FCC ID: 2ATOV-001 Personal Diabetes Assistant

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 Setup hypoglycemia/hypoglycemia alert thresholds Turn on/off Transmitter Connection Interruption alert Change the time and date Change Personal Diabetes Assistant settings Pairing with a new signal transmitter Alarm system Description Use the built-in blood glucose meter PDA Charging Additional tips and troubleshooting Transmitter Connection Interruption alert Additional troubleshooting Maintenance Cleaning Environmental protection Transportation Storage circuit diagrams, Components list Basic parameters and System specifications Electromagnetic compatibility Description of hazardous substances 1 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. The blood glucose detection module built into the Personal Diabetes Assistant can be used in conjunction with MicroTechs Exactive EQ blood glucose test strips.It cannot be used for the diagnosis and screening of diabetes, nor as a basis for drug therapy decisions. Contraindications 1. Patients with blindness or impaired vision should not use the CGMS. 2. Taking unknown drugs or medications may affect the sensor readings. 3.Hematocrit range of 30% to 55%. 4.Non-critically ill patients (such as those with severe dehydration or ketoacidosis, etc.). 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 diagnoses. The CGMS should be completely removed before magnetic resonance imaging (MRI) and replaced afterwards. The CGMS contains many small parts that can be dangerous if swallowed. During rapid changes in blood sugar (more than 0.1mmol/L per minute), glucose levels measured in interstitial fluid by the CGMS may not be the same as blood sugar levels. When blood sugar levels drop rapidly, the sensor may produce a higher reading than the blood sugar level;

Conversely, when blood sugar levels rise rapidly, the sensor may produce a lower reading than the blood sugar level. In these cases, the sensor readings are checked by using a blood glucose meter for a fingertip blood test. Severe dehydration or excessive loss of water may result in inaccurate results. If you think dehydration is occurring, consult a health care provider immediately. If the patient thinks the CGMS sensor reading is inaccurate or 2 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. If the product is not used according the instructions, the product may not function as intended. Use only accessories, disposables, and system components that are sold by MicroTech Medical. If the product is not working properly or has been damaged, cease using the product. Do not place items on top of any components of the CGMS. Do not drop or place any items into the openings, tubing or seams of this product unless specifically required by the instructions. When used in a medical facility, the operator should wear gloves to avoid the spread of infection. Product Components Name: Continuous Glucose Monitoring System Product Configuration: This product includes a Personal Diabetes Assistant, 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:

Personal Diabetes Assistant Transmitter PDA Battery PDA Charger PDA Charging Cable User Guide The Glucose Sensor Box contains Sterilized Glucose Sensor package 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. 3 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. A dialog box will open to confirm shutdown. Help Button While using the PDA, use the Help Button to display helpful information when functions are not clear. Home Button Press the Home Button to return to the Home Screen Back Button Click this button to return to the previous screen or close a pop-up dialog Up Button The Up Button can be used to navigate through PDA functions without using the touchscreen. Down Button The Down Button can be used to navigate through PDA functions without using the touchscreen. Enter Button 4 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]

Display 3.2 inch color display with touchscreen. Charging Port Connect the Charging Cable/Charger to the Charging Port to recharge the PDA battery. Blood Glucose Test Strip Port Insert a blood glucose test strip into this portand the PDAs blood glucose test function will be appear. For a more detailed description of the blood glucose test function, refer to the chapter Using the Built-in Blood Glucose Meter. 3.5mm Headphone Jack Test Strip Ejector Used to eject used blood glucose test strips. Speaker. Transmitter measure and store glucose readings. The Transmitter connects to the Glucose Sensor Base and is worn on the body to The glucose sensor package contains an sterilized glucose sensor Glucose Sensor package attached to a sensor base, and a sensor applicator. The package is sterilized by gamma irradiation. 5 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. Open the sensor package and take out the sensor applicator. 6 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. 7 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. Note: if the orientation of the transmitter and sensor base mismatch, the transmitter cannot be installed properly. 8 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. Setting up the PDA for the first time If you are using the PDA for the first time, the battery needs to be installed, the time needs to be set, and the PDA should be paired to the transmitter[H2]. PDA Battery Installation:

Remove the PDA battery cover: Holding the PDA with its back side face up, pull the battery cover off by taking hold of the battery door from bottom slot as shown in the picture. Insert the battery: Slide the battery into the battery compartment 9 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. After about 30 seconds the Setup Wizard will appear and guide you through entering basic settings. Basic Settings After entering the setup wizard, the first screen is the time setting. Set the correct date and time and timezone click OK. 10 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". Sensor Startup After the sensor is successfully applied to your body and connected to the transmitter, the paired Padwal display "New Sensor Detected, Please Confirm"

Press the "Confirm" to continue. Now the PDA will display "Sensor Initialization. Sensor Initialization typically takes about 1 hour to complete. 11 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.

