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Version:A/0 User Manual Blood Pressure Monitor Model: TMB-2276-BT Arm Type Guangdong Transtek Medical Electronics Co., Ltd. Zone A, No.105 ,Dongli Road, Torch Development District, 528437 Zhongshan,Guangdong,China Thank you very much for selecting TRANSTEK Blood Pressure Monitor TMB-2276-BT. Please read the user manual carefully and thoroughtly so as to ensure the safe usage of this product, Keep the manual well for further reference in case you have problems. CATALOGUE Table of Contents INTRODUCTION...................................................................................................................2 General Description Indications for Use Measurement Principle Receiving and Inspecting your Monitor Safety Information LCD Display Signal Monitor Components List BEFORE YOU START...........................................................................................................8 Choice of Power Supply Installing and Replacing the Batteries Setting Date, Time and Voice Pair a smart device with the monitor Select the User MEASUREMENT..................................................................................................................15 Applying the cuff Start the Measurement DATA MANAGEMENT..........................................................................................................19 Recall the Records Delete the Records INFORMATION FOR USER................................................................................................22 Tips for measurement Maintenances ABOUT BLOOD PRESSURE..............................................................................................24 What are systolic pressure and diastolic pressure?
What is the standard blood pressure classification?
Irregular pulse rate 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 arm?
TROUBLESHOOTING........................................................................................................26 SPECIFICATIONS..............................................................................................................27 AUTHORIZED COMPONENTS .........................................................................................28 CONTACT INFORMATION.................................................................................................28 EMC GUIDANCE................................................................................................................29 FCC STATEMENT...............................................................................................................33 1 INTRODUCTION General Description Thank you for selecting TRANSTEK blood pressure monitor (TMB-2276-BT). The monitor features blood pressure measurement, pulse rate measurement and the result storage. The warranty period is two years. Readings taken by the TMB-2276-BT are 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 the product. Read the manual thoroughly before using the product. Features:
60 mm71.5 mm Digital LCD display with white backlight 2 199 memory storage, Guest mode available Up-to-date measuring-during-inflation technology Indications for Use This Blood Pressure Monitor is a digital monitor intended for use in measuring blood pressure and pulse rate with arm circumference ranging from 16cm to 36cm (about 6 -14 ), 22cm to 32cm (about 8-12), 22cm to 42cm (about 8-16) or 22cm to 45cm (about 8-17). It is intended for at least 3 years of age or older and indoor use only. 3 5 Measurement Principle This product uses the Oscillometric Measuring method to detect blood pressure. Before every measurement, the unit establishes a zero pressure equivalent to the atmospheric pressure. Then it starts inflating the arm cuff, meanwhile, the unit detects pressure oscillations generated by beat-to-beat pulsatile, which is used to determine the systolic and diastolic pressure, and also 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. INTRODUCTION Safety Information The signs below might be in the user manual, labeling or other component. They are the requirement of standard and using. Recyclable Type BF applied part Direct Current Serial Number Date of manufacture Manufacturer For indoor use only Class II Equipment Refer to instruction manual/booklet To signify that the instruction manual/ booklet must be read. Note: The background color of the symbol is blue. MR Unsafe To identify an item which poses unacceptable risks to the patient, medical staff or other persons within the MR environment. 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. 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. 2 3 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 non-invasive measuring and monitoring of arterial blood pressure. It is not intended for use on extremities other than the arm, 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.
* 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 problems or diseases. Please consult with your physician first whether the blood pressure or pulse rate readings can be used as an input in determining clinical actions. Please note that clinical actions can only be determined by the physician, otherwise it may lead to delayed treatment or other dangerous situations.
* 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.
* 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, its adapter, 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. Caution
* Do not attempt to repair the unit yourself if it malfunctions. Only have repairs carried out byauthorized 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, cuff and adapter in a clean and dry place, protect it against extreme moisture, heat, lint, dust and direct sunlight. Never place any heavy objects on it.
* Make sure the rubber tube of the cuff is not squeezed, stretched, or kinked during storage.
* Dispose of accessories, detachable parts, and the device according to the local guidelines. 4 INTRODUCTION Warning
* Do not apply the cuff on an arm that has an intravenous drip or a blood transfusion attached.
