User Manual
Document No.
UM-C-002-EN
Date of Revision
2020.10.30
Revision No.
0
Page
1
/
123
AT-PATCH ECG Analysis System
MODEL ATP-C130
ATsens Co.,Ltd.
Страница 1: ...User Manual Document No UM C 002 EN Date of Revision 2020 10 30 Revision No 0 Page 1 123 User Manual AT PATCH ECG Analysis System MODELATP C130 ATsens Co Ltd...
Страница 2: ...vision History No Version Revision Date Revision Details 1 0 0 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 me...
Страница 3: ...Main Screen 9 4 LIVE Display Screen 9 5 Record Screen 9 6 Screens for Registering Symptom Note 9 7 Screens for Detailed View of Symptom Notes 9 8 View Details of Symptom Notes registered with the Dev...
Страница 4: ...114 13 Specifications 116 14 Usage and Storage Condition 116 14 1 Conditions of Use 14 2 Storage conditions 15 Disposal 117 16 Maintenance 117 16 1 Replacement of dedicated cable 17 Lifetime of the pr...
Страница 5: ...i Gyeonggi do Korea 5 Contact Tel 82 70 5220 0738 Fax 82 70 8270 0738 6 U S Representative A Name Mtech Group B Address 7707 Fannin St Ste 200 Houston TX 77054 C The person in charge Dave Kim D E mail...
Страница 6: ...sens ATreport in the Google Play Store or App StoreSM 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 det...
Страница 7: ...rillator 7 No exposure to strong electromagnetic fields 8 Disposal When disposing of this product and battery the waste disposal regulations in each region should be followed If the waste disposal reg...
Страница 8: ...es unnecessary due to the lapse of retention period or achievement of processing purposes the personal information shall be destroyed without delay 3 The following measures are taken to ensure informa...
Страница 9: ...affected by immersion in water under the specified pressure and time 6 Caution The equipment may be damaged if the instruction is not observed 7 Instruction for User manual 8 Do Not Reuse Disposable...
Страница 10: ...is ECG Like the figure 3 1 when cells or muscles move micro currents are generated due to micro resistance At this time each cell or muscle have action potential due to the micro current generated by...
Страница 11: ...cuit against signals input by ESD or external static electricity when attached to the human body 3 IN AMP RLD It detects a signal using a precision instrument amplifier for electric signals heart EMG...
Страница 12: ...8 Serial NAND Flash Memory It serves to store the digitally converted ECG signal in the internal memory 9 BLE Wireless Communication It plays the role of communication for wireless transmission 10 Af...
Страница 13: ...gnal 6 MCU The part that signal processing and various control 7 Communication Part BLE The part for BLE communication 8 Record part The part that records the ECG signal 9 Antenna part External input...
Страница 14: ...ays 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 BLE Dongle It is a BLE dongle to communicate with the devic...
Страница 15: ...nology MD1 PCB 002 FPCB Type Antenna CCL SV SS1120SFQ1 Coverlay SV SC015WFY1 Tape 3M 83710 Tested in equipment under condition of use in the ME EQUIPMENT Case SON TECHNOLOG Y LTD MD1 A1 001 MD1 A2 001...
Страница 16: ...rk which assures the agreed level of surveillance See Licenses and Certificates of Conformity for verification 6 Patient Contact Part Sterilization and Reusable Part name Patient Contact Part Patient...
Страница 17: ...o Ltd 17 123 7 Photograph and or Drawing of the Device 7 1 External Shape 1 Device Model ATP C130 Body width W Body length L1 Patch length L2 Patch Width W2 Patch thickness T Total height H Weight 39...
Страница 18: ...Case BTM It is made of PC and TPU double injection material and has an electrocardiogram electrode Power Button LED The power button turns on the power and you can check the power status through the...
Страница 19: ...evision No 0 QF 001 ATsens Co Ltd 19 123 8 Insulation Insulation is designed according to IEC 60601 1 Main Control Unit CR2032 Primary Lithium Battery Electrode Secondary Circuits Plastic Enclosure A...
Страница 20: ...Run App ATN C130 Icon Click the icon to run the App ATN C130 2 Intro Screen 1 When running App ATN C130 the relevant intro screen is displayed for about 2 seconds and then the screen is switched to th...
Страница 21: ...n 1 Button to cancel the device connection Pressing the button cancels the device connection and switches to the Figure 9 5 screen 2 Input Device SN Information Window to input Device SN information t...
