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

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AT-Patch
P94A000001A
User Manual
This product is a disposable medical device.
Reuse is prohibited.
DUG-02-EU Rev 0
02/2022

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Summary of Contents for ATsens AT-Patch

  • Page 1 AT-Patch P94A000001A User Manual This product is a disposable medical device. Reuse is prohibited. DUG-02-EU Rev 0 02/2022...

  • Page 2: Product Components

    Product Components Introduction Table of Introduction Transparent film Contents Product Components Power Button How to use the device / LED Main Body How to attach the device Additional Information ATP-C130 Sub Patch Manual Symptom Note How to use the App (1EA) (1EA) (1EA)

  • Page 3: Turning On The Power

    How to attach the device How to use the device How to use the device Checking the area to attach the device Detaching the Film & Attaching the device Draw an imaginary line between the middle of the two clavicles and Detach the device from the transparent protective film.

  • Page 4: Additional Information

    Additional Information How to use the device How to use the device Connect to App to record ECG signal 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 of the to connect the device.
  • Page 5 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 the App How to use the App 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 the App How to use the App 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 Viewing Details of Symptom Notes Registered at the App Symptom Note Revision Screen (AT-Note) How to use the App How to use the App 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 the App How to use the App 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 related to the 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 of Applied Part 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 Guidance and Manufacturer’s Declaration - Electromagnetic Emissions Symbol Description Symbol Description Symbol Description Symbol Description Emissions Test Compliance Electromagnetic Environment - Guidance Manufacturer MR unsafe Ingress Protection Caution RF Emissions The device uses RF energy only for its internal function. Therefore, its RF emissions are Group 1 CISPR 11 very low and are not likely to cause any interference in nearby electronic equipment.
  • 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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