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INFINOVO MEDICAL i3 Operator's Manual

Continuous glucose monitoring
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Summary of Contents for INFINOVO MEDICAL i3

  • Page 6: Product Overview

    1 Product overview 1.1 Product overview The Continuous Glucose Monitoring Systems is consist of a disposable sensor, transmitter, App，and analysis software, in which the core device is the sensor electrode. It is recommended to wear the sensor to the abdomen and minimize activities extent.
  • Page 7 1.2 Sensor overview 1.2.1 Sensor overview The continuous glucose monitoring sensor is a product with a sterile sealed pouch. The sensor is mainly composed of an applicator, a base and a sensor electrode. The base consists of a PC base and an adhesive patch. The sensor electrode is divided into three layers: semi-permeable membrane, glucose oxidase layer and microelectrode.
  • Page 8 1.3 Transmitter overview 1.3.1 transmitter overview The continuous glucose monitoring transmitter is a component fixed on the sensor base with chips. Once the transmitter is fixed in the sensor base and the sensor electrode is activated through the App, the transmitter sends the blood glucose message to the App.
  • Page 9 1.3.3 EMC Statement Guidance and manufacture's declaration – electromagnetic emissions The Continuous Glucose Monitoring Systems is suitable for use in the specified electromagnetic environment (s) and it has met the following standard’ s emission requirements. Guidance and manufacture's declaration – electromagnetic immunity The Continuous Glucose Monitoring Systems is suitable for use in the specified electromagnetic environment (s) and...
  • Page 10 1.4 APP overview Continuous glucose monitoring App is a mobile medical application for Continuous Glucose Monitoring Systems to receive and process glucose readings. The software displays blood glucose readings, trend curves, trend arrows, and transmitter status. It has functions of adding events, event records, wearing records, alarm notifications, reading lists, statistical analysis, data export, account management and so on.

