Wellysis S-Patch Ex User manual

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Solution Version: v.1.5.1
Last Updated: 2022.05.13
USER MANUAL
Wearable ECG Patch
(MODEL: S-Patch Ex)
Document No: WSE-UM-01 (Rev. 0.5)
Wellysis Corp.
8F, 425 Teheran-ro, Gangnam-gu, Seoul, Republic of Korea

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Contents
1 Product Introduction .............................................................................................................. 4
1.1 Introducing S-Patch Ex Wearable ECG Patch .................................................................. 4
2 Indications for Use ................................................................................................................. 5
3 Safety Information ................................................................................................................. 6
3.1 Contraindications.......................................................................................................... 6
3.2 Warnings ..................................................................................................................... 6
3.2.1 General.............................................................................................................. 6
3.3 Cautions ...................................................................................................................... 6
3.3.1 General.............................................................................................................. 6
3.3.2 MR-unsafe ......................................................................................................... 6
3.3.3 EMC .................................................................................................................. 7
4 S-Patch Ex Components ......................................................................................................... 8
4.1 Components list ........................................................................................................... 8
4.2 Components Dimensions............................................................................................. 10
4.3 Product Use and Storage Conditions ............................................................................ 10
4.3.1 Conditions for Usage ........................................................................................ 10
4.3.2 Conditions for Storage & Transport .................................................................... 10
5 Product Interoperability ........................................................................................................ 11
5.1 Compatible Accessories............................................................................................... 11
5.2 Compatible Software .................................................................................................. 12
5.2.1 S-Patch Ex Mobile Application............................................................................ 12
5.2.2 3rd-Party Cloud-Based ECG Viewing Platform ..................................................... 12
6 S-Patch Ex Operating Instructions (for healthcare professional) .............................................. 13
6.1 Preparation ................................................................................................................ 13
6.1.1 Inserting the battery......................................................................................... 13
6.1.2 Patient skin preparation .................................................................................... 13
6.1.3 Instruction for patient....................................................................................... 14
6.2 Turning On S-Patch Ex................................................................................................ 14
6.3 Connecting Electrodes ................................................................................................ 14
6.4 Applying S-Patch Ex to Patient Body ............................................................................ 15
6.5 Connecting to Mobile App ........................................................................................... 15
6.6 Preparing Returned S-Patch Ex for Next Patient............................................................ 16
6.7 Cleaning S-Patch Ex.................................................................................................... 17
7 S-Patch Ex Operating Instructions (for patient) ...................................................................... 18
7.1 Operate S-Patch Ex .................................................................................................... 18
7.1.1 (Optional) Logging symptoms ........................................................................... 18
7.1.2 (Optional) Removing and Reapplying S-Patch Ex ................................................ 18
7.2 Test Completion ......................................................................................................... 18
7.2.1 Auto Completion............................................................................................... 18
7.2.2 Removing S-Patch Ex and Disposal of Accessories .............................................. 18
7.3 Returning S-Patch Ex .................................................................................................. 19
8 Troubleshooting ................................................................................................................... 19
9 Specifications....................................................................................................................... 20
9.1 S-Patch Ex Specifications ............................................................................................ 20
9.2 FCC Compliance (FCC ID: 2AYDNS-PATCH) .................................................................. 21
9.3 Guidance and Manufacturer’s Declaration – Electromagnetic Emissions .......................... 22
9.4 Guidance and Manufacturer’s Declaration – Electromagnetic Immunity .......................... 23
9.5 Recommended separation distances between portable and mobile RF communications
equipment and the S-Patch Ex .............................................................................................. 25
10 Security Information ............................................................................................................ 26
10.1 System connectivity and Data flow diagram ................................................................. 26
10.1.1 System connectivity.......................................................................................... 26
10.1.2 Data flow......................................................................................................... 26
10.2 Sensitive information stored and transmitted................................................................ 28
10.2.1 Information storing .......................................................................................... 28

