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CT3 Series Continuous Glucose Monitoring System

User Manual

（

for Serial Models: CT3, CT3A, and CT3C

）

Zhejiang POCTech Co., Ltd.

Summary of Contents for CT3 Series

Page 1: ...I CT3 Series Continuous Glucose Monitoring System User Manual for Serial Models CT3 CT3A and CT3C Zhejiang POCTech Co Ltd...

Page 2: ...ividual parts or excerpts of these operating instructions Violations give rise to a claim for damages and may have criminal consequences This User Manual is subject to change without notice This User...

Page 3: ...te Disposal 27 7 Notifications and Troubleshooting 27 8 EMC Declaration 28 9 Product code batch number manufacturing date and service life 33 10 Maintenance Storage and Shipping 33 11 Accessories Peri...

Page 4: ...nts of the User Manual are subject to change without notice 1 3 Limits on POCTech s liability obligations POCTech shall not be liable for any personal injury or damage caused by failure to use the CT3...

Page 5: ...d glucose that leads to diabetic complications Sensors are shipped and stored in sterile packages Keep the sensor in sterile packaging until you are ready to use it Early opening may cause microbial c...

Page 6: ...n have access to your CT3 without adult supervision Do not swallow the small components that may pose a choking hazard Note Read the User Manual before you use your CT3 real time continuous glucose mo...

Page 7: ...tion Do not re use Do not dispose in unsorted municipal waste stream Do not use if package is damaged Temperature limits 2 30 IP58 Water proof level IP58 USB port Do not re sterilize Class II equipmen...

Page 8: ...5 Figure or Symbol Definition Figure or Symbol Definition Single sterile barrier system with protective packaging outside...

Page 9: ...C 3 3 Working Principle Glucose in the interstitial fluid reacts with glucose oxidase in the sensor membrane producing hydrogen peroxide which in turn reacts at the sensor electrode to generate electr...

Page 10: ...y test accuracy linear deviation within 20 4 7 The sensor can automatically monitor and correct electrochemical interference Lab test recovery ranges 80 120 n 12 with 20mg L acetaminophen and 60mg L a...

Page 11: ...e surface of the transmitter Figure 2 Transmitter Contact Pins 5 1 2 Charge your transmitter Place the transmitter into the charger to start charging A bule color indicates charging completion Make su...

Page 12: ...ur phone 5 3 1 Take the fully charged transmitter out of the charger This will turn the Bluetooth of the transmitter into broadcast search mode Place you phone next to the transmitter On the App scree...

Page 13: ...de on the sensor base with your phone as shown in Figure 7 You can manually input sensor information If the code is invalid after scaning for several times The system enters into the warmup mode after...

Page 14: ...n 5cm from your insulin pump infusion set or injection site 3 When choosing abdomen the sensor should be at least 5 cm from the belly button 4 Avoid strong muscular movement parts 5 Avoid parts that a...

Page 15: ...on carefully remove the applicator from the sensor Dispose the applicator in a medical waste bin Figure 12 and Figure 13 Figure 12 Unlock the Safety Pin and Insert the Sensor Figure 13 Remove the Appl...

Page 16: ...me begins to display CGM glucose monitoring information Figure 15 The User Interface of the App 5 8 2 The CT3 glucose monitoring user interface 1 The App displays the most recent CGM reading together...

Page 17: ...a link automatically when you tap the App to activate it again 7 The meanings of the trend arrows are shown in Figure 16 Figure 16 Trend Arrows 5 9 Calibrate the sensor 5 9 1 Your sensors are factory...

Page 18: ...glucose changes very rapidly as it may result in large error Warning Enter wrong values will result in large error 5 10 Log events To log an event tap Events on the home screen to open the event log...

Page 19: ...ensor and transmitter together 5 11 3 Check the skin of the sensor site If bruises infection redness and swelling etc are observed take a photo for your physician or ask a physician to look at 5 11 5...

Page 20: ...ect the set levels tap Save to confirm as shown in Figure 22 Figure 22 Set Your High and Low Alerts 5 12 2 Notifications Tap the icon on the top left corner of the home screen or swipe the home screen...

Page 21: ...swipe the home screen from left to right to go to the menu Tap CGM and see the SN of the transmitter when it is in normal connection status to the AnytimeWell as shown in Figure 24 Figure 24 CGM Inter...

Page 22: ...on 5 12 3 3 When the transmitter and AnytimeWell are unbound it will show No device connected This means the system is available to start the next sensor Figure 26 No Device Connected 5 13 View Glucos...

