Samsung SPATCH3 User Manual

USER MANUAL

Wearable Health Monitoring System

(MODEL: S-PATCH3-Cardio)

Caution: Federal law restricts this device to sale by or on the order of a physician.

Document No: SDS-UM-01 (Rev. 0)

Samsung SDS Co., Ltd.

125, Olympic-ro 35-gil, Songpa-gu, Seoul, Republic of Korea

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Revision History

	Revision	Issue Date	Contents of revision
	Number
	Rev.0.0	2017.07.12	Established by Manufacturer’s User Manual Policy

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Contents

1.	Product Introduction ....................................................................................................................................			5
	1.1	Introducing S-PATCH3-CARDIO.........................................................................................................		5
	1.2	Indication for Use ......................................................................................................................................		5
2.	Cautions .............................................................................................................................................................			5
	2.1	General .........................................................................................................................................................		5
	2.2	Safety ............................................................................................................................................................		5
	2.3	Contra-Indication .......................................................................................................................................		6
	2.4	Usage and Storage Conditions ................................................................................................................		7
	2.4.1		Conditions for Usage ........................................................................................................................	7
	2.4.2		Conditions for Storage......................................................................................................................	7
	2.4.3		Cleaning Condition ...........................................................................................................................	7
3. Components and Installation of S-PATCH3-CARDIO ............................................................................				8
	3.1	Main Device Components........................................................................................................................		8
	3.2	Accessory Components ............................................................................................................................		9
	3.3	How to Install S-PATCH3-CARDIO .................................................................................................		10
	3.3.1		Installing S-PATCH .......................................................................................................................	10
	3.4	Precautions ...............................................................................................................................................		11
4. Using and Operating S-PATCH3-CARDIO.............................................................................................				12
	4.1	How to Use S-PATCH3-CARDIO .....................................................................................................		12
	4.2	Specifications...........................................................................................................................................		17
	4.2.1		S-PATCH3-CARDIO Specifications .........................................................................................	17
	4.3	Error Message ..........................................................................................................................................		18
	4.4	Maintenance .............................................................................................................................................		18
	4.5	Specification of External Device connection....................................................................................		18
5.	Heart Rate Algorithm ....................................................................................................................................			19
	5.1	HR calculation per beat....................................................................................................................		19
	5.2	Average HR calculation of a section ..........................................................................................		19

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6.	Labels and Packaging ....................................................................................................................................			20
	6.1	Labels.........................................................................................................................................................		20
	6.1.1		Label for Packaging .......................................................................................................................	20
	6.1.2		Label for module.............................................................................................................................	20
	6.2	Packaging..................................................................................................................................................		21
	6.2.1		Package List .....................................................................................................................................	21
	6.2.2		Package Units ..................................................................................................................................	21
6.	Information on EMC.......................................................................................................................................			22
	6.1	Guidance and Manufacturer’s Declaration – Electromagnetic Emissions .................................		22
	6.2	Guidance and Manufacturer’s Declaration – Electromagnetic Immunity..................................		22
	6.3	Guidance and Manufacturer’s Declaration – Electromagnetic Immunity..................................		23

6.4Recommended separation distances between portable and mobile RF communications

	equipment and the EUT .....................................................................................................................................		24
	6.5	Immunity and Compliance Level ........................................................................................................	25
	6.6	Guidance and Manufacturer’s Declaration – Electromagnetic Immunity..................................	26
7.	FCC Compliance Statement .........................................................................................................................		27
8.	Expected Service Life time and Warranty ................................................................................................		27
	8.1	Expected Service Life Time .................................................................................................................	27
	8.2	Product Warranty ....................................................................................................................................	27
9.	Company Introduction...................................................................................................................................		28
	9.1	Company Name and Address ...............................................................................................................	28

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1. Product Introduction

1.1 Introducing S-PATCH3-CARDIO

This product is intended to measure, transfer and record electrocardiogram signal. The viewer on mobile device may display ECG wave form, Heart Rate, Respiration Rate, Heart Rate Variability and other information. The product consists of S-PATCH3-CARDIO body signal sensing module, ECG electrodes and mobile app viewer to monitor the signals.