  • Page 11: Safety Information

    2 Safety Information 2.1 Application definition The device is intended for continuous or periodic recording of interstitial fluid glucose levels in adult patients with diabetes aged 18 or older. The system is designed for patients to use at home and in medical institutions. The information is intended to supple, rather than replace, the information obtained from standard glucose monitor like traditional glucose meter and is intended to detect trends and...
  • Page 12 In rare cases, the sensor electrode may fracture. Don't ignore it. If the sensor electrode breaks and there is no visible sensor electrode on the skin, do not attempt to remove it. Seek professional medical help in the condition of infection symptoms or inflammation - redness, swelling or pain.
  • Page 13 It is forbidden to insert sensors within 8 cm of insulin injection and placement of insulin pump. Insulin may affect the performance of the sensor, missing low/high blood glucose levels. To calibrate the system, input the exact blood glucose value measured by the glucometer within 3minutes. Inaccurate input or blood glucose values exceeding 3minutes may affect the performance of the sensor and result in missing low/high blood glucose values.
  • Page 14 When the prompt function is turned off, the transmitter and App are not within the range of connection, and the prompt cannot be obtained. When you cannot hear the bell or feel the vibration, you may not notice the prompt. Sometimes the blood glucose readings may be slightly different from the values measured by blood glucose meter.
  • Page 15 This section helps you to make the first App settings. Read this chapter before the operation begins. 1.Remove the transmitter from the package 2.Turn on the bluetooth of the mobile phone and install the App software; 3.Click the App icon, run the App, enter the account management interface, enter the name and phone number, and click save to enter the device addition interface;...
  • Page 16 6.If the App automatically connects to the transmitter unsuccessful, you can directly click the [Disconnect] icon to reconnect. After the connection between the transmitter and App is successful, the [Connected] icon appears. You can use the App to operate the transmitter. After adding the transmitter, the connection status icon of the main interface of the App will prompt the connection status of the App and the transmitter.
  • Page 17 4.3 Menu settings The Settings menu includes account management, unit Settings, current devices, help and other functions. 1.In the main interface of App, click the icon in the upper right corner to enter the main menu. 2.In the main menu interface, click [Settings ] to enter the settings menu.
  • Page 18 4.3.2 Account Management In the Settings menu, click[account management]to enter the account management interface. Account management interface can set basic user information, including name, gender, date of birth, email, mobile phone number, etc. 4.3.3 Current device 1.Click [current device] in the Settings menu to enter the current device interface, which displays the current emitter device name, emitter address name and sensor batch number.
  • Page 19 5 Sensor insertion and startup Blood glucose meters and test strips are not included in the continuous blood glucose test system. When calibrating, you need to prepare a blood glucose meter and a test strip. The sensor continuously monitor displays blood glucose readings for 14 days.
  • Page 20 Wash your hands thoroughly and dry them. Remove the sensor from the package and check it carefully to make sure it is intact. The applicator is a disposable assistive device used alone. Safety lock can prevent accidental release of the sensor electrode before you are ready.
  • Page 21 Figure 12 remove the protective pape (Step2) 3.Place the sensor horizontally on the abdomen. 4.Press the applicator to ensure that the tape is firmly attached. Figure 13 Place the sensor in the abdomen, ensure the tape firmly bonded. (Steps 3 and 4) 5.Hold the applicator, and pull the safety lock.
  • Page 22 Figure 15 Press the top button of the applicator (Step 1) Figure 16 Ensure the tape firmly bonded (step 3) If you have any questions about insertion, please keep the whole set of sensors and contact technical support. 5.6 Reinforce the sensor base The base of the sensor should be pasted on the skin with its own adhesive tape.
  • Page 23 Warning In rare cases, the sensor electrode may fracture. Don't ignore it. If the sensor electrode breaks and there is no visible sensor electrode on the skin, do not attempt to remove it. Seek professional medical help in the condition of infection symptoms or inflammation - redness, swelling or pain.
  • Page 24 4.Do not take out the transmitter when the sensor base is attached to the skin. 6.3 Start the sensor The steps to start the sensor electrode are as follows: 1.In the main menu, click [Start sensor], a prompt dialog box will pop up; prompt to enter the sensor batch number. 2.Enter the sensor lot number and click the [OK] button in the dialog box to start the sensor electrode.
  • Page 25 Contraindications Taking acetaminophen while wearing the sensor, blood glucose readings may be higher. 7.1 Overview The glucose readings need to be calibrated to display the readings and trend curves, and to maintain the accuracy throughout the monitoring process. The time points for calibration are as follows: 1.First calibration: After the sensor is activated and the sensor polarization is complete, App prompts the reference...
  • Page 26 Caution Blood glucose should not be calibrated in a rapid change and the general rate of change is 0.11 mmol/L per minute. Do not calibrate when the rising single arrow or double arrow is displayed on the App interface which indicates that your blood glucose level increased by 0.11-0.17 mmol/L or over 0.17 mmol/L per minute.
  • Page 27 7.3 Calibrate at least once every 12 hours Calibrate at least once every 12 hours, to ensure that the blood glucose readings remain accurate. You can input the blood glucose value in advance for calibration. Warning Calibrate at least once every 12 hours. Calibrating less often than every 12 hours might cause sensor glucose readings to be inaccurate, and you might miss a low or high blood glucose value.
  • Page 28 Swipe the interface left and right to view the trend curve at different time periods. The system only reports blood glucose information in the range of 2.2-22.2 mmol/L. After the blood glucose reading goes out of range, the trend curve is not displayed.
  • Page 29 8.3 Trend arrow Trend arrows indicate the changing state of current blood glucose rising or falling. The trend arrow is on the right of the current blood sugar readings. When the trend arrow changes, recent insulin doses, activities, food intake, etc., as well as the entire trend curve and blood glucose level before the activity should be considered.