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10.2.2 Information transmission .................................................................................. 28
10.3 Security Controls ........................................................................................................ 28
10.4 End of support ........................................................................................................... 30
10.5 Manufacturer’s Disclosure Statement for Medical Device Security .................................. 31
11 Symbols .............................................................................................................................. 36
12 Expected Service Life and Warranty ...................................................................................... 37
12.1 Expected Service Life.................................................................................................. 37
12.2 Warranty.................................................................................................................... 37
13 Contact information ............................................................................................................. 38
Appendix I. Acronyms ..................................................................................................... 39

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1Product Introduction
1.1 Introducing S-Patch Ex Wearable ECG Patch
The S-Patch Ex wearable ECG patch (“S-Patch Ex”) is a light-weight electrocardiogram
(ECG) and heart rate (HR) data collection device. 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 wirelessly transmits the data via a
patient wellness smartphone app to a compatible 3rd-party cloud-based ECG viewing
platform for further analysis and interpretation by qualified clinicians.
The S-Patch Ex is intended to be used by medical professionals in accordance with the
user manual. The S-Patch Ex can be worn by patient in either a healthcare setting or at
home. Certain actions (such as replacement of battery or electrode) can be performed
by a patient at directions from a medical professional and in accordance with the user
manual.
⚫Product Name: Wearable ECG Patch
⚫Model Name: S-Patch Ex
⚫Manufacturer: Wellysis Corp.
The S-Patch Ex does not include but works with a patient wellness smartphone app, S-
Patch Ex Mobile Application (“Mobile App”), and 3rd-party lithium coin batteries, ECG
electrodes and a cloud-based ECG viewing platform. See Section 5 for interoperability.

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2Indications for Use
Indications for
Use
The S-Patch Ex wearable ECG patch is an electrocardiography
(ECG) and heart rate (HR) data recording device for use by
healthcare professionals for continuous collection of the ECG and
HR data at home and in healthcare settings.
The device is intended for use on general care patients who are
18 years of age or older for ECG and HR data collection purposes
only. The data recorded by the S-Patch Ex wearable ECG patch
can be uploaded wirelessly via a wellness app to a compatible 3rd-
party cloud-based ECG viewing platform for further analysis and
interpretation by qualified clinicians.

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3Safety Information
3.1 Contraindications
1) Patients with implantable 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.
3.2 Warnings
3.2.1General
1) Before using external defibrillator, remove S-Patch Ex from patient body
2) DO NOT swallow the device or wind the cable around the neck. Keep
components out of reach of children.
3.3 Cautions
3.3.1General
1) A healthcare professional should explain the proper use of the device to a
patient. Use this device under doctor’s prescription.
2) Follow instructions specified in Section 4.3.2 for proper storage of the product
3) A new lithium coin battery must be used for each use. Make sure the battery is
inserted in the correct orientation
4) Do not use dried out electrodes. Do not re-use electrodes. New electrodes must
be used for each use.
5) Do not place the device on top of excessive body hair. Excessive body hair may
cause noise in the recording. Body hair should be removed prior to placement
of the device.
6) Do not drop or bump with excessive force.
7) After completing the testing, peel the S-Patch Ex off the skin. Prolonged use of
electrodes may cause skin irritation. Discontinue use and consult your
healthcare provider if skin irritation occurs.
8) Please follow local laws for disposal of battery and/or electronic products.
9) Contact the manufacturer if there is a change in the performance of the device.
10) 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.
3.3.2 MR-unsafe
1) Do not expose the device to a magnetic resonance (MR) environment due to
the following:
⚫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.
⚫Thermal injury and burns may occur due to the metal components of the
device that can heat during MR scanning.

