., Ltd. 44/123...
  • Page 45 Title Bar as shown in [Figure 10.27 AT-patch import process] indicates the completion of the import. When both ECG and Note data are imported, they disappear from the patient list and can be checked in the Recording QF-001 ATsens Co., Ltd. 45/123...
  • Page 46 SN of AT-Patch are different please check SN(serial number) of AT-Patch. USB download error When it is not possible to get all the stored data of AT-Patch AT-Patch USB download is failed when downloading via USB QF-001 ATsens Co., Ltd. 46/123...
  • Page 47 SN with BLE. At this time, if AT-Patch is already connected to App via BLE, PC and BLE are not connected. Depending on the strength or weakness of the signal, you can take measures such as removing the attached device and attaching a new device in the correct position. QF-001 ATsens Co., Ltd. 47/123...
  • Page 48 10.5.3 Setup [Fig 10.21 Title Bar Menu ②] 10.5.3.1 Setup screen description Item Main function Detail About Check information SW, version, manufacturer, contact etc. License License setting License check, ID copy etc. Storage Save setting Storage location, type, capacity, etc. QF-001 ATsens Co., Ltd. 48/123...
  • Page 49 On the License screen, you can check the License Type and the ID of the S/W. According to the license type, there is a field for describing the Serial Number delivered by ATSense. For how to obtain license and registration, refer to [10.4 How to obtain SW license] Figure 10.31 License screen QF-001 ATsens Co., Ltd. 49/123...
  • Page 50 6) Back-up Path item indicates the location where back-up files are saved using the Back-up function, and shows the amount of available space on the drive where the folder is located. 10.5.3.5 User screen Figure 10.33 User screen QF-001 ATsens Co., Ltd. 50/123...
  • Page 51 Figure 10.35 AT-Report SW User screen when logging in with the added user account 2) Delete User-Deletes the user account selected in the User screen. Only the Admin account can delete the selected user account. Figure 10.36 Delete user screen QF-001 ATsens Co., Ltd. 51/123...
  • Page 52 If you select the “Manage report” option permission when creating a user account, the created account can have permission to the Report Tab. - Only Admin account can modify all privileges 10.5.3.6 Analyze screen Figure 10.38 Analyze screen QF-001 ATsens Co., Ltd. 52/123...
  • Page 53 Events that are not checked are not included in the report by default. (User can arbitrarily change whether to include report of each event.) Figure 10.39 Report screen 10.5.3.8 More screen In the 'More' option, you can set various functions used in AT-Report. Figure 10.40 More option screen QF-001 ATsens Co., Ltd. 53/123...
  • Page 54 'Medium', it is expressed in medium quality, and if it is 'Low', it is expressed in low quality. Figure 10.43 High Quality Plot and Low Quality Plot QF-001 ATsens Co., Ltd. 54/123...
  • Page 55 The selected date has a red line below the date as shown in the picture above. 2) History List [Fig 10.44 History screen ②] In the History List, a list of QRS Labels modified by the user in the Data Tab of the current working date is displayed. QF-001 ATsens Co., Ltd. 55/123...
  • Page 56 - Total – Shows the total number of QRS Labels changed on the date set by the user with the Date Tab. 5) History Graph Plot [Figure 10.44 History screen ⑤] Figure 10.47 History Graph Plot QF-001 ATsens Co., Ltd. 56/123...
  • Page 57 Start → When the import of AT-patch data or AT-note data is completed in the Patient List, patient information and data information are displayed in the Recording List of the Recording Tab screen as shown in [Fig. 10.50 Recording Tab Screen]. Figure 10.50 Recording Tab screen QF-001 ATsens Co., Ltd. 57/123...
  • Page 58 2) After selecting patient data in the Recording List, press the back-up Record button ( ) to perform back-up. [Figure 10.54 Window that appears when performing back-up after selecting patient data] appears, and click “OK” in the window. When selected, back-up is executed. QF-001 ATsens Co., Ltd. 58/123...
  • Page 59 Recording List with the mouse, press the Delete Recording button ( ) to proceed with deletion. Figure 10.55 Delete Recording dialog box 4) Back-up list – This is a function that manages the patient data back-up from the Recording List. Figure 10.56 Back-up list Figure 10.57 Back-up list function QF-001 ATsens Co., Ltd. 59/123...
