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1 | User manual | Users Manual | 814.84 KiB | July 04 2023 / January 01 2024 | delayed release |
AiDEXTM Continuous Glucose Monitoring System User Guide MicroTech Medical (Hangzhou) Co., Ltd. 0344 Index Important safety information 1 Indications for use .................................................... 2 Patients .................................................................... 2 Contraindications ...................................................... 3 Precautions .............................................................. 3 Product components 6 Component description ...........................................10 Accessories.............................................................15 Using a New Glucose Sensor 17 Applying a sensor .................................................. 17 Setting the Personal Diabetes Assistant (PDA) for the first time ...................................................... 22 Sensor start-up ...................................................... 24 Sensor calibration .................................................. 28 Removing a sensor 31 PDA settings 33 Target glucose range ............................................ 33 Date and time settings .......................................... 35 Using the PDA 36 Pairing with a new transmitter .............................. 36 PDA cautions .................................................... 40 Charing the Personal Diabetes Assistant (PDA) .. 41 Caring for your Continuous Glucose Monitoring System (CGMS) .................................. 42 Electromagnetic compatibility 50 Appendix 59 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. Interpretation of the CGMS results should be based on the glucose trends and several sequential readings over time . The CGMS also aids in the detection of episodes of hyperglycemia and hypoglycemia, and facilitating therapy adjustments . The System is designed to replace fingerstick blood glucose ( BG) testing. 1 Patients This Continuous Glucose Monitoring System is suit-
able for patients with diabetes requiring regular blood glucose monitoring. Contraindications Patients who:
1 . Suffer from alcoholism, drug abuse, severe mental disorders ( such as depression, schizophrenia) . 2. Are unconscious. 3. Are unable to understand or master the usage of the device. 4. Have severe hearing or vision impairment. 5. User below the age of 2 or are not capable of admin-
istering diabetes therapy themselves or who always 2 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. The CGMS should be completely removed before Magnetic Resonance Imaging (MRI). The CGMS contains many small parts that can be dangerous if swallowed. During rapid changes in blood glucose ( more than 0. 1mmol/L per minute), glucose levels measured in interstitial fluid by the CGMS may not be the same as blood glucose levels. When blood glucose lev-
els drop rapidly, the sensor may produce a higher reading than the blood glucose level; Conversely, 3 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. Severe dehydration or excessive loss of water may result in inaccurate results. When you suspect you are dehydrated, consult a heathcare professional immediately. If you think the CGMS sensor reading is inaccurate or inconsistent, use a blood glucose meter to test your blood glucose level or calibrate the glucose sensor. If the problem persists, remove and replace the sensor. While extensive user testing was done on AiDEXTM CGMS in Type I and Type II diabetic patients, the study groups did not include women with gestational diabetes. The performance of the CGMS has not been eval-
uated when used with another implantable medical device, such as a pacemaker. 4 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. The CGMS can not be used in oxygen rich enviro-
ment. Operator or the responsible organization shall read this instructions for use as the training or the knowledge required for using this equipment. Any serious injury or death that has occurred in relation to the device should be reported to the man-
ufacturer and the competent authority of the Member State in which the user and/or patient is established. 5 Product components Name: AiDEX continuous glucose monitoring sys-
tem 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. Sensor G7-S01 Transmitter PDA G7-T01 G7-S01A G7-T01A G7-P02 G7-S01B G7-T01B MTM-2 System G7 G7-A G7-B 6 The PDA & Transmitter system consists of the fol-
lowing components:
Personal Diabetes Assistant ( Li- ion battery included) Transmitter 7 Warning :No modification of this equipment is allowed. Unauthorized modification of the equipment may cause the product to malfunction and become unusable.Replacement of a component could result in an unacceptable risk. Warning :Remove the battery if not used for a long time If the PDA battery charger does not work, do not try to repair it. Please contact your local supplier for a replacement. Note:The device is intended to be transported and stored in waterproof case between use.Do not remove the waterproof case! Take it off, PDA waterproof performance is zero. Warning :Using accessories, detachable parts and materials that are not specified in the instructions, or connecting the equipment to other equipment that is not specified in the instructions, may cause safety problems, such as hyperglycemia or hypoglycemia. Microtech Medical Ltd cannot be held liable for problems arising from the use of third party accessories. WARNING: Use of accessories, cables, adapters, and chargers other than those specified or provided by the manufacturer of this equipment could result in increased electromagnetic emissions or decreased electromagnetic immunity of this equipment and result in improper operation. 8 Warning :Magnetic fields, and direct contact with magnets, may affect the accurate functioning of your system, which may lead to health risks such as hypoglycemia or hyperglycemia. Warning :
Do not place CGMS in direct sunlight or dusty areas. Always keep your PDA port free of debris and liquids,Lint,dirt, dust, and liquids can impair the functionality of your device or damage it. Aovid storing CGMS components in a place where children, pets, or pests may access. 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. Warning:DO NOT allow small children access to small parts, such as the sensor and its accessories. Small parts could be swallowed and pose a choking hazard. If ingested or swallowed, these small parts could cause internal injury or infection. 9 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. 10 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 . Confirm and shutdown the device. Display on: While in stand by mode, press the power button and the display will show the lock screen. Display off: When the display is on, press the power button once and the display will turn off. The PDA will enter standby mode. Help button When certain functions are not clear, you can con-
sult the Help-button to display helpful information. Home button Press the Home Button to return to the Home Screen. 11 Back button Click this button to return to the previous screen or close a pop-up dialog. Up button Down button The Up and Down Button can be used to adjust the brightness of the PDA screen dispaly. Enter button The Enter Button can be used to confirm entered information without touching the screen. Display 3.5 inch color touchscreen. USB port For PDA charging and USB data transmission. Speaker 12 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 ones 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 glucose sensor attached to a sensor base, and a sensor applicator.The package is sterilized by gamma irradiation. Note General risks associated with Sensor base tape may include skin irritation or redness. 13 Glucose sensor Sensor base tape Sensor applicator Sensor components Sterile packaging 14 Accessories PDA ChargerUse 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 DC Output Use life 5 V DC, 1A USB A to USB micro B 5V DC, 1A 5 years 15 PDA Charging CableUse 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 Type to USB 5 V DC, 1A USB A micro B 3 feet 5 years Length Use life 16 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, avoid excessive motion which may weaken the sensor and its ad-
hesive tape. Avoid accidental knocking off the sensor. It is strongly recommended to put sensor on your abdomen rath-
er than arms or other areas. Before application, use alcohol pads to disinfect your select-
17 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. Take out the sensor applicator by turning it anti-clock wise. Place the applicator on the top of the desired sensor site. Press it firmly against skin and press the button to launch the sensor. After inserting the sensor, wait a few seconds to allow the sen-
sor base patch to adhere to the skin. 18 Release button 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. Reuse may result in no glucose read-
ings and infection. Align the transmitter to the sensor base and press the transmitter firmly onto the sensor base until it snaps onto the sensor base and attaches to it securely. 14 Note If the orientation of the transmitter and sensor base mismatch, the transmitter cannot be installed properly. You wont 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. Dispose the used sensor package and sensor ap-
plicator according to your local regulations. 20 Note The applicator contains a needle, please dispose of it properly to avoid any possibility of injury to others. 21 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. First time start up: Press and hold the power but-