  • Page 30: Alarm Notifications

    When disconnected, the trend arrow is not displayed. If the trend arrow goes away, use a blood glucose meter to test your blood sugar. Warning Do not ignore the symptoms of high / low blood sugar. If the blood glucose reading does not match the symptoms, the blood glucose meter should be used to measure the blood glucose even if the reading is within the normal range, so as not to miss the low/high blood...
  • Page 31 At this point, if the same type of prompt occurs, it will not be prompted again within the repeated prompt time. If the current repeated prompt is not manually canceled or the reminder condition still exists, the App will issue a prompt according to the repeated prompt interval.
  • Page 32 9.8 Falling rate notification The default value of falling rate is 0.2 mmol/L/min. Click the [Fall Rate Alert] icon to the open state and set the prompt value. When the change rate of blood glucose is higher than the prompt value, the APP will trigger the prompt and remind it with sound or vibration.
  • Page 33 10.1.2 Diet Figure 29 Add diet interface 1.In the add record interface, click [food] to enter the event interface; 2.Click [Time] to set the date/time of the event; 3.Click [Meals] to set the type of food, such as breakfast, lunch, dinner, etc.; 4.Click [Duration] to set the duration of the diet;...
  • Page 34 10.1.4 Exercise Figure 31 Add exercise interface 1.In the add record interface, click [Exercise] to enter the event interface; 2.Click [Time] to set the date/time of the event; 3.Click [Type] to set the type of exercise, such as high strength, medium strength, low strength etc.; 4.Click [Time of Exercise] to set the duration of the exercise;...
  • Page 35 10.1.6 Others Figure 33 Others interface 1.In the add record interface, click [Others] to enter the event interface; 2.Click [Time] to set the date/time of the event; 3.Click [Type] to set the type, such as Illness, menstruation, alcohol etc.; 4.Click [description] to input more detailed information. 5.Click [Save] to save the event information entered above;...
  • Page 36 10.3 Data management 1. In the main application interface, click the [Main menu] icon in the upper right corner to enter the interface; 2. Click [Data Management], enter the data management interface; 3.Click [Statistical Analysis] to count the number of blood glucose, average value, lowest value, highest value, target blood glucose percentage, low blood sugar percentage, high blood sugar percentage, and fluctuation coefficient according to time.
  • Page 37 2. Click [OK] in the dialog box to stop the sensor; 3. After the sensor is successfully stopped, the "Start Sensor" option will show "sensor is off". 11.2 Remove the sensor The sensor can give a blood glucose reading for 14 days, but it cannot guarantee the accuracy of the blood glucose reading after 14 days.

  • Page 38: Faults And Troubleshooting

    Figure 37 Make sure transmitter seated in the sensor base. Figure 38 Gently peel the tape off the skin. 11.3 Remove the transmitter Removed the sensor together with transmitter. Do not remove the transmitter when the sensor base is attached to the skin.

  • Page 39: Maintenance

    12.1.3 Failure to pull out insert from the sensor base Make sure the guide seat is fully pulled up and the click should be heard. When pulled out, the guide seat is as close as possible to the top of the insert. Press both sides of the sensor base to release the buckle.

  • Page 40: Travel Information

    If you have any questions or concerns, please visit the website of the travel safety administration. 15 User help Technical support Technical support: INFINOVO MEDICAL CO.,LTD. Registration and Operation Address: 3rd Floor, 6th Building, No.888 Zhujiang Road, Rudong, Jiangsu, China Tel. +86.0513.68928098 Fax.
  • Page 41 16 The warranty 16.1 The scope and duration of warranty Under normal use conditions, the original purchaser is provided with a limited warranty when there are quality problems with raw materials and processes. Normal use period is within 8 months from the date of sensor and 12 months for transmitter.
  • Page 42 17 Label symbol and graphic description...

  • Page 43: Date Of Manufacture

    18 Date of manufacture The production date and expiry date are shown in the package. Appendix Appendix 1 Warranty Card If there is a problem of non-human damage to the product you purchased, please return it to us for warranty. Customer service information...
  • Page 44 I3/WJ-XT-SMS-01 version no. A/0 effective date: 2019/5/20...

This manual is also suitable for:

Ti3-wl-03