  • Page 60 If you execute the Import back-up button ( ), a dialog box as shown in [Figure 10.60 Import Back-up] appears, and the user can search the desired folder and import the back-up AT-report patient data. Figure 10.60 Import Back-up QF-001 ATsens Co., Ltd. 60/123...
  • Page 61 : This function arranges the contents of the initial Recording List according to each width. If you place the mouse arrow on the column of the Recording List and click the right button, a pop-up box appears as shown in [Figure QF-001 ATsens Co., Ltd. 61/123...
  • Page 62 : This is a function used by the user to modify Patient Data in the Recording List. When you select Edit patient data with the mouse, the Edit Patient data box appears, and the user can edit/change and save the necessary relevant information. Figure 10.66 Edit patient data QF-001 ATsens Co., Ltd. 62/123...
  • Page 63 Report Preview function is a function to show the saved report in Preview form when the correction/analysis of the patient data selected in the current Recording List is in progress and “Export to PDF / Print / Save” in the Report Tab is completed. QF-001 ATsens Co., Ltd. 63/123...
  • Page 64 When trying to load ECG data that has not been Data is not imported, empty. imported first import data or select other work from list. Remake analysis error When the imported patient's CG data cannot be QF-001 ATsens Co., Ltd. 64/123...
  • Page 65 When the backup delete icon is clicked, nothing is Check back-up recording to delete checked in the back-up list 10.6.2 Regions Tab 10.6.2.1 Regions Tab screen Figure 10.69 Regions Tab screen 10.6.2.2 Date Tab [Figure 10.69 Regions tab screen ①] QF-001 ATsens Co., Ltd. 65/123...
  • Page 66 2) Select QRS Label : This is a drop box that selects the type of QRS label displayed on the QRS Label bar of ▼ average HR Plot. Click ( ) in the select QRS Label drop box and select the QRS label you want to display. Figure 10.72 Select QRS Label QF-001 ATsens Co., Ltd. 66/123...
  • Page 67 Seconds Strip Plot. That is, if the value of Time Range Selection of Seconds Strip Plot is 10sec, the Time Range Box is displayed as 10sec, and if it is 20sec, it is displayed as a box within the range of 20sec. QF-001 ATsens Co., Ltd. 67/123...
  • Page 68 If there is changed labeling data in the Group Class Event Card, the “Save” button is activated, and the changed label is actually changed and applied by pressing the “Save” button. Depending on the option, changes are applied in a way that is saved the moment you leave the Class Tab. QF-001 ATsens Co., Ltd. 68/123...
  • Page 69 4) Label rate: It represents the ratio (%) of the number of QRS labels in each N/S / V/A group to the total QRS labels during the day. 5) QRS Peak: This indicates the location of the QRS peak of the ECG pattern currently being viewed by the user. QF-001 ATsens Co., Ltd. 69/123...
  • Page 70 Normal QRS label. ■ Group Supraventricular QRS Label - This is a normal QRS wave pattern that is faster than the normal defined QRS label pattern based on the QRS wave of the ECG. QF-001 ATsens Co., Ltd. 70/123...
  • Page 71 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 10.83 Seconds Strip Plot - 3 1) Time range information sign of Time Strip information QF-001 ATsens Co., Ltd. 71/123...
  • Page 72 0.6 ~ 1.0 seconds, and the normal range of heart rate is 60 ~ 100 bpm. The RR interval is the time between QRS, and the instantaneous heart rate can be calculated from the time between QRS. QF-001 ATsens Co., Ltd. 72/123...
  • Page 73 ■ Show/Hide Caliper: Show/Hide Caliper button is a button to enable/disable the Caliper function. As shown in the picture above, when enabled, the button color changes to pink, and when disabled, the button color appears in white. QF-001 ATsens Co., Ltd. 73/123...
  • Page 74 ■ Show/hide Divider: If you click the Show/Hide Divider button with a mouse, the Drop-down Menu of Show Right Divider / Show Left Divider appears. Figure 10.92 Show/Hide Divider Figure 10.93 Show Right Divider Figure 10.94 Show Left Divider QF-001 ATsens Co., Ltd. 74/123...
  • Page 75 7) Second Report Box Send Report Box is a function that includes the event desired by the user in the report from the ECG graph of the Seconds Strip Plot. Figure 10.97 Second Report Box ■ Event Information QF-001 ATsens Co., Ltd. 75/123...
