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

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AT-Patch
P94B010002A
User Manual
This product is a disposable medical device.
Reuse of this product is prohibited.
DUG-02-EU Rev 0
02/2022

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Summary of Contents for ATsens AT-Patch

  • Page 1 AT-Patch P94B010002A User Manual This product is a disposable medical device. Reuse of this product is prohibited. DUG-02-EU Rev 0 02/2022...
  • Page 2 Device Component Introduction Table of Introduction Transparent film Contents Device Component Power Button Attach and Installation / LED Main Body How to attach the device Additional Information Application install ATP-C130 Sub Patch Manual Symptom Note How to use devices and apps (1EA) (1EA) (1EA)

  • Page 3: Turning On The Power

    How to attach the device Attach and Installation Attach and Installation Checking the area to attach the device Detaching the Film & Attaching the device Draw an imaginary line between the two clavicles and left nipple, and Detach the device from the transparent protective film. And attach check the position to ensure the device is attached to the center of the the device with the side marked with “Up”...

  • Page 4: Additional Information

    Additional Information Attach and Installation Attach and Installation Connect to app to save ECG Attaching the sub patch 1. Bluetooth & Location service Put the sub patch on top of the attached device in the correct direction. Check if the Bluetooth and location service functions are activated After attaching the sub patch, press firmly on the entire surface for at to connect the device.

  • Page 5: Application Install

    ATsens Co., Ltd. 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”, “AT note” in your usual Google Play Store or App Store , or scan the QR code Install the App. Description...

  • Page 6: Main Screen

    Main Screen LIVE Display Screen How to use devices and apps How to use devices and apps Description Description Description Description Description A section displaying heart rate (BPM) data output Stop generating real-time ECG A section displaying the Day number of using the App (AT-Note) and current date 3-axis data graph output section Pause ECG data graph icon and 3-axis data output icon...
  • Page 7 Making Symptom Note Entries Using the App Making Symptom Note Entries Using the Device (AT-Note) How to use devices and apps How to use devices and apps Once the Power icon on the device is pressed for about 0.2 seconds, the App receives the event information from the device and a dialog box is displayed to ask whether to record the symptoms immediately in a pop-up window.
  • Page 8 Symptom Note Revision Screen Viewing Details for Symptom Note Entries Made Using the App (AT-Note) How to use devices and apps How to use devices and apps Upon tapping each revision icon or revision icon area on a single entry of Symptom Note, the previously selected values for the items are displayed on the screen.

  • Page 9: Viewing Recorded Data

    Viewing Recorded Data How to use devices and apps How to use devices and apps As shown in the red rectangular section, the recording data can be accessed through the screen that lists the registered 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.
  • Page 10 - The manufacturer should be consulted if a cybersecurity issue occurs. 11) Cautions should be communicated to the patient. ATsens Co., Ltd. : Tel. +82 70 5220 0220 / Fax. +82 70 8270 0738 / E-mail. sales@atsens.com 12) All serious accidents involving medical devices should be reported to the health authorities of the Member State where the...

  • Page 11: Clinical Information

    Clinical information Specifications Appendix Appendix Intended Purpose Item Description Device is intended to measure, analyze, and report electrocardiogram (ECG) information for long-term monitoring (up to 14 days) by attaching to the skin surface. Type BF type It is used for patients with heart disease such as arrhythmia or patients with suspected heart disease. Reported ECG metrics include single lead analysis in beats, heart rate measurement and rhythm analysis.

  • Page 12: Electrical Safety And Compatibility

    Electrical Safety and Compatibility Symbols Appendix Appendix Basic EMC standard Phenomenon Operating mode Port tested Test Voltage Symbol Description Symbol Description Symbol Description Symbol Description Test level / Requirement or test method Mains terminal CISPR 11:2015 disturbance voltage Manufacturer MR unsafe Ingress Protection Caution Continuous...
  • Page 13 ATsens Co.,Ltd. Point Town 803, 11, Gumi-ro, Bundang-gu, Seongnam-si, Gyeonggi-do, 13637, Republic of Korea Tel) +82-70-5220-0220 CMC Medical Devices & Drug S.L. C/Horacio Lengo n18 C.P 29006 Malaga-Spain © ATsens Co.,Ltd. All Rights Reserved.

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