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Version:A/0 User Manual Blood Pressure Monitor Model: TMB-2285-B Wrist Type Guangdong Transtek Medical Electronics Co., Ltd. Zone A, No.105, Dongli Road, Torch Development District, 528437 Zhongshan, Guangdong, China Thank you for selecting Transtek Blood Pressure Monitor. Please read the user manual carefully and thoroughly so as to ensure the safe usage of this product. Keep this manual for further reference in case any issues arise. INTRODUCTION
............................................................................................. 2 CATALOGUE General Description Indications for Use Measurement Principle Receiving and Inspecting your Monitor Safety Information LCD Display Symbol Monitor Components List BEFOREYOU START
...................................................................................... 13 Installing and Replacing the Batteries Setting Date and Time Pair a smartphone or a tablet with the monitor WRIST POSITIONING GUIDE Setting a user ID MEASUREMENT
.............................................................................................. 27 Tie the Cuff Start the Measurement DATA MANAGEMENT Recalling the Records Deleting the Records INFORMATION FOR USER Tips for Measurement Maintenance ABOUT BLOOD PRESSURE
...................................................................................... 31
................................................................................ 34
............................................................................... 36 What are systolic pressure and diastolic pressure?
What is the standard blood pressure classification?
Irregular heartbeat detector Why does my blood pressure fluctuate throughout the day?
Why do I get a different blood pressure at home compared to the hospital?
Is the result the same if measuring on the right wrist?
..................................................................................... 39 TROUBLESHOOTING
........................................................................................... 41 SPECIFICATIONS CONTACT INFORMATION ........................................................................................ 43
............................................................................................. 44 EMC GUIDANCE
............................................................................................. 50 FCC STATEMENT ISDE COMPLIANCE STATEMENT ................................................................................ 52 1 INTRODUCTION INTRODUCTION General Description This product features blood pressure measurement, pulse rate measurement and the result storage. Readings taken by this blood pressure monitor TMB-2285-B is equivalent to those obtained by a trained observer using the cuff and stethoscope auscultation method. This manual contains important safety and care information, and provides step by step instructions for using this blood pressure monitor. Read the manual thoroughly before using this product. Features:
Systolic blood pressure Diastolic blood pressure Pulse rate 199 records for each user Indications for Use This Blood Pressure Monitor is digital monitor intended for use in measuring blood pressure and heartbeat rate with wrist circumference ranging from 13.5cm to 21.5 cm (about 5-8). It is intended for adult indoor use only. The device can be used to detect irregular heartbeat. 2 Measurement Principle This product uses the Oscillometric Measuring Method to detect blood pressure. Before every measurement, the unit establishes a zero point equivalent to the atmospheric pressure. Then it starts inflating the cuff. Meanwhile, the unit detects pressure oscillation generated by beat-to-beat pulsatile, which is used to determine the systolic pressure and diastolic pressure as well as pulse rate. Receiving and Inspecting your Monitor Check that the device packaging has not been tampered with and make sure that all contents are present. Before use, ensure that there is no visible damage to the device or accessories and that all packaging material has been removed. If you have any doubts, do not use the device and contact your retailer or the specified Customer Services address. 3 INTRODUCTION Safety Information The signs below might be in the user manual, labeling or other component. They are the requirement of standard and using. Date of manufacture Symbol for TYPE BF APPLIED PART Symbol for MANUFACTURER SN Symbol for SERIAL NUMBER Symbol for RECYCLE Symbol for DIRECT CURRENT Refer to instruction manual/booklet To signify that the instruction manual/booklet must be read. Note: The background color of the symbol is blue. Caution Indicates that caution is necessary when operating the device or control close to where the symbol is placed, or that the current situation needs operator awareness or operator action in order to avoid undesirable consequences. MR Unsafe To identify an item which poses unacceptable risks to the patient, medical staff or other persons within the MR environment. The symbol indicates that the product should not be discarded as unsorted waste but must be sent to separate collection facilities for recovery and recycling. INTRODUCTION Precaution
* This device is intended for indoor, home use and is not intended for self-use in public areas.
* This device is portable, but it is not intended for use during patient transport.
* This device is not suitable for continuous monitoring during medical emergencies or operations.
* This device is intended for no-invasive measuring and monitoring of arterial blood pressure. It is not intended for use on extremities other than the wrist, or for any purpose other than obtaining a blood pressure measurement.
* This device is for adults. Do not use this device on neonates or infants. Do not use it on children and adolescents unless otherwise instructed by a medical professional.
* Consult with your physician before using this monitor if you suffer from the following conditions:
common arrhythmias such as premature ventricular beats or atrial fibrillation;
peripheral arterial disease; pregnancy; preeclampsia; implantation with electrical devices;
undergoing intravascular therapy; arteriovenous shunt or mastectomy. Please note that any of these conditions may affect measurement readings, in addition to patient motion, trembling or shivering.
* Do not use this device for diagnosis or treatment of any health problem or disease. Contact your physician if you have or suspect any medical problem. Do not change your medications without the advice of your physician or health care professional.
* If you are taking medication, consult your physician to determine the proper time to measure your blood pressure.
* This device may be used only for the intended use described in this manual, the manufacturer shall have no liability for any incidental, consequential, or special damages caused by misuse or abuse. 4 5 INTRODUCTION Precaution
* Please use the device under the environment which is provided in the user manual. Otherwise, the performance and lifetime of the device will be impacted and reduced.
* The device may require up to 30 minutes to warm up / cool down from the minimum / maximum storage temperature before it is ready for use.
* The blood pressure monitor and the cuff are suitable for use within the patient environment.
* Do not wash the cuff in a washing machine or dishwasher !
