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HUINNO MEMO Patch M User Manual

Ambulatory ecg monitor
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MPT-E08R-UNC01
User Manual
Ambulatory ECG Monitor
Trade/Device Name: MEMO Patch M
Model Name: MPT-E08R-UNC01
Document Number: UM-M-002
Revision Number: 0
Revision Date: July 15, 2024
UM-M-002
Page 1 / 73
HUINNO Co., Ltd.

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  • Page 1 MPT-E08R-UNC01 User Manual Ambulatory ECG Monitor Trade/Device Name: MEMO Patch M Model Name: MPT-E08R-UNC01 Document Number: UM-M-002 Revision Number: 0 Revision Date: July 15, 2024 UM-M-002 Page 1 / 73 HUINNO Co., Ltd.

  • Page 2: Table Of Contents

    Review with Web viewer ........................35 STATEMENTS AND TABLES FOR EMC ..................... 47 Table1 – ELECTROMAGNETIC EMISSIONS for MEMO Patch M (MPT-E08R-UNC01) ....47 Table2 – Electromagnetic IMMUNITY for MEMO Patch M (MPT-E08R-UNC01) ......48 TROUBLE SHOOTING GUIDE ......................51 Trouble shooting ............................
  • Page 3 7.11 Pause Determination ..........................70 PRODUCT WARRENTY ........................71 Warranty Claim ............................71 Warranty Coverage ........................... 71 Warranty Exclusion ........................... 71 Warranty Period ............................71 Warranty Card ............................72 REVISION HISTORY ..........................73 UM-M-002 Page 3 / 73 HUINNO Co., Ltd.

  • Page 4: Device Overview

    The MEMO Patch M has Bluetooth module to verify ECG signals with mobile device and to authenticate the activation of MEMO Patch M. The device is in the form of an ECG patch that records ECG signals. As well the patch connects with a cradle and transmits ECG data via USB communication to PC.

  • Page 5: Marks And Symbols

    1.3.3 Indications for Use The MEMO Patch M is intended to record and store single-channel electrocardiogram (ECG) data which are transferred to PC via USB transmission. As well the monitor is intended for use by healthcare professionals. The ECG data is not intended for automated analysis. The device has not been tested and it is not intended for pediatric use.
  • Page 6 Single-use only for electrodes Keep away from direct sunlight Unique Device Identification Direct Current WEEE Recycling Non-ionizing electromagnetic Expiration date radiation Batch code Model Number Handle with care This way up Fragile Keep dry UM-M-002 Page 6 / 73 HUINNO Co., Ltd.

  • Page 7: Safety Requirements

    If skin irritation such as severe redness, itching or allergic symptoms develop, remove the device from the patient’s chest. Call HUINNO Customer Service at +82.2.3443.3160 If a user who is not familiar with the proper usage replaces the battery of the product, there is a risk of battery ignition or explosion.
  • Page 8 If electrode is not contact well with the skin the performance and accuracy of the ECG test might not accurate. 20. When the abnormality is found during the examination, keep the patient in safe status and stop the examination. UM-M-002 Page 8 / 73 HUINNO Co., Ltd.

  • Page 9: Network

    MPT-E08R-UNC01 21. Exposure of attachment parts or other accessories of the product for a long period of time may cause skin irritation. If the skin irritation is severe, please contact HUINNO Customer Service at +82.2.3443.3160 immediately. 22. Allergic reactions may occur to the tape on the electrodes used in the product.
  • Page 10 This equipment should be installed and operated with minimum distance 5 mm between the radiator and your body. This transmitter must not be co-located or operating in conjunction with any other antenna or transmitter. UM-M-002 Page 10 / 73 HUINNO Co., Ltd.

  • Page 11: Package Components

    Information for 3M red dot (model name: 2560) ⚫ 510(k) Number : K970796(1997.4.9.) Device name: 3M Red Dot™ 2560 Monitoring Electrode with Foam Tape and Sticky Gel Biocompatibility Evaluation Criteria: ISO 10993-1 Part-1 UM-M-002 Page 11 / 73 HUINNO Co., Ltd.

  • Page 12: Ambulatory Ecg Monitor

    Electrode connection This is the part used to connect the electrodes to the device. ➃ ➄ Battery cover This is the cover that is detached when replacing the battery. UM-M-002 Page 12 / 73 HUINNO Co., Ltd.