* Do not kink, fold, stretch, compress, or otherwise deform the tube during measuring, as the cuff pressure might continuously increase, which could prevent blood flow and result injury.
* 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 arm 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 arm 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 arm 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 arm (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/adapter and the user simultaneously.
* The power cord is considered the disconnect device for isolating this equipment from supply mains. Do not position the equipment so that it is difficult to reach or disconnect.
* 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 arm 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.
* The air tube poses a risk of strangulation. Furthermore, the small parts of product and batteries present a choking hazard if swallowed. They should therefore always be kept away from infants/children.
* Sensor degradation or looseness may reduce performance of device or cause other problems. Notice
* You can use this device to take your own measurement, no third-party operator is required.
* Adapter is specified as a part of ME EQUIPMENT.
* 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 expected lifetime 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. 5 INTRODUCTION LCD Display Signal INTRODUCTION Monitor Components CUFF AIR HOSE SYMBOL DESCRIPTION EXPLANATION Systolic blood pressure High blood pressure Diastolic blood pressure Low blood pressure Pulse display Average value Memory Motion indicator Pulse in beats per minute The average value of blood pressure Indicate it is in the memory mode and which group of memory it is. Motion may result in an inaccurate measurement. mmHg Measurement Unit of the blood pressure
+ bAt Lo Low battery Batteries are low and need to be replaced Irregular pulse rate Pulse rate Blood pressure monitor is detecting an irregular pulse rate during measurement. Blood pressure monitor is detecting a pulse rate during measurement. Current Time Year/Month/Day, Hour/Minute Blood pressure level indicator User 1/User 2/User G Indicate the blood pressure level Start measurement for User 1/User 2
/User G. Bluetooth symbol Flashes when the Bluetooth is working. AIR CONNECTOR PLUG LCD DISPLAY Type-C port MEM BUTTON USER BUTTON START/STOP BUTTON BATTERY COMPARTMENT List 1.Blood Pressure Monitor
(TMB-2276-BT) 2.Cuff (Type BF applied part) Upper arm cuff:16-36cm or Upper arm cuff:22-32cm or Upper arm cuff:22-42cm or Upper arm cuff:22-45cm. 3. 4*AAA batteries (Optional!) 5.Type-C Cable and AC Adaptor (Optional!) Data transmitting Data pending to transmit 4. User manual 6 Voice broadcast The function of voice broadcast is turned off. 7 BEFORE YOU START BEFORE YOU START Choice of Power Supply 1.Battery powered mode: 6VDC 4*AAA batteries (Optional!) 2. AC adaptor powered mode: 5V 1A Please use the AC adaptor(Optional!) and Type-C cable(Optional!) just like the following picture:
AC adaptor CAUTION Type-C cable In order to get the best effect and protect your monitor,please use the right battery and special power adaptor which complies with local safety standard. Installing and Replacing the Batteries Slide off the battery cover. Install the batteries by matching the correct polarity, as shown. Replace the battery cover. Replace the batteries whenever the below happens The + bAt Lo shows The display is dim The display does not light up CAUTION New and used batteries, or different types of batteries shall not be used together. Remove batteries if the device is not likely to be used for some time. Do not heat or deform the batteries, or dispose of them in fire. Batteries should not be disposed of with household waste. Please check with your local authority for battery recycling advice. 8 Setting Date, Time and Voice It is important to set the clock before using your blood pressure monitor, so that a time stamp can be assigned to each record that is stored in the memory. (The setting range of the year:20222052 time:24H/12H) 1
.When the monitor is off, press and hold the USER button, it will display the bluetooth symbol first. No operation within 30s or Press the START/STOP button, it will skip Bluetooth pairing and enter the [Year] setting. Press the USER or MEM button to change the [YEAR]. Each press will increase or decrease the numeral by one in a cycling manner. 2
.When you get the right year, press START/STOP button to set down and turn to next step. Then the date format will flash. Press the MEM or USER switch the date format between [month/day] and [day/month]. 9 BEFORE YOU START BEFORE YOU START 3
.Press the START/STOP button to confirm the date format, then the [Month] will flash. Repeat the same steps to set the [Month] and [Day]. 5.Repeat the same steps to set the [Hour] and [Minute]. 4.Repeat the same steps to set the time format between[24H] and [12H]. 6. After confirming the [Minute], it will enter the voice setting. Press the MEM or USER button to change the vocie volume. voice off Volume 1 voice on Volume 2 voice on 7
