FCC ID: QN8MC200M Cardiac Monitoring System

User Manual Holter Monitor Model name : mobiCARE-MC200M mobiCARE-MC200ML mobiCARE-MC200M7 mobiCARE-MC200ML7 Doc. No. : ST-UM-MC200Ms-HA[E]

Vev. No. : 1.0v Issued date : 2020.01.25 Table of Contents 1. PRODUCT INTRODUCTION ...................................................................................... 3 2. MEDICAL SAFETY .......................................................................................................... 8 COMPONENTS AND INSTALLATION ..................................................................13 3. HOW TO USE MOBICARE-MC200M SERIES ...................................................17 4. 5. LABELS AND PACKAGING .......................................................................................31 EXPECTED SERVICE LIFE TIME AND WARRANTY .........................................35 6. 7. MANUFACTURE INFORMATION ...........................................................................36 DECLARATION OF CONFORMITY ........................................................................37 8. 2 1. Product Introduction 1.1. Intend of Use

- mobiCARE-MC200M/mobiCARE-MC200ML/ mobiCARE-MC200M7/

mobiCARE-MC200ML7 (hereinafter mobiCARE-MC200M series) is a light-weight electrocardiogram (ECG) and heart rate (HR) monitoring device with accompanying software. The mobiCARE-MC200M series operates wirelessly, and due to compact size is unobtrusive during daily activity. The mobiCARE-MC200M series continuously measures ECG and HR signals and measures the change in impedance for respiration rate and electrode status. And also, if necessary, measures the change in movement of the person with the product attached using the IMU sensor, and then stores measured data on the memory. Simultaneously, mobiCARE-MC200M series streams digitized signals to a mobile gateway device equipped with the mobiCARE Cardo Hospital App /mobiCARE Cardio Diary App. At the end of ECG recording, they upload measured data to a secure cloud portal via PC uploader program. After data upload takes place, physicians can access and review their patients ECG data remotely via the mobiCARE Cardio Web. The difference between four models is length of the 'Connect Cable'

and size of the 'Coin Battery'. The length and size of the mobiCARE-

MC200M is 180mm & CR2450R, mobiCARE-MC200ML is 250mm &

CR2450R, mobiCARE-MC200M7 is 180mm & CR2477, mobiCARE-

MC200ML7 is 250mm, CR2477, Others are both same. Model name Cable length Battery size mobiCARE-MC200M mobiCARE-MC200ML mobiCARE-MC200M7 mobiCARE-MC200ML7 180mm 250mm 180mm 250mm CR2450R CR2450R CR2477 CR2477

[Model difference]

The mobiCARE-MC200M series is intended to be used with direction from trained medical professionals in accordance with the user manual.

- Product name : Cardiac Monitoring System

- Model name : mobiCARE-MC200M / mobiCARE-MC200ML /

3 mobiCARE-MC200M7 / mobiCARE-MC200ML7

- Manufacturer : Seers Technology Co., Ltd. 1.2. Intended purpose of the device Intended Use The mobiCARE-MC200M series is a Heart/Cardiovascular Disease 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. Indication for use Arrhythmia 1.3. Marks and Symbols Label Symbol Description 1 2 3 4 5 6 7 8 The serial number that identifies the object. Date of manufacture Manufacturer Caution / Warning Instruction for User Manual Type of applied part Prescription only WEEE Mark 4 9 10 11 12 13 14 15 Keep Dry Temperature limit Humidity limitation Authorized European Representative address 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. Non-ionizing radiation MR unsafe 1.4. Intended Patient population 1) Age : ALL 2) Weight : ALL 3) Health :

(1) Do not use Patients with artificial cardiac pacemaker, cardioverter defibrillator, or other implantable electric devices.

(2) Do not use for pregnant women or breast-feeding mothers

(3) To be used at physician discretion on patients if patient presents current sign or medical history of skin cancer, rash, skin disorder, keloid, and/or any injury. 4) Nationality : Not limited 5) Patient state : Not limited 1.5. Intended part of the body or type of tissue applied to or interacted with 1) Intended part of the body : Near Heart on the BODY 2) Type of tissue : Skin 5 1.6. Intended user profile 1) Education

- Minimum :

(1) Main unit / Application : Patient with at least 10 years education can use the product alone, and patient without at least 10 years education (ex, child, etc.) or patient who need help (ex, senior) can use it under the care of their parents or guardian

(2) Web software : Those who have a professional license

- Maximum : No maximum 2) Knowledge

- Minimum : It is necessary to understand the numerical values and the overall description in Korean or English manual for ECG main unit and Mobile App. Medical knowledge for Web software to analysis

- Maximum : No maximum 3) Language understanding

- Be able to understand the numerical values and general technical information presented in the user manual written in Korean or English 4) Experience

- No special experience needed and no maximum for ECG main unit and Mobile App.

