Wellysis S-Patch Ex User manual

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USER MANUAL
Wearable Health Monitoring System
(MODEL: S-Patch Ex)
Document No: WS-UM-01 (Rev. 0.1)
Wellysis Corp.
1111ho, 311, Gangnam-daero, Seocho-gu, Seoul, Republic of Korea

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1 Product Introduction
1.1 Introducing S-Patch Ex
The S-Patch Ex is a light-weight electrocardiogram (ECG) and heart rate (HR) monitoring
device with accompanying software. The S-Patch Ex operates wirelessly, and due to its
compact size it is unobtrusive during daily activity. The S-Patch Ex continuously measures
ECG and HR signals, and streams the digitized signals to a mobile gateway device equipped
with S-Patch Ex App. At the end of each ECG recording session, patients can upload their
data to a secure cloud portal via their mobile device connection. After the data upload
takes place, physicians can access and review their patients’ ECG data remotely via the S-
Patch Ex Web. The S-Patch Ex is intended to be used with direction from trained medical
professionals in accordance with the user manual.
• Product Name: Wearable health Monitoring System
• Model Name: S-Patch Ex
• Manufacturer: Wellysis Corp.
1.2 Indication for Use
Intended Use
The S-Patch Ex is a wearable health monitoring system for
measuring and analyzing patient electrocardiogram (ECG)
waveforms and heart rate (HR).
The product consists of bio-signal sensing device, mobile
application and web portal of electrocardiogram analysis for
physician.
The S-Patch Ex is intended for use in the diagnosis of patients with
suspected cardiac symptoms such as but not limited to:
Abnormalities of heartbeat, abnormalities of breathing,
lightheadedness, dizziness, chest pain, sweating, pre-syncope,
syncope, fatigue, or anxiety. The device has not been tested
specifically for pediatric use.
1.3 Marks and Symbols
Labe
l Symbol Description
1 The serial number that identifies the object.
2 Date of manufacture
3 Manufacturer
4 Caution / Warning
5 Instruction for User Manual
6 Type of applied part
7 Prescription only

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8
WEEE Mark
9 Keep Dry
10 Temperature limit
11 Humidity limitation
12 Authorized European Representative address
13
The CE symbol indicates that this product complies
with the European Directive for Medical Devices
93/42/EEC as amended by 2007/47/EC as a class IIa
device.
14
Non-ionizing radiation
15 MR unsafe
1.4 Target treatment group and diseases
No Contents Description
1 Indications
Detection of cardiac arrhythmia and diagnostic evaluation of
patients who may be asymptomatic or who may suffer from
transient symptoms such as, but not limited to abnormalities of
heartbeat, abnormalities of breathing, lightheadedness, dizziness,
chest pain, sweating, pre-syncope, syncope, fatigue, or anxiety.
2 Age Adults and adolescents at physician’s discretion
3 Weight Not limited
4 Health
1. Not recommended for use on patients with artificial cardiac
pacemaker, cardioverter defibrillator, or other implantable electric
devices.
2. Not recommended for use with pregnant women or breast-
feeding mothers
3. To be used at physician’s discretion on patients with current
symptoms or medical history of skin cancer, rash, skin disorder,
keloid, and/or any skin injury.
5 Nationality Not limited
6 Condition Not limited

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2 Cautions
2.1 General
1) Store in climate controlled environments (parameters specified in section
1.4)
2) Since this product is a medical device, instructions are required to properly
dispose of it. Contact the distributor or manufacturer for such instructions
3) Contact the manufacturer if there are any problems with product
functionality.
4) Reuse of the electrodes is prohibited in any circumstances due to the risk of
infection.
5) Prolonged use of electrodes may cause skin irritation. Discontinue use and
consult your physician if skin irritation occurs.
6) DO NOT expose the device to strong electromagnetic fields.
7) No warranty is provided for any erroneous data collected by the device due to
misuse or malfunction as a result of abuse, accidents, alteration, neglect, or
failure to maintain the products as instructed.
8) Contact the manufacturer if there is a change in the performance of the device.
9) DO NOT place the device on top of excessive body hair. Body hair should be
removed prior to placement of the device.
10) This device can be operated in at least one Member State without infringing
applicable requirements on the use of radio spectrum.
2.2 Safety
1) A healthcare professional should explain the proper use of the device to a
patient
2) Use this device under doctor’s prescription.
3) Make sure the coin battery is inserted in the correct orientation
4) DO NOT use during magnetic resonance imaging (MRI) or external
defibrillation procedures.
5) DO NOT drop or bump with excessive force.
6) Keep components out of reach of children.
7) DO NOT swallow the device or wind the cable around the neck.
2.3 Contra-Indication
1) Patients with artificial cardiac pacemaker, cardioverter defibrillator, or other
implantable electric devices.
2) Pregnant women or breast-feeding mothers.
3) Patients with current symptoms or medical history of skin cancer, rash, skin
disorder, keloid, and/or any injury.
2.4 Usage and Storage Conditions
2.4.1 Conditions for Usage
1) Temperature: 5℃- 40℃ (41℉ to 104℉)
2) Relative humidity: 10%-95%(non-condensing)
3) Atmospheric pressure: 700hPa-1060hPa

