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.
Table of Contents 1. PRODUCT INTRODUCTION ...................................................................................... 3 2. MEDICAL SAFETY.......................................................................................................... 8 3. COMPONENTS AND INSTALLATION..................................................................13 4. HOW TO USE MOBICARE-MC200M SERIES ...................................................17 5. LABELS AND PACKAGING ................................
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.
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.
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.
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.
(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.
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.
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.
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 use of the equipment. 2.4.4. Conditions for Usage and Storage of Electrode 1) According to Manufacturer inspection of Electrode 2.5.
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.
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.
3. Components and Installation 3.1.
모델명 mobiCAREMC200M mobiCAREMC200ML A B C D E F mobiCAREMC200M7 mobiCAREMC200ML7 중량 단위 : g 32 180 39 48 10 12.8 285 20 32 250 39 48 10 12.8 355 22 (Without Battery) 모델명 G 단위 : mm (tolerance ± 10%) A B C D E F G 단위 : mm 중량 단위 : g 32 180 39 48 10 15.5 285 21 32 250 39 48 10 15.
(Without Battery) (tolerance ± 10%) 3.2. Cradle Label Name Description 1 USB CONNECTOR USB Connector to connect to PC 2 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 3 4 the insert pin of the main body 3.3. Component Label Name Description Power supply for mobiCARE-MC200M 1 Battery series.
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 user’s mobile device.
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.
(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. 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.
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.
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.
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.
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.
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 Enter the start symptoms and time/end time activities Click complete - Checking real-time ECG data Click the graph tab in the upper center to display ECG data for 30 seconds.
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.
(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.
4.2. Specifications Model mobiCARE-MC200M / mobiCARE-MC200ML / mobiCARE-MC200M7 / mobiCARE-MC200ML7 MAIN body : 32mm x 49mm (t=10mm) BATTERY Body 1) mobiCARE-MC200(M/ML) : Φ39mm (t=12.8mm) 2) mobiCARE-MC200(M7/ML7): Φ39mm (t=15.5mm) Size Main body connection line 1) mobiCARE-MC200M, mobiCARE-MC200M7: 180mm 2) mobiCARE-MC200ML, mobiCARE-MC200ML7: 250mm Cradle : 76mm x 60mm (t=17.
Device Firmware Software App software Web software specification of Smart device mobiCARE Cardio Hospital (v1.0.0) mobiCARE Cardio Diary (v1.0.0) mobiCARE Web Service (v1.0.0) Android 7.0 (over) OS Minimum mobiCARE Firmware (v1.0.0) iOS 12.0 (over) RAM 2GB Inside Memory 16GB mobiCAREC-MC200M / mobiCAREC-MC200ML / Component mobiCARE-MC200M7 / mobiCARE-MC200ML7, Coin Battery 1EA, Manual, Open Tool Operation Temperature 5 ~ 40℃ Humidity Operating Environment 10 ~ 95%R.
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.
blinks disconnected product and the mobile device is periodically far, the Bluetooth signal weakens during and the connection can be lost. measurement 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.
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.
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.
5.1.2.
(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 ① Serial numbers are assigned from right to left including check digits. ② Add up all the even numbers.
- 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 mobiCARE-MC200M / mobiCARE-MC200ML / mobiCARE-MC200M7 / Gift Box 1 mobiCARE-MC200ML7 product Battery 1 Manual 1 Open Tool 1 Cradle 1 5.2.2.
7. Manufacture Information Seers Technology Co., Ltd. (Sangdaewon-dong, techcenter 1314), 124, Sagimakgolro, 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.
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.
Guidance and manufacturer’ declaration – electromagnetic immunity The mobiCARE-MC200M series is intended for use in the electromagnetic environment specified below.
(30% dip in continued operation UT) during power mains for 25 cycles interruptions, it is <5% UT recommended that (>95% dip in the mobiCARE- UT) MC200M series be for 5 seconds powered from an uninterruptible power supplied or a battery Power frequency magnetic fields Power should be at levels frequency (50/60Hz) 3 A/m 3 A/m Magnetic field characteristic of a typical location in a typical commercial IEC61000-4-8 or hospital environment Note UT is the a.c.
Radiated RF IEC61000-4-3 frequency of the 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).
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 mobiCAREMC200M series is used exceeds the applicable RF compliance level above, the mobiCARE-MC200M series should be observed to verify normal operation.
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. 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.
- 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 FCC Part 15.21 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.
Seers Technology MANUFACTURER Seers Technology Co., Ltd.