ton, the PDA will vibrate, indicating that the PDA is powered on. After about 30 seconds the Setup Wiz-
ard will appear and guide you through entering basic settings. 22 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. 23 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. 24 Now the PDA will display Sensor initializing . Sensor initialization typically takes about 1 hour to complete. 25 When the sensor initialization is complete, the PDA will begin to display the current blood sugar value. 26 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-
ue immediately. If you press Confirm , the sensor will start initializing again. At this point, the PDA skips initialization and starts displaying the cur-
rent blood sugar value directly. Note Do not cancel the initialization process when using a new sensor. Skipping new sensor initialization may make the sys-
tem display incorrect blood glucose values. 27 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. Please calibrate the system only using reliable blood glucose test values - Use certified BG meter and test strips that are within expiration date; ensure the BG meter readings are consistent by performing two or three repeating tests; make sure the finger is cleaned with alcohol wipes and dried before the finger prick. Avoid any calibrations in the first 6 hours after the sen-
sor warming-up, which might affect the CGM accuracy afterwards. 28 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. 29 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. 30 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. You can use warm soapy water to remove any remaining sticky residue. Press the two locking arms on one side of the sensor base, pull the transmitter away from the sensor base, and then remove the trans-
mitter so that it can be used again. The sensor is meant for one-
time use only. Dispose the used sensor according to your local regulations. 31 WARNING Wire Breaks Off Dont 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 cant see it, dont try to remove it. Please contact your local dealer.Also seek professional medical help if you have symptoms of infection or inflammation redness, swelling, or pain at the insertion site. 32 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. 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. Press Hi BG Threshold to enter the desired sensor blood glucose threshold. The threshold range is 8.0-
25.0 mmol/L (144-450 mg/dL)(default value is 12.0 mmol/L). 33 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. After updating, the 34 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 Press Settings on the PDAs home screen to enter the Settings menu. Press the Date or Time or Time zone option. Set the correct date, time and timezone and click OK . 35 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. Press Settings on the PDA s home screen to enter the Settings Menu. Press Pair transmitter . 36 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. Note When unpairing an expired transmitter, make sure that the PDA and transmitter are within commu-
nication range and have good connection. If the connection is lost during unpairing, the transmitter may encounter difficulties re-pairing to PDA in the future. 37 Enter the transmitters serial number when prompted. 38 Click Confirm . The PDA will search for a connection and show Pairing successful when the connection has been made. 39 PDA Cautions PDA Cautions caution description Solution/Action Low Blood Glucose High Blood Glucose Sensor Expired Sensor Error Perform a finger- tip glucose measurement using an approved glucose meter to confirm the sensor glucose reading. If the measure- ment indicates low blood 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 reading. If the measure- ment 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 re- place 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, Please remove the current sensor and replace it with a new sensor. Other Unspecified Errors Please switch off the PDA and restart it. If the error message continue to appear, please contact our customer service. 40 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. 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 power outlet.
- A battery charging animation will be displayed if the PDA is off.
- When the PDA is on, the battery icon will change to the charging icon. It may take up 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. 41 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 compo-
nents can result in injury. WarningThe 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. Caring for your Continuous Glucose Monitoring System
