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Microtech AiDEX User Manual

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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 Contraindication ....................2 Precautions ......................3 BG Test Module Precautions ................5 Product Components Component Description ..................8 Starting a New Glucose Sensor Applying a Sensor .....................12 Set up the PDA for the First Time ..............14 Basic Settings ....................15 Sensor Startup ....................16 Sensor Calibration .....................20...
  • Page 4 Removing a Sensor PDA settings Target glucose range ..................25 Time and date Settings ..................27 Pairing with a new transmitter ................28 Alarm System Description .................32 Use the built-in BGM ..................34 Charging the PDA ....................41 Caring for your CGMS ..................42 Electromagnetic Compatibility Appendix...

  • Page 5: Important Safety Information

    Interpretation of the AiDEX CGM System results should be based on the glucose trends and several sequential readings over time. The AiDEX CGM System also aids in the detection of episodes of hyperglycemia and hypoglycemia, facilitating both acute and long-term therapy adjustments. Measurements should not be used to make treatment adjustments, but rather as a reminder of when fingertip testing is required.

  • Page 6: Patients

    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. Patients The blood glucose test function of the Personal Diabetes Assistant is suitable for...

  • Page 7: Precautions

    Are unconscious. Unable to understand or master the usage of the device. Have severe hearing or vision impairment. Children too young to administer diabetes therapy themselves. Precautions • CGMS readings should only be used as a reference for the supplemental moni toring of diabetes mellitus and should not be used as a basis for clinical diagno ses.
  • Page 8 If the problem persists, remove and replace the sensor. • While extensive user testing was done on AiDEX TM CGMS in Type I and Type II diabetic patients, the study groups did not include women with gestational dia- be tes.

  • Page 9: Bg Test Module Precautions

    BG Test Module Precautions • This module 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 10 firmed by other methods, such as biochemical methods. • As with all diagnostic reagents, test results must be linked with a professional doctor’s diagnosis from the other clinical symptoms. • Carefully process waste caused by blood glucose tests according to the relevant local laws and regulations, because blood samples are considered a biohazard.

  • Page 11: Product Components

    Product Components Name: Continuous Glucose Monitoring System Product Configuration: This product includes a Personal Diabetes As- sistant controller, a Transmitter and a Glucose Sensor. For convenience, Personal Diabetes Assistant will be referred as PDA in the text below. The PDA and Transmitter Box includes: •...

  • Page 12: Component Description

    Component Description Personal Diabetes Assistant When paired to transmitter that is attached to a glucose sensor, the PDA is used to display glucose readings and view historical data.
  • Page 13 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. Display off: When the display is on, press the power button once and the dis play will turn off.
  • Page 14 ⑥ Down Button The Up and Down Button can be used to adjust the brightness of the PDA screen dispaly. ⑦ Enter Button The Enter Button can be used to confirm entered information without using the touchscreen. ⑧ Display 3.2 inch color display with touchscreen. ⑨...
  • Page 15 Transmitter The Transmitter connects to the Glucose Sensor Base and is worn on the body to measure and store glucose readings. Glucose Sensor Package The glucose sensor package contains a sterilized glucose sensor attached to a sensor base, and a sensor applicator. The package is sterilized by gamma irradiation.

  • Page 16: Starting A New Glucose Sensor

    Starting a New Glucose Sensor Applying a Sensor • recommended to apply the sensor to the outside or back of the upper arm, or the abdomen. Avoid areas with scars, moles, stretch marks, or lumps. • Before application, use alcohol pads to clean the skin where you want to place the sensor, wait for a minute to let the skin dry.
  • Page 17 • Take out the sensor applicator by turning it anti-clock wise. • Place the applicator on top of the desired sensor loca tion. Press it firmly against skin and press the button to launch the sensor applicator. Wait a few seconds after the sensor is inserted and let the sensor base patch stick to the skin.

  • Page 18: Set Up The Pda For The First Time

    • Follow the steps described above carefully and be sure to only use components that are made by MicroTech Medi cal. Use of unapproved components can result in injury. Setting up the PDA for the...

  • Page 19: Basic Settings

    Basic Settings • After entering the setup wizard, the first screen is the time setting. Set the cor- rect date, time, timezone and click OK.

  • Page 20: Sensor Startup

    Sensor Startup • After the sensor is successfully applied to your body and connected to the transmitter, the paired PDA will display “New Sensor Detect- ed, Please Confirm” Press the “Confirm” to continue.
  • Page 21 • Now the PDA will display “Sensor Initializating”. Sensor Initialization typically takes about 1 hour to complete.
  • Page 22 • When the sensor initialization is complete, the PDA will begin to display the cur- rent blood sugar value.
  • Page 23 • If the sensor has previously been implanted and connected to the signal trans mitter for a period of time, after disconnecting and reconnecting with the signal transmitter, click the “Cancel” button when the PDA prompts “New Sensor De- tected, Please Confirm”. •...

  • Page 24: Sensor Calibration

    Sensor Calibration After a new sensor is initialized, you can calibrate the CGMS as needed. • Click the“Calibration”menu on the PDA’s home screen. • The PDA will prompt “Please calibrate with BG strip”. • Insert a blood glucose test strip into PDA’s the test strip port, and the display will automati- cally open the blood glucose test page.
  • Page 25 • After the test results are displayed, click on the “Calibrate” button to complete the calibration of the CGMS.
  • Page 26 • 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 dis- played. Your blood glucose reading will be recorded to history, but not used to calibrate the real-time glucose monitoring system.
  • Page 27 • The blood glucose test interface will appear any time you insert a blood glucose test strip, even when the PDA is active and on the home screen. • It is recommended to perform a calibration as soon as possible after the sensor is initialized to confirm the performance of the sensor.