- Experience need to analyze the cardiac monitoring 5) Permissible impairment

- Mild reading vision impairment or vision corrected to log MAR 0.2(6/10 or 20/32)

- Impaired by 40% resulting in 60% of normal hearing at 50Hz to 2kHz 6) Others

(1) At least the electrocardiogram graph must be confirmed

(2) At least you need to install the app on your phone and use the installed app 6

(3) At a minimum, the viewer program must be installed on the computer and the installed program must be available. 1.7. Use environment 1) Environment

- General : Home, Hospital environment, Indoor, Outdoor

- Physical

(1) Temperature : 5 ~ 40

(2) Relative Humidity : 10-95%

(3) Atmospheric pressure : 700-1060hPa 2) Frequency of use

- 24hours per a day (continuously) 3) Mobility

- Portable(Hand-held) equipment 1.8. Operating principle mobiCARE-MC200M series records every heartbeat. mobiCARE-

MC200M series automatically detects an arrhythmia, the mobiCARE Cardio App transmits information to mobiCARE Cardio Web for analysis 7 2. Medical Safety 2.1. General 1) Store in climate controlled environments (parameters specified in section 1.4) 2) This product is a medical device that contains electronics and batteries. Please dispose of it according to local regulations. Contact the distributor for more information.. 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, misuse, 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) Use of accessories other than those specified or provided by the manufacturer of this equipment could result in increased electromagnetic emissions or decreased electromagnetic immunity of this equipment and result in improper operation. 2.2. Safety 1) A healthcare professional should explain the proper use of the device to a patient 2) Use this device under a health professional'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. 8 7) DO NOT swallow the device or wind the cable around the neck. 8) DO NOT modify this equipment without authorization of the Seers Technology Co., Ltd. Any repair or maintenance service performed by non-authorized personnel immediately voids all warranty and liability claims. Maintenance services performed improperly can cause system malfunctions that may put the operator and patients at risk. 9) There is possibility that infant or child may be strangled by cable. Please keep the device away from reach of infant or child. 10) Please be aware that children may be choked by swallowing the small parts. Please keep the device away from reach of infant or child. 11) If the cable continues to be twisted, you may get inaccurate results. Recommend to check whether the tubing is kinked before use. 12) Patients with artificial cardiac pacemaker, cardioverter defibrillator, or other implantable electric devices. 13) Do not use the case that a current sign or medical history of skin cancer, rash, skin disorder, keloid, and/or any injury. 2.3. Contra-Indication 1) Do not use for patients with symptomatic episodes where variations in cardiac performance could result in immediate danger to the patient 2) Do not use for patients with known history of life threatening arrhythmias 3) Do not use in combination with external cardiac defibrillators or high frequency surgical equipment near strong magnetic fields or devices such as MRI 4) Do not use on patients with neuro-stimulator, as it may disrupt the quality of ECG data 5) Do not use on patients who do not have the competency to wear the device for the prescribed monitoring period. 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 9 2.4.2. Conditions for Storage 1) -25 C to + 5 C , and 2) +5 C to + 35C at a relative humidity up to 90%, non-condensing;

3) >35C to 70C at a water vapour pressure up to 50hPa 2.4.3. Cleaning 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. 2.4.4. Conditions for Usage and Storage of Electrode 1) According to Manufacturer inspection of Electrode 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. If the battery is left unused for a long time, there is a danger of battery leakage. 3) Please ensure hands are clean and dry when handling the mobiCARE-