  • Page 76 Motion Display is a function that displays Motion Data according to the movement of the patient attaching the AT- patch to the Seconds Strip Plot. Here, “X” indicates x-axis data among Motion Data, “Y” indicates y-axis data among Motion Data, and “Z” indicates z-axis data among Motion Data. Figure 10.99 Motion Display Button QF-001 ATsens Co., Ltd. 76/123...
  • Page 77 In the Seconds Strip Plot, the HR (Heart Rate) displayed between each QRS Label can be changed to the type desired by the user (R-R Interval / HR / Average HR / max min HR ). QF-001 ATsens Co., Ltd. 77/123...
  • Page 78 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., Ltd. 78/123...
  • Page 79 (①→②→③→④) by using the ctrl( ) key on the keyboard and the left mouse button together. In the selected state, click the selected sub-class event card in the same way as above to cancel the selected state. QF-001 ATsens Co., Ltd. 79/123...
  • Page 80 [Figure 10.111 How to Move from Sub-class QRS Label Card] shows how to move from Sub-class QRS Label Card to Card. You can move to the desired card of the sub-class QRS Label Card by using the up, down, left, and right (↑↓→←) keys on the keyboard. QF-001 ATsens Co., Ltd. 80/123...
  • Page 81 QRS label by pressing the “Save” button. Depending on the option, it may be applied in a way that is saved the moment it leaves the class tab. Figure 10.114 Save button in Sub-class QRS Label Card QF-001 ATsens Co., Ltd. 81/123...
  • Page 82 The Date Tab of the Events Tab shows 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. QF-001 ATsens Co., Ltd. 82/123...
  • Page 83 Determines whether an event label will be displayed for two consecutive SVE beats. SVE Triplet Determines whether an event label will be displayed for three consecutive SVE beats. Determines whether an event label will be displayed for three or more consecutive SVE SVE Run beats. QF-001 ATsens Co., Ltd. 83/123...
  • Page 84 2) Move function in Event Graph Plot Event Graph Plot shows all events included in the date selected in the Date Tab. Figure 10.118 Events Graph Plot Click the pentagonal area to move right/left in the current event QF-001 ATsens Co., Ltd. 84/123...
  • Page 85 10.6.5.5 Seconds Strip Plot – [Figure 10.113 Events Tab screen - ④] Refer to [10.6.3.5 seconds Strip Plot] 10.6.6 AT-Note Tab 10.6.6.1 AT-Note Tab screen Figure 10.120 AT-Note Tab screen 1) Date Tab – [Figure 10.120 AT-Note Tab screen - ①] QF-001 ATsens Co., Ltd. 85/123...
  • Page 86 You can delete the symptom stored in the AT-note List by using the Delete function. If you select the Select Check Box button of the list you want to delete and click the Delete button, the symptom item in the AT-note List is deleted. QF-001 ATsens Co., Ltd. 86/123...
  • Page 87 As in [Figure 10.126 Seconds Strip Plot operation when selecting AT-Note item], when the user selects the desired AT-note List data using the left mouse button, the selected data turns red and the selected symptom note data is displayed. The Indicator Line of the Seconds Strip Plot is located in the center. QF-001 ATsens Co., Ltd. 87/123...
  • Page 88 Error occurred The note cannot be added When you cannot add a note for an unknown reason Please try again 10.6.7 HR MIN/MAX Tab 10.6.6.1 HR MIN/MAX Tab screen Figure 10.127 HR MIN/MAX Tab screen QF-001 ATsens Co., Ltd. 88/123...
  • Page 89 3) Maximum/Min: This is a function that finds the highest heart rate per minute shown in Average HR Plot. The point with the highest heart rate in the signal analyzed by AT-report becomes Index 1, and the heart rate decreases sequentially, and the index increases. QF-001 ATsens Co., Ltd. 89/123...
  • Page 90 When changing an item that has already been fixed, click the left and right arrows and cancel the decision by selecting the “OK” button in the Question message of [Fig. 10.133 Cancellation confirmation warning message]. Figure 10.133 Cancellation confirmation warning message QF-001 ATsens Co., Ltd. 90/123...
  • Page 91 You can select graphs and data for each event and chart in ① item. After selecting the item, click the Analysis icon in ③, and the graph will appear on the screen as shown in ②. 10.6.7.3 Graph area – [Figure 10.134 Statistics Tab screen - ②] Figure 10.136 Overlapped Bar/Bar Chart/Pie Chart Graph QF-001 ATsens Co., Ltd. 91/123...
  • Page 92 In the Full Disclosure Tab, the 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. QF-001 ATsens Co., Ltd. 92/123...
  • Page 93 Figure 10.142 Signal Plot when Time Range is x 180sec 3) Time Control Box Time Control Box is a function to designate the area the user wants to move in the Full Disclosure Tab and make it move as it is. QF-001 ATsens Co., Ltd. 93/123...
