ATsens AT-Patch User Manual
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ATsens AT-Patch User Manual

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AT-Patch
User Manual
MODEL: ATP-C130
UM-C-001 Ver 5.2_08/2021
Medical device for single use only (Reuse is prohibited) "This product is a medical device."
The warranty period is 12 months from the date of manufacture.

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Summary of Contents for ATsens AT-Patch

  • Page 1 AT-Patch User Manual MODEL: ATP-C130 UM-C-001 Ver 5.2_08/2021 Medical device for single use only (Reuse is prohibited) “This product is a medical device.” The warranty period is 12 months from the date of manufacture.

  • Page 3: Table Of Contents

    Connect to Device Window ........................23 Main Screen..............................24 LIVE Display Screen ........................... 25 RECORD Screen ............................27 Symptom Note Entry Screen ........................28 Symptom Note Details Screen ........................30 Symptom Note Revision Screen......................... 32 Viewing Recorded Data ..........................34 AT-Patch User Manual︱3...

  • Page 4: Product Descriptions

    By attaching electrodes on certain sites, it displays, stores, and records the measured ECG data. Classification: Electrocardiographic Holter Analysis Product Name (Model Number): AT-Patch (ATP-C130) Manufacturer: ATsens Co., Ltd. Head Office: (13558) KINS TOWER 301, 8, Seongnam-daero...

  • Page 5: Components

    Product Descriptions︱Components Components ■ Device Components ► Basic Components AT-Patch Pad Paper Sealing Bag Quick Guide Symptom Note Gift Box Figure 1.1 AT-Patch Basic Components AT-Patch User Manual︱5...
  • Page 6 For Android™ users: Google play™ (https://play.google.com/store) ® For iPhone users: App Store (https://www.apple.com/ios/app-store/) ► Please search "AT-Note", "ATsens" in Google Play™ Store or App Store ► Download the App. ► Perform the registration step, then start using the App. ...

  • Page 7: Instructions For Use

    (Bluetooth) to be displayed on the App and the PC S/W. ► Data to be recorded  ECG Signal  3-axis Data  Temperature data of Device  Heart rate AT-Patch User Manual︱7...

  • Page 8: Cautions

    Product disposal Disposal of ATP-C130 and battery must comply with local waste disposal regulations. Non-compliance with waste disposal regulations may result in environmental pollution. NOTE: The data stored within the device must be taken care of before disposal. 8︱AT-Patch User Manual...

  • Page 9: Measuring Device (Atp-C130) And The App (At-Note)

    Once the product is detached from the body, do not reattach it. ► The smartphone on which the App is run must be one with a test report or a certificate issued by national or accredited offices. AT-Patch User Manual︱9...

  • Page 10: S/W

    PC on which the S/W is installed. (No external transmission)  Measures to be taken when a cybersecurity issue occurs. The manufacturer should be consulted if a cybersecurity issue occurs. ATsens Co., Ltd.: Tel. 070 5220 0738, Fax. 070 8270 0738, E-mail. sales@atsens.com 10︱AT-Patch User Manual...

  • Page 11: Conditions For Use And Storage

    Relative humidity range: 10% ~ 95%, non-condensing ► Atmospheric range: 700hPa ~ 1060hPa ► Dustproof and waterproof grade: IP57 ■ Conditions for Storage ► Temperature range: -20℃ ~ 55℃ ► Relative humidity range: 0% ~ 95%, non-condensing ► Atmospheric range: 700hPa ~ 1060hPa AT-Patch User Manual︱11...

  • Page 12: How To Use The Device (Atp-C130)

    Figure 1.2 External appearance of the device Name Description The Case Top is made of polycarbonate material, with the ATSens Case Top logo and S/N of the device printed on the surface. Case Bottom is made of polycarbonate material and contains ECG Case BTM electrodes.
  • Page 13 Physically turning the power off is not possible. Automatic Power-Off will occur after the duration of use (14 days) has elapsed. In case the buzzer or the Red LED blink was missed after AT-Patch's duration of use has passed, the App or AT-Report (PC S/W) Hookup can be used for confirmation.
  • Page 14 Then, fully dry for at least one minute to make sure no alcohol is left on the surface. Figure 1.4 Attachment preparation step – Removing possible obstructions from the attachment site 14︱AT-Patch User Manual...
  • Page 15 1.5] ❸, remove the bottom protective tape from the ECG Patch, then apply 3. As shown in [Figure even pressure on the attached the ECG Patch. AT-Patch User Manual︱15...

  • Page 16: Instructions For Installing The App (At-Note)

    Android™ users can download App (AT-Note) from Google play™ (https://play.google.com/store) on Android™ Market. [Figure 1.6] demonstrates the installation steps. Figure 1.6 Installing the App – Android 1.6] ❶, search for either AT-Note, ATsens, AT-Patch in the Android™ market 1. As shown in [Figure Google Play™...
  • Page 17 ), App (AT-Note) can be downloaded from App Store (https://www.apple.com/ios/app-store/) in the iOS Store. [Figure 1.7] demonstrates the installation steps. Figure 1.7 Installing the App – iOS 1.7] ❶, search either AT-Note or ATsens in the iOS App Store 1. As shown in [Figure (https://www.apple.com/ios/app-store/) search field.

  • Page 18: Specifications

    39 x 31 x 7.8 Characteristics Below 13g Weight (g) App (AT-Note) / PC S/W (AT-Report): The smartphone and PC used must be one with a test report or a certificate issued by national or accredited offices. 18︱AT-Patch User Manual...

