Related Manuals for INFINOVO MEDICAL p3
Summary of Contents for INFINOVO MEDICAL p3
- Page 1 Continuous Glucose Monitoring Systems Transmitter, Sensor, App USER MANUAL Model：p3 INFINOVO MEDICAL CO.,LTD. JN-STP-P3-SMS-001 version no. V01 effective date: 2022.06.01...
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Page 2: Table Of Contents
Table of Contents Terminology ........................1 1 Product overview ......................2 1.1 Sensor overview ....................3 1.2 Transmitter overview ..................4 1.3 App overview ....................4 1.4 Analysis Software overview ................5 2 Safety Information ...................... 8 2.1 Application definition ..................8 2.2 Important user information ................8 2.3 Contraindications ....................8 2.4 Warning ...................... -
Page 3: Terminology
Terminology Component of the monitoring system, including the applicator, sensor electrode and sensor base. The applicator inserts the Sensor sensor electrode under the skin to measure blood glucose level in interstitial fluids. Abbreviation for Continuous Glucose Monitoring CGMS Abbreviation for Continuous Glucose Monitoring Systems A disposable product that inserts the sensor electrode under the Applicator skin and will be removed after the sensor electrode is inserted. -
Page 4: Product Overview
App for processing and analysis, then gives reports. Continuous Glucose Monitoring Systems (p3) can display glucose readings automatically after when entered Sensor code at starting CGM. The CGMS measures a glucose reading every three minutes, making 480 readings in total each day. -
Page 5: Sensor Overview
1.1 Sensor overview Button Safety lock Sensor base and Adhesive patch Sensor The continuous glucose monitoring sensor is a product with a sterile sealed pouch. The sensor is mainly made up of an applicator, a sensor base and a sensor electrode. The base consists of a PC base and an adhesive patch. -
Page 6: Transmitter Overview
Power support Internal power supply 1.2 Transmitter overview The continuous glucose monitoring transmitter is a component connected to 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 sensor glucose value to the App. -
Page 7: Analysis Software Overview
Main interface of App The main interface of App mainly 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 Warning: The software does not provide any medical advice and cannot be used for such purpose. Do not adjust your treatment plan without consulting your medical diabetes team.
- Page 9 The performance parameters of Analysis Software Item Detail Windows 7 and above Operating system Tip: Software works on both 64-bit and 32-bit systems. The file exported by the app is transferred to Data transmission the analysis software via wireless or USB data cable (Android Only) Report Format Export format is PDF file...
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Page 10: Safety Information
Sensor is disposable；The transmitter can be reused up to 10 times. Warning: CGMS(p3) 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 11 blood glucose incidents. Continuous blood glucose testing cannot be used as a basis for diabetes diagnosis, such as for insulin injection treatment. It cannot replace blood glucose meter. The value of blood glucose may differ from the reading of blood glucose.
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Page 12: Precautions
them away from the reach of children. 2.5 Precautions The sensors and transmitters of the CGMS should be matched. The products of different generations cannot be connected and cannot work. Make sure that the system uses the correct software version. Before opening the sensor package, wash your hands with soap and water and ... - Page 13 application. Severe dehydration or excessive water loss may result in inaccurate CGMS readings. On rare occasions, patients may experience mild skin redness and swelling on the insertion site.
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Page 14: Risk And Efficacy
3 Risk and Efficacy 3.1 Risk Inserting sensors and wearing adhesive tapes are less likely to cause infection, bleeding, pain or skin irritation (redness, swelling, bruising, itching, scarring or discoloration). In the clinical studies, a small number of patients experience mild skin redness and swelling. -
Page 15: Installation And Use
4 Installation and Use This chapter describes how to use your p3 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 16 Check expiration date before insertion 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 17 Warning The sensors （ Model No. SP3-WL-03 ） and transmitters （ Model No. TP3-WL-03）of the Continuous Glucose Monitoring Systems（p3）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...
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Page 18: Use
the correct Glunovo software version. 4.2 Use 4.2.1 Pairing Transmitter Enter Transmitter SN and PIN Code to start pairing. Note: For problems in pairing, check <Troubleshooting>. Enter sensor LOT number and Sensor Code to “Start CGM”. - Page 19 Warm up time: 120 Mins. Note: No High/Low Alarm during warming up; Keep the connection between transmitter and phone during warming up. 1st calibration happens after warm up if not entered Sensor code when starting CGM. After that enter calibration once every 24 hours; If entered Sensor Code, this is not necessary.