Страница 22: ...0 minutes Figure 9 11 Recorded ECG 3axis Data Viewer 9 4 Screen when running the app after a long period of inactivity or 5 consecutive login failure If you run the app after 30 minutes after 5 consec...
Страница 23: ...m Description 1 Output area of heart rate data Area where heart rate data is output BPM 2 Button to register symptom notes Button to call up registration screen of symptom notes 3 Output area of days...
Страница 24: ...ured in real time 5 X axis graph Graph of X axis measured value of 3 axis sensor currently being measured 6 Y axis graph Graph of Y axis measured value of 3 axis sensor currently being measured 7 Z ax...
Страница 25: ...Pause button of 3 axis graph being measured in real time 9 7 RECORD Screen Figure 9 17 Recording Button Screen If you touch the record button on the left screen of Figure 9 17 above it is converted to...
Страница 26: ...the current date and days of use of the App ATN C130 4 Number of symptom notes registered for days of use of the App ATN C130 Number of symptom notes registered for days of use of the App ATN C130 9 8...
Страница 27: ...igure 9 19 Symptom Note by AT patch trigger buttion 9 9 Screens for Detailed View of Symptom Notes 9 9 1 View Details of Symptom Notes registered with the App ATN C130 Touching the detail view button...
Страница 28: ...registration of symptom notes has been completed Red when done Black when not done and Red when there is ECG recording data 5 Save button for modifications in symptom notes Command button to save mod...
Страница 29: ...tart 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 regi...
Страница 30: ...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 Since the items whose sym...
Страница 31: ...Screen to Search Recorded Data Recorded data can be checked on the list screen of symptom note registration for the number of days used as in the red square area ECG Record Data contains only ECG dat...
Страница 32: ...me 11 Zoom in button of 3 axis data Zoom in button for 3 axis data being measured in real time 12 Z axis graph Graph of Z axis measurement of recorded 3 axis sensor 13 Play position bar Bar that shows...
Страница 33: ...data through its own analysis algorithm Searching the specific time and seeing the ECG data in the graph Figure 10 1 ECG Data Flowchart 3 AT Report S W does not change or remove the state of ECG Data...
Страница 34: ...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 a...
Страница 35: ...No UM C 002 EN Date of Revision 2020 08 30 Revision No 0 QF 001 ATsens Co Ltd 35 123 Figure 10 5 ATR C130 AT Report S W installation password input screen Figure 10 6 License Agreement Screen for ATR...
Страница 36: ...e 10 8 Installation Screen when installing ATR C130 AT Report S W Copying files Figure 10 9 ATR C130 AT Report S W Installation Completed 4 When the program installation is complete ATsens folder is c...
Страница 37: ...installation files when uninstalling Caution when uninstalling S W 1 Even if the S W is deleted the DB File Setting Value and ECG Data Files registered in AT Report are not deleted However if you sele...
Страница 38: ...F 001 ATsens Co Ltd 38 123 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 Upon initial login a warn...
Страница 39: ...T Report S W initial password reset screen 2 Log in by entering ID PW When AT Report ATR C130 is executed ID Password input window and Authentication warning information window appear at the same time...
Страница 40: ...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...
Страница 41: ...Clipboard 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...
Страница 42: ...use is possible Evaluation Can only be used for a fixed period of time The remaining usage period can be found by looking at the Registration section of the Information window When the period expires...
Страница 43: ...tients can be imported at the same time 3 Among the input items Product SN is an AT patch s unique device number and is a mandatory input item If the SN is unknown or an error is entered the patient s...
Страница 44: ...cannot be processed When importing by dragging a file that does not match the extension Figure 10 24 New patient data screen and input items 10 5 2 2 Patient List 1 In the Patient List you can check...
Страница 45: ...to load the data stored in the AT patch 4 AT Note Import is a function to import ECG data stored in Smartphone using USB Cable or Bluetooth in App 5 If the import takes a long time depending on the am...
Страница 46: ...reconnect AT Patch turn on the power and try again USB download error PSN is empty or invalid format please enter PSN again When clicking USB download when the SN Serial Number is empty or an invalid...
Страница 47: ...0 5 2 4 Hookup function 1 The Hook up function of the Patient data screen is a screen to check whether the ECG signal is normally recorded from the device attached to the patient s body and the PSN of...
Страница 48: ...etry after a few seconds When an unknown problem occurs in the BLE connection during hookup you must try again after a certain period of time Hookup connection error not found AT Patch to PSN please c...
Страница 49: ...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 On the About screen you can check the S W Version company informa...