  • Page 13: Ecg Monitoring Electrodes

    This is the part that uses hydrogel and transmits the ➁ Electrode electrocardiogram signal from the human body. ECG Data Transferred Cradle (1port) Term Description UM-M-002 Page 13 / 73 HUINNO Co., Ltd.

  • Page 14: Electrode Bracket

    ➃ Connecting wire name: 2560) Battery cover opener Tool for opening the battery cover of the Ambulatory ECG Monitor Labeling and Packaging 3.6.1 Device Label Position Main Body Top Main Body Bottom UM-M-002 Page 14 / 73 HUINNO Co., Ltd.
  • Page 15 MPT-E08R-UNC01 Device Serial No: Device Label PXXXXXXX ECG Data Transferred Cradle ECG Data Transferred Cradle Position Bottom UM-M-002 Page 15 / 73 HUINNO Co., Ltd.
  • Page 16 MPT-E08R-UNC01 Device Device Label UM-M-002 Page 16 / 73 HUINNO Co., Ltd.
  • Page 17 MPT-E08R-UNC01 3.6.2 Package (Gift Box) Label Main body ECG Monitoring Electrodes ECG Data transferred Cradle UM-M-002 Page 17 / 73 HUINNO Co., Ltd.
  • Page 18 MPT-E08R-UNC01 Electrode bracket UM-M-002 Page 18 / 73 HUINNO Co., Ltd.

  • Page 19: Usage

    Creating account and Accessing 4.1.1 Accounting Setting 1. To use the service, the clinic needs to obtain an account from HUINNO. With an account, the clinic can access and operate our system, including ‘web viewer’, ‘MEMO Launcher’, and the ‘MEMO Patch ECG Dataloader’.
  • Page 20 Follow the link to set your password, and then log in.” 2. After entering the login credentials (email address and password) issued by HUINNO, click the login button. • 3. To manage user settings, click the ▼ button in the...

  • Page 21: When Visiting A Patient

    HUINNO. Note: Login informatio n is provided only to h ospitals that have contr acted with HUINNO ser vices. When visiting a patient To attach the Ambulatory ECG Monitor, follow the steps blow 4.2.1 Patient registration in web viewer 4.2.2 Preparing for patch attachment...
  • Page 22 ‘Add’ button. (1) Patient Name (2) Patient ID (3) Gender (4) Date of Birth (5) Phone Number (6) Test Duration (7) Prescribed by (8) Pacemaker (9) Note UM-M-002 Page 22 / 73 HUINNO Co., Ltd.
  • Page 23 Preparing for patch attachment 4.2.2 Prepare Ambulatory ECG Monitor, electrode, new Select and prepare the electrode to attach.  battery and battery cover ECG Monitoring opener Electrode bracket and 3M red dot Electrodes UM-M-002 Page 23 / 73 HUINNO Co., Ltd.
  • Page 24 ‘MEMO Launcher’ App The device is turned on within 5 minutes of by pressing the Power turning it on. Button for 3 seconds. UM-M-002 Page 24 / 73 HUINNO Co., Ltd.
  • Page 25 2. Click ‘Start a new please make sure the Bluetooth examination’, then select and function on your mobile device is click the patient registered for enabled. examination on the web viewer. UM-M-002 Page 25 / 73 HUINNO Co., Ltd.
  • Page 26 English letter ‘P’ and 3. Check the serial number of numbers and can be found on the front the 'MEMO Patch M' to be of Ambulance ECG Monitor. attached to the patient. 4. Select the serial number of the patch to attach to the patient from the list and pair.
  • Page 27 4) Check the location with the best signal using a temporary 3) Remove the white protective attachment between film on the back of the clavicle and nipple on the left electrodes. side of the patient’s chest. UM-M-002 Page 27 / 73 HUINNO Co., Ltd.
  • Page 28 Ambulatory ECG Monitor to the left side of the patient’s chest between the clavicle and nipple. 4) To prevent the electrode from falling off, press the entire adhesive area to adhere it to the skin. UM-M-002 Page 28 / 73 HUINNO Co., Ltd.
  • Page 29 8. After pressing the 'Done' button, finish the process. 9. When the examination has started, the status will change to 'Test In progress' on the UM-M-002 Page 29 / 73 HUINNO Co., Ltd.
  • Page 30 ● Patient note: Record sleep time and sy mptoms. ● MEMO Patch M storage envelope: Used to return the device to the hospita l. Please put the detached device into th e envelope and return it.

