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POCTech CT3 Series User Manual

Continuous glucose monitoring system
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CT3 Series Continuous Glucose Monitoring System
User Manual
（for Serial Models: CT3, CT3A, and CT3C）
Zhejiang POCTech Co., Ltd.
I

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Summary of Contents for POCTech CT3 Series

  • Page 1 CT3 Series Continuous Glucose Monitoring System User Manual （for Serial Models: CT3, CT3A, and CT3C） Zhejiang POCTech Co., Ltd.
  • Page 2 Document No.: A4-CGM14-004 Protective Note Zhejiang POCTech Co., Ltd. reserves all rights to these operating instructions. Without the consent of Zhejiang POCTech Co., Ltd. these operating instructions may neither be reproduced nor made accessible to third parties. The same applies to individual parts or excerpts of these operating instructions.

  • Page 3: Table Of Contents

    Table of Contents Introduction ......................1 Safety Statement ....................... 2 Basic Product Information ..................6 Performance Characteristics ..................7 Operating Procedures ....................8 Waste Disposal ......................27 Notifications and Troubleshooting ................27 EMC Declaration ...................... 28 Product code / batch number, manufacturing date and service life ....... 33 Maintenance, Storage and Shipping ...............

  • Page 4: Introduction

    Always keep the User Manual for future reference. If you have any questions or difficulties regarding the use of your CT3 series, please do not hesitate to contact us. You are encouraged to report any events of concern to us.

  • Page 5: Safety Statement

    Android Typical hardware configuration: 2.5GHz 2.0GHz Memory Hard disk 64GB 64GB Display 1792*828 1920*1080 Bluetooth Typical sardware configuration: OS IOS13 compatible version OS Android7 compatible version Safety Statement 2.1 Read the User Manual Read the entire User Manual before you use your CT3 real time continuous glucose monitoring (rtCGM) system.
  • Page 6 transmitter-sensor in water for extended periods of time . ● Avoid vigorous physical activities or bumps. It may cause complete or partial detachment of the sensor, resulting in unreliable readings. ●Remove the transmitter and sensor when you have to undergo MRI examinations.As it may cause interruptions to other medical electrical equipment under extreme circumstances.
  • Page 7 2.2 Label symbols Figure or Symbol Definition Figure or Symbol Definition Consult instructions Type BF applied part Refer to instruction DC current manual Sterilized using Non-ionizing irradiation Irradiation Do not dispose in unsorted municipal Do not re-use waste stream Do not use if package Temperature limits (2 ~ 30 ℃) is damaged Water proof level...
  • Page 8 Figure or Symbol Definition Figure or Symbol Definition Single sterile barrier system with protective packaging outside...

  • Page 9: Basic Product Information

    3.4 Method of Calibration The CT3 series sensors feature factory calibration. The factory calibration information is coded in the QR code which is printed on the sensor base (visible after opening the sterile packaging). User calibrations are generally not required. However, user calibration using finger blood glucose is available during monitoring if so desired.

  • Page 10: Performance Characteristics

    See Figure1 for details of CT3 components Name Charging indicator Applicator Safety button Release button Figure 1 CT3 Components Performance Characteristics 4.1 Warm Up Time: 1 hour. 4.2 Sensor Use Life: 14 days. 4.3 Effective Glucose Range: 1.7 - 27.8mmol/L. 4.4 Number of 24 -hour glucose data points: 480 (1 data point / 3 minutes).