Страница 50: ...ention period of the logs stored in the DB and you can delete the logs before the retention period 4 Log retention period item allows you to set the retention period of log files deletes log files bef...
Страница 51: ...ser 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 Only the Admi...
Страница 52: ...Admin Figure 10 37 Change password screen 4 User Authority Option Management patient record If you select the Manage patient record option privilege when creating a user account the created account ca...
Страница 53: ...f the Events Tab 4 Bradycadia threshold Bradycardia duration This is a number that allows you to set Bradycardia in the Event Tab 5 Tachycardia threshold Tachycardia duration This is a value that allo...
Страница 54: ...e The Auto Logout time option is an option to adjust the user logout time when the user does not use AT Report SW and there is no mouse keyboard input For example when a value of 30 is set if the user...
Страница 55: ...contain at least one symbol Length When selected the password must be at least 8 characters long 10 5 4 History Fig 10 21 Title Bar Menu 10 5 4 1 History screen Figure 10 44 History screen 1 Data Tab...
Страница 56: ...ation When the user moves the QRS Label this part displays the movement time details 3 Seconds strip Plot Figure 10 44 History screen Refer to 10 6 Second Strip Plot 4 History List Table Figure 10 44...
Страница 57: ...h is not visible Also Toggle On Off for selection can be done with the left mouse button Figure 10 48 Select History 10 5 4 Title Bar display status text As shown in Figure 10 22 Display status of Tit...
Страница 58: ...ing Manager is a function used to back up or delete the contents of the Recording List Figure 10 52 Recording Manage Function 1 Back up Record This is a function to back up patient data in the Recordi...
Страница 59: ...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...
Страница 60: ...Back up This function deletes the patient data in the back up list When the user selects the patient data check box in the Back up List it is changed to and when the user presses the Delete back up bu...
Страница 61: ...nt Data In the Recoding List information of Last Name First Name Date of birth Patient ID is displayed 2 Recording Date It is the date when patient data was imported and recorded 3 Status Displays the...
Страница 62: ...for modifying patient information and patient data If you move the mouse arrow over the Recording List and click the right button a pop up box with two functions appears as shown in Figure 10 65 Edit...
Страница 63: ...Reanalyze starts when you click the OK button in the pop up box Figure 10 67 Reanalyze function List Number Information Figure 10 50 Recording Tab At the bottom of the total number of patient data di...
Страница 64: ...n Saving error Cannot save ECG data When the changed QRS label class event information etc cannot be saved for an unknown reason or the imported patient s ECG data cannot be retrieved for an unknown r...
Страница 65: ...in the Recording list Check recording first Check recording to delete When clicking the delete icon nothing is checked in the Recording list Cannot export back up When the backed up item cannot be exp...
Страница 66: ...here the Indicator Line is located in the Average HR Plot QRS Label Rate Shows the distribution ratio of QRS Label on the date selected in the Date Tab of the Regions Tab This includes the ratio of S...
Страница 67: ...69 Regions tab screen Figure 10 75 Strips Plot 1 Time Range It shows the initial start time of ECG displayed in Strips Plot 2 Time Selection button This is a button to select the time range of the ECG...
Страница 68: ...nds Strip Plot 10 6 3 Class Tab 10 6 3 1 Class Tab screen Figure 10 77 Class Tab screen 10 6 3 2 Group Class Label Tab Figure 10 77 Class Tab The Group Class Label Tab is a tab that categorizes and di...
Страница 69: ...reatest number At the top of each Group Class Card the type of QRS label and the percentage of that type the ratio of the number of each group class to the total number of heartbeats per day are displ...
Страница 70: ...bels belonging to the class Figure 10 80 Group Class Label Card 8 Operation in case select Group Class Label Card When selecting the Group Class Label Card item the first label among the QRS labels co...
Страница 71: ...ave 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 s...
Страница 72: ...presents time information of a point where the indicator line is located in the Seconds Strip Plot If the Indicator Line is not visible on the Seconds Strip Plot you can make the Indicator Line appear...
Страница 73: ...nized as a pause 4 Amplitude selection drop box This is a function to select the voltage of the ECG displayed on the Seconds Strip Plot The initial Amplitude setting value is x1 0 and the user can sel...
Страница 74: ...clicking the Add Caliper button the Caliper appears centering on the Indicator Line of the current Seconds Strip Plot Caliper is created as many times as the Add Caliper button is pressed and if the A...
Страница 75: ...the Seconds Strip Plot After selecting the Caliper to be deleted with the left mouse button if the Caliper is changed to dark color you can delete the Caliper by pressing the Delete Caliper button Fi...
