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INFINOVO MEDICAL p3, User Manual

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INFINOVO MEDICAL p3 User Manual Download Page 7

5

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.

The performance parameters of App

Item

Detail

Operating system

Android 6.0 and above/IOS 13.2 and above

Connection

One App can only connect to one transmitter at

the same time

Data transmission

Transmitter and App (phone) transmit data via

Bluetooth protocol

The file exported by the app is transferred to

the analysis software via wireless or USB data

cable (Only Android)

Storage Format

App export data storage format is Excel file

1.4 Analysis Software overview

Analysis software downloads and collects data from the Mobile App for processing

and analysis, then produces reports.

Summary of Contents for 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 ...

Page 2: ...4 1 Installation 13 4 2 Use 16 4 3 End session and remove sensor 18 4 4 Calibration 19 5 App interface introduction and function application 22 5 1 Main interface 22 5 2 Function Bar 24 5 3 Alarm Alert 25 6 Faults and Troubleshooting 28 7 Maintenance 29 8 Travel information 30 9 EMC Statement 31 10 User help 34 11 The warranty 35 11 1 The scope and duration of warranty 35 11 2 The following condit...

Page 3: ...ation to the Mobile Application wirelessly via Bluetooth Low Energy Transmitter serial number Consisting of numbers and letters it is unique for each transmitter and can be found on the back of the transmitter App The mobile software that receives blood glucose information displays blood glucose readings trend curves trend arrows and transmitter status Default value The values that come with the s...

Page 4: ... signal and generates the blood glucose values which is sent to the mobile App The user analysis software downloads and collects data from the mobile 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 r...

Page 5: ...s of monitoring Please discard disposable sensor after wearing The performance parameters of sensor Model No SP3 WL 03 Measurement range 2 2 22 2 mmol L Effective working time 14 days Calibration method Factory calibration Calibration range 2 2 22 2 mmol L Storage conditions Temperature 2o C 25 o C Relative humidity 15 85 Transport conditions Room temperature for transportation Rated voltage d c 3...

Page 6: ...splay interval 3 mins Data receiving range 2 m without obstruction Expect product service life Reused up to 10 times Validity period 36 months Operation mode Continuous performance Protection grade IP27 Working conditions After the transmitter placed in the sensor base Temperature 10 o C 40 o C Relative humidity 10 95 Atmospheric pressure 70kPa 106 kPa Transport and Storage conditions Temperature ...

Page 7: ...ail Operating system Android 6 0 and above IOS 13 2 and above Connection One App can only connect to one transmitter at the same time Data transmission Transmitter and App phone transmit data via Bluetooth protocol The file exported by the app is transferred to the analysis software via wireless or USB data cable Only Android Storage Format App export data storage format is Excel file 1 4 Analysis...

Page 8: ...6 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: ...l Operating system Windows 7 and above Tip Software works on both 64 bit and 32 bit systems Data transmission The file exported by the app is transferred to the analysis software via wireless or USB data cable Android Only Report Format Export format is PDF file ...

Page 10: ...t discussing it with your medical diabetes team 2 2 Important user information In order to use this product safely please review your product instructions before using your Continuous Glucose Monitoring System The instructions include contraindications warnings cautions and other important user information Discuss with your doctor how to use the information to help you control your blood glucose T...

Page 11: ... lead to infection The storage temperature of the sensor is 2o C 25o C The sensor can be transported at room temperature The storage time is the lifetime of the sensor If the temperature range of the refrigerator is 2o C 25o C the sensor can be stored in the refrigerator Improper storage results in inaccurate blood glucose readings and missing low high blood glucose levels If the sensor is stored ...

Page 12: ...ut or input exceeding 3minutes may affect the performance of the sensor and result in missing low high blood glucose values Rapid changes in blood sugar can affect the accuracy of the system such as during exercise or after meals When properly worn the transmitter and App have a transmission range of 2 m without obstruction Wireless connection in the water is not very well so the range of connecti...

Page 13: ...11 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 ...

Page 14: ...ent from the values measured by blood glucose meter In most cases the sensor glucose reading moves with the blood glucose level and prompts after the glucose level exceeds the target range If you are at high low blood glucose levels but you are not prompted you will not test your blood glucose with blood glucose meter and you will miss high low blood glucose values 3 2 Efficacy The Continuous Gluc...

Page 15: ...llow the App to access your smart device location for Android system 4 1 3 Sensor Insertion 1 Prepping a Do NOT use if the sensor package seems to be damaged or is already opened b Do NOT use after the sensor expiry date c Wash your hands d Clean bottom of transmitter with alcohol wipe e Let the transmitter dry Note Be careful don t touch its metal dots and scratch it that may damage the water res...

Page 16: ...ing 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 Place sensor horizontally on the abdomen Press the applicator to ensure that the tape is firmly attached on the skin Hold the applicator and pull the Safety Lock to unlock mode ...

Page 17: ...e holder Press the other end of the transmitter until it clicks into the holder you will heard 2 clicks sound If the transmitter isn t embedded properly it may cause the transmitter to break away 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...

Page 18: ...t 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: ...rming 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 Note Do calibration before meal 4 2 2 Blood glucose readings and curve Blood glucose readings and trend curve are shown in App s Home Screen ...

Page 20: ...s a diagnostic basis for diabetes may result in low high blood glucose 4 3 End session and remove sensor Settings EXPORT NOW Note After 14 days monitoring CGMS will be stopped automatically also can be removed manually 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...