* The device contains sensitive electronic components. To avoid measurement errors, avoid taking blood pressure measurements near a strong electromagnetic field radiated interference signal or electrical fast transient/burst signal.
* Wireless communication equipment, such as wireless home network devices, mobile phones, cordless telephones and their base stations, walkie-talkies may cause interference that may affect the accuracy of measurements. A minimum distance of 1 foot (30 cm) should be kept from such devices during a measurement.
* Blood Pressure Monitor is intended for use by medical staffs and lay persons, and patient is also an intended user or operater. 6 INTRODUCTION Warning
Do not apply the cuff on an wrist that has an intravenous drip or a blood transfusion attached. Taking blood pressure measurements too frequently could disrupt blood circulation and
cause injuries.
* Do not apply cuff to areas on patient where skin is delicate or damaged. Check cuff site frequently for irritation.
* Do not place the cuff on the wrist of a person whose arteries or veins are undergoing medical treatment, i.e. intra-vascular access or intra-vascular therapy or an arteriovenous (A-V) shunt, which could disrupt blood circulation and cause injuries.
* Do not place the cuff on the wrist on the same side of a mastectomy (especially when lymph nodes have been removed). it is recommended to take measurements on the unaffected side.
* Do not wrap the cuff on the same wrist to which another monitoring device is applied. One or both devices could temporarily stop functioning if you try to use them at the same time.
* Please check (for example, by observation of the limb concerned) that the operation of the device does not result in prolonged impairment of patient blood circulation.
* On the rare occasion of a fault causing the cuff to remain fully inflated during measurement, loosen and remove the cuff immediately. Prolonged high pressure applied to the wrist
(cuff pressure >300 mmHg or constant pressure >15 mmHg for more than 3 minutes) might lead to bruising and discolored skin.
* Do not use this device with high-frequency (HF) surgical equipment at the same time.
* This device is not used in conjunction with oxygen rich environments, not intended for use with flammable anaesthetics, not intended for use in conjunction with flammable agents.
* Do not touch output of the batteries and the user simultaneously.
* Do not use this device if you are allergic to polyester, nylon, or plastic.
* Only use accessories approved by manufacturer. Using unapproved accessories might cause damage to the unit and injure users.
* If you experience discomfort during a measurement, such as pain in the wrist or other complaints, press the Power button immediately to release the air from the cuff.
* Do not use the device while under maintenance, or being serviced.
* Sensor degradation or looseness may reduce performance of device or cause other problems. 7 INTRODUCTION Caution
* Do not attempt to repair the unit yourself if it malfunctions. Only have repairs carried out by authorized service centers.
* It is recommended that the performance should be checked after repair, maintenance, and every two years of use, by retesting the requirements in limits of the error of the cuff pressure indication and air leakage (testing at least at 50 mmHg and 200 mmHg).Please contact manufacturer or distributor for authorized service personnel.
* Store your device and cuff in a clean and dry place, protect it against extreme moisture, heat, lint, dust and direct sunlight. Never place any heavy objects on it.
* Dispose of accessories, detachable parts, and the device according to the local guidelines. Notice
* You can use this device to take your own measurement, no third-party operator is required.
* At the request of authorized service personnel, circuit diagrams, component part lists, descriptions, and calibration procedures will be made available by the manufacturer or distributor.
* The service life of the cuff may vary by the frequency of washing, skin condition, and storage state.
* Please report to the manufacturer and the competent authority of the Member State / the FDA in which you are established about any serious incident that has occurred in relation to this device. LCD Display Symbol INTRODUCTION INTRODUCTION SYMBOL DESCRIPTION EXPLANATION Systolic blood pressure The High pressure measured. Diastolic blood pressure The Low pressure measured. Pulse Display Pulse in beats per minute. User ID User 1/2/Guest Current Time Time(year:month:day:hour:minute) Heartbeat Heartbeat dectetion during measurement 8 Irregular heartbeat Irregular heartbeat detected during measurement. 9 INTRODUCTION INTRODUCTION SYMBOL DESCRIPTION EXPLANATION Monitor Components Battery Indicator Indicate the current battery. Data transmitting Data is transmitting; If the data transmission fails, this symbol will be show in next measurement. Excessive Body Motion Detector Appears when talking, moving, or hand shaking is detected during the measurement. NOTE: The measured blood pressure reading may not beaccurate if the icon is displayed. Wrist Positioning Guide Guide for you to make the wrist in ideal position. LCD DISPLAY Blood pressure level Indicate blood pressure level. SYSTOLIC Bluetooth icon The bluetooth icon blinks when the bluetooth is working. Average value Displays average of last 3 readings. PULSE RATE Memory display Indicate it is in the memory mode and which group of memory it is. mmHg mmHg Measurement Unit of the blood pressure MEM BUTTON DIASTOLIC START/STOP BUTTON CUFF 10 11 INTRODUCTION BEFORE YOU START CUFF
( Type BF applied part) Installing and Replacing the Batteries Slide off the battery cover. Install the batteries as indicated in the battery compartment. Always use the correct battery type (2 AAA batteries). Replace the battery cover. BATTERY COMPARTMENT List 1) Blood Pressure Monitor TMB-2285-B 2) 2 AAA Batteries 3) User manual
(Optional!) 12 13 BEFORE YOU START BEFORE YOU START Replace the batteries whenever the below happen The shows bAt Lo The display is dim The display does not light up CAUTION Do not use new and used batteries together. Do not use different types of batteries together. Do not dispose the batteries in fire. Batteries may explode or leak. Remove batteries if the device is not likely to be used for some time. Worn batteries are harmful to the environment. Do not dispose with daily garbage. Remove the old batteries from the device following your local recycling guidelines. Setting Date and Time It is important to set the Date and Time before using your blood pressure monitor, so that a time stamp can be assigned to each record that is stored in the memory. (Year Range: 2022-2052; Time Format: 12/24 H) 1. When the monitor is off, installing the battery for the first time, it will enter the settings. The symbol will be displayed the first. 2. Short press the START/ STOP button, it will enter the setting for year. Press the MEM button to change the year. 14 15 BEFORE YOU START BEFORE YOU START 3. When you get the right year, press the START / STOP button to confirm the year. Then it will display the date format. Press the MEM button to switch the date format between
[month/day] and [day/month]. 5.Repeat the same steps to set the time format. 4.Repeat the same steps to set the
[MONTH] and [DAY]. 6. Repeat same steps to set the
[HOUR] and [MINUTE]. 16 17 BEFORE YOU START BEFORE YOU START 7. After setting the [MINUTE], the LCD will display do nE , and then the monitor will turn off automatically. Pair a smartphone or a tablet with the monitor You are the intended operator of this blood pressure monitor. You can measure your blood pressure and then save and send measurement data to a smartphone or tablet with Bluetooth wireless connectivity and application. 1.Turn on Bluetooth and the application. Make sure both are ON when pair-up is proceeding. 2. There are two ways to pairing:
A. When the monitor is o, installing the battery for the rst time , the symbol will ash on the LCD, indicating pair-up is proceeding. If successful, the Bluetooth symbol will not ash any more, and the LCD will display donE. and then it will enter the date format and time format setting.