Страница 76: ...s around you are stationary It is a collective term for all symptoms that feel like this Syncope It refers to a symptom of instantaneous loss of consciousness due to a decrease in blood flow to the br...
Страница 77: ...r right of the label corresponding to N S Only the QRS label classified as S appears in the Seconds Strip Plot and if you click the QRS Label Move button you can only move to the left or right of the...
Страница 78: ...n 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 rep...
Страница 79: ...4 2 Multi Selection Sub class QRS Label Card 1 1st selection guide As you can see in Figure 10 107 Multi Selection Sub class QRS Label Card 1st you can select multiple sub class QRS Label Cards by cli...
Страница 80: ...109 Multi Selection Sub class QRS Label Card 3rd 10 6 4 3 Generation of Sub Class QRS Label Tab Figure 10 110 Creation of Sub class QRS Label Tab shows the screen where Sub class QRS Label Tab is crea...
Страница 81: ...ding to Sub class Number list to be changed are displayed as 0 and then the user When changing class QRS Label Card the number of changes is continuously accumulated and recorded Figure 10 112 Change...
Страница 82: ...re displayed and you can edit and save the Sub class QRS Label For how to modify the sub class QRS Label refer to 10 7 6 1 Sub class QRS Label Card change method 10 6 4 8 Seconds Strip Plot Figure 10...
Страница 83: ...isplayed for two consecutive VE beats 3 VE Triplet Determines whether an event label will be displayed for three consecutive VE beats 4 VE Run Determines whether an event label will be displayed for t...
Страница 84: ...maximum duration in milliseconds msec between two normal beats that will be considered normal Any duration above that limit will be labeled a significant N N Pause 20 Atrial Fibrillation Commonly cal...
Страница 85: ...YYY is the current Event Graph Plot It means the total number of each Event in Add all to the report If you select this function all events included in the Event Graph plot are added to the report Re...
Страница 86: ...symptom notes can be added to the AT note List of the current AT note Tab by using the Create function When you click the Create button a window as shown in Fig 10 122 Create button appears and you ca...
Страница 87: ...shows the average HR during the written time Symptoms Symptoms that can be expressed using the Create function of a smartphone and AT report are the following 6 items Figure 10 125 Symptom list for wr...
Страница 88: ...e Tab Error message Detail Select notes first Select notes to delete When clicking the Delete Note button without selecting any data Time is not valid Please enter the start time When you enter an inv...
Страница 89: ...Figure 10 127 HR MIN MAX Tab screen 1 Average HR Average HR represents the heart rate per minute in the area where the indicator line is located Figure 10 128 Average HR Graph 2 Average HR Plot Displ...
Страница 90: ...ongest becomes Index 1 and the index increases as the interval between QRS peaks decreases sequentially Figure 10 131 Accept Fix function in HR MIN MAX 7 Accept Fix button In HR MIN MAX Tab this is a...
Страница 91: ...7 2 Plot Events Tab Figure 10 134 Statistics Tab screen Figure 10 135 Plot events area in Statistics Tab In the Plot Events area you can check the QRS label and statistical graph based on each event...
Страница 92: ...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 10 137 F...
Страница 93: ...Full Disclosure Amplitude can be adjusted by selecting a value between x0 5 x2 0 Figure 10 139 Signal Plot at Amplitude x 0 5 Figure 10 140 Signal Plot at Amplitude x 2 0 2 Time Range Selection Box T...
Страница 94: ...tion Display Option This is a button to select X axis data Y axis data and Z axis data of Motion Plot data displayed in Signal Plot When the user selects the axis he wants to see from the 3 axis data...
Страница 95: ...l Plot 1 Display item This area displays the type of signal and time information displayed in the Signal Display area and can be viewed including ECG Motion time information Figure 10 148 Description...
Страница 96: ...150 Noise area designation function select the desired area with Click Drag using the left button of the mouse in the Signal Display area and click the right mouse button A pop up box appears as shown...
Страница 97: ...0 and is displayed on the screen Fit Width is a function that adjusts the size of the report to fit the width of the page currently being viewed by the user and Fit Page is a function that adjusts the...
Страница 98: ...nts Tachycardia Bradycardia User Appended Note RR Pause Atrial Fibrillation are displayed including the time of occurrence do Detail Events Report Displays detailed ECG events included in the final re...
Страница 99: ...ser can use the right mouse button to delete the list of the list saved in Report History Select an item to be deleted from the list and click the right mouse button to display the Delete selected rep...