MC200M series 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 Electrode 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. 10 2.6.3. Electrode Placement Precautions 1) Do not use the electrode in fracture region, neck, face 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 2.6.4. How to supply 1) Manufacturer recommends to use the electrode introduced in this document 2) If use the replacement, manufacturer recommends to use the CE Marked electrode. 2.7. Warning 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 We are not intended to be used together with other product, and that is not assessed about safety. Therefore, we recommend to use the device as manufacturers requirement. Warnings 1) Do not use on patients with known allergic reaction to adhesives or hydrogels or with family history of adhesive skin allergies. Patient may experience skin irritation. 2) Do not reuse on multiple patients. It is a single patients use device. Reuse will cause incorrect patient data and patient may experience skin irritation. 3) Do not use on patients residing in areas with limited to no cellular reception. 4) No modification of this equipment is allowed. 11 Precaution 1) The system includes temperature and humidity limitations. If exposed, patients may experience degradation of adhesive performance causing the device to slip or fall off during the patient wear duration. 2) The system has a shelf life date. Use of expired device may cause a degradation of ECG signal quality and/or low battery condition. 3) Do not use the system if package is damaged. Device may not perform as intended. 4) Safety and effectiveness of the system on pediatric patient (younger than 18 years old) has not been established. 5) Keep device and packaging away from young children. Contents may be harmful if swallowed. Patch contains button cell batteries that are not accessible during normal use but, if exposed, are known choking hazards and may cause severe tissue injury if ingested. 6) Safety and effectiveness on patients receiving any form of pacing therapy has not been established. Paced cardiac rhythms may not be accurately detected and may be incorrectly classified 7) Registration errors may result in limited functionality or erroneous ECG reporting. Utmost caution should be applied to ensure that patient registration is accurate and complete. 2.8. Side-Effect Skin reaction. 12 3. Components and Installation 3.1. Main Device components Label Name Description 1 Main body A body including the mainboard 2 Battery body A body to insert the battery 3 Connecting cable Connecting cable between two bodies It differs between two model;

mobiCARE-MC200M : 180mm mobiCARE-MC200M7 : 180mm, mobiCARE-MC200ML : 250mm mobiCARE-MC200ML7 : 250mm 4 5 6 7 8 9 SOCKET A socket for Memory card Button Power on/off and additional function

(Symptom, BLE advertising) button Status indicating LED Flashing LED lamp indicating the status Battery cover Battery cover Insert pin Terminal for downloading data Electrode mounting Hole for connecting ECG electrodes hole 13 mobiCARE-

MC200M mobiCARE-

MC200ML A B C D E F G

: mm

: g 32 180 39 48 10 12.8 285 32 250 39 48 10 12.8 355 20 22

(Without Battery)

(tolerance 10%) mobiCARE-

MC200M7 mobiCARE-

MC200ML7 A B C D E F G

: mm

: g 32 180 39 48 10 15.5 285 32 250 39 48 10 15.5 355 21 23 14

(Without Battery) 3.2. Cradle

(tolerance 10%) Label Name Description 1 2 3 4 USB CONNECTOR USB Connector to connect to PC Power LED Displays the USB power connection status DEVICE mounting A part to mount the body Mount with the area cable direction at the bottom DOWNLOAD pin A terminal to download data by contacting the insert pin of the main body 3.3. Component

<Battery>

<Battery>

<Open Tool>

Label Name Description 1 Battery Power supply for mobiCARE-MC200M series. DC 3V Coin Battery. Battery is replaceable. mobiCARE-MC200M : CR2450R 15 mobiCARE-MC200ML : CR2450R mobiCARE-MC200M7 : CR2477 mobiCARE-MC200ML7 : CR2477 2 Open Tool Used to open the Battery Cover 3.4. How to install mobiCARE-MC200M series 1) Download the Seers mobiCARE Cardio Hospital/Diary App from Seers Technology mobile app download link

(Please access the download URL provided by your service provider to download the mobile app.) The device must support Bluetooth Low Energy. 2) Install the downloaded file on users mobile device. 3) Insert battery to Battery body of mobiCARE-MC200M series (Check the polarity of the battery and insert it correctly). Insert the coin battery (CR2450R or CR2477, 3V) as shown First, release the Battery cover on Battery body using Tool. Second, open the Battery cover of Battery body and insert the battery. Lastly, close the Battery cover and lock the Battery cover. Caution ;

Do not replace the battery at extreme environment condition

(Extremely high temperature, high pressure, high humidity and etc.) Please contact to the manufacturer, if you need more information to replace the battery. 16 3.5. Precautions before use 1) Before operating this product, please read the user manual. 2) Confirm that there are no problems with using the product according to the product precautions. 3) This device can be used for everyday activities as well as during sleep. However, you should stop using and remove the device if;

- Bath or swim

- Aircraft boarding

- Taking MRI

- Taking CT, X-ray 4. How to use mobiCARE-MC200M series 4.1. How to use 1) mobiCARE-MC200M series ON

(1) With mobiCARE-MC200M series turned off, press the power button for about 3 seconds.

(2) Release the power button when the status LED flashes quickly 3 times.