(Repeat the same steps to set them on the chapter [Setting Date and Time]. If unsuccessful within about 30 seconds or short press the START/ STOP button, it is enter [Year] setting automatically. (Repeat the same steps to set on the chapter [Setting Date and Time]. 16 18 17 19 BEFORE YOU START BEFORE YOU START pair-up is proceeding. pair-up successful B.When the monitor is o, long pressing the START/ STOP button, the symbol will ash on the LCD, indicating pair-up is proceeding. If successful, the Bluetooth symbol will not ash any more, and then the monitor will shut o automatically. If unsuccessful within about 60 seconds, it is judged timeout and the monitor will shut o automatically. Note:
The date and time will be automatically synchronized after the pair-up is nished. RF Frequency Range: 2402 MHz to 2480 MHz Output Power Range: -3.26 dBm Supply Voltage: 1.8-3.6 V Transmitting Distance: 10 meters List of compatible devices For iOS devices:
The operating system must be iOS 13.0 or more. For Android devices The operating system must be Android 5.0 or more CAUTION Interference may occur in the vicinity of equipment marked with the following symbol . And TMB-2285-B may interfering vicinity electrical equipment. Keep the monitor at least 20 centimeters away from the human body (especially the head) when the data after transmission is proceeding measurement. To enable the data transmission function, this product should be paired to Bluetooth end at 2.4 GHz. How to mitigate possible interference?
1.The range between the device and BT end should be reasonably close, from 1 meter to 10 meters. Please ensure no obstacles between the device and BT end so as to obtain quality connection and to lower the RF output range. 2. To avoid interference, other electronic devices (particularly those with wireless transmission / Transmitter) should be kept at least 1 meter away from the monitor. 20 21 BEFORE YOU START BEFORE YOU START WRIST POSITIONING GUIDE When using wrist blood pressure monitor, it is important to take the measurement while relaxing your wrist at heart level. This will help ensure an accurate reading will be taken. Because it is difficult to find the ideal location for a wrist measurement, we have included an optional Wrist Positioning Sensor that will assist in directing your wrist to the ideal location for a blood pressure measurement. Each time you take a measurement, the display will illuminate with different icons that are designed to help you move your wrist. Once the ideal location is found, the wrist symbol will flash and after several seconds, measurement will begin. Keep your arm still until measurement is completed. Please raise your wrist. Please lower your wrist. 22 23 Wrist in ideal position, the symbol flash. Do not move, Measurement start. BEFORE YOU START Setting a user ID There are 3 user ID available. The user and , each with 199 memory spaces, are designed for 2 different people to save the measured values separately. The user , no memory space, is reserved for guest. 1. When the monitor is off, long pressing the MEM button to display the current user ID and flash. Press the MEM button again to switch the user ID between the user , and . 2. Press the START/STOP button to confirm the selected user ID, the User ID will not flash any more and the monitor will turn off automatically. BEFORE YOU START Tie the Cuff Only use a cuff that has been approved by the manufacturer for this device model. Before use, please confirm if it fits your wrist circumference. 1. 2. 3. 4. 5. Remove all accessories (watch, bracelet,etc) from your wrist. If your physician has diagnosed you with poor circulation in your wrist, use the other one. Roll or push up your sleeve to expose the skin. Apply the cuff to your wrist with your palm facing up. Position the edge of the cuff about 1cm~2cm from wrist joints. Fasten the wrist cuff around your wrist, leaving no extra room between the cuff and your skin. If the cuff is too loose, the measurement will not be accurate. User 1 User 2 Visitor 24 25 BEFORE YOU START MEASUREMENT 6. 7. Sit comfortably with your tested wrist resting on a flat surface. Place your elbow on a table so that the cuff is at the same level as your heart. Turn your palm upwards. Sit upright in a chair, and take 5-6 deep breaths. Patients with Hypertension:
The middle of the cuff should be at the level of the right atrium of the heart; Before starting measurement, please sit comfortably with legs uncrossed, feet flat on the floor, back and wrist supported. Rest for 5 minutes before measuring. Wait at least 3 minutes between measurements. This allows your blood circulation to recover. Take the measurement in a silent room. The patient must relax as much as possible and do not move and talk during the measurement procedure. The cuff should maintain at the same level as the right atrium of the heart. Do not cross your legs and keep your feet on the ground. Keep your back against the backrest of the chair. For a meaningful comparison, try to measure under similar conditions. For example, take daily measurements at approximately the same time, on the same wrist, or as directed by a physician. Start the Measurement 1.When the monitor is off, press the START/STOP button to turn on the monitor, it will display the latest record of the current user, and then it will detect the position first, when you get the correct position, it will display for about 3 seconds, after then it will complete the whole measurement automatically.