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⚫The device may generate artifacts in the MR image
3.3.3 EMC
1) DO NOT expose the device to strong electromagnetic fields.
2) Use of S-Patch Ex adjacent to or stacked with other equipment should be
avoided because it could result in improper operation. If such use is necessary,
this device and the other equipment should be observed to verify that they are
operating normally.
3) Use of accessories other than those specified or provided in Section 5 could
result in increased electromagnetic emissions or decreased electromagnetic
immunity of this equipment and result in improper operation.
4) Portable RF communications equipment (including peripherals such as antenna
cables and external antennas) should be used no closer than 30 cm (12 inches)
to any part of the S-Patch Ex including cables, or in accordance to requirement
specified by the RF communication equipment manufacturer. Otherwise,
degradation of the performance of this device could result.

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4S-Patch Ex Components
4.1 Components list
< Front of S-Patch Ex >
< Rear of S-Patch Ex >
No.
Name
Description
1
Battery Unit
Containing a compartment for a coin battery
2
Power Unit
Containing main PCB, power button and LED
3
Cable
Cable between two Battery and Power Units
4
Power Button
Power On/Off button
5
LED
LED light to indicate device states
6
Electrode connection
ports
Connection ports for attaching compatible ECG
electrodes

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< Outer Carrying Case >
< Inner Carrying Case >
No.
Name
Description
1
Carrying Case
Keep the S-Patch Ex when it is not being used

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4.2 Components Dimensions
No.
Specification
1
Diameter (Power and
Battery Units)
30 mm
(1.18 inch)
2
Height (Power and
Battery Units)
6 mm
(0.24 inch)
3
Cable Length
110 ± 5 mm
(4.33 ± 0.20 inch)
4.3 Product Use and Storage Conditions
4.3.1Conditions for Usage
1) Temperature: 5℃ - 45℃(41℉ to 113℉)
2) Relative humidity: 10% - 95% (non-condensing)
3) Atmospheric pressure: 700hPa - 1060hPa
4.3.2Conditions for Storage & Transport
1) Temperature: −25℃ - 70℃ (-13°F to 158°F)
2) Relative humidity: 10% - 95% (non-condensing)
3) Atmospheric pressure: 700hPa - 1060hPa
NOTE 1) Keep the S-Patch Ex in the carrying case when it is not being used.
2) Store electrodes according to electrode manufacturer’s recommendations.

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5Product Interoperability
The S-Patch Ex wearable ECG patch works with S-Patch Ex Mobile App, compatible 3rd-party
ECG electrodes, lithium coin battery and a cloud-based ECG viewing platform.
These compatible accessories and software are not part of the S-Patch Ex wearable ECG
patch.
5.1 Compatible Accessories
The compatible ECG electrodes and batteries are not included in the package of the S-
Patch EX. They need to be purchased separately. Followings are an example of
compatible accessories:
<Electrode>
<Battery>
No.
Name
Description
1
ECG Electrode
(single use)
Multi-purpose monitoring electrodes with sticky
gel feature (high performance adhesive and foam
backing)
Model name:
HR-OP42
Dimension:
43Ø
Material:
PE foam, Ag/AgCl sensor, Nickel
plated brass, Solid hydro gel
2
Battery
CR2032 DC 3V Lithium Coin Battery.
Battery is replaceable.

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5.2 Compatible Software
The S-Patch Ex works with the following compatible software.
5.2.1S-Patch Ex Mobile Application
The S-Patch Ex Mobile Application (“Mobile App”) is used to display
electrocardiogram (ECG) and heart rate (HR) information received from the S-Patch
Ex ECG patch and transfer the data to any compatible 3rd-party cloud-based ECG
data viewing platform.
Please find the detailed description in the S-Patch Ex Application user manual (Doc.
No. WSE-UM-02)
5.2.23rd-Party Cloud-Based ECG Viewing Platform
A 3rd-Party Cloud-Based ECG Viewing Platform is used to display ECG and HR data
generated by the S-Patch Ex and transmitted via the Mobile App for further analysis
and interpretation by qualified clinicians.

