1. Manuals
  2. Brands
  3. Microtech Manuals
  4. Blood Glucose Meter
  5. AiDEX
  6. User manual

Microtech AiDEX User Manual

Continuous glucose monitoring system
Hide thumbs Also See for AiDEX:
Table of Contents

Advertisement

Quick Links

Download this manual
AiDEX
Continuous Glucose Monitoring System
TM
User Guide
MicroTech Medical (Hangzhou) Co., Ltd.

Advertisement

Table of Contents
loading
Need help?

Need help?

Do you have a question about the AiDEX and is the answer not in the manual?

Questions and answers

Subscribe to Our Youtube Channel

Related Manuals for Microtech AiDEX

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) up 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 Charging the Personal Diabetes Assistant (PDA) 51 Caring for your Continuous Glucose Monitoring System (CGMS) ........

  • 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...

  • Page 6: Patients

    Personal Diabetes Assistant can be used in conjunction with MicroTech’s Exactive EQ blood glucose test strips. It cannot be used for the diagnosis and screening of diabetes.

  • Page 7: Contraindications

    Hematocrit range of 30% to 55%. Triglycerides below 46.9 mmol/L or cholesterol below 12.9 mmol/L. 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 • CGM readings should not be used to make treatment decisions but rather to detect blood glucose trends and track patterns in persons with diabetes. • The CGMS should be completely removed before Magnetic Resonance Imaging (MRI). • The CGMS contains many small parts that can be dangerous if swallowed.
  • 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 • Triglycerides above 46.9 mmol/L and cholesterol above 12.9 mmol/L may lead to inaccurate test results. • If you are ill (for example: severe dehydration or ketoacidosis), this may lead to inaccurate test results. • The blood glucose meter is only suitable for clinical screening tests or self-blood glucose monitoring.

  • Page 12: Product Components

    Product components Name: AiDEX™ Continuous Glucose Monitoring System System configuration: This product includes a Glucose Sensor, a Transmitter, a Personal Diabetes Assistant (optional). Personal Diabetes Assistant will be referred as PDA in the text below. The PDA & Transmitter system consists of the following components: •...

  • Page 13: Component Description

    The glucose sensor system consists of the following 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 sensor- 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. P o w e r o f f : H o l d t h e p o w e r b u t t o n u n t i l a confirmation notification appears.
  • Page 15 Screen. 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 activated 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...
  • Page 17 sensor applicator. The package is sterilized by gamma irradiation. 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 w h i c h m a y w e a k e n t h e sensor and its adhesive t a p e .
  • Page 19 alcohol pads to disinfect your selected skin area and wait for a minute to let the skin dry. Change your sensor s i t e s r e g u l a r l y t o a v o i d discomfort or skin irritation.
  • Page 20 a few seconds to allow the 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.
  • Page 21 attaches to it securely. Note If the orientation of the transmitter and sensor base mismatch, the transmitter cannot be installed properly. • The applicator is meant for single use only. Dispose the used sensor package and sensor applicator according to your local regulations.

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

    • Follow the steps described above carefully and be sure to only use components that are made by MicroTech Medical. Use of unapproved components can result in injury. Setting the Personal Diabetes Assistant (PDA) up for the first time When using the PDA for the first time, set the date and time.
  • Page 23 • When you open the Setup Wizard, set the correct date, time, timezone and click OK.

  • 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 interstitial glucose value.
  • Page 27 • When the transmitter loses the connection with the sensor and reconnects, the PDA will ask you to confirm. Please press “Cancel” if you already completed the initialization process. The PDA will skip initialization and start displaying your current interstitial glucose value immediately. If you press “Confirm”, the sensor will start initializing again.

  • Page 28: Sensor Calibration

    Sensor calibration Calibrating your CGMS using your BG meter is optional. You can manually input the BG meter value for calibration when the percentage difference is greater than 20%. It’s recommended to use BG meter readings of more than 4 mmol/L to calibrate your CGMS .
  • Page 29 use testing values from alternative site(non-fingertip). Calibration is not recommended when glucose values are rising or falling fast. • Click the “Calibration” menu on the PDA’s home screen. • The PDA will prompt “Please calibrate with BG strip”.
  • Page 30 • Insert a new blood glucose testing strip into the PDA’s testing strip port to activate the blood glucose testing function. • 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 standby mode and /or in another menu screen. Important Do not calibrate more than once every 6 hours.

  • 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 and low sensor glucose alerts. These settings change the normal range of sensor glucose concentrations displayed on the home page and when high/low glucose alerts are triggered. • Before setting the target glucose range, please make sure that the transmitter is connected to the sensor base, and that the PDA and transmitter have a good wireless connection.
  • Page 36 • Press “Lo BG Threshold” to enter the desired low sensor glucose threshold. The threshold range is 2.2 -5.0 mmol/L (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

    • 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 transmitter are within communication range and try again. Date and time settings • Press “Settings” on the PDA’s home screen to enter the Settings menu.