(Take user 1 for example.) A step-by-step guide showing what youll see while taking a measurement. 26 27 Display the latest record of current User Ideal position. Measurement start MEASUREMENT MEASUREMENT 3. If the data transmits successful, the symbol and symbol will disappear, and then the monitor will turn off automatically. 4. If unsuccessful within 60 seconds, it is judged timeout and the monitor will shut off. 5. Press START/STOP button to power off, otherwise it will shut off automatically. Adjust to zero. Inflating and measuring. 2.After the measurement is finished, the symbol and will display, and the data will start transmitting. Display and save the measuring result. 28 29 DATA MANAGEMENT MEASUREMENT DATA MANAGEMENT 6. About the irregular heartbeat and excessive body motion during the measurement. During a measurement, If an irregular heartbeat is detected, the symbol will display in the measurement result. See page 37 for more information. During a measurement, when the excessive body motion, especially of the wrist cuff is detected, the symbol will flash about 5 seconds and detect again. If it is no longer detected, the symbol will disappear; If still detected, the symbol will final display in the measurement result. Note:
The measured blood pressure reading may not be accurate if this symbol is displayed. 1. Recalling the Records When the monitor is off, press MEM button the user ID will blinkingand the memory number of the reading will be shown . you can swich the user from User 1 to User 2 by pressing MEM button again. After choosing the right user, press START/STOP button to confirm. If there are less than 3 records, it will display the latest record of the current user. If there are more than 3 records, it will show the average of latest three records first. If there are no records, it will ---. 2. Press MEM button to get the record you want. If the symbol and appears along with the record, that means the record pending to transmit. Average record 30 Date and time will display alternately. The current record is Group 2. The corresponding year is 2022. The corresponding date is January 1st. The corresponding time is 08:30 (a.m.). Latest record CAUTION The most recent record (1) is shown first. Each new measurement is assigned to the first (1) record. All other records are pushed back one digit (e.g., 2 becomes 3, and so on), and the last record (199) is dropped from the list. 31 DATA MANAGEMENT Deleting the Records If you did not get the correct measurement, you can delete results by following steps below. A: To delete a single measurement:
1.When the monitor is off, press MEM button to show the memory recall mode (you could use the MEM button to switch between user1 and user 2). 2.Several seconds later, press MEM button to find the measurement you would like to erase, press and hold MEM button for 3 seconds, and the display will show a blinking dEL y and the memory number of the reading. 3.Use the MEM buttons to toggle between Y and NO. Press START/STOP to confirm the selection. If Y is selected, the unit will delete the record and return to last momery record. All the records are pushed forward one digit (e.g., 03 becomes 02, and so on) DATA MANAGEMENT B: To delete ALL measurements:
1.When the monitor is off, press MEM button to show the memory recall mode (you could use the MEM button to switch between user1 and user 2). 2.Several seconds later, hold pressing MEM +START/STOP button for 5 seconds, the display will show a blinking dEL AL and the User ID. 3.Use the MEM buttons to toggle between AL and NO. Press START/STOP to confirm the selection. If dEL AL is selected, the unit will display do nE + User ID and delete all the record of the current user. Several seconds later, it will display ---. 32 No record 33 INFORMATION FOR USER INFORMATION FOR USER Tips for Measurement Measurements may be inaccurate if taken in the following circumstances. Within 1 hour after dinner or drinking Immediate measurement after tea, coffee, smoking Within 20 minutes after taking a bath MM When talking or moving your fingers In a very cold environment When you want to discharge urine Maintenance To obtain the best performance, please follow the instructions below. 1. Cleaning Process:
Step 1: Make sure to switch off the device prior to cleaning. Step 2: Use a soft cloth wetted with soapy water to clean the cuff first, and then use a soft cloth wetted with clear water to remove residual soap until there is no visible residual contaminants. Attention shall be paid to avoid liquid invasion into the cuff. Step 3: Use a dry soft cloth to wipe the cuff, in order to remove residual moisture. Step 4: Dry the cuff at a well-ventilated place after cleaning. 2. Disinfection Process:
Step 1: Make sure to switch off the device prior to disinfection. Step 2: Use a soft cloth wetted with 70% isopropanol to disinfect the cuff for about 10 minutes. Attention shall be paid to avoid liquid invasion into the cuff. Step 3: Use a clean dry cloth or towel to wipe off the disinfectant until there is no visible residue. Step 4: Dry the cuff at a well-ventilated place after disinfection. Suggestion:
Frequency of Cleaning and Disinfection:
For single patient multiple use, its recommended to clean the device surface once a month or whenever its necessary. For multiple patient multiple use, its recommended to clean the device every time before and after usage. Maintenance procedures shall be taken as per instruction. 34 35 ABOUT BLOOD PRESSURE ABOUT BLOOD PRESSURE What are systolic pressure and diastolic pressure?
When ventricles contract and pump blood out of the heart, blood pressure reaches its maximum value, the highest pressure in the cycle is known as systolic pressure. When the heart relaxes between heartbeats, the lowest blood pressure is diastolic pressure. What is the standard blood pressure classification?
