Continuous Glucose Monitoring System User Guide Index Important Safety information Scope of application Contraindication Additional Safety Instructions Product components Product Component Description Set up the PDA for the first time Using glucose sensor Install sensor Start the sensor Calibrate sensor Removing sensor Change Personal Diabetes Assistant settings Setup hypoglycemia/hypoglycemia alert thresholds Turn on/off Transmitter Connection Interruption alert Change the time and date Pairing with a new
【Important Safety Information】 Scope of Application The AiDex Continuous Glucose Monitoring System (CGMS) is indicated for continuous or regular monitoring of glucose levels in subcutaneous tissue, and is used for daily detection and self-management of blood glucose levels in diabetic patients. Measurements should not be used to make treatment adjustments, but rather as a reminder of when fingertip testing is required.
inconsistent with the way he feels, a blood glucose meter can be used to test the blood sugar level or calibrate the glucose sensor. If the problem persists, remove and replace the sensor. The performance of the CGMS has not be evaluated when used in conjunction with another implantable medical device, such as a pacemaker. Use this product only in accordance with the instructions described in this user guide.
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 display will turn off. The PDA willgo to standby mode. Display on: While in standby mode, press the power button briefly and the display will show the lock screen. Power off: While the display is on, press and hold the power button.
The Enter Button can be used to choose PDA functions that have been accessed using the Up and Down Buttons without using the touchscreen.[H1] ⑧ Display 3.2 inch color display with touchscreen. ⑨ Charging Port Connect the Charging Cable/Charger to the Charging Port to recharge the PDA battery. ⑩ Blood Glucose Test Strip Port Insert a blood glucose test strip into this portand the PDA’s blood glucose test function will be appear.
【Starting a New Glucose Sensor】 Applying a Sensor It is recommended to apply the sensor to the outside or back of the upper arm, the abdomen or the outside of the thigh. 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. To prevent discomfort or skin irritation, select a different location than the last place you wore a sensor.
Note: Please check to be sure that the sensor is not beyond its expiration date. If the sensor is expired, do not use the sensor. Remove the protective cover from the sensor applicator。 Place the applicator on top of the desired sensor location. Note the orientation of the ridge on the applicator. Press firmly to launch the sensor applicator. Wait a few seconds after the spring has retracted and let the sensor base patch stick 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, note the ridge on the top of the transmitter and match its orientation to the ridge on the sensor applicator.. Press the transmitter firmly onto the sensor base to activate it.
The applicator is disposable and meant for single use only. Dispose of the used sensor package and sensor applicator according to your local regulations. 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.
Note: Only used approved batteries from MicroTech Medical. Replace the battery cover: Place the battery cover onto the back of the PDA making sure that the edges are aligned. Press along the edges to snap the battery cover onto the PDA. You should hear a click sound as the cover is fastened. First time start up: Press and hold the power button, the PDA will vibrate, indicating that the PDA is powered on.
Enter the transmitter serial number to be paired if prompted. The transmitter serial number can be found on the bottom of the transmitter or on the outside of the package box. 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".
When the sensor initialization is complete, the PDA will begin to display the current blood sugar value. If the sensor has previously been implanted and connected to the signal transmitter for a period of time, after disconnecting and reconnecting with the signal transmitter, click the "Cancel" button when prompted by the portable monitor to "detect the new sensor and confirm". At this point, the portable monitor skips initialization and starts displaying the current blood sugar value directly.
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 insert a blood glucose test strip”.”。 Insert a blood glucose test strip into PDA’s the test strip port, and the display will automatically open the blood glucose test page. Follow the instructions in the "Using the Built-in Glucose Meter" section for fingertip blood collection tests.
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. You can also choose to press “Manual Input” when “Please insert blood glucose test strip”appears. This allows you to input a reference blood glucose value from a different blood glucose meter.
remove any remaining sticky residue. Pry the two locking arms on one side of the sensor base, push the transmitter away from the sensor base, and then remove thetransmitter so that it can be used again. The sensor is meant for one-time use only. Dispose of the used sensor according to your local regulations. 【PDA Settings】 Target Glucose Range You can change the thresholds for high glucose alert and low sensor glucose alert.
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.” Time and Date Settings Press "Settings" on the PDA’s home screen to enter the Settings Menu. Press the "date" or "time"or ”timezone” option.
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. When unpairing an old transmitter, be sure that the PDA and transmitter are within communication distance and have a good connection.
【Alarm System Description】 The 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 CGMS only contains medium and low priority alarms – no high priority alarms (as defined by ISO standards). The low priority prompt message may be a physiological status alarm message (hyperglycemia alert) or a technical alarm/message.
Sensor expired Low Sensor Error Low Other unspecified Low errors using an approved glucose meter to confirm the sensor glucose reading. If the measurement indicates high blood glucose, please take medicine or inject appropriate amount of insulin according to doctor’s prescription. Remove the current glucose sensor and replace it with a new sensor. Check if the current sensor has peeled off or partially peeled off from the skin. If yes, please remove the current sensor and replace it with a new sensor.