<Note>Do not cancel the initialization process when using the new sensor. Skipping the initialization of the new sensor may cause the system to display incorrect glucose concentration values.</>

Sensor Calibration 12 After a new sensor is initialized, you can calibrate the CGMS as needed. Click theCalibrationmenu on the PDAs home screen. The PDA will prompt Please insert a blood glucose test strip. Insert a blood glucose test strip into PDAs 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. After the test results are displayed, click on the "Calibrate" button to complete the calibration of the CGMS. 13 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 stripappears. This allows you to input a reference blood glucose value from a different blood glucose meter. PressCalibrate to complete the calibration. If you do not wish to calibrate the CGMS, you can click Record to enter a blood glucose reading into history. The system will only record the current blood glucose value and measurement time, but it will not calibrate the CGMS 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. If you doubt that the glucose level displayed by the CGMS is correct, you can use the calibration function to confirm the performance. However, do not calibrate the system frequently within a short amount of time. 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. You can use warm soapy water to 14 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. 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. Press "Settings" on the PDAs home screen to enter the Settings Menu. PressHigh Glucose Thresholdto enter the desired sensor blood glucose threshold. The threshold range is 8-25mmol/L (default value is 12mmol/L). Press "Low Glucose Threshold" to enter the desired low sensor glucose threshold. The threshold range is 2.2-5mmol/L (default value is 3.5mmol/L). 15 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 PDAs home screen to enter the Settings Menu. Press the "date" or "time"or timezone option. Set the correct date and time and click OK. Pairing with a new transmitter

<Note>For security reasons, PDAs 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 assembled to the sensor base. Press "Settings" on the PDAs home screen to enter the Settings Menu. 16 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 communication distance and have a good connection. If the connection is lost during unpairing, the transmitter may encounter difficulties re-pairing to PDA in the future. Enter the transmitters serial number when prompted. 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". 17 Alarm System Description The low priority prompt message may be a physiological status alarm message The CGMS only contains medium and low priority alarms no high priority 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. alarms (as defined by ISO standards).

(hyperglycemia alert) or a technical alarm/message. When such an alarm is triggered, it will not have a negative impact on the user immediately, but the user needs to pay attention to such information and make decisions to restore the blood sugar to the normal range or ensure the real-time continuous glucose monitoring system continues to be reliable. PDA Alarm Priority Levels Alarm Level Visual Signal Audio Signal Sound Pressure (dB) Medium Priority Flashing Yellow Three consecutive beeps 60-90 Light Low Priority Steady Yellow Two consecutive beeps 60-90 Light PDA Alarms Alarm Description Priority Low Blood glucose Medium High Blood glucose Low Solution/Action Perform a finger-tip glucose measurement using an approved glucose meter to confirm the sensor glucose reading. If the measurement indicates low blood glucose, please take actions to raise blood glucose immediately and call for medical assistance Perform a finger-tip glucose measurement 18 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 doctors 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. If the sensor is still firmly attached to the skin, but the Sensor Error message continue to appear for more than 30 minutes, lease remove the current sensor and replace it with a new sensor. Please switch off the PDA and restart it. If the error message continue to appear, please contact our customer service. Sensor expired Low Sensor Error Low Other unspecified errors Low Using the Built-in Blood Glucose Meter 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. A transient electrical current is generated, and this current is measured to determine the correct blood glucose level reading. 1.Blood Sampling Before testing, first become familiar with how to collect blood and then choose a clean and dry place to conduct the test.Important: Prior to testing, use with either alcohol or soapy water to disinfect the sampling site. Use warm water to increase blood flow if necessary. Dry your hands and the sampling site, ensuring that there is no soap residue remaining. 19 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. Carefully install the lancing device cap onto the lancing device, 20 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. Before taking a blood sample, wash your hands or use an alcohol swab to clean the area. Washing your hands in hot water increases blood circulation. You can also massage from wrist to finger to promote better blood circulation. 21 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.Blood Glucose Test If the PDAs screen is on, the PDA will automatically go to the blood glucose test screen when a test strip is inserted into the test strip port. An animationAn 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. 22 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. Glucose concentration results can be affected by a number of factors and conditions, but these factors and conditions will not affect the test results of biochemical analyzers. Under normal conditions, the difference between measurements with your meter and laboratory results are within the range allowed by national standards. To ensure a reasonable comparison between your meter and laboratory results, please follow these guidelines:

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. Ensure that the time between tests with your PDA and the laboratory is within 15 minutes. 23 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 users blood indexes fall within the middle of the range, the result will be ideal. Otherwise, there will be some small deviations. (The deviations should be within the range allowed by local government.) 4.Quality Control Tests Control solution is a glucose solution of known concentration that is used to confirm that your PDA blood glucose meter and test strips are working properly.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. 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 PDAs test strip portand the blood glucose test screen will appear.Check the Control Solution Test check box at the bottom.The animation will be replaced with an animation of 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. When enough control solution has been applied, the screen will count down 5 seconds and then display the test result. The result is displayed in the top half of the screen. If the result falls within 24 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. Make sure that the packages have not been opened for more than 6 months. Discard any expired test strips and control solution. Confirm that you are testing within the correct temperature range

(15-30 C). Make sure that the test strip vial and control solution bottle have been tightly closed. Make sure that you are using the correct brand of control solution. Make sure you are following the user guide instructions 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. Please seek help and contact your dealer. Control Solution 1 is sufficient for most self testing needs. If you think your meter or strips may not be 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. For confirmation of results, Control Solution 1 tests should fall within the CTRL1 range, and ControlSolution 2 tests should fall within the CTRL2 range. 5.Prompt information 25 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. A battery charging animation will be displayed if the PDA is off. Insert the PDA charging cable into the PDA charger.Plug the other end of the charging cable into the PDAs charging port. Insert the PDA charger into a 120V power outlet. When the PDA is on, the battery icon will change to the charging icon. It may take at lastup to 2 hours to fully charge the PDAs battery. Batteries generally have a service life of about 4 years, but may vary depending on your usage. 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. 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. Do not use solvents, nail polish remover, or paint thinner to scrub the outer 26 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 PDAs 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. 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. 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. If you decide not to use the PDA for a prolonged period, the battery should be stored separately. Circuit Diagram, Component List The PDA, transmitter and sensor are precision instruments. If they fail, they can only be returned to the manufacturer for repair. No third-party individuals or organizations are allowed to perform repairs. Circuit diagrams and component lists are not provided in the manual. 27 Specifications Item Model Number Operating Temperature Operating Humidity Storage and Transportation Temperature Storage and Transportation Humidity Storage and Transportation Pressure Ingress Protection Level Detection Range Measurement accuracy Wireless Frequency and Bandwidth Wireless Modulation Transmitter G7-T01 G7-T01A G7-T01B Subcomponent Sensor G7-S01 G7-S01A G7-S01B 5-4041-104 10-93%non-condensing PDA G7-P02

-20-60 4-30

-20-60 5-95%non-condensing 700hpa~1060hpa IPX7 IPX0 G7-S01A14 days G7-S01B10 days G7-S01C7 days Shelf life: 1 year 2.0mmol/L-25.0 mmol/L 4 Years When the glucose concentration >4.2mmol/l (75mg/dL), the accuracy deviation of the sensor does not exceed 20%; when the glucose concentration 4.2 (75mg/dL), the accuracy deviation does not exceed 1mmol/l (18mg/dL). Frequency2.402GHz ~ 2.48 GHz Bandwidth1Mbps GFSK 28 Use Life 4 Years 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:

#

1 Item Lengthm Shielded?

Notes PDA CHARGING CABLE 1.0m YES EUT DC 5V The use of accessories other thanthose specified for the device is not recommended. They may result inincreased 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. The basic performance is described in the table below:

Performance Description Measurement Accuracy When the glucose concentration is >75mg/dL, the sensor accuracy deviation does not exceed 20%;

When the glucose concentration is 75mg/dL, the accuracy deviation does not exceed 20mg/dL IEC60601-1-2 Table 201 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. Emissions Test Compliance Electromagnetic environment - guidance The device uses RF energy only for its internal function. Therefore, its RF emissions are very low and are not likely to cause any interference in nearby electronic equipment. The device is suitable for use in all establishments, including domestic establishments and those directly connected to the public low-voltage power supply. RF Emissions CISPR 11 Group 1 RF Emissions CISPR 11 Class B Class A Complies Harmonic Emissions IEC 61000-3-2 Voltage Fluctuations/Flicker Emissions IEC 61000-3-3 IEC 60601-1-2Table 202 Guidance and manufacturers 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 29 Electrostatic discharge

(ESD) IEC 60601-4-2 Electrical fast transient burst IEC 61000-4-4 Surge IEC 61000-4-5 6KV Contact 6KV Contact 8KV Air 8KV Air 2KV Power cord 1KV input/output 2KV Power Cord 1KV input/output 1KV Line to GND 2KV Line to GND 1KVLine to GND 2KV Line to GND Voltage dips,

