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Medtrum MD3660 User Manual

Continuous glucose monitoring system
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S9 CGM System
Continuous Glucose Monitoring System
User Guide
Simplifying Diabetes

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Summary of Contents for Medtrum MD3660

  • Page 1 S9 CGM System Continuous Glucose Monitoring System User Guide Simplifying Diabetes...
  • Page 2 S9 CGM System Continuous Glucose Monitoring System User Guide © 2023, Medtrum Technologies Inc. All rights reserved.
  • Page 3 Medtrum Technologies Inc. Building 3 and Building 8, No. 200, This product complies with Niudun Road Directive 93/42/EEC (MDD) and Shanghai 201203, China Directive 2014/53/EU (RED). Tel: +86-21-50274781 Fax: +86-21-50274779 REF MD1160 www.medtrum.com Version: 1.04 Publication date: 7 July 2023 Medtrum B.V.

  • Page 4: Table Of Contents

    1.4.5 Storage ..................5 1.5 Warranty Information ..............6 2 Basics of the CGM System ............8 3 How to Use Medtrum EasySense Mobile App ......10 3.1 Install the app ................10 3.2 Login/Register ................. 12 3.3 Main Menu ................16 3.4 Add Transmitter SN to Your Account ........
  • Page 5 4.2.6 Locate the Sensor Support Mount ........... 54 4.2.7 Insert the Sensor ..............54 4.2.8 Remove the Inserter..............55 4.2.9 Check the Sensor Support Mount ..........55 4.2.10 Discard the Sensor Inserter Safely ......... 56 4.3 Attach Your Transmitter ............56 Medtrum Simplifying Diabetes...
  • Page 6 7 Appendix I: Symbols and Icons ..........66 8 Appendix II: Technical Information ......... 68 8.1 Transmitter Specifications ............68 8.2 Glucose Sensor Specifications ........... 68 8.3 Essential Performance .............. 69 8.4 CGM System Accuracy .............. 69 9 Glossary ................. 70 Medtrum Simplifying Diabetes...
  • Page 7 Medtrum Simplifying Diabetes...

  • Page 8: Introduction

    Interpretation of the CGM System results should be based on the glucose trends and several sequential readings. 1.3 Contraindications The S9 CGM System is not recommended for people who are unwilling or unable to: Maintain contact with their healthcare provider.

  • Page 9: User Safety

    Medtrum distributor. No modification of this system is allowed. Do NOT use the S9 CGM System if you have delicate skin or if you are allergic to acrylic adhesives. Do NOT use anything other than the accessories specified in this User Guide, which could permanently damage your system and voids its warranty.
  • Page 10 Do NOT clean any part of the system while it is in use. X-rays, MRIs and CT Scans The S9 CGM System may be affected by strong radiation or magnetic fields. If you are going to have an X-ray, MRI, CT scan or other type of exposure to radiation, remove your Sensor and Transmitter, and put them outside the treatment area.

  • Page 11: Consumables

    1.4.3 Radio Frequency (RF) Communication The S9 CGM System can generate, use, and radiate radio frequency energy, and may cause harmful interference to radio communications. There are no guarantees that interference will not occur in a particular installation. If the...

  • Page 12: Water

    Sensor glucose readings to be inaccurate, and you might miss a low or high blood glucose value. Store the Transmitter at temperatures between -10°C (14°F) and 55°C (131°F), and at humidity levels between 20% and 90% relative humidity. Medtrum Simplifying Diabetes...

  • Page 13: Warranty Information

    1 year from the original date of shipment of the Transmitter to the original end use purchaser (the “Warranty Period”). During the Warranty Period, Medtrum will, at its discretion, either repair or replace (with a new or recertified Transmitter at Medtrum’s discretion) any defective Transmitter, subject to the conditions and...
  • Page 14 THE REMEDIES PROVIDED FOR IN THIS WARRANTY ARE THE EXCLUSIVE REMEDIES AVAILABLE FOR ANY WARRANT CLAIMS. NEITHER MEDTRUM NOR ITS SUPPLIERS OR DISTRIBUTORS SHALL BE LIABLE FOR ANY INCIDENTAL, CONSEQUENTIAL, OR SPECIAL DAMAGE OF ANY NATURE OR KIND CAUSED BY OR ARISING OUT OF A DEFECT IN THE PRODUCT.

  • Page 15: Basics Of The Cgm System

    Basics of the CGM System 2 Basics of the CGM System The S9 CGM System consists of three parts: a wireless Transmitter, a Glucose Sensor and Medtrum EasySense Mobile App on your smart device. The Sensor detects the glucose level in interstitial fluid and the glucose reading is updated every 2 minutes.
  • Page 16 Basics of the CGM System Medtrum EasySense Mobile App downloaded to your smart device works as a receiver. It displays all your sensor information, statistics and alerts. It also allows you to calibrate the Sensor, edit all the settings, and capture the events.