  • Page 94 ■ Motion: Only motion signals are expressed in Signal Plot. Figure 10.144 In case of signal selection box is ‘all’ Figure 10.145 In case of signal selection box is ‘ECG’ Figure 10.146 In case of signal selection box is ‘Motion’ QF-001 ATsens Co., Ltd. 94/123...
  • Page 95 Signal Display area, and a number indicating HR (heart rate) is displayed between graphs of each signal. You can use the scroll bar to move up and down the Signal Display. Figure 10.149 Description of Signal Display QF-001 ATsens Co., Ltd. 95/123...
  • Page 96 To cancel the set noise area, right-click on the set noise area (the area where the red line exists) and select “Deselect a noise Regions”. 10.6.9 Report Tab 10.6.9.1 Report Tab screen QF-001 ATsens Co., Ltd. 96/123...
  • Page 97 7) Report Description: Report Description is a button to select the option to insert “Preliminary Finding” and “Physician Interpretation” into the final report of the report. QF-001 ATsens Co., Ltd. 97/123...
  • Page 98 ■ Strip Plot Length: This is a drop box that selects the time range of the strip plot added to the report final report. 9) Report History: Report History is a function that saves the history of the final report operation in the Report Tab. QF-001 ATsens Co., Ltd. 98/123...
  • Page 99 Cannot load saved report 10.7 Explanation of various operations of AT-Report 10.7.1 AT-report area selection function To select an area in AT-report, click the left mouse button as shown below. Figure 10.155 AT-Report area selection function QF-001 ATsens Co., Ltd. 99/123...
  • Page 100 To add a QRS Label in the Seconds Strip Plot, press the Shift ( ) key on the keyboard and click the left mouse button ( ) to select an arbitrary area first. When the indicator line is created after selecting an arbitrary area, click QF-001 ATsens Co., Ltd. 100/123...
  • Page 101 Strip Plot, the user can use Click & Drag of the left mouse button. After designating the time range of a certain area by using the left mouse button, and clicking the right mouse button, a box for selecting an event symptom appears. Event symptom is added by selecting the desired Event from the box. QF-001 ATsens Co., Ltd. 101/123...
  • Page 102 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. 102/123...
  • Page 103 ‘ctrl’ + When Click the mouse wheel to become Zoom Fit. 10.7.6 Modification function in Sub-class QRS Label Card 10.7.6.1 Sub-class QRS Label Card Change method Figure 10.167 Sub-class QRS Label Card change method QF-001 ATsens Co., Ltd. 103/123...
  • Page 104 In Average HR Plot of [Figure 10.170 Time Sync Function of Indicator Line], if you click the left mouse button as in ① to create an Indicator Line, the Indicator Lin is located in the center of the entire Time Range of the Strips Plot and Seconds Strip Plot. QF-001 ATsens Co., Ltd. 104/123...
  • Page 105 Delete key ( class card is deleted) Plot Arrange the graph so that the selected timeline is centered Space key ( Move to previous QRS label [ key ( Move to next QRS label ] key ( QF-001 ATsens Co., Ltd. 105/123...
  • Page 106 Modify the QRS label of the selected subclass card Subclass Tab ↑ / ↓ / ← / → key Move in Sub-class card Home / End key Move to the first and last class card QF-001 ATsens Co., Ltd. 106/123...
  • Page 107 The operation of Mouse and Keyboard in AT-report Program is described in detail in the table below. Mouse Interaction Symbol Description Use cases Action Short press and release - Button execution Left button/screen - Menu and list selection Click (Execute immediately when - Keypad input pressing) QF-001 ATsens Co., Ltd. 107/123...
  • Page 108 Hashcode does not match. Exits the program. Please contact us. When program integrity check fails - Phone: +82-70-5220-0220 - E-mail: sales@atsens.com 10.10.2 When log-in Error message Detail You cannot run the program unless you change the When you close the password reset window when password to a valid password.
  • Page 109 Authorization to save Report Report tab Please log in as authority and try again You can only print report with authority. Authorization to output Report Report tab Please log in as authority and try again QF-001 ATsens Co., Ltd. 109/123...
  • Page 110 Document No. UM-C-002-EN User Manual Date of Revision 2020.08.30 Revision No. 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. 110/123...