Page 21: ...matically after when entered Sensor code at starting CGM If choose skip in the page of entering sensor LOT and Sensor code the user will need to enter calibration after warming up and then enter calibration once every 24 hours for the display of the readings and trend curves and to maintain the accuracy throughout the monitoring process Users can calibrate during the usage selectively when the rea...

Page 22: ...d enter the value in the calibration entry box Press Calibrate button 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 Do not calibrate when the single arrow or double arrow is displayed on the App interface which indicates that your blood glucose level increases decreases by 0 11 0 17 mmol L or over 0 17 mmo...

Page 23: ...Only calibrate when your CGMS arrow is stable Do not always assume that glucose meter is right and CGMS is wrong When in doubt test two or three times CGMS has been averaging glucose meter errors only guaranteed to 20 for several days it could well be closer to the true value overtime than glucose meter 3 It s better to validate that your true BG is stable When you are not sure if your BG is stabl...

Page 24: ...able no more than 0 06 mmol L rise or fall per minute Slow increase blood glucose increases by 0 06 to 0 11 mmol L per minute Increase blood glucose increased by 0 11 0 17 mmol L per minute Rapid increase blood glucose increased by more than 0 17 mmol L per minute Add Events Trend Arrow Unit CGM Status Horizontal Screen Glucose Curve Navigator CGM Reading Reading Time Remaining Time High Zone In R...

Page 25: ...o right on the glucose curve you can review the recent sensor glucose readings Sensor glucose reading shows between 2 2 22 2mmol L During Sensor Glucose below 2 2mmol L or above 22 2mmol L there will no record in glucose curve but sensor glucose reading are still recorded once every 3 minutes in Logbook At the top of the glucose curve you can tap on the trend view you want to see glucose levels of...

Page 26: ...ou can add Events carbs insulin Medication sport by clicking 5 2 Function Bar Function bar contains Home Calibration Reports Logbook and Settings 5 2 1 Calibration To add calibrations via meter Range 2 2 22 2mmol L 5 2 2 Report Time In Range TIR time in range indicates the percentage of how long your glucose value was within the target range during a defined period Glucose Profile A profile displa...

Page 27: ...xport as an Excel file in phone s storage Uninstall App may cause data lost b Alarms and Alert Change alarm and alerts threshold and customize alarm c Device Information View sensor and transmitter information 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 ...

Page 28: ... 1mmol L 56 mg dL 3 1mmol L 56 mg dL High Limit Hyperglycemia display limit If the blood glucose is higher than this value it will be displayed in the white area of the trend chart but the app will not generate an alarm 6 7 mmol L 120 mg dL High Limit 10 0 mmol L 180 mg dL High Alarm If the blood sugar is higher than this value app will generate hyperglycemia alarm High Alarm 22 2 mmol L 400 mg dL...

Page 29: ...se press Help for help when you see this notification 5 3 4 Connecting When the phone s Bluetooth is off or the app s Bluetooth is disconnected the app will indicate that the CGMS is disconnected No data or alarms will be received when disconnected When the disconnect prompt appears keep the phone at a working distance from the transmitter and remove any obstructions or check whether the phone s B...

Page 30: ...ibration tips will appear during monitoring The suggestions for troubleshooting are as follows Do not calibrate when the main interface shows that the device is not connected Do not calibrate if the blood glucose level is lower than 2 2 mmol L or higher than 22 2 mmol L Wash your hands and let it dry make sure the blood glucose test strips are stored properly during its shelf life and make sure th...

Page 31: ... 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 problem please contact technical support Note Keep the bottom of the transmitter clean to avoid short circuit Discarded treatment of products Consult the local Medical Waste Administration for treatment ...

Page 32: ...ty 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 Inform the security agency that the sensor cannot be removed because it is inserted in the skin If you have any questions or concerns please visit the website of the travel saf...

Page 33: ...ls Higher immunity levels may cause the Continuous Glucose Monitoring Systems essential performance lost or degraded Phenomenon Basic EMC standard or test method Home healthcare facility environment Electrostatic discharge IEC 61000 4 2 8 kV contact 2 kV 4 kV 8 kV 15 kV air Radiated RF EM fields IEC 61000 4 3 10V m 80MHz 2 7GHz 80 AM at 1kHz Proximity fields from RF wireless communications equipme...

Page 34: ...unications equipment and Continuous Glucose Monitoring Systems as recommended below EMC Statement Test frequency MHz Band MHz Service Modulation Maximum power W Distance m Immunity test level V m 385 380 390 TETRA 400 Pulse modulation 18Hz 1 8 0 3 27 450 430 470 GMRS 460 FRS 460 FM 5 kHz deviation 1 kHz sine 2 0 3 28 710 704 787 LTE Band 13 17 Pulse modulation 217Hz 0 2 0 3 9 745 780 810 800 960 G...

Page 35: ...ransducers and cables other than those specified or provided by the manufacturer of this equipment could result in increased electromagnetic emissions or decreased electromagnetic immunity of this equipment and result in improper operation 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 par...

Page 36: ... 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 86 0513 68928098 Fax 86 0513 68928019 ZIP Code 226400 Website www infinovo com ...

Page 37: ...o the sales support department in proper packaging Purchase receipt or similar sales certificate with date of purchase and seller s name and address should be send back together with the product Contact the sales support department to get the address Once the product is received the company will replace it immediately If the company determines that the product is not covered by the warranty the pu...

Page 38: ...d 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 Dustproof and Waterproof class Product Number Serial Number Sensor Code Environmental Protection ...

Page 39: ...e CE marking on package 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 in the package ...

Page 40: ...em 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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