(CGMS) Cleaning the PDA and transmitter 1. Use alcohol wipes to clean the pump outer surface thoroughly until there are no obvious dust particles and stains left by visual inspection. 42 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 PDAs test strip and charging ports. Equipment s hall not be servic ed or maintai ned whil e in use. No cleani ng methods are recom mended or tested for the PDA. Only wi pe with a clean, dry cl oth. Disposal Dispose PDA, transmitters and sensors that you do not use any more in compliance with local regulations for electronic devices, batteries, sharps, and biohazard materials. Please do not discard old products or acces-
sories directly. For further information on how to dis-
pose of system components, please contact customer service. 43 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. 2. The disposal of packaging materials shall comply with the local laws and regulations or the waste disposal rules and regulations of the hospital. The packaging materials must be placed away from the children. 3.Please dispose according to the local laws or consult with dealer from whom you purchased it about waste disposal. Transportation Avoid placing heavy weight on top of the PDA and transmitter. Avoid direct sunlight and rain. 44 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. The PDA, transmitter and sensor are precision instru-
ments . If they fail, they can only be returned to the manufacturer to repair. No third- party individuals or organizations are allowed to perform repairs. Circuit diagrams and component lists are not provided in the manual. Warning:Please strictly follow the instructions to perform adjustment, cleaning, sterilization, and disinfection procedures. Warning:Avoid exposing the Transmitter and PDA to temperatures above 60 and below 20.The time required from extreme storage temperature to normal 45 infusion status is : 8mins from 60 to 20 ,1min from -20 to 20. 46 Specifications Item Transmitter Subcomponent Sensor PDA Model number G7-T01 G7-T01A G7-T01B G7-S01 G7-S01A G7-S01B G7-P02MTM-2 Operating temperature 5-40(41-104 ) Operating humidity 10-93% (non-condensing) Operating pressure 700hpa~1060hpa Storage and transporta- tion temperature Storage and transporta- tion humidity Storage and transporta- tion pressure Ingress protection level Battery Use life
-20 -60 4 -30
-20 -60 5-95% (non-condensing) 700hpa~1060hpa IP48(combination) 40mA 4 Years G7-S01: 14 days G7-S01A: 10 days IP20(without waterprof IP02) 2100mA 4 Years 47 G7-S01B: 7 days Shelf life: 1 year Detection range 2.0mmol/L-25.0 mmol/L Measurement accuracy Wireless frequency and bandwidth Wireless frequency When the glucose concentration >4 .2mmol/l
(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 1mmol/l (18mg/dL). Frequency: 2.402GHz ~ 2.48 GHz Bandwidth: 1Mbps 2402MHz~2480MHz Wireless modulation GFSK 2402MHz~2480 MHz GFSK Conducted output power -2.34dBm
-3.42dBm Security Measures The CGMS System is designed to transmit data between the transmitter and designated display devices in accordance to the industry standard BLE protocols. It will not accept radio frequency (RF) communications using any other protocol, including Bluetooth classic communication protocols. In addition to the security provided by the BLE connection, communication between the CGMS transmitter and the CGMS receiver 48 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. Unless disabled, the CGMS mobile application regularly communicates with Servers. Communication between the CGMS applications and Servers is protected by a number of mechanisms, designed to safeguard against data corruption. This includes industry standard JWIT token based authentication and authorization. All such communication takes place exclusively over encrypted data path using industry standard SSL format. 49 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. Please use the cables and accessories provided. The cable information is as follows:
Item Length(m) Shielded Notes 1 PDA charging cable 1.0m Yes EUT DC 5V The use of accessories other than those specified for the device is not recommended . They may result in increased emissions or decreased immunity of the de-
vice. 50 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 interferenc e can still occ ur in the home health care envi ronment as control over the E MC environment c annot be guaran -
teed. An interferenc e ev ent can be rec ogni zed by gaps in C GMS readi ngs or gross inaccura -
cies. The user is encouraged to try to mitigate th-ese effects by one of the following meas -
ures :
