ATSens AT-Patch ECG Holter User Manual

ATSens AT-Patch ECG Holter

Specifications

• Product Name : AT-Patch
• Model : ATP-C130
• Type : Disposable medical device
• Reuse : Prohibited
• Product Components: Transparent film, Power Button/LED, Main Body, App, Sub Patch, Manual, PC S/W (AT-Report), Symptom Note
• Accessories (Sold separately): AT-Note, AT-Report (ATR-C130), USB Memory, Dedicated USB cable (ATCBL-120), BLE Dongle

Product Usage Instructions

How to attach the device

1. Checking the area to attach the device
   • Draw an imaginary line between the middle of the two clavicles and left nipple.
   • Ensure that the device is attached to the center of the area.
2. Shaving and exfoliating the device attachment area
   • If there is a lot of chest hair in the area, use a razor to remove the chest hair and remove dead skin cells.
3. Cleaning the area where the device will be attached with alcohol
   • Clean the attachment area with an alcohol swab for at least 1 minute.
   • Clean with alcohol and dry for at least 2 minutes.
4. Detaching the Film & Attaching the device
   • Detach the device from the transparent protective film.
   • Attach the device with the side marked with “Up” facing upwards.

How to use the device

1. Turning on the power
   • Press the power button of the device for more than 3 seconds.
   • The color of the button will change to green, flash 3 times, and make a sound.
2. Checking the ECG signal
   • After attaching, check the signal status in AT-Note App.
   • If the signal is poor, reattach 1-2 times.
   • After confirming the signal, press the entire area of the device for at least 10 seconds to ensure proper adhesion.
3. Attaching the Sub Patch
   • Put the Sub Patch on top of the attached device in the correct direction.
   • Press firmly on the entire surface of the device for at least 1 minute to improve adhesion.
4. Connecting to App to record ECG signal
   • Ensure that Bluetooth and location service functions are activated on your smartphone.
   • Connect the device with the smartphone App (AT-Note).
   • Check the start of recording ECG signal in the App.
5. Removing protective tape
   • After attaching the Sub Patch, detach the protective tape from the base film slowly.
6. Turning off the power
   • Press the power button of the device for more than 3 seconds to turn off the power.
7. Checking the attachment of the device.

FAQ

• Q: Can I reuse the AT-Patch?
  • A: No, the AT-Patch is a disposable medical device and reuse is prohibited.
• Q: How long should I clean the attachment area with alcohol?
  • A: Clean the attachment area with an alcohol swab for at least 1 minute, then clean with alcohol and let it dry for at least 2 minutes.
• Q: How can I improve the adhesion of the Sub Patch?
  • A: After attaching the Sub Patch, press firmly on the entire surface of the device for at least 1 minute to improve adhesion.
• Q: How do I check the ECG signal in the AT-Note App?
  • A: After attaching the device, open the AT-Note App and check the signal status. If the signal is poor, you can try reattaching the device 1-2 times.

Product Components

PC S/W (AT-Report) & Accessories

1. For a detailed description of the AT-Report, refer to the PC S/W user manual.
2. The PC S/W manual is in the USB Memory.

How to attach the device

1. Checking the area to attach the device
   Draw an imaginary line between the middle of the two clavicles and left nipple, and check the position to ensure the device is attached to the center of the area.

2. Shaving and exfoliating the device attachment area
   If there is a lot of chest hair in the area where the device will be attached, use a razor to remove the chest hair and remove foreign substances such as dead skin cells.

3. Cleaning the area where the device will be attached with alcohol

4. Clean the attachment area with an alcohol swab for at least 1 minute.

5. Clean with alcohol and dry for at least 2 minutes.

6. Detaching the Film & Attaching the device
   Detach the device from the transparent protective film. And attach the device with the side marked with “▲ Up” facing upwards.

7. Turning on the power
   Press the power button of the device for more than 3 seconds and the color of the button will change to green, flash 3 times, and make a sound.

8. Checking the ECG signal

9. After attaching, check the signal status in AT-Note App. (Reattachment 1~2 times possible if the signal would be poor.)

10. After confirming the signal, press the entire area of the device for at least 10 seconds so that the device adheres well.

11. Attaching the Sub Patch
    Put the Sub Patch on top of the attached device in the correct direction. After attaching the Sub Patch, press firmly on the entire surface of the device for at least 1 minute to improve adhesion. Attach Sub Patch correctly at once. Reattachment can not be possible.

12. 9. 10. Removing protective tape
           After attaching the Sub Patch, detach the protective tape from the base film slowly.
13. 12. Checking the attachment of the device
        Check if the device and the Sub Patch are attached well without loose areas. If there are unattached areas on the skin, press the base film with finger smoothly to be attached well.

Additional Information

Connect to App to record ECG signal

1. Bluetooth & Location service
   Check if the Bluetooth and location service functions are activated to connect the device.

2. Connecting with the smartphone App (AT-Note)
   After attaching the device, connect the device with the smartphone App (AT- Note) to check the ECG signal. Must check the start of recording ECG signal.

Turning off the power
Once the initial connection is checked, device is not terminated for the duration of use.