The blood pressure classification published by World Health Organization (WHO) and International Society of Hypertension (ISH) in 1999 is as follows:
Level Blood Pressure
(mmHg) Optimal Normal High-normal Mild Moderate Severe SYS DIA
<120
<80 120~129 130~139 140~159 160~179 80~84 85~89 90~99 100~109
>180
>110 CAUTION Only a physician can tell you your normal blood pressure range and the point at which you are at risk. Consult your physician to obtain these values. Please contact a physician if your measuring result falls out of the range. Irregular Heartbeat Detector An irregular heartbeat is detected when a heartbeat rhythm varies while the device is measuring systolic pressure and diastolic pressure. During each measurement, blood pressure monitor will keep a record of all the pulse intervals and calculate the average value of them. If there are two or more pulse intervals , the difference between each interval and the average is more than the average value of 25% , or there are four or more pulse intervals ,the difference between each interval and the average is more than the average value of 15%, then the irregular heartbeat symbol will appear on the display with the measurement result. CAUTION The appearance of the IHB icon indicates that a pulse irregularity consistent with an irregular heartbeat was detected during measurement. Usually this is NOT a cause for concern. However, if the symbol appears often, we recommend you seek medical advice. Please note that the device does not replace a cardiac examination, but serves to detect pulse irregularities at an early stage. 36 37 ABOUT BLOOD PRESSURE TROUBLESHOOTING Why does my blood pressure fluctuate throughout the day?
1. Individual blood pressure varies multiple times everyday. It is also affected by the way you tie your cuff and your measurement position, so please take the measurement under the same conditions. 2.If the person takes medicine, the pressure will vary more. 3.Wait at least 3 minutes for another measurement. Why do I get a different blood pressure at home compared to the hospital?
The blood pressure is different even throughout the day due to weather, emotion, exercise etc, Also, there is the white coat effect, which means blood pressure usually increases in clinical settings. Is the result the same if measuring on the right wrist?
It is ok for both wrists, but there will be some different results for different people. We suggest you measure the same wrist every time. 38 What you need to pay attention to when you measure your blood pressure at home:
If the cuff is tied properly. If the cuff is too tight or too loose. If the cuff is tied on the wrist. If you feel anxious. Taking 2-3 deep breaths before beginning will be better for measuring. Advice: Relax yourself for 4-5 minutes until you calm down. If any abnormality arises during use, please check the following points:
PROBLEM SYMPTOM CHECK THIS REMEDY No power Display is dim or will not light up. Batteries are exhausted. Replace with new batteries Batteries are inserted incorrectly. Insert the batteries correctly High batteries bAt H shows Batteries are high. Replace with new batteries Low batteries bAt Lo+ shows Batteries are low. Replace with new batteries E 01 shows The cuff is not secure Refasten the cuff and then measure again. Error message E 02 shows The monitor detected motion, talking, or the pulse is too poor while measuring. movement can affect the measurement. Relax for a moment and then measure again. E 03 shows E 04 shows The measurement process does not detect the pulse signal. The treatment of the measurement failed. Loosen the clothing on the wrist and then measure again. Relax for a moment and then measure again. 39 TROUBLESHOOTING SPECIFICATIONS PROBLEM SYMPTOM CHECK THIS Error message EExx,shows on the display. A calibration error occurred. Warning message out shows Out of measurement range REMEDY Retake the measurement.If the problem persists,contact the retailer or our customer service department for further assistance. Refer to the warranty for contact information and return instructions. Relax for a moment. Refasten the cuff and then measure again. If the problem persists, contact your physician. NOTE: If the product still does not work, contact Transtek Customer Service. Under no circumstance should you disassemble or attempt to repair the unit by yourself. Power supply Display mode Battery powered mode: 2x AAA batteries 3V Digital LCD V.A.43 mm x 46 mm Measurement mode Oscillographic testing mode Measurement range Accuracy Working condition Storage & transportation condition Measurement perimeter of the wrist Weight External dimensions Attachment Rated cuff pressure:
0 mmHg ~ 299 mmHg Measurement pressure:
SYS: 60 mmHg ~ 230 mmHg DIA: 40 mmHg ~ 130 mmHg Pulse value: (40-199) beat/minute Pressure: 5C-40C within 3 mmHg Pulse value: 5%
