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Microtech AiDEX User Manual

Continuous glucose monitoring system
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AiDEX
Continuous Glucose Monitoring System
TM
User Guide
MicroTech Medical (Hangzhou) Co., Ltd.

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Summary of Contents for Microtech AiDEX

  • Page 1 AiDEX Continuous Glucose Monitoring System User Guide MicroTech Medical (Hangzhou) Co., Ltd.

  • Page 3: Table Of Contents

    Index Important safety information Indications for use ........... 1 Patients ..............2 Contraindications ............. 3 Precautions .............. 4 Blood glucose test module precautions ....6 Product components Component description ..........9 Using a New Glucose Sensor Applying a sensor ..........14 Setting the Personal Diabetes Assistant (PDA) for the first time ............
  • Page 4 Removing a sensor PDA settings Target glucose range ..........31 Date and time settings ........... 33 Using the PDA Pairing with a new transmitter ....... 34 Alarm system description ........38 Using the built-in Blood Glucose Meter (BGM) ..41 Charing the Personal Diabetes Assistant (PDA) ..

  • Page 5: Important Safety Information

    Interpretation of the AiDEX CGMS results should be based on the glucose trends and several sequential readings over time. The AiDEX CGMS also aids in the detection of episodes of hyperglycemia and hypo-...

  • Page 6: Patients

    Personal Diabetes Assistant controller can be used in conjunction with MicroTech’s Exactive EQ blood glucose test strips. It cannot be used for the diagnosis and screening of dia- betes, nor as a basis for drug therapy decisions.

  • Page 7: Contraindications

    Hematocrit range of 30% to 55%. Triglycerides below 46.9 mmol/L (3000mg/dL) or cholesterol below 12.9 mmol/L (500 mg/dL). Contraindications Patients who: Suffer from alcoholism, drug abuse, severe mental disorders (such as depression, schizophrenia). Are unconscious. Are unable to understand or master the usage of the device.

  • Page 8: Precautions

    Precautions • CGMS readings should only be used as a reference for the supplemental monitoring of diabetes mellitus and should not be used as a basis for clinical diagno- sis. • The CGMS should be completely removed before Magnetic Resonance Imaging (MRI). •...
  • Page 9 If the problem persists, remove and replace the sensor. • While extensive user testing was done on AiDEX CGMS in Type I and Type II diabetic patients, the study groups did not include women with gestational diabetes.

  • Page 10: Blood Glucose Test Module Precautions

    Blood glucose test module precautions • This function should only be used in vitro and can only be used with MicroTech’s Exactive EQ blood glucose test strips. Use of other brand test strips will result in incorrect test results. • The blood glucose test function can only be used to determine blood glucose levels using whole blood samples.
  • Page 11 L (20-600 mg/dL). • Triglycerides above 46.9 mmol/L (3000mg/dL) and cholesterol above 12.9 mmol/L (500 mg/dL) will lead to inaccurate test results. • If you are severely ill (for example: serverely dehy- dration or ketoacidosis), you blood samples are not suitable for determining the blood glucose value us- ing the built-in blood glucose meter.

  • Page 12: Product Components

    Product components Name: AiDEX™ continuous glucose monitoring sys- System configuration: This product includes a Per- sonal Diabetes Assistant, a Transmitter and a Glucose Sensor. Personal Diabetes Assistant will be referred as PDA in the text below. The PDA & Transmitter system consists of the fol- lowing components: •...

  • Page 13: Component Description

    • Quick User Guide The glucose sensor system consists of the follow- ing components: • Applicator with Built-in Sensor Component description Personal Diabetes Assistant The PDA is used to display glucose readings and historical data when paired with an operational sen- sor-transmitter set.
  • Page 14 ① Power button Power on: Press and hold the power button, the PDA will vibrate indicating that the device is starting up. After about 30 seconds, it will enter the Home Screen. Power off: Hold the power button until a confirma- tion notification appears.
  • Page 15 ④ Back button Click this button to return to the previous screen or close a pop-up dialog. ⑤ Up button ⑥ Down button The Up and Down Button can be used to adjust the brightness of the PDA screen dispaly. ⑦...
  • Page 16 When the sensor and transmitter are ac- tivated on one’s body, it measures and stores glucose readings as well as transmitting the readings to the PDA/the AiDEX ™ mobile App. Glucose sensor package The glucose sensor package contains a sterilized glu- cose sensor attached to a sensor base, and a sensor applicator.
  • Page 17 Sensor applicator Glucose sensor Sensor base tape Sensor components Sterile packaging...