• It is impossible to physically turn it off. After the operation time, the button color turns red and the power turns off automatically after 3 beeps.
  • ATP-C130 : 14 days
• After use, the device must be returned to the hospital.
• The working status of the device can be checked through the App’s real-time live Viewer.

How to install the App

AT-Note ATsens Co., Ltd.

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

For iPhone® users
App StoreSM (http://www.Apple.com/ios/App-store/)

1. Please search “AT-Note”, “ATsens”, “AT note” in your usual Google PlayTM Store or App StoreSM, or scan the QR code
2. Install the App.
3. Complete the registration steps, then start using the App.
   • Supports : Android 5.0 or later / iOS 11.0 or later

Screen with the App (AT-Note) Icon & Initial Run Screen

information input field
2| Intro screen| 5| Cancel connecting to device icon| 8| Scan data matrix icon
3| A guide to device connection| 6| Symptom Note transmission icon| 9| Connect to device button

Main Screen

the Day number of using the App (AT-Note) and current date
2| Live on function can be used for 60 minutes per day| 5| Icon to generate real-time ECG and 3-axis data output as graphs
3| Icon that leads to the Symptom Note entry screen| 6| A section displaying the ECG and 3-axis data output through graphs in real time

LIVE Display Screen

3-axis data graph icon
3| ECG data graph zoom-in icon| 6| Record real-time data icon| |

Making Symptom Note Entries Using the App (AT-Note)

Making Symptom Note Entries Using the Device
Once the power button on the device is pressed for about 0.2 seconds causes the color of button to change and sound, and 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 count on the main page increases, but no new screen shows up. Once the “Create Symptom Note” is tapped, the first screen for making Symptom Note entry is displayed.

Viewing Details of Symptom Notes Registered at the App (AT-Note)

Activity type
3| Symptom type| 7| Start time of Symptom| 11| Other explanation
4| Symptom Note entry completed / incomplete, and recorded ECG data display| 8| End time of Symptom| |

Symptom Note Revision Screen
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 values of the Symptom Note entries through the device have to be entered by tapping the revision icon or revision icon area.

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. The ECG recording data viewing screen is displayed upon tapping the red rectangular section.

Caution

Contraindications

1. Do not use if you have current symptoms or medical history of skin cancer, rash, dermatosis, keloids, wounds, etc.

Adverse Event
Physician should advise patients to seek medical attention if either of the following occurs.

1. Mild rash
2. Allergic reaction
3. Skin irritation
4. Itchiness

Warnings

1. This product is for single use only. Reuse is prohibited. Reusing it may lead to malfunction and inaccurate results.
2. DO NOT attach to any other place than the recommended bodily location of Application.
3. Only authorized technicians are allowed to repair or disassemble Device.
4. Make sure to be fully aware of how to use the product, through sufficient training, before using it.
5. Avoid use at locations where wireless communication interference may occur (e.g., places where metallic hardware or electronic devices are frequently found).
6. This product cannot be simultaneously used with a defibrillator.
7. DO NOT expose to strong electromagnetic fields.
8. The device should not be used adjacent to or stacked with other equipment.
9. The device may be interfered with by other equipment, even if that other equipment complies with CISPR EMISSIONS requirements.
10. Portable RF communications equipment (including peripherals such as antenna cables and external antennas) should be used no closer than 30 cm (12 inches) to any part of the device. Otherwise, degradation of the performance of this equipment 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 manufacturer, user and patient are located.
13. This device is not intended for use by infants weighing less than 10 kg.

Precaution

1. Inappropriate Application and use of the sensor may result in inaccurate measurements, please avoid the below.
   • Excessive movement of the patient.
   • Application outside the recommended bodily locations.
   • To prevent signal abnormalities due to the state of the patient’s skin, sufficient notice of use from physician must be obtained before use.
2. The following persons should consult physician before using the device.
   • Patients with sensitive skin or skin allergy.
   • Patients with wounds on the skin that contact the device.
   • Patients with cardiac pacemakers, cardiac defibrillators or other implantable electrical devices.
   • Pregnant women, breastfeeding mothers, infants or children.
3. Take caution to avoid getting liquid in the device, and also avoid the following.
   • Long-term exposure to water such as baths, swimming, etc.
4. Avoid letting the device come into contact with organic compounds like thinners or benzene.
5. Beware of strong shocks and vibrations.
6. Once the product is detached from the body, do not reattach it.
7. The smartphone on which the App is run must be one with a test report or a certificate issued by national or accredited offices.
8. The device needs special precautions regarding EMC and needs to be utilized according to the EMC information provided in the Electrical safety and compatibility section.
9. Portable and mobile RF communications equipment can affect medical electrical equipment.
10. If the device stops in the middle, see physician.
11. Measures to be taken when a cybersecurity issue occurs.
    • The manufacturer should be consulted if a cybersecurity issue occurs.

ATsens Co., Ltd.

• Tel. +82 70 5220 0220
• Fax. +82 70 8270 0738
• E-mail. sales@atsens.com

Clinical information

Intended Purpose

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. 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

• Patients who may be asymptomatic or who may suffer from transient symptoms such as palpitations, shortness of breath, dizziness, light-headedness, presyncope, syncope, fatigue, or anxiety.
• Patients with heart disease such as arrhythmia.