  • Page 17: How To Use Medtrum Easysense Mobile App

    How to Use Medtrum EasySense Mobile App 3 How to Use Medtrum EasySense Mobile App 3.1 Install the app If you are using a smart device with the IOS, you can download the Medtrum EasySense Mobile App from the Apple App Store. Android If you are using a smart device with the Android system, you can download the Medtrum EasySense Mobile App from Google Play.
  • Page 18 10. Make sure you allow the Medtrum EasySense Mobile app to access photos, media and files on your device so that you can select a photo as your profile photo in the app. 11. Make sure the Medtrum EasySense Mobile App is open and running in the background. Medtrum Simplifying Diabetes...

  • Page 19: Login/Register

    Make sure your smart device is connected to the Internet. Open the Medtrum EasySense Mobile App and enter the Login screen. If you already have a Medtrum account, tap the national flag on the top right corner and select the country you chose upon registration, and then login with your account and password.
  • Page 20 Tap the Get Code box once and you will receive a 6-digit Verification Code sent to you in an email by the Medtrum Team. Please make sure that you check the junk mails as well just in case the email went into that.
  • Page 21 How to Use Medtrum EasySense Mobile App for a new Verification Code and then enter the latest code sent to you. Enter your full name so that your healthcare providers can identify you easily. Create a password and remember that. Please tap the icon on the right side to see the password that you have entered.
  • Page 22 After you have read and agreed to the privacy policy and terms of use, tick the small boxes and tap Create Account to register your Medtrum account. Then return to the login screen and log in with your email and password.

  • Page 23: Main Menu

    Once you log in, the Monitor screen will appear. at the top-left corner to open the Main Menu from where you can access all the features of the Medtrum EasySense Mobile App: Monitor, CGM, Statistics, Events, Reminders, Settings, and Alerts.

  • Page 24: Add Transmitter Sn To Your Account

    How to Use Medtrum EasySense Mobile App 3.4 Add Transmitter SN to Your Account 3.4.1 Add SN If you haven’t added a Transmitter serial number (SN) to the app, you can tap “Add Transmitter” on the Monitor screen. Or you can also tap “Add Transmitter” on the CGM screen.
  • Page 25 How to Use Medtrum EasySense Mobile App You can use the camera to scan the QR code on the back of your transmitter or on the transmitter box. The transmitter SN will appear on your screen. Check if it matches the SN printed on the transmitter or on the box.

  • Page 26: Change Sn

    How to Use Medtrum EasySense Mobile App 3.4.2 Change SN Every time you change to a new Transmitter, you need to change the transmitter SN on your app. Tap CGM on the Main Menu to enter the CGM screen. Tap the existing transmitter SN, and the following screen will appear.

  • Page 27: Delete Sn

    How to Use Medtrum EasySense Mobile App code on the back of your transmitter or on the transmitter box. Or you can enter SN manually by tapping “Enter SN manually”. 3.4.3 Delete SN Tap Settings on the Main Menu to enter the Settings screen.

  • Page 28: Cgm

    How to Use Medtrum EasySense Mobile App Tap the existing transmitter SN, and the following screen will appear. Tap Delete Transmitter and then confirm. 3.5 CGM 3.5.1 Start Sensor If you haven’t connected a sensor, you can tap “Start Sensor” on the Monitor screen.
  • Page 29 How to Use Medtrum EasySense Mobile App When connected to the sensor, you will be reminded to enter the sensor code. You can tap Enter Code to enter the sensor code, the following screen will appear. Or tap No Code to skip this step.
  • Page 30 How to Use Medtrum EasySense Mobile App Use the camera to scan the QR code on the back of the sensor package which is unique for each sensor. A 4-digit sensor code will be identified and displayed on your screen. Tap OK to confirm it.

  • Page 31: Stop Sensor

    How to Use Medtrum EasySense Mobile App If you are unable to use App’s camera, tap Enter Code Manually to go to the following screen and enter the sensor code manually. Once the sensor code is entered, the calibration-free sensor session will start, and no calibration is required.