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6S-Patch Ex Operating Instructions (for healthcare professional)
6.1 Preparation
6.1.1Inserting the battery
1) Use a tool (e.g., coin, flathead screwdriver, etc.) and turn counterclockwise
to open the battery cover on the S-Patch Ex Battery Unit.
2) Insert the battery to the battery chamber.
NOTE Make sure the “+” side of the battery facing up or outward.
3) Close the battery cover by turning it clockwise using the tool.
NOTE Do not expose the battery to extreme environmental conditions
(i.e., extremely high temperature, high pressure, high humidity,
etc.)
6.1.2Patient skin preparation
1) (Optional) If excessive body hair is present on the target location for wearing
the patch, shave the area.
CAUTION Do not place the device on top of excessive body hair. Excessive
body hair may cause noise in the recording. Body hair should be
removed prior to placement of the device.
2) Clean skin in target area with soap and water, or with an alcohol wipe.
3) Dry skin completely.
NOTE Do not apply anything to skin prior to applying the S-Patch Ex, such
as lotions, oils, and sprays.
Caution Do not apply S-Patch Ex over open wounds, lesions, infected or

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inflamed skin areas. Apply only to intact and clean skin. If
patient has known skin allergies or hypersensitivities to
adhesives, consult healthcare provider.
6.1.3Instruction for patient
We recommend that all potential patients receive an instruction about how to use the
S-Patch Ex in the home healthcare environment including following information:
-Clause 3. ‘Safety Information’
-Clause 7. ‘S-Patch Ex Operating Instructions (for patient)’
6.2 Turning On S-Patch Ex
1) On the Power Unit of the S-Patch Ex, press and hold the power button for 3
seconds.
2) When the device is turned on, the LED light (i.e., the arrow) blinks 3 times in
blue color and then stays off.
6.3 Connecting Electrodes
1) Prepare two electrodes and connect each electrode to an electrode
connection port on the S-Patch Ex with a click sound.
2) After connecting the electrodes with S-Patch Ex, peel off the plastic covers
from the backside of the electrodes.

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6.4 Applying S-Patch Ex to Patient Body
1) Apply S-Patch Ex with electrodes to patient’s chest per instructions below:
Target and acceptance locations for placement of the S-Patch EX electrodes:
Power Unit (with Power Button and LED Light): As shown in green shaded area in
the figure above. target and acceptable placement is defined as:
•Electrode shall be placed on the right side of the midsternal line (Target: target 2-
3 cm to right of the midsternal line; horizontal positions between the
midsternal line and right arm are acceptable)
•Electrode vertical position shall be above the nipple line (Target: 2-3 cm above
the nipple line; vertical positions above the nipple line but below the clavicle are
acceptable)
Battery Unit: As shown in blue shaded area in the figure above. Target and acceptable
placement is defined as:
•Electrode shall be placed on the left side of the midsternal line (Target: diagonal
to Power Unit; any horizontal position to the left of the midsternal line is
acceptable)
•Electrode vertical position can be placed below the Power Unit (Target below the
curve of the chest; any vertical position below the curve of the chest is acceptable)
CAUTION Do not use dried out electrodes. Do not re-use electrodes. New electrodes
must be used for each use.
NOTE Do not place the electrodes in fracture region, neck, face or region around the
heart.
6.5 Connecting to Mobile App
See Mobile App user manual Sections 3 and 4 (Doc. No. WSE-UM-02) regarding how to
set up Bluetooth connection and start data transfer to the Mobile App.

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NOTE Patient can be sent home wearing the S-Patch EX after the healthcare provider
explains the proper use of the device.
6.6 Preparing Returned S-Patch Ex for Next Patient
NOTE User may need to insert a battery to perform this step if the battery has been
removed by the previous patient.
1) Power off the S-Patch device by pressing and holding the power button for 10
seconds.
2) With the power off, press and hold the power button for 10 seconds (after 10
seconds LED will flash in blue, and the device will restart. When the LED turns
red, release the button).
3) When S-Patch powers back on, it is reset and ready for use by the next patient.

