ATsens AT-Patch 사용자 설명서 - 페이지 11
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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 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.
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
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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
Appendix
ECG
Electrode
RF
Power
Requirement
Physical
Characteristics
Item
Type of Applied Part
Sampling Rate
Input Offset Dynamic Range
Channel
ADC Resolution
Input Impedance
Frequency Response
AC impedance
RF communication
Effective Radiated Power
RF Frequency Band of TX
Bandwidth of the Receiver
Power Supply
IP Classification
Total Size (L x W x H : mm)
Main Body Size (L x W x H : mm)
Sub Patch Size (L x W x H : mm)
Weight (g)
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Appendix
Description
BF type
250 sample / sec
± 300mV
1 channel
10 bits
>10㏁
0.67Hz to 40Hz
Less than 3KΩ (10Hz)
2.4GHz BLE 4.2
< 1mW
2.4GHz
2400 ~ 2480MHz
DC 3V, Coin Battery (CR2032)
IP 57
84 x 48.8 x 8.5
31 x 39 x 7.8
104 x 68.8 x 0.05
Main Body : Below 12g
Sub Patch : Below 1g
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