Samsung S-PATCH, User Manual

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Samsung Confidential [3]
Table of Contents
1. Product Introduction ..................................................................................................................................................... 5
1.1. Introduction........................................................................................................................................................... 5
1.2. Indications for Use & Intended Use ........................................................................................................... 5
1.3. Contraindication.................................................................................................................................................. 5
2. Cautions ................................................................................................................................................................................ 6
2.1. General ..................................................................................................................................................................... 6
2.2. Safety ......................................................................................................................................................................... 6
2.3. Usage and Storage Conditions ...................................................................................................................... 7
2.3.1. Conditions for Usage ........................................................................................................................... 7
2.3.2. Conditions for Storage ........................................................................................................................ 7
2.3.3. Cleaning Condition ............................................................................................................................... 7
3. Warning ................................................................................................................................................................................. 7
4. Components and Installation of S-PATCH ........................................................................................................... 7
4.1. Main Device Components ............................................................................................................................... 7
4.1.1. Sensor device .......................................................................................................................................... 7
4.1.2. Cradle .......................................................................................................................................................... 8
4.1.3. PC software .............................................................................................................................................. 9
4.1.4. Mobile app ............................................................................................................................................. 10
4.2. Accessory Components ................................................................................................................................. 10
4.3. How to Start S-PATCH .................................................................................................................................... 11
4.3.1. Required Environment .................................................................................................................... 11
4.3.2. System Initialization ......................................................................................................................... 11
4.3.3. Sensor device Setup .......................................................................................................................... 14
4.4. Precautions ......................................................................................................................................................... 15
5. Using and Operating S-PATCH ................................................................................................................................ 15
5.1. How to Use S-PATCH ...................................................................................................................................... 15
5.1.1. Attachment to the patient body and Power On .................................................................. 15
5.1.2. Connection to the Mobile app...................................................................................................... 16
5.1.3. Completion of recording ................................................................................................................ 19
5.1. Daily Usage .......................................................................................................................................................... 19
5.2. Data download and management............................................................................................................ 19
5.2.1. ECG Data Download and Display ............................................................................................... 19
5.2.2. ECG Data Import and Export ........................................................................................................ 20
5.3. Specifications ..................................................................................................................................................... 21
5.4. Error Message .................................................................................................................................................... 22
5.4.1. Device Disconnection....................................................................................................................... 22
5.4.2. Abnormal Signal Detect .................................................................................................................. 22
5.4.3. Low Battery Mode ............................................................................................................................. 22
5.4.4. Low Remaining Recording Time ................................................................................................ 22
5.5. Maintenance ....................................................................................................................................................... 23
5.6. Specification of External Device connection...................................................................................... 23
5.7. Heart Rate Algorithm ..................................................................................................................................... 24
6. Labels and Packaging .................................................................................................................................................. 25
6.1. Labels ..................................................................................................................................................................... 25
6.1.1. Label for Packaging ........................................................................................................................... 25
6.1.2. Label for the Sensor device ........................................................................................................... 25
6.1.3. Label for the Cradle ........................................................................................................................... 25
6.1.4. Descriptions of the visual symbols of the label .................................................................. 26
6.2. Packaging ............................................................................................................................................................. 26
7. Electromagnetic Environment ............................................................................................................................... 27
7.1. Guidance and Manufacturer’s Declaration – Electromagnetic Emissions .......................... 27