POCTech CT10 User Manual
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POCTech CT10 User Manual

Continuous glucose monitoring system
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Copyright
The device bears CE mark indicating its conformity with the provisions of the Council Directive 93/42/EEC concerning
medical devices and fulfills the essential requirements of Annex I of this directive.
The CT10 Continuous Glucose Monitoring System is manufactured by Zhejiang POCTech Co., Ltd.
© Zhejiang POCTech Co., Ltd. All rights reserved. This User Manual may change without notice. When this happens, a new
issue of the User Manual will be released.
Definitions of Safety Notes
A WARNING statement provides important information about a potentially hazardous situation which, if not avoided, could
result in serious consequences.
A CAUTION statement provides important information about a potentially hazardous situation which, if not avoided, may
result in minor or moderate injury to the user or patient or damage to the medical device or other property.

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Summary of Contents for POCTech CT10

  • Page 1 The CT10 Continuous Glucose Monitoring System is manufactured by Zhejiang POCTech Co., Ltd. © Zhejiang POCTech Co., Ltd. All rights reserved. This User Manual may change without notice. When this happens, a new issue of the User Manual will be released.

  • Page 2: Table Of Contents

    A NOTE provides additional information intended to avoid inconvenience during operation. Contents Section 1. Safety Information 1.1. Important Safety Information 1.2. Labels Section 2. Product Introduction 2.1. Intended Use 2.2. Contraindications 2.3. System Introduction 2.4. System Components 2.5. Receiver Menu Description Section 3.

  • Page 3: Section 1. Safety Information

    Section 1. Safety Information 1.1. Important Safety Information Read this entire manual before using your Continuous Glucose Monitoring System. If you do not understand something or have any questions, please ask your Diabetes Management Team or another health care provider. Contraindications, warnings, precautions, cautions, and other important safety information can be found in this User Manual.
  • Page 4 Non-ionizing electromagnetic radiation Symbol for the marking of electrical and electronic equipment Batch code Use-by date Temperature limit （2℃~30℃） IP27 Degrees of protection against water indicated Manufacturer Do not use if package is damaged Date of manufacture Authorized representative in the European Community...

  • Page 5: Section 2. Product Introduction

    The receiver converts the sensor signal to a glucose reading that is displayed to the user. The CT10 allows you to continually see your readings every 3 minutes for up to 10 days. Reagents Glucose oxidase.

  • Page 6: Receiver Menu Description

    Users can get the latest version of User Manual of POCTech CGM App at www.poctechcorp.com Users can contact the supplier to obtain POCTech Care software for Windows, which is used to input the stored CGM data into the computer through the USB cable to display the glucose data collected by the CGM.
  • Page 7 Figure 3. Receiver Display 2.5.1 Top Status Line: Date, Time; (yy-mm-dd) Vibrator Alert; ( Remaining Sensor Days(10) Audio Alert; Bluetooth; Battery. 2.5.2 Middle Glucose Information: Glucose Reading& Unit Glucose Arrow Glucose Trend Graph. 2.5.3 Bottom Menu Line: Sensor ON/OFF/Signals ( Parameters Settings ( Events Input( Data Review (...
  • Page 8 Figure 4. View Signal Screen Parameters Settings (Fig. 5): Date/Time; Keypad Tone. Alert On/Off (Audio/Vibrator/Audio+Vibrator). Alert Setting (Hyperglycemia/Hypoglycemia threshold values). Language . Figure 5. Parameters Settings Menu Events Input(Fig. 6): RefBG: User enters Blood glucose (BG) Event Input: User Logs: Exercise;...
  • Page 9 Figure 6. Events Input Data Review (Fig.7): Review Data: Review historical sensor data. 24 Hours Data: Display a 24-hour Overlay of the selected sensor data file. Figure 7. Data Menu...

  • Page 10: Section 3. Preparation Before Use

    Section 3. Preparation before Use 3.1. Preparation before Use The Sensor: Check the sterile packaging and the expiration date to make sure that the sensor is in good condition. The Transmitter: Make sure that one new CR1620 (3V) cell button battery is available for each sensor when beginning the monitoring. Prepare the transmitter (Fig.8): Install a CR1620 battery in the transmitter.
  • Page 11 correct, and that the battery indicator indicates sufficient battery power. When the transmitter has been successfully started, its ID number will be displayed on the receiver. Verify the number of the transmitter. Touch the number on the screen to select the transmitter. And then “Yes” to connect the transmitter The Bluetooth antenna icon appears on the receiver screen, indicating the data communication has been established.