A temperature range of: +5C to +40C A relative humidity range of 15% to 90%, non-condensing, but not requiring a water vapour partial pressure greater than 50 hPa An atmospheric pressure range of 700 hPa to 1060 hPa Temperature:-20C to +60C A relative humidity range of 93%, non-condensing, at a water vapour pressure up to 50 hPa An atmospheric pressure range of 500 hPa to 1060 hPa About 13.5-21.5 cm Approx.106 g (Excluding the batteries) Approx. 85.7 mm 60.8 mm 24.7 mm (Excluding the cuff) 2x AAA batteries, user manual 40 41 SPECIFICATIONS EMC GUIDANCE Mode of operation Continuous operation Degree of protection Type BF applied part Device Classification Internally Powered ME Equipment IP Classification IP22 It means the device could be protected against solid foreign objects of 12,5mm and greater, and against vertically falling water drops when enclosure titled up to 15. Software Version A01 Expected Lifetime Device: 3 years or 30,000 measurements (may vary based on usage conditions) Cuff: 10000 times Alkaline battery: About 200-300 times Types of use/reuse Multiple patient multiple use WARNING: No modification of this equipment is allowed. CONTACT INFORMATION Contact Information For more information about our products, please visit www.transtekcorp.com. You can get customer service, usual problems and customer download, Transtek will serve you anytime. Manufactured by:
Company:
Address: Zone A, No.105, Dongli Road, Torch Development District, Guangdong Transtek Medical Electronics Co., Ltd. 528437 Zhongshan, Guangdong, China 42 43 EMC GUIDANCE EMC Guidance The ME EQUIPMENT or ME SYSTEM is suitable for home healthcare environments. Warning: Dont be near the active HF surgical equipment and the RF shielded room of an ME system for magnetic resonance imaging, where the intensity of EM disturbances is high. Warning: Use of this equipment adjacent to or stacked with other equipment should be avoided because it could result in improper operation. If such use is necessary, this equipment and the other equipment should be observed to verify that they are operating normally. Warning: Use of accessories, transducers and cables 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. Warning: Portable RF communications equipment (including peripherals such as antenna cables and external antennas) should be used no closer than 30 cm (12 inches) to any part of the equipment including cables specified by the manufacturer. Otherwise, degradation of the performance of this equipment could result. Technical description:
1. All necessary instructions for maintaining BASIC SAFETY and ESSENTIAL PERFORMANCE with regard to electromagnetic disturbances for the excepted service life. 2. Guidance and manufacturers declaration - electromagnetic emissions and Immunity EMC GUIDANCE Table 1 Guidance and manufacturers declaration - electromagnetic emissions Emissions test Compliance RF emissions CISPR 11 RF emissions CISPR 11 Harmonic emissions IEC 61000-3-2 Voltage fluctuations/
flicker emissions IEC 61000-3-3 Group 1 Class B Not applicable Not applicable 44 45 Table 5 EMC GUIDANCE Table 2 Guidance and manufacturers declaration electromagnetic Immunity Immunity Test IEC 60601-1-2 Test level Compliance level 8 kV contact 2 kV, 4kV, 8 kV, 15 kV air 8 kV contact 2 kV, 4kV, 8 kV, 15 kV air Not applicable Not applicable Not applicable Not applicable Electrostatic discharge (ESD) IEC 61000-4-2 Electrical fast transient/burst IEC 61000-4-4 Surge IEC61000-4-5 46 Not applicable Not applicable EMC GUIDANCE 30 A/m 50Hz/60Hz 30 A/m 50Hz/60Hz Not applicable Not applicable Voltage dips, short interruptions and voltage variations on power supply input lines IEC 61000-4-11 Power frequency magnetic field IEC 61000-4-8 Conduced RF IEC61000-4-6 Radiated RF IEC61000-4-3 10 V/m 80 MHz 2,7 GHz 80 % AM at 1 kHz 10 V/m 80 MHz 2,7 GHz 80 % AM at 1 kHz NOTE UT is the a.c. mains voltage prior to application of the test level. 47 Table 5 EMC GUIDANCE EMC GUIDANCE Table 3 Radiated RF IEC61000-4-3
(Test specifications for ENCLOSURE PORT IMMUNITY to RF wireless communicati-
ons equipment) Guidance and manufacturers declaration - electromagnetic Immunity Test Frequency
(MHz) Band
(MHz) Service Modulation 385 380-390 TETRA 400 450 430-470 704-787 800-960 710 745 780 810 870 930 GMRS 460, FRS 460 LTE Band 13, 17 GSM 800/900, TETRA 800, iDEN 820, CDMA 850, LTE Band 5 Pulse modulation 18 Hz FM 5k Hz deviation 1 kHz sine Pulse modulation 217 Hz Pulse modulation 18 Hz Maximum Power
(W) Distance
(m) IEC 60601-1-2 Test Level
(V/m) 1.8 0.3 27 2 0.3 28 0.2 0.3 9 Compliance level
(V/m) 27 28 9 2 0.3 28 28 1700-
1990 1720 1845 1970 2450 2400-
2570 Pulse modulation 217 Hz Pulse modulation 217 Hz 2 2 GSM 1800;
CDMA 1900;
GSM 1900;
DECT;
LTE Band 1, 3, 4,25;
UMTS Bluetooth, WLAN, 802.11 b/g/n, RFID 2450, LTE Band 7 0.3 28 28 0.3 28 28 5100-
5800 WLAN 802.11 a/n Pulse modulation 217 Hz 5240 5500 5785 0.2 0.3 9 9 48 49 FCC STATEMENT FCC Statement FCC ID: OU9TMB2285BT 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. Caution: The user is cautioned that changes or modifications not expressly approved by the party responsible for compliance could void the user's authority to operate the equipment. NOTE: 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. 50 FCC STATEMENT 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. FCC Radiation Exposure Statement:
This equipment complies with FCC radiation exposure limits set forth for an uncontrolled environment. This transmitter must not be co-located or operating in conjunction with any other antenna or transmitter. 51 ISDE COMPLIANCE STATEMENT ID ISED HVIN:TMB-2285-B IC:12725A-TMB2285BT This device contains licence-exempt transmitter(s)/receiver(s) that comply with Innovation, Science and Economic Development Canadas licence-exempt RSS(s). Operation is subject to the following two conditions:
(1) This device may not cause interference.