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6.7 Cleaning S-Patch Ex
The S-Patch Ex is a reusable device and requires cleaning after each use. For best
results, the following cleaning procedures are recommended. Confirm the used
battery and electrodes were removed from the patch, and follow the instructions
below when cleaning the S-Patch Ex.
•Use a disinfecting wipe (such as Super Sani-Cloth® ) to clean all S-Patch Ex
surfaces thoroughly. Do not get excess liquid in any hole or opening on the
device.
NOTE Please use the EPA registered disinfecting wipes.
•When all surfaces are dry, store the S-Patch Ex in the carrying case.
•Follow local laws and facility guidelines for the disposal of gloves and cleaning
supplies.

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7S-Patch Ex Operating Instructions (for patient)
7.1 Operate S-Patch Ex
7.1.1 (Optional) Logging symptoms
Patients can add symptoms when experienced.
1) Log a symptom by pressing the device's power button for 2 seconds.
NOTE Logging Symptom Using S-Patch Ex Device:
Log a symptom by pressing the device's power button for 2 seconds.
And follow instructions specified in the S-Patch Ex Application user
manual (Doc. No. WSE-UM-02) Section 5.1.1 –steps 2) to 4).
NOTE When logging symptoms, do not press the power button for more than
5 seconds unless the device needs to be powered off.
NOTE Patients can also log symptoms using the Mobile App. See the Mobile
App user manual (Doc. No. WSE-UM-02) Section 5.2.
7.1.2 (Optional) Removing and Reapplying S-Patch Ex
See the Mobile App user manual (Doc. No. WSE-UM-02) Section 5.2 for pausing the
S-Patch Ex.
Following instructions in Section 7.2.2 to remove the S-Patch Ex.
Following instructions in Section 6.1.2 (Skin Preparation), Section 6.3 (Connecting
Electrodes) and Section 6.4 (Applying S-Patch Ex) to reapplying S-Patch Ex with new
electrodes back to chest.
See the Mobile App user manual (Doc. No. WSE-UM-02) Section 5.2 for resuming the
S-Patch Ex.
7.2 Test Completion
7.2.1Auto Completion
The ECG test automatically completes once it reaches the end of the prescribed
duration. The patient receives 'Test Ended' notification on the Mobile App and the
ECG and HR data for the entire evaluation session is automatically uploaded from the
Mobile App to any compatible 3rd-party cloud-based ECG viewing platform. No user
action is required for completing test with full prescribed duration.
NOTE Do not delete the Mobile App before any further guidance from medical staff.
7.2.2Removing S-Patch Ex and Disposal of Accessories
1) After the completion of the testing, use an adhesive removal pad to wipe
along the edge of the electrode adhesive pads.
2) Grab edge of the electrode and peel it off the skin while continuing to sweep
the adhesive removal pad underneath.
3) Clean skin with an alcohol pad and allow to dry.
4) Remove two electrodes and the battery from the S-Patch Ex.
5) Dispose the electrodes and battery according to local laws for routine
electronic waste.

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7.3 Returning S-Patch Ex
Wipe clean the S-Patch Ex (i.e., Power Unit, Battery Unit and cable) patch with a soft,
dry cloth, using the carrying case to return it to the clinic.
8Troubleshooting
Circumstances
Recommended Action
I cannot connect Bluetooth
between the patch and the
Mobile App.
Please check if Bluetooth is enabled on the smartphone.
Please activate the Bluetooth and try again.
When I press the power button
to turn on the power, the
indicator does not respond.
Please replace the battery for the S-Patch Ex, then try
to power on again by pressing and holding the power
button for 3 seconds.
When I press the power button
to turn on the power, the LED
light shows the red color.
Please reset the ECG patch following instructions below
and try again: (if the connection fails 3 times the device
will power off)
1) First, power off the S-Patch device by pressing and
holding the power button for 10 seconds.
2) With the power off, press and hold the power button
for 10 seconds (after 10 seconds LED will flash in
blue, and the device will restart. When the LED turns
red, release the button).
3) When S-Patch powers back on, it is reset and ready
for connection.