  • Page 32: Monitor Sensor Status

    How to Use Medtrum EasySense Mobile App sensor again or receive any sensor glucose data or alerts. 3.6 Monitor Sensor Status Once your Sensor and Transmitter are connected with the app, you can use the app to monitor your real-time glucose information.
  • Page 33 How to Use Medtrum EasySense Mobile App i. CGM Signal The CGM Signal icon shows the Bluetooth signal strength between the Transmitter and your smart device. ii. Add Event The Add Event icon provides a shortcut to add an event. The Events section contains more relevant information.
  • Page 34 How to Use Medtrum EasySense Mobile App No rate of change information No arrow iv. Last Sensor Reading & Time of the Reading Under the trend arrow, you can find the most recent sensor reading received by the app and the time of the reading.

  • Page 35: Detailed Glucose Information

    How to Use Medtrum EasySense Mobile App The Sensor Trend Graph shows the glucose trend of the most recent 3 hours, 6 hours or 9 hours. Tap the duration to change the graph range. 3.7 Detailed Glucose Information Tap the Sensor Trend Graph to view more detailed glucose information.
  • Page 36 How to Use Medtrum EasySense Mobile App Touch and hold in the graph area to generate a cursor. Move the cursor along the x-axis to view the sensor glucose (SG) or sensor status at different time points. The cursor will disappear after 5 seconds of no operation.

  • Page 37: Calibrate Your Sensor

    How to Use Medtrum EasySense Mobile App sensor glucose, and the number of hypoglycemic episodes (below 3.1 mmol/L / 56 mg/dL). The Distribution Statistics includes the percentage of target SG (target range set by user), the percentage of high SG (above the high limit of SG target range), the percentage of low SG (below the low limit of SG target range) and the percentage of hypoglycemia (below 3.1 mmol/L / 56 mg/dL).

  • Page 38: Statistics

    How to Use Medtrum EasySense Mobile App Enter your current finger stick blood glucose level to calibrate your sensor. If you skip the sensor code input step, you must calibrate your sensor twice on the first day. The app will prompt you when a calibration is needed. After the initial calibration, your sensor data will be displayed in real time.

  • Page 39: Daily Sensor Report

    How to Use Medtrum EasySense Mobile App Swipe left to go to Sensor Overlay, Trend Analysis and Event Summary successively. Swipe right to return to the previous screen. If you want to view a graph in landscape mode, double tap the graph or hold your smart device horizontally.

  • Page 40: Sensor Overlay (Ios Only)

    How to Use Medtrum EasySense Mobile App The Basic Statistics includes the minimum, maximum, and mean value of sensor glucose, and the number of hypoglycemic episodes (below 3.1 mmol/L / 56 mg/dL). The Distribution Statistics includes the percentage of target SG (target range...

  • Page 41: Trend Analysis

    How to Use Medtrum EasySense Mobile App 3.9.3 Trend Analysis This screen shows the sensor reading distribution within a given number of days (7, 30 or 90) before a certain date which can be changed by tapping and selecting a day or tapping to move back / forward.

  • Page 42: Event Summary

    How to Use Medtrum EasySense Mobile App 3.9.4 Event Summary This screen shows the event summary within a given number of days (7, 30 or 90) before a certain date which can be changed by tapping and selecting a day or tapping to move back / forward.

  • Page 43: Events

    How to Use Medtrum EasySense Mobile App 3.10 Events 3.10.1 Events Screen Tap Events on the Main Menu to enter the Events screen. This screen shows all of the events before a certain date which can be changed by tapping and selecting a day or tapping to move back / forward.

  • Page 44: Add Event Screen

    How to Use Medtrum EasySense Mobile App 3.10.2 Add Event Screen to enter the Add Event screen. Select a category. Add BG The default date and time are the current date and time. Tap the date and time to change if needed. Tap Fingerstick or Lab Calibration to select the test method.
  • Page 45 How to Use Medtrum EasySense Mobile App Add Insulin Injection The default date and time are the current date and time. Tap the date and time to change if needed. Enter a name for this insulin injection record (optional). Select the type of insulin from Not Set, Rapid-acting, Short- acting, Intermediate-acting, Long-acting, and Pre-mixed.
  • Page 46 How to Use Medtrum EasySense Mobile App Add Exercise The default date and time are the current date and time. Tap the date and time to change if needed. Enter the type of exercise (optional). Select the intensity and duration of exercise. Tap Note to add a note if needed. Tap Done to save the note and return to the Add Event screen.

  • Page 47: Edit Event Screen

    How to Use Medtrum EasySense Mobile App 3.10.3 Edit Event Screen Tap an event on the Events screen to enter the Edit Event screen. After editing, tap Done to save the changes. You can also tap Delete to delete the event.

  • Page 48: Reminder Screen

    How to Use Medtrum EasySense Mobile App 3.11.2 Reminder Screen 1. This screen shows a list of saved reminders, each with an ON/OFF switch. Tap a switch to turn on/off the reminder. If no reminder has been saved, this screen would be blank.

