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TMB-2084-T-CE-A4-User Manual FCC20210205 | Users Manual | 1.54 MiB | April 09 2021 | |||
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4789796104-1 FCC Part 15C BLE Report TMB-2084-T | Test Report | 4.65 MiB | April 09 2021 | |||
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1 | TMB-2084-T-CE-A4-User Manual FCC20210205 | Users Manual | 1.54 MiB | April 09 2021 |
version:1.0 User Manual Blood Pressure Monitor TMB-2084-T Arm Type Guangdong Transtek Medical Electronics Co., Ltd. Zone B, No.105 ,Dongli Road, Torch Development District, Zhongshan,528437,Guangdong,China EC REP Thank you very much for selecting TRANSTEK Blood Pressure Monitor TMB-2084-T. Please read the user manual carefully and throughtly so as to ensure the safe usage of this product, keep the manual well for further reference in case you have problems. Table of Contents CATALOGUE INTRODUCTION..................................................................................................................2 BEFORE YOU START..........................................................................................................9 General Description Indications for Use Contraindications Measurement Principle Safety Information LCD Display Signal Monitor Components List The Choice of Power Supply Installing and Replacing the Batteries Setting Date, Time and Measurement Unit Setting the voice switch Setting the clock Setting the user ID Install the App and Pair-Up Search your Test Information Tie the Cuff Start the Measurement Recall the Records Delete the Records Tips for measurement Maintenances MEASUREMENT...............................................................................................................19 DATA MANAGEMENT........................................................................................................22 INFORMATION FOR USER...............................................................................................24 ABOUT BLOOD PRESSURE.............................................................................................26 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 arm?
TROUBLESHOOTING.......................................................................................................28 SPECIFICATIONS..............................................................................................................29 AUTHORIZED COMPONENT ...........................................................................................30 CONTACT INFORMATION.................................................................................................30 COMPLIED STANDARDS LIST..........................................................................................31 EMC GUIDANCE................................................................................................................32 INTRODUCTION INTRODUCTION Safety Information The signs below might be in the user manual, labeling or other component. They are the requirement of standard and using. Symbol for THE OPERATION GUIDE MUST BE READ Symbol for TYPE BF APPLIED PARTS Symbol for COMPLIES WITH MDD 93/42/EEC REQUIREMENTS Symbol for MANUFACTURER SN Symbol for SERIAL NUMBER Symbol for ENVIRONMENT PROTECTION - Electrical waste products should not be disposed of with household waste. Please recycle where facilities exist. Check with your local authority or retailer for recycling advice Symbol for Authorised Representative in the European Community Symbol for DIRECT CURRENT EC REP Symbol for MANUFACTURE DATE For indoor use only F1
Symbol for Class II Equipment Caution: These notes must be observed to prevent any damage to the device. Symbol for Recycle General Description Thank you for selecting TRANSTEK arm type blood pressure monitor
(TMB-2084-T). The monitor features blood pressure measurement, pulse rate measurement and the result storage. The design provides you with two years of reliable service. Readings taken by the TMB-2084-T 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:
61mm74 mm Digital LCD display with white backlight Maximum 120 records per each user 3rd technonoly: Measuring during inflation Indications for Use The Transtek Blood Pressure Monitor is digital monitors intended for use in measuring blood pressure and heartbeat rate with arm circumference ranging
Contraindications 1.The device is not suitable for use on may be pregnant women or pregnant women. 2.The device is not suitable for use on patients with implanted,electrical devices, such as cardiac pacemakers, defibrillators. 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.
INTRODUCTION CAUTION
implanted, electronical devices, patients with pre-eclampsia, premature ventricular beats, atrial fibrillation, peripheral, arterial disease and patients undergoing intravascular therapy or arterio-venous shunt or people who received a mastectomy. Please consult your doctor prior to using the unit if you suffer from illnesses.
before using it on older children.
pressure.It is not intended for use on extremities other than the arm or for functions other than obtaining a blood pressure measurement.
blood pressure.Do not begin or end medical treatment without asking a physician for treatment advice.
to measure your blood pressure. Never change a prescribed medication without consulting your physician.
dose of a medicine prescribed by a doctor. Consult your doctor if you have any question about your blood pressure.
atrial or ventricular premature beats or atrial fibrillation, the best result may occur with deviation. Please consult your physician about the result.
increase which can prevent blood flow and result in harmful injury to the PATIENT.
blood flow and influence blood circulation of the patient, thus cause harmful injury to the patient: connection tubing kinking too frequent and consecutive multiple measurements; the application of the cuff and its pressurization on any arm where intravascular access or
mastectomy.
around simultaneously, because this could cause temporary loss of function of those simultaneously-used monitoring ME equipment.
ment, open the cuff immediately. Prolonged high pressure (cuff pressure 300mmHg or constant pressure ecchymosis.
patient blood circulation.
INTRODUCTION CAUTION
was clinically investigated according to the requirements of ISO 81060-2:2018.
the manufacturer.
Besides providing inaccurate readings, the effects of this device on the fetus are unknown.
circulation and injuries.
operations.Otherwise, the patients arm and fingers will become anaesthetic, swollen and even purple due to a lack of blood.
extreme moisture, heat, lint, dust and direct sunlight. Never place any heavy objects on the storage case.
manufacturer cannot be held liable for damage caused by incorrect application.
the storage and operating conditions described in this booklet.
flammable anesthetic mixture with air of with oxygen or nitrous oxide.
can measure ,transmit data and change batteries under normal circumstanc-
es and maintain the device and its accessories according to the user manual.
radiated interference signal or electrical fast transient/burst signal.
device.
been tested and found to comply with requirements of ISO 10993-5:2009 and ISO 10993-10:2010. It will not cause any potential sensization or irritation reaction.
complaints, press the START/STOP button to release the air immediately from the cuff. Loosen the cuff and remove it from your arm.
from the arm and press the START/STOP button to stop inflation.