.After confirming the voice setting, the LCD will display all the settings you have done, and then it will display do nE and the device will turn off automatically. 10 11 BEFORE YOU START BEFORE YOU START Pair a smart device 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 smart device (such as smartphone or tablet) with Bluetooth wireless connectivity. 1. Turn on Bluetooth and the app on your smart device. Make sure both are ON when pair-up is proceeding. 2. When the monitor is off, press and hold the START/STOP button to start pair-up, the bluetooth symbol will flash. 3. If successful, the bluetooth symbol will not flash any more and the monitor will display do nE, and then it will shut off after about several seconds automatically. Note:
1. The date and time on your monitor will automatically be set after paired with your smart device successfully. 2. The device can also enter the Bluetooth pairing automatically when the battery is installed for the first time. If unsuccessful within 60 seconds, it is judged timeout and the monitor will shut off. Bluetooth Specifications for Bluetooth Transmission Throughput 2.5K-5K 50ms Latency 0 when-70dBm Error Rate Operating Frequency 2402-2480MHz Transmission Power Transmission Distance same as report 10m Note:
1. The necessary Quality of Service (QoS) is fully considered here for wirelessly enabled functions. 2. Interference may occur in the vicinity of equipment marked with the following symbol . And TMB-2276-BT may interfere the vicinal electrical equipment. 3. Keep the monitor at least 20 centimeters away from the human body (especially the head) when data transmission is proceeding after measurement. 4. To enable the data transmission function, this device shall be paired to an appropriate BT mobile terminal. Warning About a wireless communication interference The monitor operates in the unlicensed ISM band at 2.4 GHz. In case it is used around the other wireless devices including microwave and wireless LAN, which operate at the same frequency band as the monitor, there is a possibility that interference occurs between the monitor and such other devices. If such interference occurs, please stop the operation of other devices or relocate the monitor before using it or do not use it around the other wireless devices. 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. 12 13 BEFORE YOU START Select the User 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, press the USER button to enter user setting mode. The user ID will blink. Press the USER button again to switch the user ID among the user , and . Applying 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 arm circumference. MEASUREMENT 1. 2. 3. Remove all jewelry, such as watches and bracelets from your left arm. Note: If your doctor has diagnosed you with poor circulation in your left arm, use your right arm. Roll or push up your sleeve to expose the skin. Make sure your sleeve is not too tight. Hold your arm with your palm facing up and tie the cuff on your upper arm, align the Artery indicator with the main Artery (on the inside of your arm). Note: Locate the main Artery by pressing with 2 fingers approximately 2 cm above the bend of your elbow on the inside of your left arm. Identify where the pulse can be felt the strongest, that is your main Artery 4. Make sure the bottom edge of the 5. arm cuff 2 to 3 cm above the inside elbow. Then wrap the cuff securely. Note: The cuff should be snug but not too tight. You should be able to insert one finger between the cuff and your arm. Sit upright in a comfortable chair with your back against the backrest of the chair. Keep your feet flat and your legs uncrossed. Place your arm resting comfortably on a flat table. The cuff worn on your arm should be placed at the same level as your right atrium of the heart. 6. Take 5-6 deep breaths and let's start measuring!
2~3cm 2. Press the START/STOP button to confirm the selected user ID, it will enter the measurement automatically. 14 Helpful tips:
Take the measurement in a silent room. Rest for 5 minutes before a measurement. Wait at least 3 minutes before another measurement. This allows your blood circulation to recover. Be relaxed and do not move and talk during the measurement procedure. For a meaningful comparison, try to measure under similar conditions. For example, take daily measurements at approximately the same time, on the same arm, or as directed by a physician. 15 MEASUREMENT MEASUREMENT Start the Measurement 1.When the monitor is off, press START/STOP button to turn on the monitor, and it will finish the whole measurement. If the voice is on, it will speak Starting measurement, please remain still and quiet first, and then complete the measurement process.