•Product Name– Wearable health Monitoring System

•Model Name– S-PATCH3-CARDIO

•Manufacturer–SAMSUNG SDS Co., Ltd.

1.2Indication for Use

This product is intended to measure, transfer and record electrocardiogram signal. The viewer on mobile device may display ECG wave form, Heart Rate and other information. The product consists of S-PATCH3-CARDIO body signal sensing module, mobile application and web portal of electrocardiogram analysis for physician.

The S-PATCH3-CARDIO signal sensing module transmits data through wireless communication to mobile device.

The S-PATCH3-CARDIO wearable health monitoring system monitors and displays:

-Heart Rate

-ECG signal

-The connection between S-PATCH3-CARDIO and mobile device is using Bluetooth communication.

2.Cautions

2.1General

1)DO NOT store in extremely hot, cold, humid, or wet conditions.

2)Since this product is a medical device, instructions are required to properly dispose of it. Contact the deputy or manufacturer for such instructions. Improper disposing of this device can lead to legal consequences.

3)Contact the manufacturer if the product functions abnormally, problematically, or not at all. Any attempt to repair without the manufacturer’s guide is not recommended.

4)Reuse of the electrodes is prohibited in any circumstances due to the infection.

5)Use of electrodes sticker may cause a skin irritation or reaction.

6)DO NOT expose to strong electromagnetic fields.

7)Too much body hair may cause an unsuccessful recording.

8)DO NOT use to diagnose heart related conditions.

9)No warranty for any data or information that is collected erroneously by the device, or misuse or malfunction as a result of abuse, accidents, alteration, misuse, neglect, or failure to maintain the products as instructed.

10)If there is a change in the performance of a medical device, contact the manufacturer for action.

2.2Safety

1)Before use, the doctor must explain cautions to the patient.

2)Operate the product in the correct order as described in this manual.

3)Use this device under doctor’s prescription.

4)Beware of the polarity of the Coin battery when exchange and insert the battery.

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5)DO NOT use during magnetic resonance imaging (MRI) or external defibrillation procedures.

6)DO NOT drop or bump with excessive force.

7)DO keep components out of reach of children.

8)DO NOT swallow the device or wind the cable around the neck.

9)Conductive parts of electrodes and associated connectors for type CF applied parts, should not contact other conductive parts including earth;

2.3Contra-Indication

1)Patients with artificial cardiac pacemaker, cardioverter defibrillator, or other implantable electric devices.

2)Pregnant or breast-feeding mothers

3)A current sign or medical history of skin cancer, rash, skin disorder, keloid, and/or any injury.

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2.4Usage and Storage Conditions

2.4.1Conditions for Usage

1)Temperature: 5 - 40 (41 to 104 )

2)Relative humidity: 10%-95%(non-condensing)

3)Atmospheric pressure: 700hPa-1060hPa

2.4.2Conditions for Storage

1)Temperature: −25 - 70 (-13°F to 158°F)

2)Relative humidity: 10%-95%( non-condensing)

3)Atmospheric pressure: 700hPa-1060hPa

4)Keep the device in the case when it doesn't use.

2.4.3Cleaning Condition

1)Clean the device with soft, dry cloth

2)Equipment failure may occur due to dust and debris during long-term use of the equipment.

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3.Components and Installation of S-PATCH3-CARDIO

3.1Main Device Components

2

1

4

S-PATCH3-CARDIO

6	5	3	6

<S-PATCH3-CARDIO>

	Labe	Name	Description
	l
	1	Main Body1	Coin battery inset module
	2	Main Body2	Main PCB module
	3	Connect Cable	Cable between two main bodies
	4	Power Button	Power On/Off button
	5	LED	LED Lamp to indicate the states
	6	Electrode connect	Holes for ECG electrodes connecting
		hole

S-PATCH3-CARDIO

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3.2 Accessory Components

			<Electrode>
			<Battery>
	Label	Name	Description
			Multi-purpose monitoring electrodes with sticky gel
	1	Electrode	feature (high performance adhesive and foam backing)
			Note: Use the FDA registered Electrode.
	2	Battery	Power supply for S-PATCH3-CARDIO. DC 3V Coin
			Battery.
The Applied Parts are main device and electrode

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