Related Manuals for INFINOVO MEDICAL i3
Summary of Contents for INFINOVO MEDICAL i3
- Page 1 Continuous Glucose Monitoring Systems Transmitter, Sensor, App USER MANUAL Model：i3 INFINOVO MEDICAL CO.,LTD. JN-STP-I3-SMS-001 version no. V01 effective date: 2022.05.25...
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Page 2: Table Of Contents
Table of Contents Terminology .......................... 1 1 Product overview ........................ 2 1.1 Sensor overview ......................2 1.2 Transmitter overview ....................4 1.3 App overview ......................4 1.4 Analysis overview ..................... 5 2 Safety Information ......................6 2.1 Application definition ....................6 2.2 Important user information ..................6 2.3 Contraindications ..................... -
Page 3: Terminology
Terminology Component of the monitoring system, containing the applicator, sensor electrode and sensor base. The applicator inserts the Sensor sensor electrode under the skin to measure glucose level in interstitial fluids. Abbreviation for Continuous Glucose Monitoring CGMS Abbreviation for Continuous Glucose Monitoring Systems A disposable component that inserts the sensor electrode under Applicator the skin and will be removed after the sensor electrode is... -
Page 4: Product Overview
480 readings each day. The system is indicated for continuous monitoring of the blood glucose data for 14 days and form a continuous blood glucose curve. In addition, dining, sport, medication and other activities can be recorded as an event. Glunovo i3 CGM Analysis Software 1.1 Sensor overview... - Page 5 Button Safety lock Sensor base and Adhesive patch Sensor The continuous glucose monitoring sensor is a product in a sterile sealed pouch. The sensor is mainly made up of an applicator, a sensor base and a sensor electrode. An adhesive pad is attached to the sensor base. Insert the sensor electrode into the subcutaneous tissue of the abdomen and remove the applicator.
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Page 6: Transmitter Overview
1.2 Transmitter overview The continuous glucose monitoring transmitter is a component connected to the sensor base. Once the transmitter is embedded in the sensor base and the sensor electrode is activated through the App, the transmitter sends the sensor glucose value to the App. -
Page 7: Analysis Overview
Main interface of App The main interface of App displays blood glucose readings, trend curves and trend arrows. App and transmitter can be connected through Bluetooth, pairing for data communication. A blood glucose meter is also needed to use the Continuous Glucose Monitoring System. -
Page 8: Safety Information
Sensor is disposable；The transmitter can be reused up to 8 times. Warning CGMS(i3) does not provide any medical advice and cannot be used for such purpose. Do not adjust your treatment plan without discussing it with your medical diabetes team. -
Page 9: Warning
2.4 Warning Read the instructions thoroughly. incorrect use of the continuous blood glucose monitoring system may lead to misunderstanding of the information provided by the system or affect the performance of the system and miss low/high blood glucose incidents. Continuous glucose monitoring cannot be used as a basis for diabetes diagnosis, ... -
Page 10: Precautions
perform a fingerstick blood test using a blood glucose meter. The CGMS contains small parts that may cause choking once swallowed, keep them off the reach of children. 2.5 Precautions The sensors and transmitters of the CGMS should be matched. The products of ... -
Page 11: Risk And Efficacy
Intense exercise may cause the sensor to be detached or loosened. If the Sensor is loose, you may not get a reading or the reading may not be reliable and may not match how you feel. Follow instructions on selecting the appropriate site for wearing the sensor. -
Page 12: Installation And Use
4 Installation and Use This chapter describes how to use your i3 systems, please read carefully before use, and follow the indication step-by-step. 4.1 Installation 4.1.1 App installation and setting a) Download App from Google Play / App Store； b) After installed, please complete personal information. - Page 13 Insertion site 3）Clean insertion site a) Clean the insertion site with an alcohol wipe and allow it to dry before proceeding. b) Make sure area is clean and free of lotions, perfumes, and medications. 4）Apply Sensor Remove the protective liners from the bottom of the sensor base, and don't touch the adhesive tape.
- Page 14 Press the top button of the applicator, and the sensor electrode will be inserted automatically; Gently pull applicator up until you see adhesive patch. Ensure the tape firmly bonded. Run your fingers around the adhesive. Slide transmitter (pointy side) into the slot against one end of the sensor base.
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Page 15: Use
Warning The sensors （ Model No. SI3-WL-03 ） and transmitters （ Model No. TI3- WL-03 ） of the Continuous Glucose Monitoring Systems （ i3 ） should be suitable for each other. The products of different generations cannot be connected to each other and thus cannot work. Make sure that the system uses the correct Glunovo software version. - Page 16 Warm up time: 190 Mins. Note: No High/Low Alarm during warming up; Keep the connection between transmitter and smart phone during warming up. Initial calibration after warm-up; Note: Do the calibration before meal. 4.2.2 Sensor glucose readings and curve Blood glucose readings and trend curve are shown in App’s Home Screen. Home Screen...
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Page 17: End Session And Remove Sensor
Logbook Caution Continuous glucose monitoring cannot be used as a basis for diabetes diagnosis, such as insulin injection. It cannot replace the blood glucose meter. The value of blood glucose may not be consistent with the reading of blood glucose. Using glycemic readings as a diagnostic basis for diabetes may result in low/high blood glucose. -
Page 18: Calibration
Settings→Device Information→Remove Current Device Note: After the sensor is ended ， the App will not receive BG readings and Alarm/Alert. Note:Data for this session will be reserved for future export Take off adhesive pad. Note: Remove sensor and transmitter together. Take out transmitter with the releaser. - Page 19 After the sensor is activated and the sensor warm-up is complete, App will send a notification for the first calibration. The App will not display the blood glucose readings and trend curves until the first reference blood glucose is entered for calibration.