[Press for 3seconds]

[Flashes 3times]

[LED OFF]

2) mobiCARE-MC200M series attachment

(1) Attaching electrodes Prepare a disposable electrode with a diameter of 4mm Attach disposable electrodes to each side of the body as shown below Attaching electrodes Attaching electrodes MAIN body BATTERY body 17

(2) Attaching main body Remove the release paper on the contact surface of the electrode. Attach the body to the patient's body as shown in the figure below. Note : After attaching the MAIN part first as shown in the figure, attach the battery part diagonally from the MAIN part under the chest as shown in the figure. When attaching, keep adequate spacing between the electrodes to avoid over tightening the wires. Be careful not to reverse the attachment positions of the main and battery parts. In case of poor electrode attachment, the LED flashes periodically. 18 3) mobiCARE-MC200M series connecting device and APP

(1) Launch the mobiCARE Cardio For Hospital App on your mobile device.

(2) Enter your ID and password to log in. The ID and password are the same as the web software login information.

(3) After entering the measurement code, click Search to connect to the device. Login and connecting the device Initial page Login page Connecting device

- Generating measurement code If the measurement code is not generated, you can click the Generate Measurement Code button to generate the measurement code. When the measurement code generation is complete, press the measurement code generation button at the bottom and enter the generated measurement code to connect it with the device. 19 Measurement code Measurement code generating page 1 generating page

(4) After checking the patch connection status, battery level, and patch signal in the app, the measurement start button will be activated. After pressing the measurement start button, check the contents of the third party information provision agreement, and select consent to activate the consent button at the bottom. Click Agree to see the user's ECG graph on the screen, Checking device Checking device Agreement to terms status status completed and conditions 20 Third party information provision agreement Live ECG graph to display

(5) After confirming that the ECG Data is displayed normally, click the End button to close the mobiCARE Cardio For Hospital App. Closing App 21 4) mobiCARE-MC200M series Connecting the device and diary app

(1) Launch the mobiCARE Cardio Diary App on the mobile device.

(2) Press and hold the device's Power button for more than 3 seconds to change to the advertising mode.

(3) Enter the measurement code and device number to connect to the device. Initial page Device connection Connection completed 22 5) Write a heart diary

(1) Click the + button to write the heart diary.

(2) Click to select symptoms and activities.

(3) Enter the start time and end time and click the complete button to record the heart diary. Add the symptoms and activities Select the symptoms and activities Enter the start time/end time Click complete

- Checking real-time ECG data Click the graph tab in the upper center to display ECG data for 30 seconds. When the display time is over, the screen changes to the heart diary. Click the graph Displays the ECG for 30seconds 23 Heart diary 6) Edit the heart diary

(1) Select the item that needs to be corrected in the heart diary.

(2) Click and edit symptoms and activities, then save or delete the contents. Select item Edit the symptoms Complete editing or and activities delete 7) Transfer the heart diary

(1) Click Transfer diary button in Settings. A pop-up window will appears.

(2) Click Transfer diary button in the pop-up window.

(3) When data transmission is completed, click OK to move to the heart diary page. Click Transfer diary Click Transfer diary Click OK to move to button button 24 the heart diary page

(4) App termination proceeds with the app termination process of each OS. 8) Data upload 1) When the test is completed, open the battery cover, remove the battery, and close the cover. 2) Run the Data upload program on the PC. 3) Connect PC and cradle with USB cable for data transmission. 4) After mounting the main body on the cradle, check if the main body is connected to the data upload program.

(Please pay attention to the orientation when attaching the body to the cradle. If the body is still operating without removing the battery, it may take several seconds longer) 5) Click upload in Data upload program. 6) When data transmission is completed, remove the main unit from the cradle and close the data upload program. Run the program Connect the Cradle and the PC with the cable Mount the main body on the Cradle Data download Data upload Data transmission completed and close the program 25 4.2. Specifications Model mobiCARE-MC200M / mobiCARE-MC200ML /

mobiCARE-MC200M7 / mobiCARE-MC200ML7 MAIN body : 32mm x 49mm (t=10mm) BATTERY Body Size 1) mobiCARE-MC200(M/ML) : 39mm (t=12.8mm) 2) mobiCARE-MC200(M7/ML7): 39mm (t=15.5mm) Main body connection line 1) mobiCARE-MC200M, mobiCARE-MC200M7: 180mm 2) mobiCARE-MC200ML, mobiCARE-MC200ML7: 250mm Cradle : 76mm x 60mm (t=17.4mm) 1) mobiCARE-MC200M : 20g (without battery) 2) mobiCARE-MC200M7 : 21g (without battery) Weight 3) mobiCARE-MC200ML : 22g (without battery) 4) mobiCARE-MC200ML7 : 23g (without battery) 5) mobiCARE-Cradle : 200g 1) mobiCARE-MC200M, mobiCARE-MC200ML

