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