  • Page 31: Procedures After Completing The Examination

    3. After the ECG analysis is completed, schedule a treatment day and return home. 4.3.2 Clinic : Checking the ‘MEMO Patch M’ device, processing returns, and uploading data 1 After checking the appearance of the device and the electrode bracket for abnormalities, disinfect them...
  • Page 32 Patch M will be displayed. Then, click the download button. 7 When the download is successfully completed, a 'Done' message will appear. On the memo web, the status changes from waiting for upload to Cloud Analysis. UM-M-002 Page 32 / 73 HUINNO Co., Ltd.
  • Page 33 Relative humidity: 10% to 95% (non-condensing)  Transport The device should be stored in the room without acid, alkali, and harmful  gas. Avoid exposure to violent vibration, rain, sunshine, and high humidity  during transportation. UM-M-002 Page 33 / 73 HUINNO Co., Ltd.
  • Page 34 Reuse of electrodes is prohibited and discarded after Disposal use. Follow local, state, and national governing ordinances and recycling  instructions regarding disposal or recycling of the device components. UM-M-002 Page 34 / 73 HUINNO Co., Ltd.

  • Page 35: Review With Web Viewer

    • Prescribed Date: The period for which the patient was prescribed the examination. • Examination Period: The duration from when the patient started wearing the ‘MEMO Patch M’ to just before removal. • Analysis Period: The period during the examination period that was analyzed, excluding any noise or lead-of f periods.
  • Page 36 (3) Set Max/Set Min: Sets the maximum or minimum R-R value for the inspection. (4) Unset: Set Max/Set Min: After functional operation, it can be restored to the Min or Max range before the cha nge. UM-M-002 Page 36 / 73 HUINNO Co., Ltd.
  • Page 37 When selecting the section to edit the event, click the starting point, hold down the Shift button, and select the last point. In addition, you can select an event by selecting a beat or selecting an episode. UM-M-002 Page 37 / 73 HUINNO Co., Ltd.
  • Page 38 NOTE: To add the strip on the report, follow the process as below ** After selecting the event to include in the report, click the strip and, click ‘+Add to a report’ UM-M-002 Page 38 / 73 HUINNO Co., Ltd.
  • Page 39 MPT-E08R-UNC01 * Select the page to contain in the final report, and click ‘Next’ * Enter the title of the strip, and choose a range of 10 seconds, and click ‘Complete’ UM-M-002 Page 39 / 73 HUINNO Co., Ltd.
  • Page 40 The number of notifications that have not been checked in the top notification center icon (1) is displayed. In the check list below, the check that receives notifications is marked with an orange highlight (2), along with the icon. UM-M-002 Page 40 / 73 HUINNO Co., Ltd.
  • Page 41 Enter the Notification Center and click the (1) View All Notifications button at the top or (2) View All Notifications at the bottom of the list to go to the Details page where you can view all notifications. UM-M-002 Page 41 / 73 HUINNO Co., Ltd.
  • Page 42 The first page of the report is structured as follows and provides a summary of the ECG analysis results. * NOTE: The data shown is from a sample report and does not represent real patient data The detailed descriptions for each component are as follows. UM-M-002 Page 42 / 73 HUINNO Co., Ltd.
  • Page 43 Summary of key information about events found in the test ⚫ Written after Medical Affair Team completes the analysis ⚫ Plays the role of quickly conveying the most essential information during a short treatment time UM-M-002 Page 43 / 73 HUINNO Co., Ltd.
  • Page 44 Atrial fibrillation ( ≥ 30 sec) A.fib episodes: Number of episodes lasting more than 30 seconds among A.fib episodes  % : Ratio of A.fib time lasting more than 30 seconds during the entire analysis  period UM-M-002 Page 44 / 73 HUINNO Co., Ltd.
  • Page 45 Beats excluding Q Beats • Beats: Number of VPC/APC (Isolated+couplet) Beats Isolated • % : Ratio of the number of Isolated VPC/APC Beats to the total number of Beats excluding Q Beats UM-M-002 Page 45 / 73 HUINNO Co., Ltd.
  • Page 46 A strip of the most clinically significant arrhythmia event found in the test Rhythm Strips • Typically displays 3 strips and can display up to 10 strips • Different information is displayed depending on the type of each event. UM-M-002 Page 46 / 73 HUINNO Co., Ltd.