: Min. 7 days (continuously) 2) mobiCARE-MC200ML, mobiCARE-MC200ML7

: Min. 10 days (continuously) Monitoring Time Expected service life About 2 years Sampling 256 Samples/Second Range of filter 0.05~55Hz Signal Measurement Continuous measurement time mobiCARE-MC200(M/ML): 7 days mobiCARE-MC200(M7/ML7): 10days

(replaceable) Consumption power 1.4mW Power Main unit 3VDC (coin type) Battery mobiCARE-MC200(M/ML):CR2450R mobiCARE-MC200(M7/ML7):CR2477 Protective degree Internal powered, CF type Communication communication Data Bluetooth 5.1 (Bluetooth Smart) Transfer distance 10m [LOS(Line of sight) condition]

26 Device Firmware mobiCARE Firmware (v1.0.0) Software App software mobiCARE Cardio Hospital (v1.0.0) mobiCARE Cardio Diary (v1.0.0) Web software mobiCARE Web Service (v1.0.0) Minimum OS specification of Smart device RAM 2GB Inside Memory 16GB Android 7.0 (over) iOS 12.0 (over) mobiCAREC-MC200M / mobiCAREC-MC200ML /

Component mobiCARE-MC200M7 / mobiCARE-MC200ML7, Coin Battery 1EA, Manual, Open Tool Operating Environment Operation Storage/Transport Temperature 5 ~ 40

-25 C to + 5 C , and Humidity 10 ~ 95%R.H

+5 C to + 35C at a

(Non-condensing) relative humidity up to 90%, non-condensing;

Atmospheric 700 ~ 1060

>35C to 70C at a pressure hPa water vapour pressure up to 50hPa IP grade IP44 Technical Characteristic Heart Rate Range 30 ~ 280bpm Heart Rate 30 ~ 120 2bpm Accuracy

<120 ~ 280 3bpm RF Frequency 2.4 GHz band RF Output Power Max. 0 dBm Manufacturer/country Seers Technology Co., Ltd / KOREA 4.3. Maintenance For cleaning, gently wipe the mobiCARE-MC200M series with medical grade disinfectant. DO NOT immerse the mobiCARE-MC200M series is water resistant, but should be kept dry. This device does not have user serviceable components. Do not disassemble, crush, puncture, short external contacts or circuits, dispose of in fire or water. 4.4. Specification of External Device connection 27 The mobiCARE-MC200M series is connect to the Android & iOS Application. The data indicating the status of the device is transmitted to the application from the device. The required specification of the interface

- Main Device / Mobile App interface

- Data format : Bluetooth

- Mobile Application : Application on based Android & iOS

- Device status information

- Device information (Bringing information when connecting to BLE)

- Battery information (Bringing information when connecting to BLE)

- Data to Device External memory

- Transmits the data to server 4.5. Error Message & Troubleshooting 4.5.1. Error Message & LED Display Message & LED Description Solution Check the status Cant connect to a Check the patch connection of the device patch status . Check the battery level and replace it if it is insufficient. Check the signal strength and replace the device if the error continues. Battery status Battery remaining Replace the battery. less than 100%

Patch signal No ECG Signal Check if the electrode is properly status connected and make sure that the attachment is correct. Orange LED External memory Check if the external memory is lights up during error properly installed in the product measurement socket and the installation status is correct. Orange LED No ECG Signal Check if the electrode is properly blinks during measurement connected and make sure that the attachment is correct. Green LED Bluetooth If the distance between the 28 blinks disconnected product and the mobile device is periodically during measurement far, the Bluetooth signal weakens and the connection can be lost. When writing a heart diary, it is recommended that the product and mobile device be kept close each other. Battery level is Battery remaining Recommended to replace the low. less than 10 battery. 4.5.2. Troubleshooting Problem Cause Solution If the device does not work even if you press the power button for more than 3 seconds Battery Replace the battery If the battery cover Battery does not close mounting When searching for mobiCARE-MC200M mobiCARE-

series in mobile APP, MC200M and mobiCARE-

series Power mobiCARE-MC200M and status series is not found Check the mark on the part to be fastened with the battery cover, connect it correctly, and then fasten again. Check if the power of mobiCARE-MC200M series is turned on. or check if mobiCARE-

mobiCARE-MC200M series is in Advertising mode. If not in Advertising mode, mobiCARE-MC200M series will not be searched. Mobile app says there Unregistered Verify that the entered is no measurement measurement measurement code is code code generated. An error occurs while sending the heart diary Check if the current Network network environment is normal. If the Wi-Fi signal 29 is weak, we recommend turning off Wi-Fi and using LTE or 3G, or moving to an area with a strong Wi-Fi signal to transmit. 30 5. Labels and Packaging 5.1. Labels 5.1.1. Device Label MAIN BODY BOTTOM MAIN BODY TOP BATTERY BODY BOTTOM