Page 23: ...Report Tap Data Report on the menu scroll up to view the data report generated for a sensor session 5 13 2 1 Select sensor session as shown in Figure 28 Figure 28 Select Sensor Session 5 13 2 2 Device...

Page 24: ...ure 30 Monitoring Results 5 13 2 4 Blood glucose panorama as shown in Figure 31 Figure 31 Blood Glucose Panorama 5 1 3 2 5 24 hour Overlay Graph as shown in Figure 32 Figure 32 24 hour Overlay Graph 5...

Page 25: ...rly Trend Graph within 24 hours 5 1 3 2 7 Daily Highs and Lows graph showing your highs and lows as shown in Figure 34 Figure 34 Highs and lows 5 1 3 2 8 Time percentages of your highs and lows as sho...

Page 26: ...own in Figure 37 Figure 37 Data lists 5 13 3 AGP Report Tap AGP Report on the menu to view and share the AGP Ambulatory Glucose Profile report generated for a sensor session 5 14 Other Sub menus 5 14...

Page 27: ...lp Center 5 14 3 Settings Tap Settings on the menu to view About Synchronize Data to Apple Health Account Management to learn about software updates user license agreement and terms of use legal state...

Page 28: ...onitoring results with your physicians guardians and family members via the Anytime Follow App After you send your invitation to people Followers they will be able to follow the invitation to download...

Page 29: ...e Followers 5 14 6 2 You may check Followers you have invited and notifications on the lists under Followers and Notifications as shown in Figure 44 Figure 44 Followers and Notifications Lists 5 14 6...

Page 30: ...send notifications when it fails to establish the initial connect with a transmitter when transmitter battery is low In such situation you must fully charge the transmitter before trying to connect 7...

Page 31: ...the current sensor session remove the sensor and start a new sensor 7 12 Insufficient adhesion of the adhesive patch If the adhesive shows early peeling off use an additional medical tape to protect...

Page 32: ...sions The CT3 rtCGM system is intended for use in the electromagnetic environment specified in the next table The customer or user of the CT3 rtCGM system should ensure it is used in such an environme...

Page 33: ...s Not applicable Main power quality should be that of a typical commercial or hospital environment Voltage dips short interruptions and voltage variations on power supply input lines IEC61000 4 11 0...

Page 34: ...t than the recommended separation distance including cables The recommended separation distance can be estimated using the equation applicable to the frequency of the transmitter Recommended separatio...

Page 35: ...ons Equipment and CT3 CT3 is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled The customer or the user of the CT3 can help to prevent electromagnetic...

Page 36: ...e kept away from humidity and electromagnetic field 10 1 2 Transmitter transmitter charger and power adapter do not need special maintenance Wipe it with alcohol pads and let it dry if you see contami...

Page 37: ...hock internal power supply operating class II charging 2 Classification by degree of protection against electric shock Type BF applied operating Type BF not applied charging 3 Classification by degree...

Page 38: ...unapproved medical devices is excluded from this warranty There is no warranty for the compatibility of the product or its associated accessories with other medical devices The warranty remains valid...

Page 39: ...uct Make a warranty claim To make a warranty claim contact the dealer from whom the product was purchased or the customer service department of Zhejiang POCTech Co Ltd The product must be returned at...

Page 40: ...swipe to go to Notifications list Figure 3 Sharers list 4 Notifications list Notifications list shows both invitations received and sent as shown in Figure 4 Figure 4 Notifications list on Anytime Fo...

Page 41: ...time Follow 5 2 Daily View Your Followers will see your readings of the day and choose date to look at your diagram events records and daily view as shown in Figure 6 Figure 6 Daily View on Anytime Fo...

Page 42: ...1 Urgent Low Alert Urgent Low Alert level is set at 3 1mmol L Your Followers cannot change it on their Anytime Follow When your CT3 readings go below 3 1mmol L they will receive sound and message ale...

Page 43: ...as advised by HCP or as needed on their AnytimeFollow 6 Set up profile on AnytimeFollow Your Followers can tap the icon on the top left corner of the home screen or swipe the home screen from left to...

Page 44: ...and terms of use legal statements and privacy policies Figure 12 About 10 Account management Your Followers can tap Account Management on the menu to manage their account and change their password as...

Page 45: ...313000 Zhejiang China Prolinx GmbH Brehmstr 56 40239 D sseldorf Germany Note See the User Manual for technical instructions All rights reserved by Zhejiang POCTech Co Ltd subject to change without pri...

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