<5% UT for 0.5 weeks (>95% dip in UT) 40% UT for 5 weeks (60% dip in UT) 70% UT for 25 weeks (30% dip in UT) <5% UT for 5s

(>95% dip in UT)

<5% UT for 0.5 weeks (>95% dip in UT) 40% UT for 5 weeks (60% dip in UT) 70% UT for 25 weeks (30% dip in UT) <5% UT for 5s

(>95% dip in UT) short interruptions and voltage variations on power supply input lines IEC 61000-4-11 Power frequency

(50/60 Hz) magnetic field IEC 61000-4-8 3A/m 3A/m Floors should be wood, concrete or ceramic tile. If floors are covered with synthetic material, the relative humidity should be at least 30 %. Mains power quality should be that of a typical commercial or hospital environment. Mains power quality should be that of a typical commercial or hospital environment. Mains power quality should be thatof a typical commercial or hospitalenvironment. If the user of the devicerequires continued operation duringpower mains interruptions, it isrecommended that the device bepowered from an uninterruptible powersupply or a battery. The power frequency magnetic fieldshould have the characteristics of powerfrequency magnetic field level at atypical place in a typical commercial andhospital environment 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 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 -

3VVrms 3VVrms 150kHz~80MHz 10VEngineering 10V

(Engineering medical frequency band Conducted RF IEC 61000-4-6 medical frequency band guidance Portable and mobile RF communications equipment should be used no closer to any part of the device, including cables, than the recommended separation distance calculated from the equation applicable to the frequency of 30 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.b Interference may occur in the vicinity of equipment marked with the following symbol:

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 below, according to the maximum output power of thecommunications equipment Maximum rated output power of Transmitter (W) Separation distance according to frequency of transmitter (m) 150kHz~80MHz 80MHz~800MHz 800MHz~2.5GHz d=1.2P d=1.2P d=2.3P 0.01 0.1 1 10 100 0.12 0.38 1.2 3.8 12 0.12 0.38 1.2 3.8 12 For transmitters rated at a maximum output power not listed above, the 0.23 0.73 2.3 7.3 23 31 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. Appendix Symbols 1.PDA Biohazard In Vitro Diagnostic Device Non-Ionizing Radiation 2.Transmitter Water Resistance Level IPX7 Type BF Applied Part 3.Glucose Sensor Storage Temperature Sterilized by Radiation Manufacturer: Microtech Medical Devices (Hangzhou) Co., Ltd. Manufacturer Address: 3-4F, Building 3, No. 9, Haishu Road, Cangqian Street, Yuhang District, Hangzhou Address: Cangqian Street, Yuhang District, Hangzhou 4.Other Class 2 Equipment See Instructions for Use Non-Ionizing Radiation See Instructions for Use Single Use Only See Instructions for Use Consult Instructions for Use 32 Product Name: Continuous Glucose Monitoring System Model Continuous Glucose Monitoring System G7 G7-A G7-B Transmitter G7-T01 G7-T01A G7-T01B Glucose Sensor

(Disposable, Sterile) Personal Diabetes Assistant FCC Statement G7-S01 G7-S01A G7-S01B G7-P02 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. These limits are designed to provide reasonable protection against harmful interference in a residential installation. This equipment generates uses and can radiate radio frequency energy and, if not installed and used in accordance with the instructions, may cause harmful interference to radio communications. However, there is no guarantee that interference will not occur in a particular installation. If this equipment does cause harmful interference to radio or television reception, which can be determined by turning the equipment off and on, the user is encouraged to try to correct the interference by one or more of the following measures:

-- Reorient or relocate the receiving antenna.

-- Increase the separation between the equipment and receiver.

-- Connect the equipment into an outlet on a circuit different from that to which the receiver is connected.

-- Consult the dealer or an experienced radio/TV technician for help. This device complies with part 15 of the FCC Rules. Operation is subject to the following two conditions:

(1) This device may not cause harmful interference, and (2) this device must accept any interference received, including interference that may cause undesired operation. Changes or modifications not expressly approved by the party responsible for compliance could void the user's authority to operate the equipment. 33 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., Yuhang District Hangzhou 311121 Zhejiang China Manufacturer Name: Microtech Medical (Hangzhou) Co.,Ltd. Fax: 0571-88566539 After-Sales service unit: Microtech Medical (Hangzhou) Co.,Ltd. Service Hotline: 4000-831-811 Production Date: see Packaging labels. 34