User's Manual

User Manual
Document No.
UM-C-002-EN
Date of Revision
2020.10.30
Revision No.
0
Page 8 / 123
10) If the patch appears to be floating or falling off, apply medical tape to prevent the patch from falling off.
11) When connecting multiple BLEs (more than 2), the App does not work properly. Please stop using BLE
as much as possible while using the AT-note App.
12) When take a shower, be careful not to get soap, etc. on the patch as much as possible.
13) Federal (USA) law restricts the sale of this device to or on the order of a physician.
14) If you delete an app while using the device, you can reinstall the app, but the record for AT-note is
deleted. It is recommended not to delete the app while in use, except for forgotten password.
15) Adhere extra patches on the top of the attached patch when the previous patch is about to fall off.
2.4 S/W
2.4.1This Product is an auxiliary device to assist in the diagnosis. It may only be used to the extent that it. This
Product and installed equipment shall be capable of Bluetooth connection.
2.4.2 Cautions in Handling Patient Personal Information
2.4.3 It is very important to protect patient's personal information and comply with [Personal Information
Protection Act].
2.4.4 The patient's personal information will not be used for purposes other than the analysis and monitoring
of the patient's heart rhythm. If the purpose of use is changed, prior consent will be obtained.
1) The collected patient's personal information is stored and managed for up to 5 years.
2) When personal information becomes unnecessary due to the lapse of retention period or achievement of
processing purposes, the personal information shall be destroyed without delay.
3) The following measures are taken to ensure information safety.
- Administrative measures: Training on Personal Information Protection Act every year
- Technical measures: Encrypting personal information, installing security program, managing access to
personal information data and keeping access records for more than 6 months
- Physical measures: No access for unauthorized persons and the use of document encryption devices
2.5 Usage and Storage Conditions
2.5.1 Conditions of Use
1) Temperature range: 10-45℃
2) Range of relative humidity: 10-95%, non-condensing
3) Range of atmospheric pressure: 700-1060hPa
4) Rating for water and dust resistance: IP57
※ The IP 57 rating prevents dust-proof dust from entering the interior. Even a slight intrusion of dust does
not impede normal operation. Protection against underwater immersion is not adversely affected by
immersion in water under the specified pressure and time.
2.5.2 Storage Conditions
1) Temperature range: -20-55℃
2) Range of relative humidity: 10-95%, non-condensing
3) Range of atmospheric pressure: 700-1060hPa
2.6 Warning
1) Do not use ATP-C130 on patients with known allergic reaction to adhesives or hydrogels or with family
history of adhesive skin allergies. Patient may experience skin irritation.
2) Do not reuse ATP-C130. This is a single use medical device. Reuse may cause incorrect patient data and
patient may experience skin irritation.
3) Do not use ATP-C130 on patients residing in areas with limited to no smartphone reception.
4) If skin irritation such as severe itching or allergic symptoms develop, please remove the patch.