If y our symptoms don t matc h your CGMS readings, use your BG meter w hen maki ng treatment decisions. If y our CGMS readings dont c onsis tently match y our s ymptoms or BG meter val ues , then talk to your heal thc are professi onal about how y ou should be 51 using the CGMS to 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 Measurement accuracy Description When the glucose concentration is
>4 .2mmol/L (75mg/dL), the sensor accuracy deviation does not exceed 20%;
When the glucose concentration is 4.2mmol/L (75mg/dL), the accuracy deviation does not exceed 20mg/dL 52 IEC60601-1-2 Table 201 Guidance and manufacturer s declaration electromag-
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. Emissions test Compliance RF emissions CISPR 11 Group 1 RF emissions CISPR 11 Class B Harmonic emis-
sions IEC 61000-
3-2 Voltage fluctua-
tions/Flicker emis-
sions IEC 61000-
3-3 Class A Complies 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 near-
by electronic equipment. The device is suitable for use in all establishments, including domestic establishments and those directly connected to the public low- volt-
age power supply. Move to a place within the normal operating temperature range and repeat the test. Repeat test. If you see the same result, contact your healthcare professional immediately. 53 IEC60601-1-2: Table 202 Guidance and manufacturer s declaration
electromagnetic i mmu n i ty The device customer or is intended the user of for use the device should ensure in that it is used the electromagnetic environment specified below. Immunity test IEC 60601 test level Compliance level Electrostatic discharge(ESD) IEC 60601-4-2 6KV contact 8KV air 6KV contact 8KV air Electrical fast transient burst IEC 6 1000-4-4 2KV power cord 1KV input/output 2KV power cord 1KV input/output Surge IEC 61000-4-5 1KV line to GND 2KV line to GND 1KV line to GND 2KV line to GND V o l t a g e dips, short interruptions and voltage variations on power supply input lines IEC 61000-4- 11
<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) Power frequen-
cy (50/60 Hz) magnetic field IEC 6 1000-4-8 3A/m 3A/m 54 The in such an environment. Electromagnetic environment
- guidance 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 commer-
cial or hospital environment. Mains power quality should be that of a typical commer-
cial or hospital environment. Mains power quality should be that of a typical commer-
cial or hospital environment. If the user of the device requires continued operation during power mains inter-
ruptions, it is recommended that the device be powered from an uninterruptible power supply or a battery. The power frequency magnetic field should have the characteristics of power frequency magnetic field level at atypical place in a typical commercial and hospital environment IEC 60601-1-2: Table 204 Guidance The device and manufacturer s declaration electromag-
immunity the electromagnetic environment specified the device should ensure the user of netic for use intended is used that in it is The customer or below. in such an environment . Immunity test IEC 60601 test level Compliance level Electromagnetic environment -
guidance Conduct-
ed RF IEC 61000-4-6 Radiated RF IEC 61000-4-3 3V(Vrms) 150kHz~80MHz 1 0 V( engineering medical frequency band) 1 5 0 kHz~ 8 0 MHz 3 V( Vrms) 10V
( engineering medical frequency band) 3V/m 80MHz~2.7GHz 3V/m Portable and mobile RF communica-
tions equipment should be used no closer to any part of the device, includ-
ing cables, than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter. Recommended separation distance d=1.2 P d= 1 . 2 P 8 0 MHz~ 8 0 0MHz d= 2 . 3 P 8 0 0 MHz~ 2 . 5 GHz where P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manu-
facturer and d is the recommended separation distance in metres (m).Field strengths from fixed RF transmitters, as determined by an electromagnetic site surveya, should be less than the compliance level in each frequency rangeb. Interference may occur in the vicinity of equipment marked with the following symbol:
55 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 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. Maximum rated output power of transmitter (W) Separation distance according to frequency of transmitter (m) 1 5 0 kHz~ 8 0 MHz d=1.2P 8 0 MHz~ 8 0 0 MHz d=1.2P 8 0 0 MHz~2 . 5GHz 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 0.23 0.73 2.3 7.3 23 For transmitters rated at a maximum output power not listed above, the 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 8 0 MHz and 8 0 0 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. 56 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. This equipment generates uses and can radiate radio frequency energy and, if not installed and used in acco rdance 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. 