(2) This device must accept any interference, including interference that may cause undesired operation of the device. Lmetteur/rcepteur exempt de licence contenu dans le prsent appareil est conforme aux CNR dInnovation, Sciences et Dveloppement conomique Canada applicables aux appareils radio exempts de licence. Lexploitation est autorise aux deux conditions suivantes :
(1) Lappareil ne doit pas produire de brouillage;
(2) Lappareil doit accepter tout brouillage radiolectrique subi, mme si le brouillage est susceptible den compromettre le fonctionnement. ISDE COMPLIANCE STATEMENT ISED Radiation Exposure statement This equipment complies with IC RSS-102 radiation exposure limits set forth for an uncontrolled environment. This equipment should be installed and operated with minimum distance 0 mm between the radiator and your body. Cet quipement est conforme aux limites d'exposition aux radiations IC CNR-102 tablies pour un environnement non contrl. Cet quipement doit tre install et utilis avec une distance minimale de 0mm entre le radiateur et votre corps. 52 53
1 | Label | ID Label/Location Info | 1.09 MiB | May 28 2023 |
Cuff model:
TMB-2285-B
(Optional!) FCC ID: OU9TMB2285BT IC:12725A-TMB2285BT 2022-11 Guangdong Transtek Medical Electronics Co., Ltd. Zone A, No.105, Dongli Road, Torch Development District, 528437 Zhongshan, Guangdong, China Web: www.transtekcorp.com Due to the size, appearance, shape, cost and shell material of the product, the warning words related to the requirements of FCC Part 15.19 cannot be placed on the product mainbody, thus the content of the warning words will be described in the user manual. Location
1 | Declaration Letter | Attestation Statements | 189.17 KiB | May 28 2023 |
SGS North America Inc. 620 Old Peachtree Road SUITE 100 Suwanee, Georgia 30024 United States Applicant Declaration Applicant Legal Business Name Guangdong Transtek Medical Electronics Co.,Ltd Address Grantee Code FCC ID Zone A, No.105 ,Dongli Road Torch Development District Zhongshan , Guangdong, 528437, China OU9 OU9TMB2285BT Authorized Contact Name Jerry Fan Contact Email Contact Phone gt-rateam@transtekcorp.com
+86-760-85166220 I, the undersigned, certify that I am an authorized signatory for the Applicant and therefore declare;
a) b) c) d) e) in accordance with 47CFR2.911(d), all of the statements herein and the exhibits attached hereto are true and correct to the best of my knowledge and belief. in accepting a Grant of Equipment Authorization issued by a TCB, under the authority of the FCC, as a result of the representations made in this application, the Applicant is responsible for:
(1)
(2)
(3) labeling the equipment with the exact FCC ID as specified in this application, compliance statement labeling pursuant to the applicable rules, compliance of the equipment with the applicable technical rules, if the Applicant is not the actual manufacturer of the equipment, appropriate arrangements have been made with the manufacturer to ensure that production units of this equipment will continue to comply with the FCCs technical requirements. in accordance with 47 CFR 2.909 and KDB394321, the Applicant has read, understood and agrees to accept that they are the responsible party and agree to abide by their responsibilities as specified under 47 CFR 2.909 and KDB394321. in accordance with ISO 17065, FCC KDB641163, FCC KDB610077, KDB394321 and RSP-100, the Applicant has read, understood, accepts and agrees to abide by the post market surveillance requirements.
(1)
(2)
(3) the Applicant understands, accepts and agrees that a sample may be requested for surveillance testing. the Applicant shall make provisions to always have a production sample available upon request by SGS, FCC and/or ISED. the Applicant shall, upon request by SGS, at the Applicants expense, provide a production sample of the requested product to SGS, FCC and/or ISED as instructed. The sample shall include all support devices, cables, software, accessories or other hardware or software required for evaluation, review, certification and audit surveillance of products certified by SGS. f) g) neither the Applicant nor any party to the application is subject to a denial of Federal benefits, that includes FCC benefits, pursuant to Section 5301 of the Anti-Drug Abuse Act of 1988, 21 U.S.C. 862 because of a conviction for possession or distribution of a controlled substance. See 47CFR 1.2002(b) for the definition of a party for these purposes. the Applicant has read, understood, accepts and agrees to abide by the SGS North America, Inc.(TCB) terms and conditions. Link to CFRs: https://www.fcc.gov/wireless/bureau-divisions/technologies-systems-and-innovation-division/rules-regulations-title-47 Link to KDBs: https://apps.fcc.gov/oetcf/kdb/index.cfm Link to RSP-100: https://www.ic.gc.ca/eic/site/smt-gst.nsf/eng/sf01130.html Link to the Covered List: Covered List
[Guangdong Transtek Medical Electronics 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.
[Guangdong Transtek Medical Electronics 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, established pursuant to 1.50002, as an entity producing covered equipment. Applicant Signature:
Date: 2023-4-14 Print Name:
Jerry Fan Title:
RA Manager
*NOTE: This declaration cannot be signed by an Agent, it shall be signed by an authorized person listed in the FCC database QSF27-14-04 Rev 1.0 Rev. Feb 6, 2023 Page 1 of 2 Original Issue: Jan. 4, 2021 SGS North America Inc. 620 Old Peachtree Road SUITE 100 Suwanee, Georgia 30024 United States Applicant Declaration QSF27-14-04 Rev 1.0 Rev. Feb 6, 2023 Page 2 of 2 Original Issue: Jan. 4, 2021
1 | FCC Authority letter | Cover Letter(s) | 58.15 KiB | May 28 2023 |
Guangdong Transtek Medical Electronics Co.,Ltd TO:
Federal Communication Commission Equipment Authorization Branch 7435 Oakland Mills Road Columbia, MID 21046 Regarding: FCC ID: OU9TMB2285BT To whom it may concern:
