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Summary of Contents for Microtech AiDEX G7
- Page 1 AiDEX Continuous Glucose Monitoring System User Guide 0344 MicroTech Medical (Hangzhou) Co., Ltd.
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Page 3: Table Of Contents
Index Important safety information Indications for use ............ Patients ..............Contraindications ............Precautions .............. Product components Component description ...........10 Accessories.............15 Using a New Glucose Sensor Applying a sensor ..........Setting the Personal Diabetes Assistant (PDA) for the first time ............Sensor start-up ............ - Page 4 Removing a sensor PDA settings Target glucose range ..........Date and time settings .......... Using the PDA Pairing with a new transmitter ......PDA cautions ............ Charing the Personal Diabetes Assistant (PDA) .. 41 Caring for your Continuous Glucose Monitoring System (CGMS) ........
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Page 5: Important Safety Information
Important safety information Indications for use The 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 people 2 years and older. It is intended for use by patients at home and in healthcare facilities. -
Page 6: Patients
Patients This Continuous Glucose Monitoring System is suit- able for patients with diabetes requiring regular blood glucose monitoring. 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 7: Precautions
need to use Continuous Glucose Monitor under strict supervision of parents or qualified healthcare professionals. 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. - Page 8 when blood glucose levels rise rapidly, the sensor may produce a lower reading than the blood glucose level. When experiencing symptoms of hypoglycemic or hyperglycemic, the sensor readings are checked by using a blood glucose meter for a fingertip blood glucose test.
- Page 9 • Only MicroTech Medical consumables should be used with the CGMS. • If the product is not working properly or has been damaged, stop using the product. • When used in a medical facility, the operator should wear gloves while using.
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Page 10: 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. System Sensor Transmitter G7-S01 G7-T01 、... - Page 11 The PDA & Transmitter system consists of the fol- lowing components: • Personal Diabetes Assistant ( Li- ion battery included) • Transmitter...
- Page 12 Microtech Medical Ltd cannot be held liable for problems arising from the use of third party accessories.
- Page 13 Unintended access could result in damage to system parts or impact their sterility. Warning:Use only batteries and chargers from MicroTech Medical. Use of third party accessories may cause unexpected behavior and will void your warranty.
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Page 14: Component Description
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 sensor transmitter set. - Page 15 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 16 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 17 Transmitter The transmitter is used together with the glucose sensor base.sensor and ransmitter set as applied parts. 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 ™...
- Page 18 Sensor applicator Glucose sensor Sensor base tape Sensor components Sterile packaging...
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Page 19: Accessories
Accessories • PDA Charger（Use only with AiDEX™ continuous glucose monitoring system packaging） Waring:The included charger can be used in wall outlets rated at AC 100-240V ～50/60Hz. Connection to outlets that are outside this range can cause damage. Power Supply/Charger Specifications Input 5 V DC, 1A USB A to USB micro B... - Page 20 • PDA Charging Cable（Use only with AiDEX™ continuous glucose monitoring system packaging） Warning:Please keep the charging cable away from children, the charging cable may wrap around the neck and cause strangulation USB Charging/Download Cable Specifications Input/Output 5 V DC, 1A Type micro B Length...
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Page 21: Using A New Glucose Sensor
Using a new glucose sensor Applying a sensor • Recommended areas sensor application includes the abdomen, the outside and the back of the upper arm . For best performance, avoid excessive motion which may weaken the sensor and its ad- hesive tape. - Page 22 ed 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,,which may result in no glucose readings and infection.
- Page 23 • Remove the applicator. The sensor should be applied suc- cessfully. 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. Note The sensor and sensor applicator are designed for single use.
- Page 24 Note If the orientation of the transmitter and sensor base mismatch, the transmitter cannot be installed properly. You won’t get s or CGMS readings during the 1- hour warmup or after a sensor session ends.Sensor coming out of body. • The recyclable applicator is meant for single use only.
- Page 25 Note The applicator contains a needle, please dispose of it properly to avoid any possibility of injury to others.
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Page 26: Setting The Personal Diabetes Assistant (Pda) For The First Time
• Follow the steps described above carefully and be sure to only use components that are made by Mi- croTech Medical . Use of unapproved components can result in injury. Setting the Personal Diabetes Assistant (PDA) for the first time When using the PDA for the first time, set the date and time. - Page 27 • When you open the installation wizard, the first thing you will see is the date and time setting. Set the cor- rect date, time, timezone and click OK.
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Page 28: 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 29 • Now the PDA will display “Sensor initializing” . Sensor initialization typically takes about 1 hour to complete.
- Page 30 • When the sensor initialization is complete, the PDA will begin to display the current blood sugar value.
- Page 31 • 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- If you press “...
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Page 32: 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 33 • 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 34 • 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 abuse the calibration. i.e. No more than once every 6 hours. Important Do not calibrate more than once every 6 hours.
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Page 35: 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 36 WARNING Wire Breaks Off Don’t ignore broken or detached sensor wires. A sensor wire could remain under your skin. If a sensor wire breaks off under your skin and you can’t see it, don’t try to remove it. Please contact your local dealer.Also seek professional medical help if you have symptoms of infection or inflammation –...