  • Page 18: Using A New Glucose Sensor

    Using a new glucose sensor Applying a sensor • Recommended areas for sensor application includes the abdomen, the outside and the back of the upper arm. For best performance, a v o i d e x c e s s i v e m o t i o n which may weaken the sen- sor and its adhesive tape.
  • Page 19 lected skin area and wait for a minute to let the skin dry. Change your sensor sites regularly to avoid discomfort or skin irritation. • Open the sensor package. Note Ensure the sensor is not expired by checking its expiration date. If the sensor is expired or the steril- ized package is damaged, please do not use it.
  • Page 20 sensor base patch to adhere to the skin. • Remove the applicator. The sensor should be applied successfully. Note Applying a sensor may cause bruising or bleeding. If bleeding does not stop, remove the sensor and apply a new sensor to a different location. Align the transmitter to the sensor base and press the transmitter firmly onto the sensor base until it snaps onto the sensor base and attaches to it securely.
  • Page 21 Note If the orientation of the transmitter and sensor base mismatch, the transmitter cannot be installed properly. • The recyclable applicator is meant for single use only. Dispose the used sensor package and sensor appli- cator according to your local regulations.

  • Page 22: Setting The Personal Diabetes Assistant (Pda) For The First Time

    Setting the Personal Diabetes Assistant (PDA) for the first time When using the PDA for the first time, set the date and time. • First time start up: Press and hold the power but- ton, the PDA will vibrate, indicating that the PDA is powered on.

  • Page 24: Sensor Start-Up

    Sensor start-up • After the sensor is successfully applied to your body and connected to the transmitter, the paired PDA will display “New sensor detected, please confirm.” Press the “Confirm” to continue.
  • Page 25 • Now the PDA will display “Sensor initializing”. Sensor initialization typically takes about 1 hour to complete.
  • Page 26 • When the sensor initialization is complete, the PDA will begin to display the current blood sugar value.
  • Page 27 • When the transmitter loses the connection with the sensor and reconnects, the PDA will ask you to con- firm. Please press “Cancel” if you already completed the initializing process. The PDA will skip initialization and starts displaying your current blood glucose val- ue immediately.

  • Page 28: Sensor Calibration

    Sensor calibration After a new sensor is initialized, you can calibrate the CGMS as needed. Please calibrate the system only when blood glucose is relatively stable - the interstitial glucose has a physiological lag compared to capillary blood glucose so calibrate the CGMS when blood glu- cose is rapidly changing may cause the CGMS to be less accurate.
  • Page 29 • Click the “Calibration” menu on the PDA’s home screen. • The PDA will prompt “Please calibrate with BG strip”. • Insert a new blood glucose testing strip into the PDA’s testing strip port to activate the blood glucose testing function.
  • Page 30 • Please follow the instructions in the “Using the built- in blood glucose meter” section. • When your test result is displayed, click “Calibrate” to complete the sensor calibration process.
  • Page 31 • If you only intend to use the blood glucose meter and do not want to calibrate the CGMS, press “Record” after the test result is displayed. Your blood glucose reading will be recorded to history, but not used to calibrate the real-time glucose monitoring system.
  • Page 32 • If you want to use the measurement from a different blood glucose meter for calibration, press “Manual Calibration” when the PDA shows “Please insert blood glucose test strip”. Enter the value manually and press “Calibrate” to finish the calibration.
  • Page 33 • The blood glucose test interface will appear any time you insert a blood glucose test strip, even when the PDA is in stand-by mode and /or in another menu screen. • It is strongly recommended to calibrate the sensor as soon as possible after it is initialized to confirm the sensor’s performance.

  • Page 34: Removing A Sensor

    Removing a sensor Remove the old sensor when the PDA indicates that the sensor has expired or if you feel any site irritation or discomfort. • Carefully pull the tape that holds the sensor to the skin from the edge and slowly uncover it until the entire sensor is removed.