57 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. Any changes or modifications not expressly approved by the party responsible for compliance could void the user's authority to operate the equipment. 58 Appendix Symbols Atmospheric pressure limitation Humidity limitation Do not re-use Temperature limitation than from small tools Protected wires and greater 1 millimeter. Protected term from long immersion up to a specified pressure. Protected from touch than by fingers and objects 12 greater millimeters. Protected immersion from between 15 centimeters and 1 meter in depth. IP48 Protection against solid particle of diameter greater IP20 than 12.5 mm IP27 Medical Device 59 Consult Instructions for Use Type BF Applied Part Use by date Modle Number Manufacturer Date of manufacture Lot Number Handle With Care Serial Number Do Not Dispose with Household Waste Sterilized by EO Class 2 Equipment Biohazard Keep Dry 60 Non-Ionizing Radiation Recyclable See Instructions for Use Protected from touch by fingers and objects greater than 12 millimeters. Protected from condensation. Not protected from solids. Protected from water spray less than 15 degrees from vertical. IP21 IP02 Refer to Instruction Manual Protected from touch by fingers and objects greater than 12 millimeters.Protected from water spray less than 15 degrees from vertical. Protected from touch by fingers and objects greater than 12 millimeters. Protected from long term immersion up to a specified preasure. IP22 IP28 61 1016-PMTL-251.V03 2023.06.09
1 | Attestation Statements | Attestation Statements | 123.78 KiB | July 04 2023 |
C5266091_X24_Ed.2 Attestation Statements TO:
Office of Engineering Technology Federal Communications Commission 7435 Oakland Mills Road Columbia, MD 21046 The Commission adopted rules for covered telecommunications equipment and video surveillance equipment produced by entities identified on the Commissions Covered List1, which is periodically updated. See the Covered List for more details. This Attestation Statement is to confirm that we follow the Section 2.911(d)(5)(i)-(ii) that prohibit equipment authorization Applicant Company name: MicroTech Medical (Hangzhou) Co., Ltd. Grantee code: 2ATOV FCC ID: 2ATOV-P-G7 Contact Name: Leo wang Address: No. 108 Liuze St., Cangqian, Yuhang District, Hangzhou, 311121 Zhejiang, P.R. China Telephone No: +86 18621889766 Email: jason_pse@163.com i. ii. MicroTech Medical (Hangzhou) Co., Ltd. (the applicant) certifies that the equipment for which authorization is sought is not covered equipment prohibited from receiving an equipment authorization pursuant to section 2.903 of the FCC rules. The applicant must sign this certification. MicroTech Medical (Hangzhou) Co., Ltd. (the applicant) certifies that, as of the date of the filing of the application, the applicant is not (as a specifically named entity or any of its subsidiaries or affiliates) identified on the Covered List as an entity producing covered equipment. The applicant must sign this certification. MicroTech Medical (Hangzhou) Co., Ltd. (the applicant) certifies that, as of the date of the filing of the application, the applicant is not identified on the Covered List as an entity producing covered equipment. Date: 2023/06/06 Applicants Name: Leo wang Title: Registration Specialist Signature 1 The Commissions Covered List is published by the Public Safety and Homeland Security Bureau and posted on the Commissions website. This Covered List, which is periodically updated, identifies particular equipment, produced by particular entities, that constitutes covered equipment. https://www.fcc.gov/supplychain/coveredlist 1/1
1 | Confidentiality | Cover Letter(s) | 56.42 KiB | July 04 2023 |
MicroTech Medical (Hangzhou) Co., Ltd. C5266091_X10_Ed.1 Office of Engineering Technology Federal Communications Commission 7435 Oakland Mills Road Columbia, MD 21046 Subject: Request for Confidentiality FCC ID: 2ATOV-P-G7 To Whom It May Concern, Date: 2023/06/06 Pursuant to the provisions of Sections 0.457 and 0.459 of Commission's rules
(47CFR0.457, 0.459), we are requesting the Commission to withhold the following attachment(s) as confidential document from public disclosure. Exhibits ID Label/Location Attestation Statement External Photos Block Diagram Schematics Test Report Test Setup Photos Users Manual Internal Photos Parts List / Tune Up RF Exposure Info Operational Description Cover Letter(s) SDR Software / Security Info Long-Term Confidentiality No No No Short-Term Confidentiality No No No No No No No No In case of short-term Confidentiality, the applicant requests the exhibits selected above are withheld from public view for a period of _180_ days from the date of the Grant of Equipment Authorization and prior to marketing. Above mentioned document contains detailed system and equipment description are considered as proprietary information in operation of the equipment. The public disclosure of above documents might be harmful to our company and would give competitor an unfair advantage in the market. It is our understanding that all measurement test reports, FCC ID label format and correspondent during certification review process cannot be granted as confidential documents and those information will be available for public review once the grant of equipment authorization is issued. Sincerely, Signature:
1/1 C5266091_X10_Ed.1 Name: Leo wang Title: Registration Specialist 1/1
1 | Family declaration | Attestation Statements | 24.75 KiB | July 04 2023 |
Declaration of difference Date: 2023/06/06 To Whom It May Concern:
The Product: Personal Diabetes Assistant Model No.: G7-P02, MTM-2 The appearance, color and internal circuitry of all models are consistent, the only difference is their built-in software. There is no influence on the test results. Yours sincerely, Signatory Name Leo wang Registration Specialist Position Company Name MicroTech Medical (Hangzhou) Co., Ltd. Address No. 108 Liuze St., Cangqian, Yuhang District, Hangzhou, 311121 Zhejiang, P.R. China
+86 18621889766 jason_pse@163.com Tel E-Mail 1/1
1 | Letter Authorization | Cover Letter(s) | 56.90 KiB | July 04 2023 |
C5266091_X8_Ed.1 Letter of Authorization MicroTech Medical (Hangzhou) Co., Ltd. Company: MicroTech Medical (Hangzhou) Co., Ltd. Address: No. 108 Liuze St., Cangqian, Yuhang District, Hangzhou, 311121 Zhejiang, P.R. China Product Name: Personal Diabetes Assistant Model Number: G7-P02, MTM-2 FCC Identifier: 2ATOV-P-G7 We authorize LGAI Technological Center S.A., Ronda de la Font del Carme, s/n, 08193 Bellaterra, Spain, to act on our behalf on all matters concerning the above named equipment. Any individual within LGAI Technological Center S.A. is authorized to act on our behalf and take action on the application. We declare that authorize LGAI Technological Center S.A., Ronda de la Font del Carme, s/n, 08193 Bellaterra, Spain, is allowed to forward all information related to the approval project to the Federal Communication Commission and to discuss any issues concerning the approval application. Any and all acts carried out by LGAI Technological Center S.A. on our behalf shall have the same effect as acts of our own. Name: Leo wang Date: 2023/06/06 Title: Registration Specialist Signature of applicant:
1/1
1 | Test setup photos | Test Setup Photos | 318.23 KiB | July 04 2023 / January 01 2024 | delayed release |
1 | US Agent Letter | Attestation Statements | 584.32 KiB | July 04 2023 |
US Agent for Service of Process LETTER OF ATTESTATION TO:
Office of Engineering Technology Federal Communications Commission 7435 Oakland Mills Road Columbia, MD 21046 US Agent for Service of Process:
Company Name: MicroTech Medical, Inc. FRN: 0033955881 Contact Name: Dore Mark Address: 1999 S, Bascom Ave, Suite 700, Campbell, CALIFORNIA 95008, United States Telephone No: 408 5440744 Email: Dore.Mark@Microtechmd.Com Applicant:
Company name: MicroTech Medical (Hangzhou) Co., Ltd. Product Description: Personal Diabetes Assistant Grantee code: 2ATOV FCC ID: 2ATOV-P-G7 Contact Name: Leo wang Address: No. 108 Liuze St., Cangqian, Yuhang District, Hangzhou, 311121 Zhejiang, P.R. China Telephone No: +86 18621889766 Email: jason_pse@163.com
{MicroTech Medical (Hangzhou) Co., Ltd.] certifies that, as of the date of this filing of the application with the TCB, [Microtech Medical, Inc.] is our designated US agent for service of process for the above referenced FCC ID. [MicroTech Medical (Hangzhou) Co., Ltd.}] accepts to maintain an agent for no less than one year after the grantee has terminated all marketing and importation or the conclusion of any commission related proceeding involving equipment.
[Microtech Medical, Inc.] accepts, as of the date of the filing of the application, the obligation of the designated US agent for service of process for the above reference FCC ID. The US Agent for Service of Process is aware of and agrees to comply with the requirements outlined in the FCC Equipment Authorization Program, Report and Order FCC 22-84, and clause 2.911. The Applicant is aware of and agrees to comply with the requirements outlined in the FCC Equipment Authorization Program, Report and Order FCC 22-84, and clause 2.911. Date: 2023/06/30 Applicants Name: Leo wang US Agents Name: Dore Mark Title: Registration Specialist Title: Vice President Signature: i loowang-
1/1
frequency | equipment class | purpose | ||
---|---|---|---|---|
1 | 2023-07-04 | 2402 ~ 2480 | DTS - Digital Transmission System | Original Equipment |
app s | Applicant Information | |||||
---|---|---|---|---|---|---|
1 | Effective |
2023-07-04
|
||||
1 | Applicant's complete, legal business name |
MicroTech Medical (Hangzhou) Co., Ltd.