  • 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 appear. 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...
  • 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 system 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. The AiDEX CGMS only contains medium and low priority alarms –...
  • 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 Priority Solution/Action description Perform a finger-tip blood glucose measure- ment using an approved glucose meter to Low Blood confirm the sensor glucose reading. If the Medium Glucose measurement indicates low blood glucose, please take actions to raise blood glucose immediately and call for medical assistance Perform a finger-tip blood glucose measure- ment using an approved glucose meter to...

  • 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 reagent (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 Important Prior to testing, disinfect the sampling site with an alcohol wipe or soapy water. Use warm water to in- crease blood flow if necessary. Dry your hands and the sampling site, ensuring that there is no soap residue remaining. Fingertip testing Adjust the insertion depth of the lancing device to reduce any discomfort.
  • Page 47 Eject the test strip A f t e r t h e t e s t h a s b e e n completed, slide the test strip ejector to pop out the test strip, as shown in the picture.
  • Page 48 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. However, variations between the two are normal, and your meter results and laboratory results may be slightly different. To ensure a reasonable comparison between your meter and laboratory results, please follow these guidelines:...
  • Page 49 • Wash and dry your hands before obtaining a blood sample. • Make sure you closely follow the instructions in this manual. Test results may show small deviations, this may be due to the following reasons: Blood oxygen and red blood cell count vary from person to person, and even with in the same person.
  • Page 50 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 51 a control solution drop. Shake the control solution bottle, gently squeeze out the control solution, discard the first drop, and drop the second drop onto a clean nonabsorbent surface. Now touch the second drop to the sample area of the test strip. Do not let the bottle come into contact with the strip itself.
  • Page 52 - 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. Discard any expired test strips and control solutions. - Confirm that you are testing within the correct temperature range (15-30 °C).
  • Page 53 working correctly, you may also want to do a level 2 test. The ranges for both (CTRL 1 and CTRL 2) are displayed on the test strip vial (or on the foil pouch). Simply repeat the test procedure, using Control Solution 2.
  • Page 54 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 55: Charging The Personal Diabetes Assistant (Pda)

    Charging 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 56: Caring For Your Continuous Glucose Monitoring System (Cgms)

    • When the battery needs replacement, please contact your local distributor 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. Caring for your Continuous Glucose Monitoring System...
  • Page 57 • Do not use solvents, nail polish remover, or paint 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.
  • Page 58 local distributor. Do not discard the battery if it is damaged or expired. Please recycle batteries in accordance with local battery 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,...
  • Page 59 diagrams and component lists are not provided in the manual. Specifications Subcomponent Item Transmitter Sensor G7-T01 G7-S01 Model number G7-T01A G7-S01A G7-P02 G7-T01B G7-S01B Operating temperature 5-40℃ Operating humidity 10-93%（non-condensing） Storage and transporta- -20℃ -60℃ 4℃ -30℃ -20℃ -60℃ tion temperature Storage and transporta- 5-95%（non-condensing）...

  • Page 60: Electromagnetic Compatibility

    Electromagnetic compatibility T h e s e d e v i c e s a r e i n t e n d e d f o r u s e i n t h e electromagnetic environment specified below. The user of the device should ensure that the device is used in such an environment.
  • Page 61 the device is not recommended. They may result in increased emissions or decreased immunity of the device. 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 62 IEC60601-1-2 Guidance and manufacturer’s declaration – electromagnetic immunity The device is intended for use in the electromagnetic environment specified below. The user of the device should ensure that it is used in such an environment. Electromagnetic environment - Emissions test Compliance guidance The device uses RF energy only for...
  • Page 63 IEC 60601-1-2 Guidance and manufacturer’s declaration - electromagnetic immunity The device is intended for use in the electromagnetic environment specified below. The user of the device should ensure that it is used in such an environment. IEC 60601 test Electromagnetic environment Immunity test Compliance level level...
  • Page 64 IEC 60601-1-2 Guidance and manufacturer’s declaration – electromagnetic immunity The device is intended for use in the electromagnetic environment specified below. The user of the device should ensure that it is used in such an environment. Immunity IEC 60601 test Compliance Electromagnetic environment - test...
  • Page 65 IEC60601-1-2 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 user of the device should ensure that it is used in such an environment by maintaining a minimum distance between portable and mobile RF communications equipment(transmitters) and the device as recommended below, according to the maximum output power of...

  • Page 66: Appendix

    Appendix Symbols Class II equipment Single use only Type BF applied part Storage temperature Sterilized by radiation Refer to instruction manual/booklet Biohazard Medical Device Non-ionizing radiation Caution Water resistance level Consult instructions for use...
  • Page 68 Lotus NL B.V. Koningin Julianaplein 10, 1e Verd, diabetes@homemed.co.za 2595AA, The Hague, Netherlands. 1016-PMTL-437. V01...

Table of Contents