  • Page 35: Pda Settings Target Glucose Range

    PDA settings Target glucose range You can change the thresholds for high glucose alert and low sensor glucose alert. These settings change the normal range of sensor glucose concentrations dis- played on the home page and when high/low glucose alerts are triggered. •...
  • Page 36 • Press “Lo BG Threshold” to enter the desired low sensor glucose threshold. The threshold range is 2.2 -5.0 mmol/L (39.6 mg/dL – 90 mg/dL) (default value is 3.5 mmol/L). • Add “Press “OK” to confirm” . • After entering the preferred threshold values the PDA will update the system settings.

  • Page 37: Date And Time Settings

    PDA will display “settings changed successfully”. • When the PDA and the transmitter are not within the communication range, the PDA will show “settings change failed”. Make sure that the PDA and transmit- ter are within communication range and try again. Date and time settings •...

  • Page 38: Using The Pda

    Using the PDA Pairing with a new transmitter Note For safety reasons, the PDA can only be paired with one transmitter at a time. • Before pairing, please find your transmitter serial number on the transmitter box. Make sure the new transmitter is assembled to the sensor base.
  • Page 39 • If the PDA is already paired with a transmitter, click “Transmitter Pairing” and a pop-up window will ap- pear. It shows “ The PDA already had a transmitter paired to it. Unpair the old transmitter, Press OK to unpair the old transmitter and pair a new one. Note When unpairing an expired transmitter, make sure that the PDA and transmitter are within commu-...
  • Page 40 • Enter the transmitter’s serial number when prompted.
  • Page 41 • Click “Confirm”. The PDA will search for a connection and show “Pairing successful” when the connection has been made.

  • Page 42: Alarm System Description

    Alarm system description The AiDEX CGMS has a comprehensive safety sys- tem to check if abnormal situations require immediate attention. The system will send notification alarms using sound, LEDs, or vibrations as well as provide information on the PDA display.
  • Page 43 PDA alarm priority levels Sound pres- Alarm level Visual signal Audio signal sure (dB) Three Medium Flashing consecutive 60-90 priority yellow light beeps Steady yellow Two consec- Low priority 60-90 light utive beeps...
  • Page 44 PDA alarms Alarm de- Priority Solution/Action scription Perform a finger-tip glucose measurement using an approved glucose meter to confirm Low Blood the sensor glucose reading. If the measure- Medium Glucose ment indicates low blood glucose, please take actions to raise blood glucose immedi- ately and call for medical assistance Perform a finger-tip glucose measurement using an approved glucose meter to confirm...

  • Page 45: Using The Built-In Blood Glucose Meter (Bgm)

    Using the built-in Blood Glucose Meter (BGM) The built-in blood glucose meter uses a chemical re- agent (glucose oxidase, GOD) reaction to determine blood glucose levels. After the test strip is placed into the test strip port and a blood sample is applied, the blood automatically wicks into test window.
  • Page 46 Fingertip testing Adjust the insertion depth of the lancing device to re- duce any discomfort. Keep the lancet cap for later. Blood glucose test If the PDA’s screen is on, the PDA will automatically go to the blood glucose test screen when insert a test strip into the test strip port.
  • Page 47 Eject the test strip After the test has been com- pleted, slide the test strip ejector to pop out the test strip, as shown in the picture. Comparing blood glucose meter and laboratory results Your PDA’s blood glucose meter and laboratory equipment both report glucose concentrations in the serum or plasma component of your blood.
  • Page 48 • Make sure your PDA is working properly. • Comparisons will be more accurate if you do not eat for at least four hours (preferably eight hours) before testing. • Bring your PDA, test strips, and control solution to the lab. •...
  • Page 49 Control solution 1 is usually used first and control solution 2 is used when a second level test is required. MicroTech offers a separately available control solution package that contains both Control Solution 1 and Control Solution 2. Always use a control solution for quality control testing to ensure you get accurate blood glucose levels.
  • Page 50 • When the PDA display is on, just insert a test strip into the PDA’s test strip port and the blood glucose test screen will appear. Check the “Control Solution Test” check box at the bot- tom. The animation will be replaced with an animation of a control solution drop.
  • Page 51 of the screen. If the result falls within the range print- ed on the test strip package (typically CTRL 1) the device is working properly. • After the test is finished, eject the test strip. If the control solution results are outside of the reference range: - Confirm you are matching the correct range.
  • Page 52 tions properly. After checking all of the conditions above, repeat the quality control test with a new test strip. If the quality control test results are still outside of the range printed on the test vial (or foil pouch), there may be a problem with your meter.
  • Page 53 Prompt information BG alert message Message type Solution Audio and vibration Restart your PDA. If the BG Meter initialization alert with message problem persists, contact error window your distributor. Audio and vibration Test strip was removed Repeat the test and ensure alert with message during the test test strip remains in place.

