ATsens AT-Patch Manuale utente

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.

AT-Patch

User Manual

MODEL: ATP-C130

UM-C-001 Ver 5.2_08/2021

AT-Patch User Manual︱3
Contents 
 
Product Descriptions ..............................................................................................4
Intended Purpose ..........................................................................................................................................4
Components ..................................................................................................................................................5
Instructions for Use........................................................................................................................................7
CAUTIONS................................................................................................................8
Contraindications...........................................................................................................................................8
Warnings (Precautions).................................................................................................................................8 
Measuring device (ATP-C130) and the App (AT-Note).................................................................................9
S/W............................................................................................................................................................. 10 
Conditions for Use and Storage ................................................................................................................. 11 
How to Use the Device (ATP-C130)......................................................................12
Instructions for Operating and Attaching the Device (ATP-C130).............................................................. 12 
Instructions for Installing the App (AT-Note) .............................................................................................. 16 
Specifications.............................................................................................................................................. 18 
Product Disposal...................................................................................................19
Labeling and Packaging .......................................................................................20
Labeling...................................................................................................................................................... 20 
Packaging................................................................................................................................................... 21 
How to Use the AT-Note App................................................................................22
Screen with the App (AT-Note) Icon & Initial Run Screen.......................................................................... 22 
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 
 
 
 
 
 
 

4︱AT-Patch User Manual

Product Descriptions

This product (ATP-C130) is a patch-type ECG device that measures the

potential differences transmitted to the surface of the body from the action

potential generated from the activated myocardium. By attaching electrodes on

certain sites, it displays, stores, and records the measured ECG data.

Intended Purpose

►ATP-C130 is intended to measure, analyze, and report electrocardiogram (ECG) information for

long-term monitoring (up to 14 days) by attaching to the skin surface. 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. Used by

patients as prescribed by physician or medical personnel.

►Target Treatment group

asymptomatic or who may suffer from transient symptoms such as palpitations, shortness of breath,

dizziness, light-headedness, pre-syncope, syncope, fatigue, or anxiety and patients who are

asymptomatic

►Target User

physician or medical personnel

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

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

Contact: Tel. 070-5220-0220/Fax. 070-8270-0738

Authorized Representative

•Name: CMC Medical Devices & Drug S.L.

•Address: C/Horacio Lengo n18 C.P 29006 Málaga-Spain

•Tel.: +34 951 214 054

•E-mail: info@cmcmedicaldevices.com

Product Descriptions︱Components

AT-Patch User Manual︱5

Components

■Device Components

►Basic Components

AT-Patch

Pad Paper

Sealing Bag

Quick Guide

Symptom Note

Gift Box

Figure 1.1 AT-Patch Basic Components

Product Descriptions︱Components

6︱AT-Patch User Manual

►Accessories & PC S/W (AT-Report)

Accessory. Dedicated USB

cable/ATCBL-120

PC S/W(AT-Report)

USB Memory

BLE Dongle

Our dedicated cable that

connects the device with

PC S/W for the purpose of

transmitting the ECG data

recorded in the device to

PC S/W. It is connected via

the USB Port located on

the side of the device.

A USB memory stick for

storing the PC S/W

installation file to be

provided to the users. A

product with a test report or

a certificate issued by

national or accredited

offices is used.

A dedicated BLE dongle

used when connecting the

device with PC S/W

through BLE connection. A

product (BLED112) with a

test report or a certificate

issued by national or

accredited offices is used.

■App

For Android™ users: Google play™ (https://play.google.com/store)

For iPhone®users: App StoreSM (https://www.apple.com/ios/app-store/)

►Please search "AT-Note", "ATsens" in Google Play™ Store or App StoreSM.

►Download the App.

►Perform the registration step, then start using the App.

Supports: Android 5.0 or later / iOS 11.0 or later

Product Descriptions︱Instructions for Use

AT-Patch User Manual︱7

■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

RAM

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

1920 x 1080 / 24 inch Full-HD Monitor

Windows 10 (64bit)

Instructions for Use

►ATP-C130 is a device that measures, records, and stores the data from one ECG channel, and

transmits the measured data using wireless communication (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

8︱AT-Patch User Manual

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)

►This product is for single use only. Reuse is prohibited. Reusing it may lead to malfunction and

inaccurate results.

►DO NOT attach to any other place than the recommended bodily location of application.

►Only authorized technicians are allowed to repair or disassemble ATP-C130.

►Make sure to be fully aware of how to use the product, through sufficient training, before using it.

►Avoid use at locations where wireless communication interference may occur (e.g., places where metallic

hardware or electronic devices are frequently found).

►This product cannot be simultaneously used with a defibrillator.

►DO NOT expose to strong electromagnetic fields.

►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.

CAUTIONS︱Measuring device (ATP-C130) and the App (AT-Note)

AT-Patch User Manual︱9

Measuring device (ATP-C130) 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

To prevent signal abnormalities due to the state of the patient's skin, sufficient notice of use from

a medical specialist must be obtained before use.

►The following persons should consult a physician before using the device.

Patients with sensitive skin or skin allergy

Patients with wounds on the skin that contact the device

Pregnant women, breastfeeding mothers, infants or children

Patients with pacemakers, defibrillators, or other implantable electronic devices

►Take caution to avoid getting liquid in the device, and also avoid the following:

(Dustproof and waterproof grade IP57)

Long-term exposure to water such as baths, swimming, etc.

►Avoid letting the device come into contact with organic compounds like thinners or benzene.

►Beware of strong shocks and vibrations.

►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.

CAUTIONS︱S/W

10︱AT-Patch User Manual

S/W

►This Holter ECG recorder is intended to provide diagnostic aid.

►It may be used within the boundaries of medical laws.

►This Holter ECG recorder and installed equipment require a Bluetooth connection.

The product functions by connecting a single device with a single software (App, PC S/W);

connecting multiple devices is not supported.

►Cautions when handling patient's personal information

Protection of patient's personal information and compliance with the [Privacy Act] is of great

importance to ATsens.

Patient's personal information will not be used for any purpose outside analyzing the patient's cardiac

impulse and data management; in the case where the purpose of use is changed, consent must be

obtained beforehand.

Personal information collected from patients is stored and managed for up to 5 years.

Personal information that elapses the retention period or that is no longer required to fulfill the

identified purposes will be destroyed immediately.

The following measures are being taken to ensure the safety of information.

- Administrative Measures: Annual personal information protection act training

- Technical Measures: Encryption of personal information, installing security software, managing

access to personal information data, and storing access records for more than 6 months

- Physical Measures: Restricting unauthorized access and using document encryption device.

Our dedicated cable must be used when transmitting the ATP-C130's ECG data.

- ECG data cannot be transmitted using commercial USB cables.

The PC on which the S/W is used must meet following requirements.

- A product with a test report or a certificate issued by national or accredited offices must be used.

- A product protected by an anti-virus software must be used.

This S/W does not utilize any network connection.

- No network connection, such as a closed network within a medical facility, shared network, etc., is

used; data is stored within the 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

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