  • Page 11: Operating Procedures

    4.11 Sensor operating conditions: normal ambient temperature 4.12 Pressure: 700-1060hPa 4.13 Transmitter, sensor, transmitter charger and power adapter are all suitable for patient use. The patient can be the intended operator. 4.14 CT3 Clinical data Main performance data Glucose Range Percent A+B area A+B area ratio of...
  • Page 12 Figure 3 Login 5.2.2 Set up your profile If it is the first time you log in, you will see the profile screen, as shown in Figure 4. Fill in the information as guided to set up your profile. Or you can skip it and complete your profile later. Figure 4 Set Up Your Profile 5.3 Connect the transmitter to your phone 5.3.1...
  • Page 13 Figure 6 Connect to transmitter 5.4 Warm up your sensor 5.4.1 Once the connection between your App and the transmitter is successful, you will come to a screen that prompts you to scan or enter the QR code of the sensor. Scan the QR code on the sensor base with your phone as shown in Figure 7.
  • Page 14 5.5.1 Check the sterile package of the sensor. Do not use the sensor if its sterile package has been damaged or opened. 5.5.2 Check the sensor package for expiration date before opening. Do not use if expired. 5.5.3 Choose either the abdomen or arm as the sensor site (Figure 6): 1) Avoid part of skin that has scars, wounds, redness, swelling or infection.
  • Page 15 Figure 10 Pull off the Adhesive’s Backing 5.6.2 Firmly press the sensor down to the cleaned and dried skin site. (Figure 11) Figure 11 Firmly press the sensor 5.6.3 Move the safety pin to the unlock position. Hold the applicator steady and push the release buttons to insert the sensor.
  • Page 16 Figure 14 Sensor in place and Align the transmitter 5.8 The AnytimeWell main user interface is shown in Figure 15. 5.8.1 After the 1-hour warmup period, Anytime 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 with the time.
  • Page 17 4）You can choose to view the glucose curve for 4/8/12/24 hours periods. 5）Information such as data link status and remaining sensor life is also displayed. 6）If the Bluetooth communication with the transmitter becomes inactive after a period of non-active time, AnytimeWell is capable of reconnecting the data link automatically when you tap the App to activate it again.
  • Page 18 5.9.2 Tap to start a new calibration, as shown in Figure 18. Figure 18 Enter the Meter Value 5.9.3 Enter your finger blood glucose value, tap Confirm to complete the calibration, as shown in Figure 18. Figure 19 Calibration Completed Warning Do not calibrate when blood glucose changes very rapidly as it may result in large error.
  • Page 19 Figure 20 Events 5.11 End a monitoring session 5.11.1 During your 14-day sensor session, AnytimeWell displays sensor time countdown. The system will automatically terminate the monitoring at the end of the sensor session and await your confirmation. 5.11.2 Remove your sensor: Start from one edge of the adhesive, carefully pull off the sensor and transmitter together.
  • Page 20 Tap the icon on the top left corner of the home screen or swipe the home screen from left to right to go to the menu. Tap High and Low Targets. Scroll the numbers to select the set levels, tap Save to confirm, as shown in Figure 22.
  • Page 21 Figure 23 Notification Settings 5.12.3 CGM Sub-menus 5.12.3.1 Tap the icon on the top left corner of the home screen or 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.
  • Page 22 pop-up window for you to confirm, as shown in Figure 25. If the monitoring session is terminated from AnytimeWell, it will show “No device connected”. This results in permanent detachment between the transmitter and the phone App. The system is ready to start a new link for a new sensor. Figure 25 Confirm End Session 5.12.3.3 When the transmitter and AnytimeWell are unbound, it will show “No device connected”.
  • Page 23 Figure 27Daily View 5.13.2 Data 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 information as shown in Figure 29.
  • Page 24 Figure 29 Device Information 5.13.2.3 Monitoring results as shown in Figure 30. Figure 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 5.1.3.2.6 24 hourly trend graph representing daily glucose trend, as shown in Figure 33.
  • Page 25 Figure 33 Hourly 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 shown in Figure 35.
  • Page 26 Figure 35 Time percentages of highs and lows 5.13.2.9 Distribution of glucose levels as shown in Figure 36. Figure 36 Distribution of Glucose Levels 5.13.2.10 Tap on the top right corner of the screen to share data reports and data lists, as shown 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...
  • Page 27 Figure 38 Set Up Your Personal Data 5.14.2 Help Center Tap Help Center on the menu to view supporting materials, as shown in Figure 39. Figure 39 Help 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 statements and privacy policies, instructions on synchronizing data to Apple Health, and to change the password in Account Management, as shown in Figure 40.
  • Page 28 Figure 40 Settings 5.14.4 Logout Tap icon on the top left corner of the home screen to go to the Menu. Tap Logout at the bottom to log out your current account. You will have to re-login next time to enter your account, as shown in Figure 41. Figure 41 Logout 5.14.5 Glucose Unit Settings Tap Unit Settings on the menu to enter the unit settings, as shown in Figure42.
  • Page 29 download, install and set up their AnytimeFollow or log in their existing AnytimeFollow account to see your monitoring information. Figure 43. Invite 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 5.14.6.3 Set up your Followers.

  • Page 30: Waste Disposal

    Figure 45 Follower Settings Waste Disposal 6.1 Sensor: Used sensors should be handled according to local medical waste regulations for disposal. 6.2 Transmitter, transmitter charger and power adapter: Transmitter, transmitter charger and power adapter are reusable after cleaning. It is recommended to use alcohol pad for surface cleaning. Expired device should be handled according to local electronic medical waste regulations for disposal.