  • Page 28: Removing A Sensor

    Removing a Sensor Remove an 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 29: 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 30 • After you finish this setting, press “OK” and the PDA will attempt to update the system settings. The PDA will display “settings change successful” when the setup is complete. • If the PDA and transmitter are not within communication range, the PDA will display “Settings change failed, please verify that the PDA and transmitter are within communication range.”...

  • Page 31: Time And Date Settings

    Time and Date Settings • Press “Settings” on the PDA’s home screen to enter the Settings Menu. • Press the “Date” or “Time” or “Time zone” option. • Set the correct date and time and click OK.

  • Page 32: Pairing With A New Transmitter

    Pairing with a new transmitter Note For security reasons, PDA’s are only allowed to be paired with one transmitter at a time. • Before pairing, please confirm that the serial number of the new transmitter is available, and the new transmitter has been successfully as sembled to the sensor base.
  • Page 33 • Press “Pair Transmitter”. • If the PDA is already paired with a transmitter, clicking “Pair Transmitter” will open a prompt “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 old transmitter, be sure that the PDA and transmitter are within...
  • Page 34 • Enter the transmitter’s serial number when prompted.
  • Page 35 • Click “Confirm” on the PDA and it will attempt to establish a connection to the Transmitter. After the PDA connects to the Transmitter, the PDA will display “pairing successful”.

  • Page 36: Alarm System Description

    Alarm System Description The AiDEX CGMS has a comprehensive safety system to check if abnormal sit- uations require immediate attention. The system will send notification alarms using sound, LEDs, or vibrations as well as provide information on the PDA display.
  • Page 37 PDA Alarms Alarm Description Priority Solution/Action Perform a finger-tip glucose measurement using an approved glucose meter to confirm the sensor glucose reading. If the Low Blood Glucose Medium measurement indicates low blood glucose, please take ac- tions to raise blood glucose immediately and call for medical assistance Perform a finger-tip glucose measurement using an approved glucose meter to confirm the sensor glucose reading.

  • Page 38: Use The Built-In Bgm

    Using the Built-in BGM The built-in blood glucose meter uses an chemical reagent (glucose oxidase, GOD) reaction to detect 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 39 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. An animation will prompt you to apply blood to the test strip. After applying a blood sample to the test strip, the PDA will count down 5 seconds and display the test result.
  • Page 40 Eject the test strip After the test has been completed, 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 41 Control solution 1 is usually used first and control solution 2 is used when a sec- ond 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 glu- cose levels.
  • Page 42 You should perform the control solution test below if you suspect that the meter or test strips are not working properly or when you suspect that your test results are inaccurate, or inconsistent with how you feel: • When the PDA display is on, just insert a test strip into the PDA’s test strip portand the blood glucose test screen will appear.
  • Page 43 . Confirm you are matching the correct range. Control Solution 1 results should be matched to the CTRL1 range printed on the test strip vial (or foil pouch). . Check the expiration date of the test strip and control solution. Make sure that the packages have not been opened for more than 6 months.
  • Page 44 Prompt information BG Alert Message Message Type Solution BG Meter initialization Audio and Vibration Alert Restart your PDA. If the problem per- error with Message Window sists, contact your distributor. Test strip was removed Audio and Vibration Alert Repeat the test and ensure test strip during the test with Message Window remains in place.

  • Page 45: Charging The Pda

    • 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 components can result in injury.

  • Page 46: Caring For Your Cgms

    Caring for Your CGMS Cleaning the PDA and Transmitter • Clean the outer surface of the PDA using a mild detergent and a soft damp cloth. Use another cloth to dry. • Disinfect the PDA and Transmitter with an alcohol wipe. •...
  • Page 47 tions for electronic devices, batteries, sharps, and biohazard materials. Please do not discard old products or accessories directly into trash. For further information on how to dispose of system components, please contact customer service. Do not discard the battery if it is damaged or expired. Please recycle batteries in accordance with local battery disposal regulations.
  • Page 48 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 49: Electromagnetic Compatibility

    Electromagnetic Compatibility These devices are intended for use in the electromagnetic 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 50 jacent or stacked use is necessary, the device should be observed to verify normal operation in the configuration in which it will be used. The basic performance is described in the table below: Performance Description When the glucose concentration is >75mg/dL, the sensor accuracy deviation does not exceed ±20%;...
  • Page 51 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. Immunity Test IEC 60601 Test Level Compliance Level Electromagnetic environment - guidance Electrostatic...
  • Page 52 IEC 60601-1-2: Table 204 Guidance and manufacturer’s declaration – electromagnetic immunity The device is intended for use in the electromagnetic environment specified below. The cus- tomer or the user of the device should ensure that it is used in such an environment. Immunity Test IEC 60601 Test Compliance Electromagnetic environment - guidance...
  • Page 53 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 interfer- ence by maintaining a minimum distance between portable and mobile RF communications equip- ment(transmitters) and the device as recommended below, according to the maximum output...

  • Page 54: Appendix

    Appendix Symbols 1. PDA Biohazard Class 2 Equipment In Vitro Diagnostic Device See Instructions for Use Non-Ionizing Radiation 2. Transmitter Water Resistance Level Non-Ionizing Radiation Type BF Applied Part See Instructions for Use 3. Glucose Sensor Storage Temperature Single Use Only Sterilized by Radiation See Instructions for Use 4.
  • Page 56 MicroTech Medical (Hangzhou) Co., Ltd. Address: No.9 Haishu Road,Yuhang District Hangzhou, Zhejiang 311121 China Website: http://www.microtechmd.com Lotus NL B.V. Koningin Julianaplein 10, 1e Verd, 2595AA, The Hague, Netherlands. 1016-PMTL-203. V01...

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