  • Page 47: Statements And Tables For Emc

    30 cm (12 inches) to any part of the MPT-E08R- UNC01, including cables specified by the HUINNO. Table1 – ELECTROMAGNETIC EMISSIONS for MEMO Patch M (MPT-E08R-UNC01) Guidance and manufacturer’s declaration – electromagnetic emissions Ambulatory ECG Monitor (MPT-E08R-UNC01) is intended for use in the electromagnetic environment specified below.
  • Page 48 MPT-E08R-UNC01 such as re-orienting or relocating the device or shielding the location Table2 – Electromagnetic IMMUNITY for MEMO Patch M (MPT-E08R-UNC01) Guidance and manufacturer’s declaration – electromagnetic immunity The Ambulatory ECG Monitor (MPT-E08R-UNC01) is intended for use in the electromagnetic environment specified below.
  • Page 49 MPT-E08R-UNC01 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 MPT-E08R-UNC01, including cables specified by the HUINNO. IEC 60601 Compliance Immunity test...
  • Page 50 217 Hz These guidelines may not apply in all situations. Electromagnetic propagation is affected by NOTE: absorption and reflection from structures, objects and people. For some services, only the uplink frequencies are included. UM-M-002 Page 50 / 73 HUINNO Co., Ltd.

  • Page 51: Trouble Shooting Guide

    The e-mail or password you entered does not match. To retrieve your account, email Please check your account information and try again. sales@huinno.com and we will help you. Your account is dormant. Your account has been To continue the service, contact inactive because you haven't used the service for over sales@huinno.com to terminate the dormant...
  • Page 52 Couldn't connect There was a problem communicating with the server. Please try again later. Login Import complete The data is entirely imported. System Error Restart the program to solve the unexpected error. UM-M-002 Page 52 / 73 HUINNO Co., Ltd.
  • Page 53 Check the internet connection and re-log in. the Internet status. Unable to find file to upload. Please check the upload file. Your login time has expired. Please log in To continue service, log in. again… Web viewer UM-M-002 Page 53 / 73 HUINNO Co., Ltd.
  • Page 54 Unable to Edit Test Ensure the correct test row is selected for 4.4.1 Edit and Information editing. publish ‘Web 2. Carefully follow the steps to access and use viewer’ reports the Edit icon. UM-M-002 Page 54 / 73 HUINNO Co., Ltd.
  • Page 55 4.4.1 Edit and Working 2. Review user guides to understand the publish ‘Web purpose of navigation buttons. viewer’ reports 3. Wait for a moment or refresh the page to update the test count. UM-M-002 Page 55 / 73 HUINNO Co., Ltd.
  • Page 56 ECG strip exploration. 4.4.1 Edit and 2. Try accessing the feature from a different publish ‘Web browser or device. viewer’ reports 3. Refresh the page or wait for the system to load ECG strips. UM-M-002 Page 56 / 73 HUINNO Co., Ltd.
  • Page 57 4.4.1 Edit and 2. Check internet connectivity and reload the publish ‘Web page if HRV data does not load completely. viewer’ reports 3. Understand the significance of blue dots as indicators of patient-triggered events. UM-M-002 Page 57 / 73 HUINNO Co., Ltd.
  • Page 58 Check system and browser compatibility for Download Report viewing the report. 4.4.1 Edit and 2. Ensure a stable internet connection for publish ‘Web seamless report download. viewer’ reports 3. Verify user permissions to access and download reports. UM-M-002 Page 58 / 73 HUINNO Co., Ltd.
  • Page 59 Ensure the "Complete" button is clicked after Review the review. 2. Refresh the page and attempt the completion process again. 3. Follow the correct sequence of steps for completing the test review. UM-M-002 Page 59 / 73 HUINNO Co., Ltd.

