Related Manuals for ATsens AT-Patch ATP-C70
Summary of Contents for ATsens AT-Patch ATP-C70
- Page 1 AT-Patch User Manual MODEL: ATP-C70 UM-C-002 Ver 2.0_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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Page 3: Table Of Contents
Contents Product Descriptions ....................4 Components ..............................4 Instructions for Use ............................6 CAUTIONS ........................ 7 Contraindications ............................7 Warnings (Precautions) ..........................7 Measuring device (ATP-C70) and the App (AT-Note) ...................8 S/W ................................9 Conditions for Use and Storage ......................... 10 How to Use the Device (ATP-C70) ................ 11 Instructions for Operating and Attaching the Device (ATP-C70) .............. -
Page 4: Product Descriptions
ECG data. Classification: Electrocardiographic Holter Analysis Product Name (Model Number): AT-Patch (ATP-C70) Manufacturer: ATsens Co., Ltd. Head Office: (13558) KINS TOWER 301, 8, Seongnam-daero 331beon- gil, Bundang-gu, Seongnam-si, Gyeonggi-do, Republic of Korea... - Page 5 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. ...
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Page 6: Instructions For Use
Product Descriptions︱Instructions for Use ■ PC S/W ► USB provided: Storage size of 4 GB or greater & a CE-certified product ► Minimum requirements (PC) Feature Specification Processor Intel Core i7-9700K 16 gigabyte (GB) Hard disk space Main SSD: 512GB/Back-up HDD: 1TB Graphics card DirectX 9 or later with WDDM 1.0 driver Display... -
Page 7: Cautions
CAUTIONS This product is to be used by the patient themself; the intended operator is the patient. Contraindications ► DO NOT use if you have current symptoms or medical history of skin cancer, rash, dermatosis, keloids, wounds, etc. Warnings (Precautions) ►... -
Page 8: Measuring Device (Atp-C70) And The App (At-Note)
CAUTIONS︱Measuring device (ATP-C70) and the App (AT-Note) Measuring device (ATP-C70) and the App (AT-Note) ■ Caution ► Since improper application and use of the sensor may result in inaccurate measurements, please avoid: Excessive movement on the patient's part Application outside the recommended bodily locations ... -
Page 9: 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 AT-Patch User Manual︱9... -
Page 10: Conditions For Use And Storage
CAUTIONS︱Conditions for Use and Storage Conditions for Use and Storage ■ Conditions for Use ► Temperature range: 10℃ ~ 45℃ ► Relative humidity range: 10% ~ 95%, non-condensing ► Atmospheric range: 700hPa ~ 1060hPa ► Dustproof and waterproof grade: IP44 ■... -
Page 11: How To Use The Device (Atp-C70)
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 12 How to Use the Device (ATP-C70)︱Instructions for Operating and Attaching the Device (ATP-C70) ■ Instructions for Operating the Device (ATP-C70) ① The device (ATP-C70) is initially packaged in Sleep Mode and delivered to the customer. Patient who wishes to attach the device should press the Power Button, #❸ in [Figure 1.2], for 3 seconds, upon which the green LED blinks twice and a long “beep”...
- Page 13 How to Use the Device (ATP-C70)︱Instructions for Operating and Attaching the Device (ATP-C70) ■ Instructions for Attaching the Device on the Body (ATP-C70) ► State of the skin before attachment An area larger than the device (ATP-C70) attachment area needs to be cleaned on the patient's skin. If body hair is abundant in the attachment area, shaving will be required to remove the hair.
- Page 14 How to Use the Device (ATP-C70)︱Instructions for Operating and Attaching the Device (ATP-C70) ► Attaching the device to the body After pressing the device (ATP-C70) Power Button, attach as follows Figure 1.5 How to attach ATP-C70 1.5] ❶, remove the tape designed to protect the patch side. Once the 1.
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Page 15: 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 16 ), 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.
