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 with heart disease such as arrhythmia.
- 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.
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.
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
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.
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Clinical information
Product Disposal
Conditions for use and Storage
Appendix
04
21
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
Specifications
Appendix
04