- Page 20 The steps to enter the blood glucose value during calibration are as follows: a) Wash hands and dry, make sure the blood glucose test strips are stored properly during the shelf life, and make sure the blood glucose meter can work normally; b) Follow the instructions and use the blood glucose meter to test the blood glucose;...
- Page 21 4.4.2 How to do a good calibration Not to do Do not over-calibrate: calibrate two or three times per Calibrate when CGM reading is within your target range, if day, no more – unless, in the event of such: CGMS possible close to your BG target.
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Page 22: App Interface Introduction And Function Application
5 App interface introduction and function application 5.1 Main interface The main interface contains glucose readings, glucose curve, trend arrows, CGM status. Add Events CGM Reading Trend Arrow Unit Reading Time CGM Status Remaining Time Horizontal Screen High Zone Glucose Curve In Range Zone Low Zone Event... - Page 23 Slow decrease: blood glucose decreased by 0.06 to 0.11 mmol/L (1.08- 1.98 mg/dL) per minute. Decrease: blood glucose decreased by 0.11-0.17 mmol/L (1.98 mg/dL - per minute. 3.06mg/dL) Rapid decrease: blood glucose decreased by more than 0.17 mmol/L (3.06 mg/dL) per minute. App cannot, for the moment, calculate the rate of increase or decrease No arrow in blood glucose (data synchronization or disconnection).
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Page 24: Function Bar
Sensor Current latest current from sensor Last Calibration The latest calibration time App Version The full version of App 5.1.4 Events You can add Events (carbs, insulin, Medication, sport, and BG) by clicking 5.2 Function Bar Function bar contains: Home, Calibration, Reports, Logbook and Settings. 5.2.1 Calibration To add calibrations via meter. -
Page 25: Alarm/Alert
Note: Data can be analyzed by Analysis Software. Settings 5.3 Alarm/Alert App provides Urgent Low Alarm, High/Low Alarm with sounds, vibrations, view, and notifications. Alarm/Alert can be snoozed. Glucose Alarm will still sound, even in phone’s vibration or mute mode for Android. Note ：... -
Page 26: Faults And Troubleshooting
Limit than this value, will 22.2 mmol/L (234 mg/dL) generate hyperglycemia alarm. (400 mg/dL) Warning Don’t make medical decision based on sensor glucose levels. 5.3.2 Snooze Alarm You can press-hold circles for 4 seconds during an Alarm to snooze Alarm for 10 mins, 20 mins or 30 mins. 5.3.3 System Recovering System recovering, means CGMS is not in normal operation. -
Page 27: Calibration Troubleshooting
Before inserting the sensor, clean the skin with alcohol wipes and let it dry. The position of the sensor needs to be shaved and cleaned so that the adhesive tape can be attached firmly. Use medical adhesive tape to reinforce sensor base, the medical adhesive tape should be pasted around the white adhesive tape. - Page 28 Wearing sensors and transmitters is safe when passing through metal detectors. If you have concerns or discomfort with crossing security doors, follow the regulations of the Transportation Security Administration: You should inform the security inspection agency that you are wearing a continuous blood glucose monitoring system. You can request a full-body search and visual inspection instead of security door scanning.
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Page 29: Emc Statement
9 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. Phenomenon Home healthcare environment Conducted and radiated RF emissions CISPR 11, Group 1, Class B Harmonic distortion Voltage fluctuations and flicker... - Page 30 Recommended minimum separation distances RF wireless equipment is used in various healthcare locations therefore when the CGMS is used in close proximity to other medical equipment and/or systems, the medical equipment and/or systems’ basic safety and essential performance may be affected.
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Page 31: User Help
Continuous Glucose Monitoring Systems including cables specified by the manufacturer. Otherwise, degradation of the performance of this equipment could result. 10 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. +86.0513.68928019 ZIP-Code. -
Page 32: The Warranty
11 The warranty 11.1 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. Note: if a warranty replacement is received, all remaining warranty rights of the original purchaser are transferred to the replacement and the warranty page is invalid. -
Page 33: Label Symbol And Graphic Description
12 Label symbol and graphic description Label symbol and graphic description Symbol Description Please Read the Instructions before Use No Secondary Use Do not Use if Package is Damaged Type BF Applied Part Temperature Limitation Humidity Limitation Sterilized Using Irradiation Keep Dry Keep away from sunlight Caution... -
Page 34: Date Of Manufacture
Date of Manufacture After passed CE certification, mark the CE-marking on package; 0197 INFINOVO MEDICAL Co., LTD. 3rd Floor, 6th Building, No.888 Zhujiang Road, Rudong, Jiangsu, China Llins Service & Consulting GmbH Obere Seegasse 34/2, 69124, Heidelberg, Germany Tel: +49 1754870819 13 Date of manufacture The production date and expiry date are shown on the package. -
Page 35: Appendix
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 Customer name Contact number Contact address Product name Product model Date of purchase Maintenance date Fault description Maintenance state...
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