1.1 Fingertip Testing Adjust the depth penetration to reduce the discomfort. You do not need the clear cap for fingertip sampling. Remove the lancing devicecap. Insert the lancet into the lancet holder until it comes to a complete stop.。 Twist off the safety cap from the lancet, save the safety cap forlancet disposal.
avoid touching the lancet needle tip. Adjust the puncture depth by rotating the depth adjustor (the lancing device has 5 puncture depth settings). To reduce discomfort, choose the lowest setting that still produces an adequate blood sample. Note: Greater pressure between the lancing device against the finger will also increase the puncture depth.。 Pull back the cocking barrel until you hear a click. Now the lancing device is loaded and ready to draw blood.
Holding the lancing device against the side of the finger to be lanced, press the release button and then put down the lancing device. Massage forward slowly from the base of your finger to the tip to increase the sample size. Tip: To reduce pain, lance on the sides of the fingertips, where there are less nerve endings. Rotate finger locations as much as possible to accelerate wound healing and decrease callouses. 2.
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. 3.Comparing Blood Glucose Meter and Laboratory Results Your 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.
Wash and dry your hands before obtaining a blood sample. Make sure you closely follow the instructions in this manual. Blood oxygen and red blood cell count vary from person to person, and even within the same person. The Exactive Vital glucose meter tests blood glucose concentrations for the widest range of people possible. If the user’s blood indexes fall within the middle of the range, the result will be ideal. Otherwise, there will be some small deviations.
the range printed on the test strip package (typically CTRL1) the device isworking 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. 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.
【Charging the 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. Insert the PDA charging cable into the PDA charger.Plug the other end of the charging cable into the PDA’s charging port. Insert the PDA charger into a 220V power outlet. A battery charging animation will be displayed if the PDA is off.
surface. Keep the PDA and Transmitter dry, avoid water. 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. Disposal Dispose of old PDA's, transmitters, and sensors in compliance with local regulations for electronic devices, batteries, sharps, and biohazard materials.
【Specifications】 Item Transmitter Model Number G7-T01 G7-T01A G7-T01B Operating Temperature Operating Humidity Storage and Transportation Temperature Storage and Transportation Humidity Storage and Transportation Pressure Ingress Protection Level PDA G7-P02 10-93%（non-condensing） -20℃-60℃ 4℃-30℃ -20℃-60℃ 5-95%（non-condensing） 700hpa~1060hpa IPX7 4 Years Detection Range Wireless Frequency and Bandwidth Wireless Modulation Radiated Power G7-S01 G7-S01A G7-S01B 5-40℃（41-104℉） Use Life Measure
【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. Please use the cables and accessories provided. The cable information is as follows: # Item Length（m） Shielded? Notes 1 PDA CHARGING CABLE 1.
Electrostatic discharge (ESD) IEC 60601-4-2 Floors should be wood, concrete or ceramic tile. If floors are covered with synthetic material, the relative humidity should be at least 30 %. ±6KV Contact ±8KV Air ±6KV Contact ±8KV Air Electrical fast transient burst IEC 61000-4-4 ±2KV Power cord ±1KV input/output ±2KV Power Cord ±1KV input/output Mains power quality should be that of a typical commercial or hospital environment.
150kHz~80MHz Radiated RF IEC 61000-4-3 10V/m 80MHz~2.5GHz 10V/m the transmitter. Recommended separation distance d=1.2 √P d=1.2 √P 80MHz~800MHz d=2.3 √P 800MHz~2.5GHz where P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer and d is the recommended separation distance in metres (m).Field strengths from fixed RF transmitters, as determined by an electromagnetic site survey,a should be less than the compliance level in each frequency range.
recommended separation distance d in meters (m) can be estimated using the equation applicable to the frequency of the transmitter, where P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer. NOTE 1 At 80 MHz and 800 MHz, 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 structures, objects and people.
Product Name: Continuous Glucose Monitoring System Model： Continuous Glucose Monitoring System G7 G7-A G7-B Transmitter G7-T01 G7-T01A G7-T01B G7-S01 G7-S01A G7-S01B Glucose Sensor (Disposable, Sterile) Personal Diabetes Assistant G7-P02 FCC Statement This equipment has been tested and found to comply with the limits for a Class B digital device, pursuant to Part 15 of the FCC Rules.
Adapter shall be installed near the equipment and shall be easily accessible. CAUTION: RISK OF EXPLOSION IF BATTERY IS REPLACED BY AN INCORRECT TYPE. DISPOSE OF USED BATTERIES ACCORDING TO THE INSTRUCTIONS. This product can be used across EU member states. We declares that this device is in compliance with the essential repuirements and other relevant provisions of Directive 2014/53/EU. Registered Address: No.9 Haishu Rd., Yuhang District Hangzhou 311121 Zhejiang China Production address: No.9 Haishu Rd.