  • Page 12: Section 4. Product Operation And Notice

    Section 4. Product Operation and Notice 4.1. Using a New Sensor Prepare the Receiver: When the receiver is turned ON, it searches for all nearby transmitters and displays a list of transmitters (or other Bluetooth devices nearby). Check receiver battery. Charge the battery if necessary. Set Date and Time, Alerts Modes, Hyper/Hypo Thresholds, and Language Prepare the Skin: Choose one upper arm or middle abdomen for sensor insertion (Fig.12).
  • Page 13 Press the sensor base and the adhesive tape to achieve a firm adhesion(Fig.14). Figure14.Press the sensor plate firmly to ensure adhesion Remove the protection cap on the release button (Fig 15). Remove the protection cap on the release button (Fig 15). Bend down the inserter handle until the front sensor base plate pulls the skin up.
  • Page 14 Figure 16b. The Correct Insertion Angle After sensor insertion, pull back to remove the inserter lock pin with the thumb of hand holding the inserter (Fig 17). Figure 17. Remove the Lock Pin Then, press the arms on the sides of the inserter to disengage the sensor. Remove and discard the inserter in medical sharp disposal (Fig.

  • Page 15: Initialize The Sensor

    Figure 19. Push the Sensor Connection Block into Position 4.2. Initialize the Sensor The screen then displays “Start Sensor? Yes/No". When choosing “Yes”, the system enters next Initialization Mode and begins to store sensor data (Fig.20). Figure 20. Starting Sensor Data Acquisition Install the transmitter to the sensor: Slide the transmitter onto the sensor base and lock (Fig.

  • Page 16: Events Input

    Figure 22. Entering Reference Blood Glucose The sensor glucose value and a continuous glucose graph will be displayed after the BG entry (Fig. 23). Figure 23. Receiver Display for Normal Glucose Monitoring The sensor requires reference finger blood glucose (BG) for calibration. Follow the next Calibration Table to measure BG and enter to the receiver within 5 minutes.

  • Page 17: Features Of The Touch-Screen Display

    4.5. Features of the Receiver Touch-Screen Display The Default Display: The default display includes a 5-hour glucose graph and a glucose value. The unit for glucose concentration is mg/dL (mmol/L is available in countries where this unit is used). Normal graph and glucose concentration are displayed in white.

  • Page 18: Ending Your Continuous Glucose Monitoring

    your doctor. Outdoor Activities: Avoid vigorous sports activities that might involve physical bumps. Itchiness: Adhesive dressing tape usually may cause skin itchiness. This can be relieved by changing the cover dressing tape every few days. When changing tape, be careful not to disturb the sensor. If swelling or redness accompanying extreme itchiness happens under the sensor area, the sensor may need to be removed.

  • Page 19: Section 5. Troubleshooting And Maintenance

    Section 5. Troubleshooting and Maintenance 5.1. Troubleshooting Receiver Memory Over-Flow. The receiver’s memory stores no less than 10 cycles of sensor’ data. However, it is recommended that you upload the sensor data to your computer (the desktop software can be obtained via customer service or dealers).
  • Page 20 Receiver Time Difference. You may notice that the time on the receiver is different from that of the actual clock. It is normal as long as the time difference is within a few minutes. You are not allowed to reset the time during a sensor monitoring session.

  • Page 21: General Maintenance Of Device -Inspection And Maintenance

    not be reliable. measurement when the receiver is showing a rapid glucose change in the last 15 minutes. Wait until blood glucose becomes stable to take next measurement for calibration. Sensor failure. Please end the The anomaly change of current Turn off the sensor from the Sensor Menu and session.

  • Page 22: Section 6. Specifications And Emc Declaration

    Clinical data A clinical trial for continuous glucose monitoring system (CGMS) was completed in 2015 by POCTech, involving 80 patients in two hospitals. An overall MARD (vs finger sticks) of 9.61% was achieved. The sensor also showed an overall MARD of 8.67% (vs venous blood glucose).

  • Page 23: Emc Declaration

    ≤93% RH Humidity(RU)/% 6.2. EMC Declaration Guidance and Manufacturer’s Declaration-Electromagnetic emission CT10 Continuous Glucose Monitoring System is expected to be used in the following environment. Buyers and users should ensure that such electronic conditions are met. Emission Test Conformity Electromagnetic Environment——Guidance CT10 system adopts emission only for its internal communication.
  • Page 24 Note 1：At 80MHz and 800MHz frequencies，use higher frequency formula. Note 2：The guidance may not be suitable for all circumstances. Electromagnetic transmission is affected by buildings, objects and human bodies. ⚫ Fixed position Transmitters, such as cordless phones, hubs for wireless networks, amateur shortwave radios, FM,/AM radios, and TVs, etc., emit electronic fields whose intensity may not be accurately known.

  • Page 25: Eu Radio Equipment Directive (Red)Declaration

    Recommended Distances for Portable RF Equipment with CT10 system CT10 Continuous Glucose Monitoring System is expected to be used in an environment where RF interferences are controlled. Based on the maximum output power levels, buyers or users may use the below calculation to estimate the minimum distances from an RF emitting device required to use the CT10 system.

  • Page 26: Section 7. Warranty

    • Damage or malfunction caused by other causes not attributed to the manufacturing. • POCTech Co., Ltd. reserves right of explanation to the above terms and conditions. Zhejiang POCTech Co., Ltd. No. 1633 Hongfeng Road, Building 11 & 12 Huzhou City 313000, Zhejiang, China Prolinx GmbH Brehmstr.

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