  • Page 49: Settings

    How to Use Medtrum EasySense Mobile App 3.12 Settings Tap Settings on the Main Menu to enter the Settings screen. 3.12.1 CGM System Settings Tap CGM System on the Settings screen to enter the CGM System screen. Medtrum Simplifying Diabetes...
  • Page 50 How to Use Medtrum EasySense Mobile App CGM Type:If you want to connect to the S9 CGM, please change the CGM type to S9. Glucose Alerts: The default setting is off. After you turn it on, you can view the following list of alert settings.
  • Page 51 How to Use Medtrum EasySense Mobile App you turn Low Glucose on, you can set up to eight Low Limits throughout a day and receive alerts when your glucose is below the set Low Limit. The highest high limit and the lowest low limit among all the time segments are used to determine the high glucose, target glucose, and low glucose in Trend Analysis.

  • Page 52: General Settings

    How to Use Medtrum EasySense Mobile App (1.1 mg/dL/min and 5.0 mg/dL/min) with an increment of 0.005 mmol/L/min (0.1 mg/dL/min). 5. Rapid Fall: The default setting is off. After you turn it on and set a fall rate limit, you can receive alerts when your glucose is falling faster than the set rate limit.

  • Page 53: Account Security

    How to Use Medtrum EasySense Mobile App You can turn on/off Audio and Vibrate, set the snooze time between 10 min and 3 hours, and customize unit settings here. Choose the Tone Types for App Reminders and Alerts under ALERT TONES.
  • Page 54 How to Use Medtrum EasySense Mobile App Re-enter the passcode. If correct, the passcode lock will be turned on. Medtrum Simplifying Diabetes...
  • Page 55 How to Use Medtrum EasySense Mobile App Once the passcode lock is on, you will be required to enter the correct passcode to gain access to the Medtrum EasySense Mobile App. The correct passcode would be required if you want to turn the passcode lock off.

  • Page 56: Reset

    How to Use Medtrum EasySense Mobile App 3.12.4 Reset Tap Reset on the Settings screen to enter the Reset screen. You can reset the app settings to factory defaults. Note: When the app is paired with an active sensor, you cannot reset any settings.
  • Page 57 How to Use Medtrum EasySense Mobile App By tapping Show More, you can view the sensor glucose curve of the past 6 hours. If you are using an Android phone, swipe down to view the EasySense notification. Medtrum Simplifying Diabetes...

  • Page 58: How To Change The Sensor

    2. Fold and break the sensor support mount, and gently pull the Transmitter away from the sensor support mount. 3. Discard the sensor support mount and reuse the Transmitter. Note: Make sure that you completely disconnect the Transmitter from the Sensor when you do. Medtrum Simplifying Diabetes...

  • Page 59: Insert A New Sensor

    Within 7.5 cm (3 inches) of an insulin pump infusion site or manual injection site. If you choose an insertion site on the upper arm, apply the Sensor vertically. If you choose an insertion site on your abdomen (buttock for children), apply the Sensor horizontally. Medtrum Simplifying Diabetes...

  • Page 60: Prepare The Insertion Site

    Hold the inserter part of the Sensor and try not to touch the adhesive surface. Remove the liners from the Sensor support mount one after another. Use your thumb and finger to bend off the safe lock by pushing it to the left or right. Medtrum Simplifying Diabetes...

  • Page 61: Remove The Protective Liner From The Sensor Support Mount

    Place the Sensor vertically on the upper arm. 4.2.7 Insert the Sensor Hold the inserter as shown below and press swiftly the inserter. You might feel a slight pinch as the Sensor is placed just under your skin. Medtrum Simplifying Diabetes...

  • Page 62: Remove The Inserter

    Sensor, treat the site as necessary, and insert a new Sensor at a different site. Warning: Check the insertion site frequently for infection or inflammation— redness, swelling or pain. Remove the Sensor and seek professional medical help if one of these conditions occurs. Medtrum Simplifying Diabetes...

  • Page 63: Discard The Sensor Inserter Safely

    After you install the transmitter, the green light on the transmitter will flash 3 times immediately, indicating that the transmitter is correctly connected with the sensor. The green light will flash another 6 times within one minute, Medtrum Simplifying Diabetes...
  • Page 64 How to Change the Sensor indicating that the system has completed its self-check. Then the following screen will appear on your App. Note: It will take 30 minutes for the sensor to warm up. Medtrum Simplifying Diabetes...