  • Page 60: Faqs

    When you press and release the button for 1 second, the Green LED will flash once. 3. How can you confirm if the connections are secure? If the connections are unstable, the orange LED will blink once every 3 seconds. UM-M-002 Page 60 / 73 HUINNO Co., Ltd.
  • Page 61 If the green LED does not Patient Questions flash, please contact the HUINNO customer service at 02-3443-3160. If the device is not activated, the green LED will flash every 5 seconds, and the power will turn off after 5 minutes.
  • Page 62 *However, it is okay to use the devices after unplugging the power cord. **Use of electric cars, microwave ovens, and induction cooktops do not affect the Ambulatory ECG Monitor and are okay to use. UM-M-002 Page 62 / 73 HUINNO Co., Ltd.
  • Page 63 13. Is it okay to board a plane while wearing the patch? Are there any issues going through airport security? No, there is no issue. There might be some additional noise in the signal or alterations in the ECG waveform, which do not impact the analysis UM-M-002 Page 63 / 73 HUINNO Co., Ltd.
  • Page 64 15. If I have any questions during the test, where can I call? Call HUINNO customer service. Depend on the question, you may also need to contact the hospital directly. 1. What is Web viewer? Web viewer is a comprehensive remote patient monitoring solution •...
  • Page 65 Event Review feature. 10. How do I generate and view reports in Web viewer? To view and download reports: • 1. Click the "View Report" button. 2. Click the "Download Report" button. UM-M-002 Page 65 / 73 HUINNO Co., Ltd.

  • Page 66: Device Specification

    Follow the necessary steps to make adjustments. To receive support for installation, use, or maintenance of the device, or to report unexpected behavior or events, please contact HUINNO's customer service. Customer service operate from 09:00 to 18:00 on weekdays, with a one-hour lunch break from 12:00 to 13:00, closed on holidays and weekends (KST).

  • Page 67: Power Characteristics

    Data transferred cradle (1port) Dimensions 41.5mm(W) x 44.8mm(D) x 13.9mm(H), 30g Wireless communication characteristics Frequency, number of channels and 2.4 GHz radio transceiver the band Number of Channels: 40 (2402-2480MHz) Bandwidth of the receiving section UM-M-002 Page 67 / 73 HUINNO Co., Ltd.

  • Page 68: Compatible Devices

    10% to 95% (non-condensing) Operation, transport and storage Pressure 700hPa – 1060hPa Shipping and transporting Temperature -20℃ - 60℃ IP classification IP27 *Note: avoid exposure to violent vibration, rain, sunlight and high humidity during transportation. UM-M-002 Page 68 / 73 HUINNO Co., Ltd.

  • Page 69: Minimum Specification For Software

    • Low Battery • Orange LED, flashing Twice every 6 seconds • Reset due to malfunctioning When Device reset • White LED On -> Reset-> Power on and Green LED flashing Once UM-M-002 Page 69 / 73 HUINNO Co., Ltd.

  • Page 70: 7.10 Heart Rate Calculation

    The average overall heart rate (ex. Duration-weighted average of all rhythm episode heart rates within the record) 7.11 Pause Determination Pause is defined as an RR interval greater than 3 seconds. UM-M-002 Page 70 / 73 HUINNO Co., Ltd.

  • Page 71: Product Warrenty

    MPT-E08R-UNC01 PRODUCT WARRENTY Warranty Claim Contact the HUINNO customer service if you are unable to resolve the issue after reviewing the user manual. Warranty Coverage The warranty provides at no extra cost to the user. The device is warranted for a period of 1 year The device is warranted for the functional or performance defects arising when used for normal purposes in accordance with the user manual.

  • Page 72: Warranty Card

    3. Damage resulting from a force majeure event such as fire, explosion, storm, flood, earthquake, or other natural disasters 4. Removal, obliteration, or alteration of identification labels (Model Number, Serial Number etc.) of the product UM-M-002 Page 72 / 73 HUINNO Co., Ltd.

  • Page 73: Revision History

    MPT-E08R-UNC01 REVISION HISTORY Rev. Rev. Date Page(s) Affected Revision Description June 15, 2024 Newly Established UM-M-002 Page 73 / 73 HUINNO Co., Ltd.

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