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Page 17: Specifications
How to Use the Device (ATP-C70)︱Specifications Specifications ■ ATP-C70 Specifications ATP-C70 Item Description Type BF type Sampling Rate 250 sample/sec Input Offset Dynamic Range ±300mV Channel 1 channel ADC Resolution 10 bits ≥10MΩ Input Impedance Frequency Response 0.05Hz to 40Hz Less than 3KΩ... -
Page 18: Product Disposal
Product Disposal ► This product is a medical device for single use only. Reuse is prohibited. ► Disposal of ATP-C70 and battery must comply with local waste disposal regulations. Non- compliance with waste disposal regulations may result in environmental pollution. 18︱AT-Patch User Manual... -
Page 19: Labeling And Packaging
Labeling and Packaging Labeling ■ Package Label ■ Explanation of Visual Symbols of Label Symbol Descriptions The serial number that identifies the object Date of manufacture For European Authorized Representative Keep dry Protected against solid objects bigger than 1mm / Water splashing from all directions. -
Page 20: Packaging
Labeling and Packaging︱Packaging Packaging ■ Basic Components Internal Packaging Classification Components Quantity Tools Used packaging Material External: Box gift Bag Sealing Gift Paper Scissors / Tape Bag Sealing Gift ATP-C70 BAG GIFT Scissors Basic Sub Patch Handling Components Symptom Note Vellum paper Handling Quick Guide... -
Page 21: How To Use The At-Note App
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 22: Connect To Device Window
How to Use the AT-Note App︱Connect to Device Window Connect to Device Window Figure 1.9 Initial & in-progress screen for connecting to the device Item Description Once the icon is clicked, connecting to the device is Cancel connecting to device icon canceled, and [Figure 1.9] screen shows up... -
Page 23: Main Screen
How to Use the AT-Note App︱Main Screen Main Screen Figure 1.10 AT-Note initial Main Screen Item Description Heart rate data output section A section displaying heart rate (BPM) data output Make Symptom Note entry icon Icon that leads to the Symptom Note entry screen The Day number of using the App A section displaying the Day number of using the App (AT-Note) and current date output... -
Page 24: 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) 24︱AT-Patch User Manual... - Page 25 How to Use the AT-Note App︱LIVE Display Screen Item Description Stop generating real-time ECG and Icon to stop generating ECG and 3-axis data output through 3-axis data output icon graphs ECG graph output section A section displaying real-time graph of the ECG data output ECG graph Real-time graph of ECG data ECG graph zoom-in icon...
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Page 26: Record Screen
How to Use the AT-Note App︱RECORD Screen RECORD Screen Figure 1.12 Screen displayed after the Record button is clicked 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. 26︱AT-Patch User Manual... -
Page 27: Symptom Note Entry Screen
How to Use the AT-Note App︱Symptom Note Entry Screen Symptom Note Entry Screen ■ Making Symptom Note Entries Using the App (AT-Note) The screens in [Figure 1.13] shows the steps of making Symptom Note entries using the App in order. Upon tapping the Make Symptom Note Entry icon on the lower right side in the Main Screen (i.e. - Page 28 How to Use the AT-Note App︱Symptom Note Entry Screen ■ Making Symptom Note Entries Using the Device (AT-Patch) Below [Figure 1.14] is the symptom note registration screen using the device. Once the Power icon on the device is pressed for about 0.2 seconds, the relevant information is transmitted wirelessly (via Bluetooth) to the App, and the App receives the event information from the device.
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Page 29: Symptom Note Details Screen
How to Use the AT-Note App︱Symptom Note Details Screen Symptom Note Details Screen ■ Viewing Details for Symptom Note Entries Made Using the App (AT-Note) By tapping the registered Symptom Note details icon in the Main Screen, the screen listing the registered Symptom Note for a Day number of using the App is displayed as shown in [Figure 1.15]. - Page 30 How to Use the AT-Note App︱Symptom Note Details Screen ■ Viewing Details for Symptom Note Entries Made Using the Device (AT-Patch) When Symptom Note entry is made using the device, the time of the event, as seen in the red rectangular section in [Figure 1.16], is displayed with only the symptom start time.
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Page 31: Symptom Note Revision Screen
How to Use the AT-Note App︱Symptom Note Revision Screen Symptom Note Revision Screen The top left screen from the [Figure 1.17] below shows the details screen for a single entry of Symptom Note, with the revision icon or revision icon area for each item indicated. Upon tapping each revision icon or revision icon area, the previously selected values for the items are displayed on the screen. - Page 32 How to Use the AT-Note App︱Symptom Note Revision Screen Item Description Symptom occurrence start time Area serving as the command icon for symptom revision icon area occurrence start time revision Symptom occurrence end time revision Area serving as the command icon for symptom icon area occurrence end time revision Area serving as the command icon for symptom type...
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Page 33: Viewing Recorded Data
How to Use the AT-Note App︱Viewing Recorded Data Viewing Recorded Data 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. - Page 34 How to Use the AT-Note App︱Viewing Recorded Data Item Description ECG recording start time and ECG recording start time and end time end time Move to ECG recording data Command icon for moving to the ECG recording data viewing viewing screen icon screen Move to Main Screen icon Command icon for moving to the Main Screen...
- Page 35 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...
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