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2.4.2 Conditions 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.
2.4.3 Conditions for Cleaning
1) Disinfect by wiping with standard hospital disinfectant
2) DO NOT immerse device in liquid
2.4.4 Conditions for Usage and Storage of Electrode
1) Temperature: −10℃- 40℃ (14°F to 104°F)
2.5 Use of Device
1) The electrodes and coin battery are disposable. Please observe local laws for
disposal of electrodes and coin battery.
2) Remove the battery if the device is not likely to be used for an extended
period of time.
3) Please ensure hands are clean and dry when handling the S-Patch Ex
4) Excessive body hair may cause noise in the recording.
5) Clean and disinfect the device by wiping with standard hospital disinfectant.
Do not immerse the device in liquid.
6) This product must not be disposed of with household waste. Please recycle
with other electrical equipment.
2.6 Use of Electrodes
2.6.1 Storage
1) Store electrodes according to manufacturer recommendations
2.6.2 Patient Preparation
1) Get the electrode ready for treatment.
Wash the target area of the body and dry out the region. If necessary, shave
the area for a better adhesion of the electrode to the skin.
2.6.3 Electrode Placement Precautions
1) Do not use the electrode in fracture region, neck, face or region around the
heart.
2) Do not use this electrode to the patient who has a pacemaker and/or any
kinds of transplantations inside his or her body.
3) Do not use this electrode while taking a shower, bathing or swimming.
4) Dried out electrodes should not be used
5) Electrodes should not be reused
2.7 Warning

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2.7.1 MR-unsafe!
Do not expose the device to a magnetic resonance (MR) environment.
1) The device may present a risk of projectile injury due to the presence of
ferromagnetic materials that can be attracted by the MR magnet core.
2) Thermal injury and burns may occur due to the metal components of the
device that can heat during MR scanning.
3) The device may generate artifacts in the MR image
2.7.2 FCC
1) This equipment has been tested and found to comply with the limits for a class
B digital device, pursuant to Part 15 of the FCC Rules.
These limits are designed to provide reasonable protection against harmful
interference in a residential installation.
This equipment generates uses and can radiate radio frequency energy and, if not
installed and used in accordance with the instructions, may cause harmful
interference
to radio communications. However, there is no guarantee that interference will not
occur in a particular installation. If this equipment does cause harmful interference
or television
reception, which can be determined by turning the equipment off and on, the user
is encouraged to try to correct the interference by one or more of the following
measures:
- Reorient or relocate the receiving antenna.
- Increase the separation between the equipment and receiver.
- Connect the equipment into an outlet on a circuit different from that to which
the receiver is connected.
- Consult the dealer or an experienced radio/TV technician for help.
2) This device comply with part15 of FCC rules.
Operation is subject to the following two conditions:
- This device may not cause harmful interference.
- This device & its accessories must accept any interference received, including
interference that may cause undesired operation.
3) This equipment may generate or use radio frequency energy.
Changes or modifications to this equipment may cause harmful interference
unless the modifications are expressly approved in the instruction manual.
This user could lose the authority to operate this equipment if an unauthorized
change or modifications is made.
3 Components and Installation of S-Patch Ex
3.1 Main Device Components

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< Front of S-Patch Ex >
< Rear of S-Patch Ex >
Label Name Description
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
hole Holes for ECG electrodes connecting
3.2 Accessory Components

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<Electrode>
<Battery>
Labe
l Name Description
1 Electrode(single use)
Model name: HR-OP42
Dimension: 43Ø
Multi-purpose monitoring electrodes with sticky gel
feature (high performance adhesive and foam backing)
Material: PE foam, Ag/AgCl sensor, Nickel plated brass,
Solid hydro gel
2 Battery Power supply for S-Patch Ex. DC 3V Coin Battery.
Battery is replaceable.
3 S-Patch Ex Web The S-Patch Ex Web is a cloud-based server which
stores the encrypted ECG data
3.3 Material
No. Title Material Grade
1 Exterior of Signal Detection Module PVC V-0
2 Connection cable PVC V-0

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3.4 How to Install S-Patch Ex
3.4.1 Installing S-Patch Ex
1) Download the S-Patch Ex App (Android 8 and above /iOS 12 and above) from S-
Patch Ex mobile app download link
(https://play.google.com/store/apps/details?id=com.wellysis.spatchcardio.app&
hl=en_US&gl=US or https://apps.apple.com/kr/app/s-patch-
cardio/id1496099268?l=en). The device must support Bluetooth Low Energy.
2) Install the downloaded file on user’s mobile device.
3) Insert battery to main body 1 of S-Patch Ex (Check the polarity of the battery and
insert it correctly).
First, Open the Battery cover on main body 1.
Second, Insert the battery.
Lastly, close the battery cover and turn it clockwise.
Caution ;
Do not expose the battery to extreme environmental conditions (Extremely high
temperature, high pressure, high humidity and etc.)

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4 Using and Operating S-Patch Ex
4.1 Turning S-Patch Ex on and Positioning it on Body
1) Push and hold the power button for 3 second.
2) Confirm that the LED blinks ON 1 time and OFF for 5 seconds.
On Off
3) Make sure Bluetooth is enabled on the mobile device.
4) After connecting the electrodes with S-Patch Ex, peel off the plastic covers from
the backside of the electrodes.
5) Attach the S-Patch Ex according to the recommended position as shown below.