|
||||
1 | FCC Registration Number (FRN) |
0028573830
|
||||
1 | Physical Address |
No. 108 Liuze St., Cangqian, Yuhang District
|
||||
1 |
Hangzhou, 311121 Zhejiang, P.R. China, N/A
|
|||||
1 |
China
|
|||||
app s | TCB Information | |||||
1 | TCB Application Email Address |
e******@applus.com
|
||||
1 | TCB Scope |
A4: UNII devices & low power transmitters using spread spectrum techniques
|
||||
app s | FCC ID | |||||
1 | Grantee Code |
2ATOV
|
||||
1 | Equipment Product Code |
P-G7
|
||||
app s | Person at the applicant's address to receive grant or for contact | |||||
1 | Name |
L**** w****
|
||||
1 | Title |
Registration Specialist
|
||||
1 | Telephone Number |
+86 1********
|
||||
1 | Fax Number |
+86 0********
|
||||
1 |
j******@163.com
|
|||||
app s | Technical Contact | |||||
1 | Firm Name |
Dongguan Dongdian Testing Service Co., Ltd
|
||||
1 | Name |
D****** H******
|
||||
1 | Physical Address |
Dongguan
|
||||
1 |
China
|
|||||
1 | Telephone Number |
86-07********
|
||||
1 |
D******@dgddt.com
|
|||||
app s | Non Technical Contact | |||||
1 | Firm Name |
Dongguan Dongdian Testing Service Co., Ltd
|
||||
1 | Name |
D****** H******
|
||||
1 | Physical Address |
Donguan
|
||||
1 |
China
|
|||||
1 | Telephone Number |
86-07********
|
||||
1 |
D******@dgddt.com
|
|||||
app s | Confidentiality (long or short term) | |||||
1 | Does this application include a request for confidentiality for any portion(s) of the data contained in this application pursuant to 47 CFR § 0.459 of the Commission Rules?: | Yes | ||||
1 | Long-Term Confidentiality Does this application include a request for confidentiality for any portion(s) of the data contained in this application pursuant to 47 CFR § 0.459 of the Commission Rules?: | Yes | ||||
1 | If so, specify the short-term confidentiality release date (MM/DD/YYYY format) | 01/01/2024 | ||||
if no date is supplied, the release date will be set to 45 calendar days past the date of grant. | ||||||
app s | Cognitive Radio & Software Defined Radio, Class, etc | |||||
1 | Is this application for software defined/cognitive radio authorization? | No | ||||
1 | Equipment Class | DTS - Digital Transmission System | ||||
1 | Description of product as it is marketed: (NOTE: This text will appear below the equipment class on the grant) | Personal Diabetes Assistant | ||||
1 | Related OET KnowledgeDataBase Inquiry: Is there a KDB inquiry associated with this application? | No | ||||
1 | Modular Equipment Type | Does not apply | ||||
1 | Purpose / Application is for | Original Equipment | ||||
1 | Composite Equipment: Is the equipment in this application a composite device subject to an additional equipment authorization? | No | ||||
1 | Related Equipment: Is the equipment in this application part of a system that operates with, or is marketed with, another device that requires an equipment authorization? | No | ||||
1 | Grant Comments | Output power listed is conducted. | ||||
1 | Is there an equipment authorization waiver associated with this application? | No | ||||
1 | If there is an equipment authorization waiver associated with this application, has the associated waiver been approved and all information uploaded? | No | ||||
app s | Test Firm Name and Contact Information | |||||
1 | Firm Name |
Dongguan Dongdian Testing Service Co., Ltd.
|
||||
1 | Name |
M**** Y******
|
||||
1 | Telephone Number |
+86-0********
|
||||
1 |
j******@dgddt.com
|
|||||
Equipment Specifications | |||||||||||||||||||||||||||||||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Line | Rule Parts | Grant Notes | Lower Frequency | Upper Frequency | Power Output | Tolerance | Emission Designator | Microprocessor Number | |||||||||||||||||||||||||||||||||
1 | 1 | 15C | 2402.00000000 | 2480.00000000 | 0.0005000 |
some individual PII (Personally Identifiable Information) available on the public forms may be redacted, original source may include additional details
This product uses the FCC Data API but is not endorsed or certified by the FCC