(Take User 1 with vocie for example) START STOP Adjust the zero. Inflating and measuring. Display, save and broadcast the results. Note:
Any time, to stop the measurement, press the START/STOP button. If you dont pair with the device or dont keep the app ON, the bluetooth symbol will flash during the measurement. 2. Press START/STOP button to power off, otherwise it will turn off within 1 minute. START STOP 3. If your monitor is already paired with your smart device and both Bluetooth and app are ON, when the measurement completed, the measurement result will start transmitting. (only user 1 and 2 available) If successful, the symbol will disappear first , after sevral seconds, will also disappear, and then the monitor will turn off automatically. If unsuccessful within 60 seconds, it is judged timeout and the monitor will shut off. In the case of a data transmission failure, up to 199 measurements are saved on the device and will be sent when a successful connection is achieved. 16 17 MEASUREMENT DATA MANAGEMENT 4.About the irregular pulse rate and excessive body motion during the measurement. During a measurement, If an irregular pulse rate is detected, the symbol will display in the measurement result. See page 24 for more information. During a measurement, when the excessive body motion, especially of the arm the cuff is worn 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. Recall the Records 1. When the monitor is off, press the MEM button to display the average value of last 3 readings. If the records are less than 3 groups, it will display the latest record instead.
( Take user 1 for example.) Note 1. If the voice is on, it will broadcast the value for you. 2. When you pass the limit, every time you recall the records, the monitor will display FULL along with the group number 199. 2. Press MEM button or USER button to get the record you want. The date and time of the record will be shown alternately. The current record is Group 1. The corresponding year is 2023. The corresponding date is January 3rd. The corresponding time is 8:30 (a.m.). Note:
If there is untransmitted data, the symbol and will display on the record. The latest 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) will be dropped from the list. 18 19 DATA MANAGEMENT DATA MANAGEMENT Delete the Records Delete the records by following the steps below. B: Delete all records (Example shown below for User 1) 1. Enter the memory recall mode as described in the previous section A: Delete one record (Example shown below for User 1)
"Recall the records". 1. Enter the memory recall mode as described in the previous section
"Recall the records", find out the record you want to delete. 2. Press and hold the START/STOP button about 3 seconds, the LCD will display dEL y and blink. 3. Press the START/STOP button to confirm the deletion, the LCD will display donE and then the previous record will be displayed. 2. Press and hold the MEM and USER button about 3 seconds, the LCD will display dEL ALand blink. 3. Press the START/STOP button to confirm the deletion, the LCD will display donE. Several seconds later, it will display ---. Note Before you confirm the deletion, you could press the MEM or USER button to switch the LCD display from dEL y to dEL no. Then press the START/STOP button, you could stop clearing the memory. Note Before you confirm the deletion, you could press the MEM or USER button to switch the LCD display from dEL AL to dEL no. Then press the START/STOP button, you could stop clearing the memory. 20 21 INFORMATION FOR USER INFORMATION FOR USER Tips for Measurement Measurements may be inaccurate if taken in the following circumstances. Maintenance In order to get the best performance, please follow the instructions below. Within 1 hour after dinner or drinking Immediate measurement after tea, coffee, smoking Within 20 minutes after taking a bath When talking or moving your fingers 1. Cleaning Process:
Step 1: Make sure to switch off and unplug 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 and unplug the device prior to disinfection. Step 2: Use a soft cloth wetted with 70% isopropanol to disinfect the cuff for about 3 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. In a very cold environment When you want to discharge urine 22 23 ABOUT BLOOD PRESSURE ABOUT BLOOD PRESSURE What are systolic pressure and diastolic pressure?