Страница 100: ...e selected time to the current time by pressing the space key the indicator changes to a solid line while moving to the center Figure 10 157 Indicator color according to whether the selected time matc...
Страница 101: ...ected time is in the event section the name of the event is displayed and you can enter a comment or decide whether to add it to the report To add an event to the report select the check box of Includ...
Страница 102: ...d 102 123 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 Plo...
Страница 103: ...10 7 5 Zoom In Out function of Average HR Plot Figure 10 166 Zoom In Out function of Average HR Plot When clicking dragging in the diagonal direction using ctrl the left mouse button an expanded squa...
Страница 104: ...el using the keyboard or the right mouse button press the Enter key on the keyboard to the next sub class tab You can move to Figure 10 168 Creation Index of Sub class Tab in Group Class QRS Label Car...
Страница 105: ...10 8 AT Report Hotkey Division Action Description AT Report 1 key Move to Regions Tab 2 key Move to Classes Tab 3 key Move to Events Tab 4 key Move to AT Note Tab 5 key Move to HR Min Max Tab 6 key Mo...
Страница 106: ...el or Indicator Line wheel motion CTRL Left drag Drop 1 step Zoom in CTRL Right Click 1 step Zoom out CTRL Wheel click Zoom Fit Regions Tab key Move to previous date key Move to next date Classes Tab...
Страница 107: ...ab key Move to previous date key Move to next date Full Disclosure Tab Page Up Key Move to up Page Down Key Move to down key Move to previous date key Move to next date Average HR Plot CTRL Left drag...
Страница 108: ...message may be displayed depending on the user s actions 10 10 1 When running the program Error message Detail Hashcode does not match Exits the program Please contact us Phone 82 70 5220 0220 E mail...
Страница 109: ...port authorization Importer You can only import note data with authority Please log in as authority and try again Note data import authorization Importer You can only delete patient data with authorit...
Страница 110: ...ent No UM C 002 EN Date of Revision 2020 08 30 Revision No 0 QF 001 ATsens Co Ltd 110 123 You can only export PDF with authority Please log in as authority and try again Authorization to save report a...
Страница 111: ...is terminated as shown in 2 The device does not work properly After the initial connection even if AT Report PC SW Hook up or App Bluetooth is terminated due to reasons ECG measurement is performed no...
Страница 112: ...rder 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 an...
Страница 113: ...After attaching the tape removed device to the human body Figure 11 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...
Страница 114: ...ay https play google com store as shown in the picture in Figure 12 1 ATnote ATsens ATpatch 2 If AT Note is searched as shown in in Figure 12 1 click Install to download and install the app 3 If the i...
Страница 115: ...ww apple com ios app store as shown in in Figure 12 2 ATnote ATsens ATpatch 2 As shown in in Figure 12 2 if AT Note is searched click Install to download and install the app 3 If the installation is c...
Страница 116: ...eceiver 2400 2480MHz SW CPU ARM Cortex M4 Supported App Android 5 x or iOS 12 x Supported PC S W Version Window 10 Power Requirement Power Supply DC 3V Coin Battery CR2032 Intended use period Up to 14...
Страница 117: ...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 1 Replacement of dedica...
Страница 118: ...User Manual Document No UM C 002 EN Date of Revision 2020 08 30 Revision No 0 QF 001 ATsens Co Ltd 118 123 18 Label...
Страница 119: ...cked with other equipment should be avoided because it could result in improper operation If such use is necessary this equipment and the other equipment should be observed to verify that they are ope...
Страница 120: ...ion mode Enclosure Battery 3 V m 80 MHz 2 7 GHz 80 AM at 1 kHz Immunity to Proximity Fields from RF wireless Communications Equipment EN 61000 4 3 2006 A2 2010 IEC 61000 4 3 2010 N A N A N A N A Elect...
Страница 121: ...User Manual Document No UM C 002 EN Date of Revision 2020 08 30 Revision No 0 QF 001 ATsens Co Ltd 121 123 Not applicable 5 2 2 3 5 2 2 4 Frequency range 2 42 MHz 2 480 MHz LE Number of channels 40 ch...
Страница 122: ...on You can download and use the App only on phones with the operating environment mentioned in the user manual 5 The ECG signal is not output from the App Please check AT patch adhesion status If the...
Страница 123: ...in condition the attachment period may be shorter than the intended period 12 Is it normal to experience skin irritation or itchiness in the area of the Patch Depending on the patient s skin condition...
Страница 124: ...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 responsi...