Date: 2023-03-01 We, the undersigned, hereby authorize SGS-CSTC Standards Technical Services Co., Ltd. to act on our behalf in all manners relating to application for equipment authorization with respect to the FCC ID above, including signing of all documents relating to these matters. Any and all acts carried out by the agent on our behalf shall have the same effect as acts of our own. We, the undersigned, hereby certify that we are not subject to a denial of federal benefits, that includes FCC benefits, pursuant to Section 5301 of the Anti-Drug Abuse Act of 1988, 21 U.S.C. 853(a). Where our agent signs the application for certification on our behalf, I acknowledge that all responsibility for complying with the terms and conditions for Certification, as specified by SGS North America, Inc., still resides with Guangdong Transtek Medical Electronics Co.,Ltd. This authorization is valid until further written notice from the applicant. Sincerely, Print Name: Jerry Fan Title: RA Manager Signature:
On behalf of Company: Guangdong Transtek Medical Electronics Co.,Ltd Telephone: +86-760-85166220 E-mail: gt-rateam@transtekcorp.com
1 | FCC Confidentiality Letter | Cover Letter(s) | 72.91 KiB | May 28 2023 |
Guangdong Transtek Medical Electronics Co.,Ltd TO:
Federal Communication Commission Equipment Authorization Branch 7435 Oakland Mills Road Columbia, MID 21046 Regarding:
Confidentiality Request regarding application for FCC ID: OU9TMB2285BT LONG TERM CONFIDENTIALITY Pursuant to 47 CFR Section 0.459 and 0.457 of the commissions rules, the applicant hereby request confidential treatment of the documents listed below, associated with the certification application referenced above. Schematic(s) Block Diagrams Operational Descriptions The documents above contain proprietary information not released to the public. Public disclosure of this information may prove harmful to the business of the applicant. SHORT TERM CONFIDENTIALITY Additionally, the applicant requests the following documents be held confidential until the device is marketed or 180 days from the grant date, whichever is less. aforementioned days of the Grant Date, the applicant will notify the TCB per FCC KDB 726920 D01 Confidentiality Request Procedures. If the device is marketed within External Photos Internal Photos Test Setup Photos User manual(s) Sincerely, Print Name: Jerry Fan Title: RA Manager Signature:
On behalf of Company: Guangdong Transtek Medical Electronics Co.,Ltd Telephone: +86-760-85166220 E-mail: gt-rateam@transtekcorp.com
1 | US Agent for Service of Process | Attestation Statements | 437.08 KiB | May 28 2023 |
UNITED STATES DESIGNATED AGENT LETTER Date: 2023/04/12 TO:
Federal Communication Commission Equipment Authorization Branch 7435 Oakland Mills Road Columbia, MID 21046 Applicant Company Name: Guangdong Transtek Medical Grantee Code:
Electronics Co.,Ltd OU9 U.S. designated agent Company Name: MIO LABS INC. FRN:
0032569972 Contact Name:
Chengcen Su Contact Name:
Jerry Fan Address:
4500 Great America Pkwy Suite 1023 CA United States Address:
Zone A, No.105 ,Dongli Road Torch Development District City/Province/Zip: 95054 City/Province/Zip: Zhongshan , Telephone:
Guangdong/528437 Telephone:
Fax:
Email:
+86-760-85166220
+86-760-86742877 gt-rateam@transtekcorp.com Fax:
Email:
157 286 6685 ext. 28(301-
910-0529)
mio@transtekcorp.com Applicable Equipment: FCC ID: <OU9TMB2285BT>
ATTN: Director of Certification:
We, < Guangdong Transtek Medical Electronics Co.,Ltd > and <MIO LABS INC.> understand and acknowledge the applicants consent and the designated agents obligation to accept service of process in the United States for matters related to the applicable equipment, and at the physical U.S. address and e-
mail of the designated agent listed above. We, < Guangdong Transtek Medical Electronics Co.,Ltd > and <MIO LABS INC.> acknowledge the applicants acceptance of its obligation to maintain an agent for service of process in the United States for no less than one year after either the grantee has permanently terminated all marketing and importation of the applicable equipment within the U.S., or the conclusion of any Commission-related administrative or judicial proceeding involving the equipment, whichever is later. Applicant U.S. designated agent Name (Printed): Jerry Fan Name (Printed): Chengcen Su Title: RA Manager Title: Sales Manager Signature:
Signature:
frequency | equipment class | purpose | ||
---|---|---|---|---|
1 | 2023-05-28 | 2402 ~ 2480 | DTS - Digital Transmission System | Original Equipment |
app s | Applicant Information | |||||
---|---|---|---|---|---|---|
1 | Effective |
2023-05-28
|
||||
1 | Applicant's complete, legal business name |
Guangdong Transtek Medical Electronics Co.,Ltd
|
||||
1 | FCC Registration Number (FRN) |
0021999248
|
||||
1 | Physical Address |
Zone A, No.105,Dongli Road
|
||||
1 |
Zhongshan, Guangdong, N/A 528437
|
|||||
1 |
China
|
|||||
app s | TCB Information | |||||
1 | TCB Application Email Address |
U******@SGS.COM
|
||||
1 | TCB Scope |
A4: UNII devices & low power transmitters using spread spectrum techniques
|
||||
app s | FCC ID | |||||
1 | Grantee Code |
OU9
|
||||
1 | Equipment Product Code |
TMB2285BT
|
||||
app s | Person at the applicant's address to receive grant or for contact | |||||
1 | Name |
J******** F********
|
||||
1 | Title |
RA Manager
|
||||
1 | Telephone Number |
+86-7********
|
||||
1 | Fax Number |
+86-7********
|
||||
1 |
g******@transtekcorp.com
|
|||||
app s | Technical Contact | |||||
1 | Firm Name |
SGS-CSTC Standards Technical Services Co., Ltd.
|
||||
1 | Name |
K******** X******
|
||||
1 | Physical Address |
No.1 Workshop, M-10, Middle Section
|
||||
1 |
518057
|
|||||
1 |
China
|
|||||
1 | Telephone Number |
+8675********
|
||||
1 |
k******@sgs.com
|
|||||
app s | Non Technical Contact | |||||
1 | Firm Name |
SGS-CSTC Standards Technical Services Co., Ltd.
|
||||
1 | Name |
K****** X****
|
||||
1 | Physical Address |
No.1 Workshop, M-10, Middle Section
|
||||
1 |
518057
|
|||||
1 |
China
|
|||||
1 | Telephone Number |
+8675********
|
||||
1 |
k******@sgs.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) | 11/25/2023 | ||||
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) | Blood pressure monitor | ||||
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 |
SGS-CSTC Standards Technical Services Co., Ltd. Sh
|
||||
1 | Name |
K****** X****
|
||||
1 | Telephone Number |
+86 (********
|
||||
1 |
K******@sgs.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