(1) Barcode format A B C D E F Name of 2-digit 2-digit identificati productio productio on n year n month GHIJKL

SN

- AB : 2-digit Name of identification (mobiCARE-MC200M series SD)

- CD : 2-digit production year. (2021 year 21)

- EF : 2-digit production month (January 01, April 04, October 10, November 11, December 12)

- GHIJKL : Convert the back five digits of the MAC Address into a decimal number and use the back six digits as the device number. ex) mobiCARE-MC200M series January 2021 Products produced by Seers Technology + Mac Address (08:D5:C0:70:74:23) SD2101-029731 31 5.1.2. Gift Box label

(1) mobiCARE-MC200M

(2) mobiCARE-MC200ML 32

(3) mobiCARE-MC200M7

(4) mobiCARE-MC200ML7 The barcode label on the gift box is the same as the barcode on the product label 33

(5) Barcode Format A. Product identifier code AB C DEF GHIJK LMNO P Application Logistics Country Company Product Parity Identifier identifier code code code bit

- AB : 01 (2-digit Application Identifier code)

- C : 0 (1-digit Logistics identifier code)

- DEF : 880 (Country code)

- GHIJK : 00964 (Company code)

- LMNO : 4-digit product code

- P : 1-digit parity bit Serial numbers are assigned from right to left including check digits. Add up all the even numbers. Multiply the result of step 2 by 3. Sum all the remaining numbers (odd number excluding check digits). Sum the result of step 3 and the result of step 4. The maximum value added to the result of step 5 to be a multiple of 10 is the check digit. Here, if the result of step 5 is a multiple of 10, the check digit is 0. B. Lot number A B C D E F G H Application Name production production Identifier identification year month

- AB : 10 (2-digit Application Identifier code)

- CD : 2-digit Name of identification (mobiCARE-MC200M series SD)

- EF : 2-digit production year. (2021 year 21)

- GH : 2-digit production month.(January 01, September 09, November 11, December 12) C. Serial number A B C D E F G H Application Identifier Serial number

- AB : 21 (2-digit Application Identifier code) 34

- CDEFGH : Convert the back five digits of the MAC Address into a decimal number and use the back six digits as the device number. 5.2. Packaging 5.2.1. Packing List Classifications Components Quantity Gift Box mobiCARE-MC200M /

mobiCARE-MC200ML /

mobiCARE-MC200M7 /

mobiCARE-MC200ML7 product Battery Manual Open Tool Cradle 1 1 1 1 1 5.2.2. Packing Unit 1) mobiCARE-MC200M / mobiCARE-MC200ML / mobiCARE-MC200M7 /

mobiCARE-MC200ML7 product Main Product 2) Battery 1 Coin Cell battery is shipped at package 3) Manual 4) Open Tool 5) Cradle 6. Expected Service Life time and Warranty 6.1. Product Warranty 1) The product is guaranteed to be free of manufacturing defects and has a limited warranty for 1 year from the date of purchase 2) Damage or malfunction of the device to the following conditions are excluded from the warranty.

- Normal wear and tear of the product from normal daily usage

- Product damage due to improper storage

- Product damage due to improper usage

. 35 7. Manufacture Information Seers Technology Co., Ltd.

(Sangdaewon-dong, techcenter 1314), 124, Sagimakgol-

ro, Jungwon-gu, Seongnam-si, Gyeonggi-do, Korea Tel) +82-31-8023-9811 Fax) +82-31-8023-9812 Inter KOTRA GmbH Kurfurstenplatz 34 D-60486 Frankfurt am Main Germany Phone +49 (0)49-71675855 / Fax +49 (0)49-778918 Mobile +49 (0)173-3085294 /

