Seers Medical mobiCARE-MC200M User Manual

Holter monitor

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Model name : mobiCARE-MC200M

Doc. No. : ST-UM-MC200Ms-HA[E]

Vev. No. : 1.0v

Issued date : 2020.01.25

User Manual

Holter Monitor

mobiCARE-MC200ML

mobiCARE-MC200M7

mobiCARE-MC200ML7

Table of Contents

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Summary of Contents for Seers Medical mobiCARE-MC200M

Page 1 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...
Page 2: Table Of Contents
Table of Contents PRODUCT INTRODUCTION ..................3 MEDICAL SAFETY ......................8 COMPONENTS AND INSTALLATION ..............13 HOW TO USE MOBICARE-MC200M SERIES ...........17 LABELS AND PACKAGING ..................31 EXPECTED SERVICE LIFE TIME AND WARRANTY .........35 MANUFACTURE INFORMATION ................36 DECLARATION OF CONFORMITY ................37...
Page 3: Product Introduction
250mm 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 /...
Page 4 - 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.
Page 5 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 :...
Page 6 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...
Page 7 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...
Page 8: Medical Safety
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.
Page 9 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.
Page 10 2.4.2. Conditions for Storage 1) -25 °C to + 5 °C , and 2) +5 °C to + 35°C at a relative humidity up to 90%, non-condensing; 3) >35°C to 70°C 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...
Page 11 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.
Page 12 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.
Page 13: Components And Installation
Main body A body including the mainboard Battery body A body to insert the battery Connecting cable between two bodies It differs between two model; mobiCARE-MC200M : 180mm Connecting cable mobiCARE-MC200M7 : 180mm, mobiCARE-MC200ML : 250mm mobiCARE-MC200ML7 : 250mm SOCKET...
Page 14 중량 모델명 단위 : mm 단위 : g mobiCARE- 12.8 MC200M mobiCARE- 12.8 MC200ML (Without Battery) (tolerance ± 10%) 중량 모델명 단위 : mm 단위 : g mobiCARE- 15.5 MC200M7 mobiCARE- 15.5 MC200ML7...
Page 15 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 Power supply for mobiCARE-MC200M series. Battery DC 3V Coin Battery. Battery is replaceable. mobiCARE-MC200M : CR2450R...
Page 16 The device must support Bluetooth Low Energy. 2) Install the downloaded file on user’s 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.
Page 17: How To Use Mobicare-Mc200M Series
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.
Page 18 (2) Attaching main body ① Remove the release paper on the contact surface of the electrode. ② 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.
Page 19 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.
Page 20 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.
Page 21 Third party information Live ECG graph to display provision agreement (5) After confirming that the ECG Data is displayed normally, click the End button to close the mobiCARE Cardio For Hospital App. Closing App...
Page 22 4) mobiCARE-MC200M series Connecting the device and diary app Launch the mobiCARE Cardio Diary App on the mobile device. Press and hold the device's Power button for more than 3 seconds to change to the advertising mode. Enter the measurement code and device number to connect to the device.
Page 23 5) Write a heart diary Click the “+” button to write the heart diary. Click to select symptoms and activities. Enter the start time and end time and click the complete button to record the heart diary. Select the Enter the start Add the symptoms symptoms and time/end time...
Page 24 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. Edit the symptoms Complete editing or Select item and activities delete 7) Transfer the heart diary (1) Click Transfer diary button in Settings.
Page 25 App termination proceeds with the app termination process of each 8) Data upload When the test is completed, open the battery cover, remove the battery, and close the cover. Run the Data upload program on the PC. Connect PC and cradle with USB cable for data transmission. After mounting the main body on the cradle, check if the main body is connected to the data upload program.
Page 26 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)
Page 27 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.
Page 28 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 &...
Page 29 If the battery cover Battery the battery cover, connect does not close mounting it correctly, and then fasten again. Check if the power of mobiCARE-MC200M series When searching for is turned on. mobiCARE-MC200M mobiCARE- or check if mobiCARE- series in mobile APP, MC200M...
Page 30 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.
Page 31: Labels And Packaging
- 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 →...
Page 32 5.1.2. Gift Box label (1) mobiCARE-MC200M (2) mobiCARE-MC200ML...
Page 33 (3) mobiCARE-MC200M7 (4) mobiCARE-MC200ML7 ※ The barcode label on the gift box is the same as the barcode on the product label...
Page 34 - 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 →...
Page 35: Expected Service Life Time And Warranty
Gift Box Battery Manual Open Tool Cradle 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 Expected Service Life time and Warranty 6.1.
Page 36: Manufacture Information
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...
Page 37: Declaration Of Conformity
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...
Page 38 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 Electromagnetic...
Page 39 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-...
Page 40 Radiated RF frequency of the IEC61000-4-3 10V/m transmitter 80MHz to Recommended separation 2,700MHz 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...
Page 41 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.
Page 42 Note 2. These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects and people. 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.
Page 43 This user could lose the authority to operate mobiCARE-MC200M series if an unauthorized change or modifications is made. Wireless Tx/Rx frequency 2402-2480 MHz information The mobiCARE-MC200M series can be operated in at least one Member State without infringing applicable requirements on the use of radio spectrum.
Page 44 Seers Technology MANUFACTURER Seers Technology Co., Ltd. 1314, SKnTechnopark, Tech-dong, 124, Sagimakgol-ro, Jungwon-gu, Seongnam-si, Gyeonggi-do, South Korea...

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