  • Page 111: How To Use And Attach The Device (Atp-C130)

    The skin care area of the patient should be larger than the area where the Device (ATP-C130) is attached. If there is a lot of hair in the attachment area, shaving is necessary. However, if there is a wound or bleeding during hair removal, it should be attached after the bleeding has stopped. QF-001 ATsens Co., Ltd. 111/123...
  • Page 112 (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., Ltd. 112/123...
  • Page 113 [Figure11.2] ③ Start ECG measurement as shown in the figure. When the device is attached to the human body, press the entire patch so that there is no gap. QF-001 ATsens Co., Ltd. 113/123...

  • Page 114: How To Install The App (Atn-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”. 2) If [AT-Note] is searched as shown in ② in [Figure 12.1], click [Install] to download and install the app.
  • Page 115 (https://www.apple.com/ios/app-store/), as shown in ① 1) In the search term window of IOS Store App Store 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.

  • Page 116: Specifications

    3) Range of atmospheric pressure: 700 ~ 1060hPa 4) Rating for water and dust resistance: IP57 14.2 Storage conditions 1) Temperature range: -20 ~ 55℃ 2) Range of relative humidity: 0 ~ 95%, non-condensing 3) Range of atmospheric pressure: 700 ~ 1060hPa QF-001 ATsens Co., Ltd. 116/123...

  • Page 117: Disposal

    If data is not transmitted from the equipment to PC S/W using the dedicated cable, contact our company or the agency to replace the cable. 17. Lifetime of the product 12 months from the manufacturing date QF-001 ATsens Co., Ltd. 117/123...

  • Page 118: Label

    Document No. UM-C-002-EN User Manual Date of Revision 2020.08.30 Revision No. 18. Label QF-001 ATsens Co., Ltd. 118/123...

  • Page 119: Annex1 - Emc (Electromagnetic Compatibility) Information

    5.2.2.1 a) ~ c) Basic EMC Test Operating Test Phenomenon standard or test Port tested level/require mode Voltage method ment Mains terminal CISPR 11:2015 disturbance voltage Radiated disturbance CISPR 11:2015 Continuous Enclosure Battery Group 1, QF-001 ATsens Co., Ltd. 119/123...
  • Page 120 Power Frequency 30 A/m EN 61000-4-8:2010 Continuous Magnetic Field Enclosure Battery 50 Hz & 60 IEC 61000-4-8:2009 operation mode Immunity EN 61000-4-11:2004 Voltage dips IEC 61000-4-11:2004 EN 61000-4-11:2004 Voltage interruptions IEC 61000-4-11:2004 5.2.2.2 a) ~ d) QF-001 ATsens Co., Ltd. 120/123...
  • Page 121 Document No. UM-C-002-EN User Manual Date of Revision 2020.08.30 Revision No. 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. 121/123...

  • Page 122: Faqs

    The ECG and motion data graphs are First, Turn off the App. displayed abnormally in the App. Second, Turn off BLE communication with other devices. After then, run the App again. A normal signal will appear. QF-001 ATsens Co., Ltd. 122/123...

  • Page 123: Contact Us

    Office: No. 806, Point Town, 11 Gumi-ro, Bundang-gu, Seongnam-si, Gyeonggi-do, Korea Email: sales@atsens.com Tel: +82-70-5220-0220 Fax: +82-70-8270-0738 www.atsens.com Authorized Representative: Dave Kim Name: Mtech Group Address: 7707 Fannin St. Ste 200 Houston, TX 77054 Email: davekim@mtech-inc.net QF-001 ATsens Co., Ltd. 123/123...
  • Page 124 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.

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