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Continuous Glucose Monitoring

Systems

Transmitter, Sensor, App

USER MANUAL

Model

：

IGF 2.1

INTELLIGO B.V.

IGF 2.1

version no. A/2

effective date: 2020/07/01

Содержание IGF 2.1

Страница 1: ...Continuous Glucose Monitoring Systems Transmitter Sensor App USER MANUAL Model IGF 2 1 INTELLIGO B V IGF 2 1 version no A 2 effective date 2020 07 01...

Страница 2: ...r 18 4 4 Calibration 20 5 App interface introduction and function application 23 5 1 Main interface 23 5 2 Function Bar 25 5 3 Alarm Alert 28 6 Faults and Troubleshooting 30 The Sensor pad is not stic...

Страница 3: ...mation 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 t...

Страница 4: ...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 During the monitoring period blood glucose values op...

Страница 5: ...rding to your local regulations for medical waste after the sensor session is finished The performance parameters of sensor Model No IG2 SR 1P Measurement range 2 2 22 2 mmol L Effective working time...

Страница 6: ...e length33 1 mm width19 35 mm height 8 3mm Weight 3 7 g Display interval 3 mins Calibration method Blood Glucose Meter Calibration frequency optional Data receiving range 2 m without obstruction Expec...

Страница 7: ...ted 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...

Страница 8: ...eshare com The user can give access to third users for remote monitoring The portal includes statistical Analysis software for processing and analyzing glucose data and producing useful statistical re...

Страница 9: ...e Do not adjust your treatment plan without discussing it with your medical diabetes team 2 2 Important user information In order to use this product safely please review your product instructions bef...

Страница 10: ...ensor can be transported at room temperature The storage time is the shelf life 8 months of the sensor If the temperature range of the refrigerator is 2o C 25o C the sensor can be stored in the refrig...

Страница 11: ...and result in missing low high blood glucose values Rapid changes in blood glucose level may not be displayed in time such as during exercise or after meals There is always a time lag between glucose...

Страница 12: ...10 wearing the sensor 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...

Страница 13: ...nsor glucose reading moves with the blood glucose level and will remind you when the glucose level exceeds the target range If you are at high low blood glucose levels and you miss the reminding and w...

Страница 14: ...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 trans...

Страница 15: ...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...

Страница 16: ...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...

Страница 17: ...and transmitters Model No IG2 TR 1P of the Continuous Glucose Monitoring Systems should be suitable for each other The products of different generations cannot be connected to each other and thus can...

Страница 18: ...16 Enter Sensor Lot Number to Start CGM Warm up time 190 Mins Note No High Low Alarm during warming up Keep the connection between transmitter and smart phone during warming up...

Страница 19: ...Sensor glucose readings and curve Blood glucose readings and trend curve are shown in App s Home Screen Home Screen Logbook Caution Continuous glucose monitoring cannot be used as a basis for diabetes...

Страница 20: ...cose 4 3 End session and remove sensor Settings Export Data Note After 14 days monitoring CGMS will be stopped automatically also can be ended manually Export Now CGMS monitoring information can be ex...

Страница 21: ...nsmitter and sensor together from your body 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...

Страница 22: ...d glucose meter to routinely test blood glucose for calibration Do not replace the glucometer during the monitoring process The accuracy of different brands of blood glucose meters and test strips wil...

Страница 23: ...ions and use the blood glucose meter to test the blood glucose c Enter the Calibration screen from Home Screen d Using a BG meter do a fingerstick test and enter the value in the calibration entry box...

Страница 24: ...able 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 cou...

Страница 25: ...23 5 App interface introduction and function application 5 1 Main interface The main interface contains glucose readings glucose curve trend arrows CGM status...

Страница 26: ...apid decrease blood glucose decreased by more than 0 17 mmol L 3 06 mg dL per minute No arrow App cannot for the moment calculate the rate of increase or decrease in blood glucose data synchronization...

Страница 27: ...ED Transmitter ID Transmitter SN Sensor ID Sensor LOT number Sensor Started When this sensor session starts Last Calibration The latest calibration Replace Sensor When this sensor session ends and the...

Страница 28: ...ly Report Data available for reviewing glucose levels in certain day Glucose Events Display the blood glucose readings that generated high and low blood glucose alarms Daily Average Average Data of a...

Страница 29: ...27...

Страница 30: ...ill still sound even in phone s vibration or mute mode Note If the Android Phone is in Do Not Disturb Mode the urgent low alarm may not be triggered Remember to turn off Do Not Disturb or Battery Savi...

Страница 31: ...arm Limit If the glucose levels is higher than this value app will generate hyperglycemia alarm High Alarm 22 2 mmol L 400 mg dL 13 0mmol L 400 mg dL 5 3 2 Snooze Alarm You can press hold circles for...

Страница 32: ...Calibration troubleshooting Calibration 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 conn...

Страница 33: ...m of the transmitter with a wet cloth or alcohol wipe before after using each time Continuous glucose monitoring transmitters are not repairable If you have a problem please contact technical support...

Страница 34: ...y 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...

Страница 35: ...g immunity test levels Higher immunity levels may cause the Continuous Glucose Monitoring Systems essential performance lost or degraded Phenomenon Basic EMC standard or test method Home healthcare fa...

Страница 36: ...e between RF wireless communications equipment and Continuous Glucose Monitoring Systems as recommended below EMC Statement Test frequency MHz Band MHz Service Modulation Maximum power W Distance m Im...

Страница 37: ...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 c...

Страница 38: ...free The purchaser must return the product to the sales support department in proper packaging Purchase receipt or similar sales certificate with date of purchase and seller s name and address should...

Страница 39: ...37...

Страница 40: ...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...

Страница 41: ...acture 0197 After passed CE certification mark the CE marking on package INTELLIGO B V Keizersgracht 241 1016EAAmsterdam Netherlands 13 Date of manufacture The production date and expiry date are show...

Страница 42: ...m 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 purc...

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