When ventricles contract and pump blood out of the heart, the blood pressure reaches its maximum value in the cycle, which is called systolic pressure. When the ventricles relax, the blood pressure reaches its minimum value in the cycle, which is called diastolic pressure. Systolic blood discharging artery Diastolic blood entering vein press relax 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:
CAUTION Only a physician can tell your normal BP range. Please contact a physician if your measuring result falls out of the range. Please note that only a physician can tell whether your blood pressure value has reached a dangerous point. Level Blood Pressure (mm Hg) SYS DIA Optimal Normal High-normal Mild Moderate Severe
<120 120-129 130-139 140-159 160-179 180
<80 80-84 85-89 90-99 100-109 110 Irregular Pulse Rate Detector An irregular pulse rate will be detected if there is an irregular pulse rhythm while measuring systolic and diastolic blood pressure. When measurements were performed, the monitor will record all pulse intervals and calculate the average. If two or more pulse intervals were recorded, and the difference between each interval and the average is larger than 25% of the average; or if four or more pulse intervals were recorded, and the difference between each interval and the average is larger than 15% of the average value, the irregular pulse symbol will be displayed along with measurement results. CAUTION The appearance of the IPR icon indicates that a pulse irregularity consistent with an irregular pulse rate 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 irregular pulse rate detector only serves as a non-medical feature, and the results cannot be used directly for clinical judgement. Please seek medical advice from professionals before making any medical decisions. 24 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 arm?
It is ok for both arms, but there will be some different results for different people. We suggest you measure the same arm every time. 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 upper arm. 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. 25 TROUBLESHOOTING SPECIFICATIONS If any abnormality arises during use, please check the following points:
External dimensions Approx.94 mm x 130.6 mm x 31.7 mm PROBLEM SYMPTOM CHECK THIS REMEDY Display mode Digital LCD V.A. 60 mm x 71.5 mm Batteries are depleted. Replace with new batteries. Weight Approx.186 g (Excluding the batteries and cuff) High Battery bAt H shows The battery is too high. Replace with new batteries. Measurement range No power Display can not light up. Batteries are inserted incorrectly. Insert the batteries correctly. Adapter is inserted incorrectly. Insert the AC adapter correctly. Low Battery Error message bAt Lo &
shows E 1 shows E 2 or shows The battery is too low. Replace with new batteries. The cuff is not wrapped or wrapped incorrectly, or the cuff air plug is loose. Excessive body motion
(such as shaking of the arm with the cuff on) or weak pulse is detected. Refasten the cuff and insert air tube plug correctly then measure again. Relax for 5 minutes. and then keep still, measure again. E 3 shows E 4 shows Pulse is not detected during measuring. Loosen the clothing on the arm and measure again. The measurement failed. Relax for 5 minutes and measure again. EEx shows Hardware error
(X can be some digital symbol, such as1, 2, etc.) USb Err shows The voltage of the adapter is too high or too low. Warning message out shows Out of measurement range Turn off monitor and measure again. If EEx still appears on the display, please contact the retailer or our customer service. Replace with the authorized adapter. Relax for a moment and then measure again. If the problem persists, contact your physician. NOTE: If the product still does not work, contact Customer Service. Under no circumstance should you disassemble or attempt to repair the unit by yourself. 26 Measurement mode Oscillographic testing mode Mode of operation Continuous operation 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 Static Pressure: 5-40 within 3mmHg Pulse value: 5%
Clinical validation: Mean difference within 5mmHg;
Standard deviation 8mmHg 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 16-36 cm or 22-32 cm or 22-42 cm or 22-45cm Accuracy Normal working condition Storage & transportation condition Measurement perimeter of the upper arm Degree of protection Type BF applied part Protection against ingress of water Device Classification Expected Lifetime IP21 It means the device could be protected against solid foreign objects of 12,5mm and greater, and against vertically falling water drops. Battery Powered Mode:
Internally Powered ME Equipment AC Adapter Powered Mode: Class II ME Equipment 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. 27 AUTHORIZED COMPONENT EMC GUIDANCE Authorized Component Please use the authorized adapter (Optional!). Adapter Type: BLJ06L050100U-U Input: 100-240V, 50-60Hz, 0.2A max Output:
5V 1000 mA Contact Information For more information about our products, please visit www.transtekcorp.com. Manufactured by:
Guangdong Transtek Medical Electronics Co., Ltd. Company:
Guangdong Transtek Medical Electronics Co., Ltd. Address:
Zone A, No.105, Dongli Road, Torch Development District, 528437 Zhongshan, Guangdong, China EMC Guidance The ME EQUIPMENT or ME SYSTEM is suitable for home healthcare environments. Essential performance:
Accuracy of measuring blood pressure and pulse rate Measurement Range Systolic pressure: 60-230 mmHg Diastolic pressure: 40-130 mmHg Pulse: 40-199 beats/minute Rated Cuff Pressure 0-299 mmHg (0-39.9 kPa) Accuracy Static Pressure: 5-40 within 3mmHg Pulse value: 5%
Clinical validation: Mean difference within 5mmHg;
Standard deviation 8mmHg The Basis Safety of the Blood Pressure Monitor (TMB-2276-BT) is as following:
Deviation from normal operation that poses an unacceptable risk to the patient or operator. 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. 28 29 EMC GUIDANCE Technical description 1. All necessary instructions for maintaining BASIC SAFETY and ESSENTIAL PERFOR-
MANCE with regard to electromagnetic disturbances for the expected lifetime. 2. Guidance and manufacturers declaration-electromagnetic emissions and Immunity. 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 ]
Class A Comply SPECIFICATIONS AUTHORIZED COMPONENTS EMC GUIDANCE Table 2 Guidance and manufacturers declaration electromagnetic Immunity Immunity Test IEC 60601-1-2 Test level Compliance level Electrostatic discharge (ESD) IEC 61000-4-2 8 kV contact 2 kV, 4 kV, 8 kV, 15 kV air 8 kV contact 2 kV, 4 kV, 8 kV, 15 kV air Electrical fast transient/burst IEC 61000-4-4 2 kV for power supply lines 1 kV signal input/output 100 kHz repetition frequency 2 kV for power supply lines Not Applicable 100 kHz repetition frequency Surge IEC61000-4-5 0.5 kV, 1 kV differential mode 0.5 kV, 1 kV, 2 kV common mode 0.5 kV, 1 kV differential mode Not Applicable Voltage dips, short interruptions and voltage variations on power supply input lines IEC 61000-4-11 0% UT; 0,5 cycle. At 0, 45, 90, 135, 180, 225, 270 and 315. 0% UT; 1 cycle and 70% UT;
25/30 cycles; Single phase: at 0. 0% UT; 250 / 300 cycle 0% UT; 0,5 cycle. At 0, 45, 90, 135, 180, 225, 270 and 315. 0% UT; 1 cycle and 70% UT;
25/30 cycles; Single phase: at 0. 0% UT; 250 / 300 cycle Power frequency magnetic field IEC 61000-4-8 30 A/m 50 Hz / 60 Hz 30 A/m 50 Hz / 60 Hz Conduced RF IEC61000-4-6 3 V 0,15 MHz 80 MHz 6 V in ISM and amateur radio bands between 0,15 MHz and 80 MHz 80% AM at 1 kHz 3 V 0,15 MHz 80 MHz 6 V in ISM and amateur radio bands between 0,15 MHz and 80 MHz 80% AM at 1 kHz 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 U T is the a.c. mains voltage prior to application of the test level. 30 31 EMC GUIDANCE SPECIFICATIONS AUTHORIZED COMPONENTS 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 GMRS 460, FRS 460 704-787 800-960 1700-
1990 710 745 780 810 870 930 1720 1845 1970 2450 2400-
2570 LTE Band 13, 17 GSM 800/900, TETRA 800, iDEN 820, CDMA 850, LTE Band 5 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 Pulse modulation 18 Hz FM 5k Hz deviation 1 kHz sine Pulse modulation 217 Hz Pulse modulation 18 Hz Pulse modulation 217 Hz Pulse modulation 217 Hz 5100-
5800 WLAN 802.11 a/n Pulse modulation 217 Hz 5240 5500 5785 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 2 2 0.3 28 28 0.3 28 28 0.3 28 28 0.2 0.3 9 9 FCC Statement FCC ID: OU9TMB2276BT 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. FCC Regulatory Compliance Changes or modifications not expressly approved by the party responsible for compliance could void the users authority to operate the equipment. This equipment has been tested and found to comply with the limits for a Class B digital device, pursuant to Part 15 of the FCC Rules. These limits are designed to provide reasonable protection against harmful interference in a residential installation. This equipment generates, uses and can radiate radio frequency energy and, if not installed and used in accordance with the instructions, may cause harmful interference to radio communications. However, there is no guarantee that interference will not occur in a particular installation. If this equipment does cause harmful interference to radio or television reception, which can be determined by turning the equipment off and on, the user is encouraged to try to correct the interference by one or more of the following measures:
-- Reorient or relocate the receiving antenna.