Target User
The patient (AT-Note & Device)

Clinical Benefit
It measures patient electrocardiogram (ECG) information for a long-term monitoring, analyzes and reports measured data, and helps physician or medical personnel prescribe it.

Product Disposal
Disposal of Device 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.

Conditions for use and Storage

Conditions for Use

1. Temperature range : 10℃ ~ 45℃
2. Relative humidity range : 10% ~ 95%, non-condensing
3. Atmospheric range : 700hPa ~ 1060hPa

Conditions for Storage

1. Temperature range : -20℃ ~ 55℃
2. Relative humidity range : 0% ~ 95%, non-condensing
3. Atmospheric range : 700hPa ~ 1060hPa
4. Keep dry and keep away from sunlight.

Specifications

| Item| Description
---|---|---
ECG| Type of Applied Part| BF type
Sampling Rate| 250 sample / sec
Input Offset Dynamic Range| ± 300mV
Channel| 1 channel
ADC Resolution| 10 bits
Input Impedance| >10㏁
Frequency Response| 0.67Hz to 40Hz
Electrode| AC impedance| Less than 3KΩ (10Hz)
RF| RF communication| 2.4GHz BLE 4.2
Effective Radiated Power| < 1mW
RF Frequency Band of TX| 2.4GHz
Bandwidth of the Receiver| 2400 ~ 2480MHz
Power Requirement| Power Supply| DC 3V, Coin Battery (CR2032)
Physical Characteristics| IP Classification| IP 57
Total Size (L x W x H : mm)| 84 x 48.8 x 8.5
Main Body Size ( L x W x H : mm)| 31 x 39 x 7.8
Sub Patch Size (L x W x H : mm)| 104 x 68.8 x 0.05
Weight (g)|

• Main Body : Below 12g
• Sub Patch : Below 1g

Electrical Safety and Compatibility

Guidance and Manufacturer’s Declaration – Electromagnetic Emissions

Emissions Test| Compliance| Electromagnetic Environment – Guidance
RF Emissions CISPR 11| Group 1| The device uses RF energy only for its internal function. Therefore, its RF emissions are very low and are not likely to cause any interference in nearby electronic equipment.
RF Emissions CISPR 11| Class B| c The device is suitable for use in all establishments, including domestic establishments and those directly onnected to the public low-voltage power supply network that supplies buildings used for domestic purposes.

Immunity Test| IEC 60601 Test and Compliance Level| Electromagnetic Environment – Guidance

• Electrostatic Discharge (ESD)
• IEC 61000-4-2

|

• ± 2, ± 8 kV/Contact
• ± 4, ± 8, ± 15 kV/Air

| Floors should be wood, concrete, or ceramic tile. If floors are covered with synthetic material, the relative humidity should be at least 30 %.

• Power Frequency (50/60 Hz)
• Magnetic Field IEC 61000-4-8

| 50 30 A/m Hz Hz or 60| Power frequency magnetic fields should be at levels characteristic of a typical location in a typical commercial or hospital environment.
**** IERCad6i1a0te0d0-R4F-3| Test Frequency MHz – 2,7G| Level|

• Portable and mobile RF communications equipment should be used r no closer to any part of the device, including cables, than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter.
• Recommended separation distance d = 1.2√P d = 1.2√P 80 MHz to 800 MHz d = 2.3√P 800 MHz to 2.5 GHz
• Where P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer and d is the recommended separation distance in meters (m).
• Field strengths from fixed RF transmitters, as determined by an electromagnetic site survey, should be less than the compliance level in each frequency range.
• Interference may occur in the vicinity of equipment marked with the following symbol :

80%3AM5Mat 1z kHz 8 H| 10 V/m
(Pulse Modulation 18Hz) 450MHz| 27 V/m
(FM ±5 7kHz deviation 1 kHz sine) 10, 745, 780 MHz| 28 V/m

• (Pulse Modulation 217Hz)
• (Pu8ls1e0M, 8o7d0u, l9a3ti0onMH18zHz)

| 9 V/m
1720, 1845, 1970, 2450 MHz| 28 V/m
(Pulse Modulation 217Hz) 5240, 5500, 5785 MHz| 28 V/m
(Pulse Modulation 217Hz) 30 kHz| 9 V/m
(CW)| 8 A/m
(Pulse Mo1d3u4l.a2tikoHnz21.1 kHz)| 65 A/m
(Pulse M1o3d.5u6laMtioHnz 50 kHz)| 7.5 A/m

Symbols

• www.atsens.com
• ATsens Co., Ltd.
• Point Town 803, 11, Gumi-ro, Bundang-gu, Seongnam-si, Gyeonggi-do, 13637, Republic of Korea
• Tel : +82-70-5220-0220
• Fax : +82-70-8270-0738
• CMC Medical Devices & Drugs S.L.
• C/ Horacio Lengo n18 C.P 29006 Málaga-Spain
• © ATsens Co., Ltd. All Rights Reserved.

References

• ATsens
• App Store - Apple
• AT-Patch 14-DayHolter ECG from ATSens

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