  • Page 65: Safety System And Alerts

    To make you aware of a condition that is outside normal CGM system activity or a potentially serious condition, your smart device with the Medtrum EasySense Mobile App vibrates or emits a tone on an alert and displays an on- screen message.
  • Page 66 Change sensor in 30 30 MINUTES in 30 minutes. minutes. Change sensor soon. SENSOR EXPIRED Sensor expired. Change Sensor. Change sensor now. RAPID RISE Sensor glucose is Monitor trend and glucose rising rapidly. level. Follow instructions from your healthcare provider Medtrum Simplifying Diabetes...
  • Page 67 Please treat as Continue to monitor blood necessary. (Sensor glucose. glucose below 56 mg/dL. Please treat as necessary.) Note: When BELOW 3.1 mmol/L (BELOW 56 mg/dL) occurs, the app will sound an alert even if audio was turned off. Medtrum Simplifying Diabetes...

  • Page 68: Manufacturer's Declaration

    10 V/m (for home environments. Keep IEC 61000-4-3 healthcare portable RF environment) communications 80 % AM at 1 kHz equipment at least 0,3 3V/m (for professional m away. healthcare facility environment) 80 % AM at 1 kHz Medtrum Simplifying Diabetes...
  • Page 69 Section “Recommended Smart Device Settings” in Chapter “How to use the App”. If you are unable to re-enter your EasyPatch App settings, change a new patch, or otherwise believe there is a problem with your device, contact your local representative. Medtrum Simplifying Diabetes...
  • Page 70 DISTURBANCES is high. 3) Portable RF Communications equipment should be used no closer than 30 cm (12 inches) to any part of the Medtrum products. Otherwise, degradation of the performance of this equipment could result. 4) It should be avoided to use this equipment adjacent to or stacked with other medical equipment, because it could result in improper operation.
  • Page 71 18Hz CDMA 850, LTE Band 1720 1800; 1845 CDMA 1900; Pulse 1700- 1900; modulation 1990 DECT; 217Hz 1970 LTE Band 1, 3, 4, 25; UMTS Bluetoot WLAN, Pulse 2400- 2450 802.11 modulation 2570 b/g/n, 217Hz RFID 2450, Medtrum Simplifying Diabetes...
  • Page 72 The carrier shall be modulated using a 50 % duty cycle square wave signal. c) As an alternative to FM modulation, 50 % pulse modulation at 18 Hz may be used because while it does not represent actual modulation, it would be worst case. Medtrum Simplifying Diabetes...

  • Page 73: Appendix I: Symbols And Icons

    Follow instructions Caution for use Temperature Radio limit communication Protection Against Insertion of Large Objects and IP28 Do NOT reuse Immersion in Water for up to 2.5 m for 1 hour CE mark by Serial number notified body Medtrum Simplifying Diabetes...
  • Page 74 Electronic part Equipment Protection Authorized Against representative in IP22 Insertion of the European Large Community Objections and Dripping Water IEC 60529 Date of Importer Manufacture Humidity Unique device identifier limitation Indicates the item is a Medical Device Medtrum Simplifying Diabetes...

  • Page 75: Appendix Ii: Technical Information

    Storage Temperature Range: +2°C~+30°C Storage Relative Humidity Range: 20%~90%RH Storage Atmospheric Pressure: 700~1060 hPa Glucose Range: 2.2~22.2 mmol/L (40~400 mg/dL) Sterilization Method: By radiation Battery: Powered by one button batteries (3.0 V*1) Sensor Life: Up to 14 days Medtrum Simplifying Diabetes...

  • Page 76: Essential Performance

    Table. Percentage of CGM Glucose Reading within ±20% / ±20 mg/dL, ±30% / ±30 mg/dL and ±40% / ±40 mg/dL of the YSI. Number of Matched Pairs Within Within Within CGM-YSI ±20% / ±30% / ±40% / ±20 mg/dL ±30 mg/dL ±40 mg/dL 13116 89.0% 97.8% 99.4% Medtrum Simplifying Diabetes...

  • Page 77: Glossary

    9 Glossary A mobile app is a computer program designed to run on mobile devices such as smartphones and tablet computers. The Medtrum EasySense Mobile App is used with the EasySense system for continuous glucose monitoring. Abbreviation for blood glucose. See Blood Glucose.
  • Page 78 A smart device is an electronic device that is cordless (unless charging), mobile (easily transportable), connected (via Wi-Fi, 3G, 4G, etc.) that can operate to some extent autonomously. Examples of smart devices are smartphones, tablets, or phablets. Warning A warning notifies you of a potential hazard. Medtrum Simplifying Diabetes...
  • Page 79 Medtrum Simplifying Diabetes...
  • Page 80 UG883260WW 348791 Version: 1.04 Simplifying Diabetes...

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