-- Increase the separation between the equipment and receiver.
-- Connect the equipment into an outlet on a circuit different from that to which the receiver is connected.
-- Consult the dealer or an experienced radio/TV technician for help. RF Exposure Compliance 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. 32 33
1 | Internal Photos | Internal Photos | 567.56 KiB | July 03 2023 / December 31 2023 | delayed release |
1 | External Photos | External Photos | 617.47 KiB | July 03 2023 / December 31 2023 | delayed release |
1 | Label | ID Label/Location Info | 346.56 KiB | July 03 2023 |
Model: TMB-2276-BT Rating:Battery powered mode: 4xAAA batteries, 6V Optional!
AC adaptor powered mode: 5V 1AOptional!
(Please use the AC adaptor which authorized by the manufacturer!) IP Classification:IP21 Guangdong Transtek Medical Electronics Co., Ltd. Zone A, No.105 ,Dongli Road, Torch Development District, 528437 Zhongshan,Guangdong,China GS1 Datamatrix
(UDI) 20mm FCC ID: OU9TMB2276BT 2023-02
(01)XXXXXXXXXXXXXX
(21)2EB1235230200001 SN Location:
45mm
1 | Authorization Letter | Cover Letter(s) | 74.12 KiB | July 03 2023 |
Guangdong Transtek Medical Electronics Co.,Ltd TO:
Federal Communication Commission Equipment Authorization Branch 7435 Oakland Mills Road Columbia, MID 21046 Regarding: FCC ID: OU9TMB2276BT To whom it may concern:
Date: 2023-05-24 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 | Confidentiality Letter | Cover Letter(s) | 74.13 KiB | July 03 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: OU9TMB2276BT 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 | Declaration Letter | Attestation Statements | 145.35 KiB | July 03 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 OU9TMB2276BT 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: 2023-05-24 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 | Test Setup Photos | Test Setup Photos | 342.73 KiB | July 03 2023 / December 31 2023 | delayed release |
1 | US Agent | Attestation Statements | 126.12 KiB | July 03 2023 |
UNITED STATES DESIGNATED AGENT LETTER Date: 20230524 TO:
Federal Communication Commission Equipment Authorization Branch 7435 Oakland Mills Road Columbia, MID 21046 Applicant Company Name:
Grantee Code:
Guangdong Transtek Medical Electronics Co.,Ltd OU9 Contact Name:
Jerry Fan Address:
City/Province/Zip:
Zone A, No.105 ,Dongli Road Torch Development District Zhongshan , Guangdong/528437 Telephone:
Fax:
+86-760-85166220
+86-760-86742877 Email:
gt-rateam@transtekcorp.com Applicable Equipment: FCC ID: <OU9TMB2276BT>
ATTN: Director of Certification:
U.S. designated agent Company Name: MIO LABS INC. FRN:
Contact Name:
Address:
City/Province/Zip:
0032569972 4500 Great America Pkwy Suite 1023 95054 Telephone:
Fax:
Email:
157 286 6685 ext. 28(301-
910-0529)
mio@transtekcorp.com 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 Signature:
Title:Sales Manager Signature:
frequency | equipment class | purpose | ||
---|---|---|---|---|
1 | 2023-07-03 | 2402 ~ 2480 | DTS - Digital Transmission System | Original Equipment |
app s | Applicant Information | |||||
---|---|---|---|---|---|---|
1 | Effective |
2023-07-03
|
||||
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 |
TMB2276BT
|
||||
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 Science & Tech
|
||||
1 |
Shenzhen, 518057
|
|||||
1 |
China
|
|||||
1 | Telephone Number |
+8675********
|
||||
1 | Fax Number |
N/A********
|
||||
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 Science & Tech
|
||||
1 |
Shenzhen, 518057
|
|||||
1 |
China
|
|||||
1 | Telephone Number |
+8675********
|
||||
1 | Fax Number |
N/A********
|
||||
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) | 12/31/2023 | ||||
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 | 0.0006000 |
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