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AT-Patch

User Manual

P94A000001A

DUG-02-EU Rev 0

02/2022

This product is a disposable medical device.
Reuse is prohibited.

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Summary of Contents for AT-Patch

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

Page 2: ...attach the device Additional Information 4 7 Caution Clinical information Specifications Electrical Safety and Compatibility Symbols 18 20 21 22 23 3 Introduction 01 Product Components Sub Patch 1EA M...

Page 3: ...least 2 minutes Cleaning the area where the device will be attached with alcohol How to attach the device How to use the device 02 How to use the device 02 5 2 3 4 Turning on the power Press the power...

Page 4: ...at once Reattachment can not be possible Attaching the Sub Patch 7 After attaching the Sub Patch detach the protective tape from the base film slowly Removing protective tape 8 Checking the attachment...

Page 5: ...ps then start using the App Supports Android 5 0 or later iOS 11 0 or later How to install the App 8 Screen with the App AT Note Icon Initial Run Screen How to use the App 03 How to use the App 03 No...

Page 6: ...e Symptom Note entry screen 6 A section displaying the ECG and 3 axis data output through graphs in real time LIVE Display Screen No Description No Description No Description 1 Stop generating real ti...

Page 7: ...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 If the Later is tapped the Symptom Note entry...

Page 8: ...gistered at the App AT Note 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 Empty value...

Page 9: ...data viewing screen is displayed upon tapping the red rectangular section No Description 1 ECG recording start time and end time 2 Move to ECG recording data viewing screen icon 3 Go Back icon 4 Move...

Page 10: ...could result 11 Cautions should be communicated to the patient 12 All serious accidents related to the medical devices should be reported to the health authorities of the Member State where the manufa...

Page 11: ...th waste disposal regulations may result in environmental pollution NOTE The data stored within the device must be taken care of before disposal Conditions for Use 1 Temperature range 10 45 2 Relative...

Page 12: ...Immunity Immunity Test IEC 60601 Test and Compliance Level Electromagnetic Environment Guidance Electrostatic Discharge ESD IEC 61000 4 2 8 kV Contact 2 4 8 15 kV Air Floors should be wood concrete or...

Page 13: ...s Co Ltd All Rights Reserved 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...

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