E-mail) pauluskwon@interkotra.de 36 8. Declaration of Conformity 8.1. Electromagnetic Compatibility It has been independently tested and it manufactured in compliance with the following EMC standard IEC 60601-1-2:2014 Guidance and manufacturer declaration electromagnetic emissions The mobiCARE-MC200M series is intended for use in the electromagnetic environment specified below. The customer or the user of the mobiCARE-MC200M series should assure that it is used in such an environment Emissions test RF emissions CISPR 11 RF emissions CISPR 11 Harmonic emissions IEC 61000-3-2 Voltage fluctuations/

flicker emissions IEC 61000-3-3 Compliance Electromagnetic environment-

guidance The mobiCARE-MC200M series use RF energy only for its internal function. Group 1 Therefore, its RF emissions are very low and are not likely to cause any interference in nearby electronic equipment. Class B The mobiCARE-MC200M series must be used only in a shielded location

with a minimum RF shielding effectiveness and, for each cable that exists the shielded location, a minimum RF filter attenuation of 13dB from 30MHz to 1000MHz The mobiCARE-MC200M series, when installed in such a shielded location, is suitable for use in all establishments other than domestic and those directly connected to the public low-voltage power supply network that supplies buildings used for domestic purposes. 37 IEC 610 kV air Guidance and manufacturer declaration electromagnetic immunity The mobiCARE-MC200M series is intended for use in the electromagnetic environment specified below. The customer or the user of the mobiCARE-

MC200M series assure that it is used in such an environment Immunity IEC60601 Compliance test test level level Electrostatic discharge

(ESD) 00-4-2 8 kV contact 2, 4, 8, 15 kV air 8 kV contact 2, 4, 8, 15 transient/burst power supply

typical commercial Electromagnetic environment-

guidance Floors should be wood, concrete or ceramic tile. If floors are covered with synthetic material, the relative humidity should be at least 30%

Mains power quality should be that of a or hospital environment Mains power quality should be that of a

typical commercial or hospital environment Mains power quality should be that of a typical commercial or hospital Electrical fast 2 kV for IEC 61000-4-4 lines 1 kV line(s) Surge to line(s) IEC61000-4-5 2 kV line(s) to earth

<5% UT

(>95%dip in UT) for 0.5 cycle Voltage dips, short interruptions and voltage variations on power supply lines IEC6100-4-11 40% UT

environment

(60% dip in UT) for 5 cycles 70% UT 38 If the user of the mobiCARE-

mobiCARE-MC200M series requires

(30% dip in UT) for 25 cycles

<5% UT

(>95% dip in UT) for 5 seconds Power frequency

(50/60Hz) Magnetic field IEC61000-4-8 3 A/m 3 A/m continued operation during power mains interruptions, it is recommended that the mobiCARE-

MC200M series be powered from an uninterruptible power supplied or a battery Power frequency magnetic fields should be at levels characteristic of a typical location in a typical commercial or hospital environment Note UT is the a.c. mains voltage prior to the application of the test level Guidance and manufacturer declaration electromagnetic immunity The mobiCARE-MC200M series is intended for use in the electromagnetic environment specified below. The customer or the user of the mobiCARE-

MC200M series should assure that it is used in such an environment Immunity IEC60601 Compliance Electromagnetic test test level level environment-guidance Conductive 3Vrms

Portable and mobile RF RF 150kHz communications IEC61000-4-6 to 80MHz equipment should be no closer to any part of the mobiCARE-MC200M series Including cables, than the recommended distances calculated from the 10V/m equation applicable to the 39 Radiated RF IEC61000-4-3 10V/m 80MHz to 2,700MHz frequency of the transmitter Recommended separation distance Where P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer and d is the recommended separation distance in metres(m). Field strengths from fixed RF transmitters, as determined by an electromagnetic surveya should be less than the compliance level in each frequency rangeb Interference may occur in the vicinity of equipment marked with the following symbol:

Note 1 At 80MHz and 800MHz the higher frequency range applies. Note 2 These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects and people. a Field strengths from fixed transmitted, such as base stations for radio

(cellular/cordless) telephones and land mobile radios, amateur radio, AM 40 and FM radio broadcast cannot be predicted theoretically with accuracy. To assess the electromagnetic environment in the location due to fixed RF transmitters, an electromagnetic site survey should be considered. If the measured field strength in the location in which the mobiCARE-

MC200M series is used exceeds the applicable RF compliance level above, the mobiCARE-MC200M series should be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as reorienting or relocating mobiCARE-MC200M series b Over the frequency range 150kHz to 80MHz, field strengths should be less than 3V/m. Recommended separation distances between portable and mobile communication equipment and the mobiCARE-MC200M series The mobiCARE-MC200M series is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of the mobiCARE-MC200M series can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communication equipment (transmitters) and mobiCARE-MC200M series as recommended below, according to the maximum output power of the communications equipment. Rated maximum output power of transmitter Separation distance according to frequency of transmitter (m) 150kHz to 80MHz to 800MHz to 2.5GHz 80MHz 800MHz W 0.01 0.1 1.0 10 100 0.12 0.38 1.2 3.8 12 0.12 0.38 1.2 3.8 12 0.23 0.73 2.3 7.3 23 For transmitter rated at a maximum output power not listed above, the recommended separation distance d in meters (m) can be estimated using the equation applicable to the frequency of the transmitter, where 41 P is the maximum output power of the transmitter in watts (W) according to the transmitter manufacturer. Note 1. At 80MHz and 800MHz the higher frequency range applies. Note 2. These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects and people. FCC Part 15.105 The mobiCARE-MC200M series 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. The mobiCARE-MC200M series 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 mobiCARE-MC200M series 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. The mobiCARE-MC200M series comply with part15 of FCC Part FCC rules. 15.19(a) Operation is subject to the following two conditions:

- This device may not cause harmful interference. 42

- This device & its accessories must accept any interference received, including interference that may cause undesired operation. The mobiCARE-MC200M series may generate or use radio frequency energy. Changes or modifications to mobiCARE-MC200M series may cause harmful interference unless the modifications are expressly approved in the instruction manual. This user could lose the authority to operate mobiCARE-MC200M series if an unauthorized change or modifications is made. FCC Part 15.21 Wireless Tx/Rx frequency 2402-2480 MHz information The mobiCARE-MC200M series can be operated in at CE least one Member State without infringing applicable requirements on the use of radio spectrum. 43 Seers Technology MANUFACTURER Seers Technology Co., Ltd. 1314, SKnTechnopark, Tech-dong, 124, Sagimakgol-ro, Jungwon-gu, Seongnam-si, Gyeonggi-do, South Korea 44

FCC ID : QN8MC200M SAMPLE LABEL & LOCATION LABELLING REQUIREMENTS The Label shown shall be permanently affixed at a conspicuous location on the device and be readily visible to the user at the time of purchase. Sample label Location

- The FCC label shown is representative of the label that will appear on the radio when in production. Other information may also be included on this label. Copyright 2021, DT&C Co., Ltd.

Seers Technology Co., Ltd.

(Sangdaewon-dong, techcenter 1314) 124, Sagimakgol-ro, Jungwon-gu, Sungnam-si, Gyeonggi-do, South Korea Date: 04/20/2021 Timco Engineering, Inc. 849 N.W. State Road 45 P.O. Box 370 Newberry, Florida 32669 USA RE: Request of Confidentiality for FCC ID: QN8MC200M To Whom It may Concern:

Pursuant to Sections 0.457 and 0.459 of the Commission`s Rules(CFR 47), and Section 552 (b) (4) of the Freedom of Information Act, Seers Technology Co., Ltd. hereby requests confidentiality and treatment of certain information accompanying this application. The materials contain trade secrets and proprietary information not customarily released to the public. The public disclosure of these matters might be harmful to the Applicant and provide unjustified benefits to its competitors. We are also hereby request Short-Term Confidentiality for 180 days after the grant as outlined in Public Notice DA 04-1705. This provision will give Seers Technology Co., Ltd. temporary confidentiality of commercially sensitive information prior to product release. The requested permanent and Short-Term Confidential exhibits are listed as follows:

Description PERMANENT & SHORT-TERM CONFIDENTIAL LIST PERMANENT SHORT-TERM Exhibit 1 2 3 4 5 6 7 8 9 Block Diagram Schematics Part Lists Operation Description NA Internal Photos External Photos Test-Setup Photos User Manual The Applicant understands that pursuant to Rule 0.457, disclosure of this application and all accompanying documentations, where applicable, will not be public before the date of the Grant for this application. Sincerely, Name: Dae Yeop, Kang Position: president

Seers Technology Co., Ltd.

(Sangdaewon-dong, techcenter 1314) 124, Sagimakgol-ro, Jungwon-gu, Sungnam-si, Gyeonggi-do, South Korea Date: 04/20/2021 Timco Engineering, Inc. 849 N.W. State Road 45 P.O. Box 370 Newberry, Florida 32669 USA Letter of Authorization We, the undersigned, hereby authorize Geunki Son of DT&C Co., Ltd. to act on our behalf in all manners relating to application for equipment authorization for FCC ID: QN8MC200M including signing of all documents relating to these matters. Any and all acts carried out by Geunki Son of DT&C Co., Ltd. on our behalf shall have the same affect as acts of our own. This authorization is valid until further written notice from Seers Technology Co., Ltd. I, the undersigned, hereby certify that we are not subject to a denial of federal benefits, that includes FCC benefits, pursuant to Section 5301 of the Anti-Drug Abuse Act of 1988, 21 U.S.C. 853(a). Sincerely, Name: Dae Yeop, Kang Position: president