  • Page 31: Emc Declaration

    you cannot receive real time alerts. Once the Bluetooth data link is recovered, the delayed data will be retrieved. There is no loss of data in general. 7.6 Urgent Low Alert: The Urgent Low Alert is set at 3.1mmol/L and it cannot be changed or the sound muted. When your CT3 readings is below 3.1mmol/L, you will receive sound and message alerts.
  • Page 32 and immunity: Type Length USB DATA CABLE 1.2m Use of accessories and cables other than those specified or provided by the manufacturer of this equipment could result in increased electromagnetic emissions or decreased electromagnetic immunity. Do not place CT3 in the vicinity of other equipment or stack the CT3 with other equipment. If adjacent use inevitable, CT3 shall be observed to verify normal operation.
  • Page 33 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 shall ensure it is used in such an environment. IEC60601 Electromagnetic environment - Immunity test Compliance level Test level guidance...
  • Page 34 table. The customer or user of the CT3 rtCGM system should ensure it is used in such an environment. IEC60601 Electromagnetic environment - Immunity test Compliance level Test level guidance Portable mobile communications equipment should not be placed closer to any part of the equipment than the recommended separation distance, including cables.
  • Page 35 Note 1: At 80MHz and 800MHz, the separation distance for the higher frequency range applies. Note 2: These guidelines may not apply in all situations, Electromagnetic propagation is affected by absorption and reflection from building structures, objects and people. a ） Theoretically field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones and land mobile radios, amateur radio, AM and FM radio broadcast, and TV broadcast, cannot be accurately predicted.

  • Page 36: Product Code / Batch Number, Manufacturing Date And Service Life

    Product code / batch number, manufacturing date and service life 9.1 Transmitter 9.1.1 Transmitter SN.: see the label on the transmitter 9.1.2 Transmitter manufacturing date: see the package label 9.1.3 Transmitter service life: 2 years 9.2 Transmitter charger and power adapter 9.2.1 Manufacturing date: see the package label 9.2.2...

  • Page 37: Accessories, Peripherals And Consumables

    8) Defibrillation-proof applied parts: none; 9) Signal output or input applied parts: none; 10) Permanent or non-permanent installation: non-permanent EU Radio Equipment Directive (RED) Hereby, POCTech Co, LTD declares that the transmitter of the CT3 system is in compliance with Directive 2014/53/EU. Warranty 14.1...
  • Page 38 Zhejiang POCTech Co., Ltd. has been advised of the possibility of such damages, caused by negligence or otherwise. Unless applicable state law does not allow such exclusion or limitation.

  • Page 39: Annex : Anytimefollow Setting-Up Guide

    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 the original end user's expense - to a location designated by the dealer or Zhejiang POCTech Co, Ltd.
  • Page 40 Figure 2 Add Sharer 3 Sharers list Your Followers will see Sharers’ list on their home screen, including the Sharer and the Sharer’s glucose readings, as shown in Figure 3. They can tap specific Sharer to go to details and 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.
  • Page 41 Figure 5 Real-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 Follow 5.3Settings...
  • Page 42 Your Followers can tap the top right corner of the Real-time Follow screen to enter Settings to view information, set note, customize notifications and stop following. If they stopped following a Sharer, a notification would be synchronized to Sharer’s AnytimeWell, as shown in Figure 7. Figure 7 Anytime Follow Settings 5.3.1 Urgent Low Alert Urgent Low Alert level is set at 3.1mmol/L.
  • Page 43 Figure 8 Low Alert settings on AnytimeFollow 5.3.3High Alert The default High Alert level is set at 11.1mmol/L. When your CT3 readings go above 11.1mmol/L, alerts will be sent. Your Followers can change High Alert level, switch off High Alert, set alert intervals as advised by HCP or as needed on their AnytimeFollow.
  • Page 44 8 Help Center Your Followers can tap Help Center on the menu to view supporting materials, as shown in Figure 11. Figure 11 Help Center on AnytimeFollow 9About Your Followers can tap About on the menu to view details as shown in Figure 12, i.e., software updates, user license agreement and terms of use, legal statements and privacy policies.
  • Page 45 Brehmstr.56, 40239 Düsseldorf, Germany Note: See the User Manual for technical instructions All rights reserved by Zhejiang POCTech Co., Ltd., subject to change without prior notice In case of any change, a new version of User Manual will be issued.

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