  • Page 54: Charing The Personal Diabetes Assistant (Pda)

    Charing the Personal Diabetes Assistant (PDA) A fully charged PDA should last up to 4 days. Battery life may vary depending on your usage. When the remaining battery power is about enough for one day, the PDA will give a low battery warning. •...

  • Page 55: Caring For Your Continuous Glucose Monitoring System (Cgms)

    • When the battery needs replacement, please contact our customer service staff to obtain a new one. Note Be sure to use batteries and chargers provided by MicroTech Medical. Use of unapproved compo- nents can result in injury. Caring for your Continuous Glucose Monitoring System...
  • Page 56 thinner to scrub the outer surface. • Keep the PDA and transmitter dry. • Do not use any lubricant. • Keep the test strip port area clean. Note Do not immerse the PDA or transmitter in water or other liquids. Avoid dust, dirt, blood, chemicals, water, or other substances on the PDA’s test strip and charging ports.
  • Page 57 Do not discard the battery if it is damaged or expired. Please recycle batteries in accordance with local bat- tery disposal regulations. Transportation Avoid placing heavy weight on top of the PDA and transmitter. Avoid direct sunlight and rain. Storage If you are temporarily not using the PDA, transmitter, or sensor system, store the components in a cool, dry, clean and well-ventilated area.
  • Page 58 Specifications Subcomponent Item Transmitter Sensor G7-T01 G7-S01 Model number G7-T01A G7-S01A G7-P02 G7-T01B G7-S01B 5-40℃（41-104 ℉） Operating temperature Operating humidity 10-93%（non-condensing） Storage and transporta- -20℃ -60℃ 4℃ -30℃ -20℃ -60℃ tion temperature Storage and transporta- 5-95%（non-condensing） tion humidity Storage and transporta- 700hpa~1060hpa tion pressure Ingress protection level...

  • Page 59: Electromagnetic Compatibility

    Electromagnetic compatibility These devices are intended for use in the electromag- netic environment specified below. The customer or the user of the device should assure that the device is used in such an environment. Portable and mobile RF communication interference may have an impact on the device.
  • Page 60 increased emissions or decreased immunity of the de- vice. The device should not be used adjacent to or stacked with other equipment. If adjacent or stacked use is necessary, the device should be observed to verify normal operation in the configuration in which it will be used.
  • Page 61 IEC60601-1-2 Table 201 Guidance and manufacturer’s declaration – electromag- netic immunity The device is intended for use in the electromagnetic environment specified below. The customer or the user of the device should en- sure that it is used in such an environment. Electromagnetic environment - Emissions test Compliance...
  • Page 62 IEC 60601-1-2: Table 202 Guidance and manufacturer’s declaration - electromagnetic immunity The device is intended for use in the electromagnetic environment specified below. The customer or the user of the device should ensure that it is used in such an environment. IEC 60601 test Electromagnetic environment Immunity test...
  • Page 63 IEC 60601-1-2: Table 204 Guidance and manufacturer’s declaration – electromag- netic immunity The device is intended for use in the electromagnetic environment specified below. The customer or the user of the device should ensure that it is used in such an environment. Immunity IEC 60601 test Compliance...
  • Page 64 IEC60601-1-2: Table 206 Recommended separation distances between portable and mobile RF communications equipment and the device These devices are intended for use in an environment in which radiated RF disturbances are controlled. The customer or the user of the device can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment(transmitters) and the device as recommended...

  • Page 65: Appendix

    Appendix Symbols Class II equipment Single use only Type BF applied part Storage temperature Sterilized by radiation Refer to instruction manual/booklet Biohazard In vitro diagnostic device Non-ionizing radiation See instructions for use Water resistance level Consult instructions for use...
  • Page 66 Lotus NL B.V. Koningin Julianaplein 10, 1e Verd, 2595AA, The Hague, Netherlands. 1016-PMTL-251. V02...

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