  • Page 19: Product Disposal

    This product is a medical device for single use only. Reuse is prohibited. ► Disposal of ATP-C130 and battery must comply with local waste disposal regulations. Non- compliance with waste disposal regulations may result in environmental pollution. AT-Patch User Manual︱19...

  • Page 20: Labeling And Packaging

    Protected against solid objects bigger than 1mm / Water splashing from all directions. Caution The equipment may be damaged if the instruction is not observed Instruction for User manual Do Not Reuse (Disposable medical devices) Type of applied part Manufacturer CE Marking of Conformity 20︱AT-Patch User Manual...

  • Page 21: Packaging

    Vellum paper Handling ■ PC S/W & Accessories Internal Packaging Classification Components Quantity Tools Used packaging Material Accessories Dedicated USB Cable BAG PE Handling USB Memory PC S/W(AT-Report) BAG PE Handling BLE Dongle BLE Dongle BAG PE Handling AT-Patch User Manual︱21...

  • Page 22: How To Use The At-Note App

    AT-Note is a smartphone APP (Android / iOS) that controls AT-Patch wirelessly (Bluetooth) and provides ECG data output transmitted from AT-Patch in real time. The 3-axis sensor measures and records rapid movements of the patient or user. The 3-axis sensor checks the magnitude of the movements by detecting speed changes in the X, Y, and Z axes measured through a single acceleration sensor, and displays the measured data in a two-dimensional form.

  • Page 23: Connect To Device Window

    A bar displaying the connection progress to the device Once the icon is clicked, the Data Matrix scan screen shows Scan Data Matrix icon Button for transmission of the Symptom Note to PC Symptom Note transmission button (AT-Report) Table 1.3 AT-Patch User Manual︱23...

  • Page 24: Main Screen

    ECG and 3-axis data real-time Icon to generate real-time ECG and 3-axis data output as output icon graphs A section displaying the ECG and 3-axis data output through ECG and 3-axis data output section graphs in real time Table 1.4 24︱AT-Patch User Manual...

  • Page 25: Live Display Screen

    How to Use the AT-Note App︱LIVE Display Screen LIVE Display Screen Figure 1.11 Live display screen (left) & zoomed in ECG graph section (top right) & zoomed in 3-axis data graph section (bottom right) AT-Patch User Manual︱25...
  • Page 26 3-axis sensor A section displaying the graph within the zoomed-in 3-axis 3-axis data graph output section data screen Pause 3-axis data graph icon Icon to temporarily stop the 3-axis data graph being played Table 1.5 26︱AT-Patch User Manual...

  • Page 27: Record Screen

    Upon tapping the Record icon in the left screen of the [Figure 1.12] above, the Record icon is replaced with the Stop icon and recording begins, with the recording time displayed to the right of the Stop icon. AT-Patch User Manual︱27...

  • Page 28: Symptom Note Entry Screen

    The Day number of using the App (AT-Note) The Day number of using the App (AT-Note) and and current date current date displayed Symptom Note entry count for the Day number of Symptom Note entry count using the App (AT-Note) Table 1.6 28︱AT-Patch User Manual...
  • Page 29 If the Later icon is tapped, the Symptom Note entry count on the main page increases, but no new screen shows up. Once "Write symptoms" is tapped, the first screen for making Symptom Note entry is displayed. Press for about 0.2 seconds Figure 1.14 Making Symptom Note entries using the device (AT-Patch) AT-Patch User Manual︱29...

  • Page 30: Symptom Note Details Screen

    Icon for the close Symptom Note details command Start time Symptom occurrence start time End time Symptom occurrence end time Symptom type Displays symptom type Activity type Displays activity type Other explanation Icon for adding other explanation Table 1-7 30︱AT-Patch User Manual...
  • Page 31 Symptom Note entries made using the device. Figure 1.16 Details screen for Symptom Note entries made using the device (AT-Patch) AT-Patch User Manual︱31...

  • Page 32: Symptom Note Revision Screen

    Symptom Note through the device, they have to be entered by tapping the revision icon or revision icon area. Figure 1.17 Symptom Note revision screen 32︱AT-Patch User Manual...
  • Page 33 Area serving as the command icon for symptom type Symptom type revision icon revision Activity type revision icon Icon for activity type revision command Add other explanation icon Icon for adding other explanation Table 1.8 AT-Patch User Manual︱33...

  • Page 34: Viewing Recorded Data

    Symptom Note entries for a Day number of using the App. The ECG recording data does not include Symptom Note contents, only ECG data. The ECG recording data viewing screen is displayed upon tapping the red rectangular section. Figure 1.18 ECG and 3-axis recording data viewing screen 34︱AT-Patch User Manual...
  • Page 35 Displays the progress in time of the file currently being played Playback progress back Displays the data storing end time of the file currently being Data storing end time played back PLAY / PAUSE Start and pause command icon for the file being played back Table 1.9 AT-Patch User Manual︱35...
  • Page 36 Contact Us Head Office: (13558) KINS TOWER 301, 8, Seongnam-daero 331beon-gil, Bundang-gu, Seongnam-si, Gyeonggi-do, Republic of Korea Factory: (13637) Point Town 803, 11, Gumi-ro, Bundang-gu, Seongnam-si, Gyeonggi-do, Republic of Korea Email: sales@atsens.com Tel: 070-5220-0220 Fax: 070-8270-0738 www.atsens.com 36︱AT-Patch User Manual...

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Atp-c130At-patch atp-c130

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