- Page 37 PDA settings Target glucose range You can change the thresholds for high glucose and low sensor glucose . These settings change the normal range of sensor glucose concentrations dis- played on the home page and when high/low glucose s are triggered. •...
- Page 38 • 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.
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Page 39: 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 40 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 41 • 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.
- Page 42 • Enter the transmitter’s serial number when prompted.
- Page 43 • Click “Confirm” . The PDA will search for a connection and show “Pairing successful” when the connection has been made.
- Page 44 Cautions PDA Cautions caution Solution/Action description Perform a finger- tip glucose measurement using an approved glucose meter to confirm the sensor glucose reading. If the measure- ment indicates low blood Low Blood Glucose 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 the sensor glucose...
- Page 45 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 46 Note Be sure to use batteries and chargers provided by MicroTech Medical. Use of unapproved compo- nents can result in injury. Warning：The included charger can be used in wall outlets rated at AC 100-240V ～50/60Hz. Connection to outlets that are outside this range can cause Damage.
- Page 47 2. It is recommended to clean every 3 days. 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. Equipment s hall not be servic ed or maintai ned whil e in use.
- Page 48 Do not discard the battery if it is damaged or expired. Please recycle batteries in accordance with local bat- tery disposal regulations. Note: 1. At the end of service life or scrap of the device, remove the batteries and send batteries and device to the corresponding designated recycling locations separately.
- Page 49 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.
- Page 50 infusion status is : 8mins from 60 ℃ to 20 ℃,1min from -20℃ to 20℃.
- Page 51 Specifications Subcomponent Item Sensor Transmitter Model number G7-T01 G7-S01 G7-P02、MTM-2 G7-T01A G7-S01A G7-T01B G7-S01B Operating temperature 5-40℃(41-104 ℉) Operating humidity 10-93% (non-condensing) Operating pressure 700hpa~1060hpa Storage and -20℃ -60℃ 4℃ -30℃ -20℃ -60℃ transporta- tion temperature Storage and 5-95% (non-condensing) transporta- tion humidity Storage and...
- Page 52 G7-S01B: 7 days Shelf life: 1 year Detection range 2.0mmol/L-25.0 mmol/L Measurement When the glucose concentration >4 .2mmol/l accuracy (75mg/dL), the accuracy deviation of the sensor does not exceed ± 20%; when the glucose con- centration ≤4.2 (75mg/dL), the accuracy deviation does not exceed ±...
- Page 53 and mobile applications is protected by additional levels of security and safety mitigations using an encrypted and proprietary data format. This format embeds various methods to verify data integrity and to detect potential instances of data tampering. While the format is proprietary, industry standard encryption protocols (e.g., RSA and AES) are used in different parts of this proprietary data format.
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Page 54: 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 55 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. Electromagnetic int erferenc e can still occ ur in the home health care envi ronment as control over the E MC environment c annot be guaran - teed.
- Page 56 using the CGMS t o help manage your diabetes. Your healthcare profes sional can hel p you deci de how you should best us e this devic e. The basic performance is described in the table below: Performance Description When the glucose concentration is >4 .2mmol/L (75mg/dL), the sensor accuracy deviation does not exceed Measurement accuracy...
- Page 57 IEC60601-1-2 Table 201 – electromag- Guidance and manufacturer’ s declaration 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 58 IEC60601-1-2: Table 202 Guidance manufacturer’ declaration electromagnetic i mmu n i ty The device is intended for use in electromagnetic environment specified below. customer or the user of the device should ensure that it is used in such an environment. Electromagnetic environment IEC 60601 test Immunity test...
- Page 59 IEC 60601-1-2: Table 204 – Guidance manufacturer’ declaration electromag- netic immunity device intended electromagnetic environment specified below. customer user device should ensure that used in such an environment . Electromagnetic environment - IEC 60601 test Immunity Compliance guidance test level level Portable and mobile RF communica- tions equipment should be used no...
- Page 60 IEC60601-1-2: Table 206 Recommended separation distances between portable mobile communications equipment 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 dis- tance between portable and mobile RF communications equipment(trans- mitters) and the device as recommended below, according to the maximum output power of the communications equipment.
- Page 61 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. These limits are designed to provide reason- able protection against harmful interference in a residential installation.
- Page 62 —Consult the dealer or an experienced radio/TV technician for help. This device complies with FCC radiation exposure limits set forth for an uncontrolled environment. 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.
- Page 63 Appendix Symbols Atmospheric Humidity limitation pressure limitation Do not re-use Temperature limitation Protected from tools small wires Protection against solid greater than IP48 IP20 millimeter. Protected particle of diameter greater from long term than 12.5 mm immersion up to a specified pressure.
- Page 64 Consult Instructions for Type BF Applied Part Use by date Modle Number Manufacturer Date of manufacture Lot Number Handle With Care Do Not Dispose with Serial Number Household Waste Sterilized by EO Class 2 Equipment Biohazard Keep Dry...
- Page 65 Non-Ionizing Radiation Recyclable Instructions Refer to Instruction Manual Protected from touch by Protected from touch fingers and objects greater by fingers and objects than IP21 IP22 greater than millimeters.Protected from millimeters. Protected water spray less than 15 from condensation. degrees from vertical. Protected from touch by protected from...
- Page 66 1016-PMTL-251.V03 2023.06.09...
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