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Page 20: End Session And Remove Sensor
Home Screen Caution Continuous blood glucose testing 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. -
Page 21: Calibration
4.4 Calibration Continuous Glucose Monitoring Systems (p3) can display glucose readings automatically after when entered Sensor code at starting CGM. If choose “skip” in the page of entering sensor LOT and Sensor code, the user will... - Page 22 not replace the glucometer during the monitoring process. The accuracy of different brands of blood glucose meters and test strips will vary. d) The accuracy of blood glucose readings used for calibration may affect the accuracy of sensor glucose readings. Caution Blood glucose should not be calibrated in a rapid change of glucose level and the general rate of change is 0.11 mmol/L per minute.
- Page 23 4.4.2 How to do a good calibration Not to do Do not over-calibrate: calibrate two or three times per Calibrate when within your target range, if possible close to your day, no more – unless, for some reason: CGMS readings BG target.
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Page 24: 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 25 Slow decrease: blood glucose decreased by 0.06 to 0.11 mmol/L per minute. Decrease: blood glucose decreased by 0.11-0.17 mmol/L per minute. Rapid decrease: blood glucose decreased by more than 0.17 mmol/L per minute. App can not calculate the rate of increase or decrease in blood glucose No arrow (data synchronization or disconnection).
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Page 26: Function Bar
Sensor Current latest current from sensor Last The latest calibration time Calibration App Version The full version of App CGM Status: RUNNING STOPPED, ， SESSION END, LINK LOST Transmitter SN Transmitter SN Sensor LOT Sensor LOT number Sensor Current latest current from sensor Last Calibration The latest calibration time App Version... -
Page 27: Alarm/Alert
target range during a defined period. Glucose Profile A profile displaying glucose fluctuation. The chart needs at least 24 hours valid data. 5.2.3 Logbook All calibrations, alarm/alert and sensor readings are recorded in Logbook and marked with different icons. 5.2.4 Settings The screen of Settings has three main sections：... - Page 28 5.3.1 Thresholds Threshold Alarm Introduction Default setting 3.3- 5.6 If the blood sugar is lower 3.9mmol/L mmol/L Low Limit than this value, app will give (60-101 (70 mg/dL) an alarm of hypoglycemia. mg/dL) If the blood glucose is less 3.1mmol/L 3.1mmol/L than 3.1 mmol/l, app will Urgent Low...
- Page 29 You can press-hold circles for 5 seconds during an Alarm to snooze Alarm for 3 mins, 10 mins or 15 mins. 5.3.3 System Recovering System recovering, means CGMS is not in normal operation. CGM readings will not be displayed during this period. Please use glucose meter to check blood glucose; Please press “Help”...
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Page 30: Faults And Troubleshooting
6 Faults and Troubleshooting Failure to press the top button of the applicator Slide the safety lock in the direction of the arrow，then press the top button of the applicator. The Sensor pad is not sticky enough Before inserting the sensor, clean the skin and let it dry. ... -
Page 31: Maintenance
7 Maintenance Sensor Continuous glucose monitoring sensors are not repairable. If you have a problem, please contact technical support. Transmitter Wipe the bottom of the transmitter with a wet cloth or alcohol wool before/after using. Continuous glucose monitoring transmitters are not repairable. If you have a ... -
Page 32: Travel Information
8 Travel information 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. -
Page 33: 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 34 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. Continuous Glucose Monitoring Systems has been tested with the immunity test level in the below table and meet the related requirements of IEC 60601-1-2:2014.
- Page 35 5240 WLAN Pulse 5500 5100-5800 802.11 modulation 217Hz 5785 WARNING Use of this equipment adjacent to or stacked with other equipment should be avoided because it could result in improper operation. If such use is necessary, this equipment and the other equipment should be observed to verify that they are operating normally.
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Page 36: User Help
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. 226400 Sales support Sales support: INFINOVO MEDICAL CO.,LTD. Registration and Operation Address: 3rd Floor, 6th Building, No.888 Zhujiang Road, Rudong, Jiangsu, China Tel. -
Page 37: 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 38: 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 39: Date Of Manufacture
Non-ionizing Radiation 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... -
Page 40: 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...