Check the device, do not use the device if it is damaged in any way. The continuous use of a damaged unit may cause injury, improper results, or serious danger.
INTRODUCTION CAUTION
storage state. The typical service life is 10000 times.
maintenance and repair, by retesting at least the requirements in limits of the error of the
according to the local guidelines.
descriptions, calibration instructions,etc., to assist to service personnel in parts repair.
device in a position where it is difficult to disconnect from the supply mains to safely terminate operation of ME equipment.
cloth to clean the whole unit before and after use. Dont use any abrasive or volatile cleaners.
please contact the SERVICE PERSONNEL of Transtek. Dont open or repair the device by yourself in the event of malfunctions. The device must only be serviced, repaired and opened by individuals at authorized sales/service centers.
any unexpected operation or events occur.
swallowing of small parts. It is dangerous or even fatal.
uses until it is ready for intended use. At least 30 min required for ME equipment to cool from the maximum storage temperature between uses until it is ready for intended use.
provided in the ACCOMPANYING DOCUMENTS;
cordless telephones and their base stations, walkie-talkies can affect this equipment and should be kept at least adistance d away from the equipment. The distance d is calculated by the MANUFAC-
TURER from the 80MHz to 5.8 GHz column of Table 4 and Table 9 of IEC 60601-1-2:2014, as appropriate.
Otherwise, it may cause damage to the unit or danger to the user/patients.
might be inadvertently connected to intravascular fluid systems, allowing air to be pumped into a blood vessel.
performance and lifetime of the device will be impacted and reduced.
LCD display signal INTRODUCTION SYMBOL SYMBOL DESCRIPTION DESCRIPTION EXPLANATION EXPLANATION Systolic blood pressure High pressure result Diastolic blood pressure Low pressure result PUL/min Pulse display Pulse in beats per minute kPa kPa Measurement Unit of the blood pressure mmHg User ID Measurement Unit of the blood pressure
User 1/2/Guest Current Time
Heartbeat Heartbeat dectetion during measurement Hand shaking Hand shaking makes results inaccurate Battery Indicator Indicate the current battery Irregular heartbeat Irregular heartbeat Data transmitting Data is transmitting Voice broadcast The function of voice broadcast is turned off Blood pressure level Indicate blood pressure level Bluetooth icon Average value Memory Query The bluetooth icon blinks when the bluetooth is working The average value of the latest three groups bood pressure value Indicate it is in the memory mode and which group of memory it is. Cuff wearing The cuff is secured Alarming setting switch Alarming setting switch function
INTRODUCTION Monitor Components CUFF AIR HOSE AIR CONNECTOR PLUG SET BUTTON START/STOP BUTTON MEM BUTTON Component list of pressure measuring system 1 Cuff 2 Air Hose 3 PCBA 4 Pump 5 Valve DC POWER SOCKET BATTERY COMPARTMENT BEFORE YOU START The Choice of Power Supply 1.Battery powered mode:
6VDC 4AAA batteries 2.AC adaptor powered mode:
5V 1A
(Please only use the recommended AC
Please unplug the adaptor to depart from the using utility power. CAUTION In order to get the best effect and protect your monitor,please use the right batteries and special power adapter which complies with local safety standard. AC adaptor LCD DISPLAY Installing and Replacing the Batteries Open the battery cover. Install the batteries by matching the correct polarity, as shown. Replace the battery cover. List 1.Blood Pressure Monitor
2.Cuff
(22cm~32cm,22~42cm,
3. 4AAA batteries 4.User manual 5. AC Adapter
(BLJ06L050100U-V BLJ06L050100U-S BLJ06L050100U-B
Replace the batteries whenever the below happen The shows 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.
BEFORE YOU START BEFORE YOU START Setting Date, Time and Measurement Unit 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 :20202099) 3.When you get the right year, press START/STOP to set down and turn to next step. 1.When the monitor is off, long press SETbutton,it will display [YEAR]. Each press SET button will increase the number. 2.Press the MEM to change the [YEAR]. Each press will decrease the numeral by one in a cycling manner. 4.Repeat steps 2 and 3 to set the [MONTH] and [DAY].
BEFORE YOU START BEFORE YOU START 5.Repeat steps 2 and 3 to set the [HOUR]
and [MINUTE]. 7.After the unit is set,the LCD will display dOnE and then it will turn off. 6.Repeat steps 2 and 3 to set the [UNIT]. Setting the voice switch 1.When the monitor is off,press both STRAT/STOP and SET button, it will enter voice setting mode. The vocie switch will blink, press MEM button to decrease the volume, press SET button to increase the volume, the press START/STOP button to confirm then the monitor will turn off.
BEFORE YOU START Setting the clock 1. When the monitor is off, long press both SET and MEM button, it will enter clock setting mode. Press MEM or SET button to choose turn off or turn on. PressSTART/STOP button to confirm. BEFORE YOU START Setting the User ID 1.When the monitor is off, hold press SET button and then the user ID will shows. Press MEM or SETbutton to switch the user ID between user 1 and user 2 mode. 2. When you choose turn on, press START/STOP button, the LCD will display the time, Choose MEM or SET button to set the time, press START/STOP button to cofirm, the LCD will displaydOnE and then the monitor will turn off. 2.Press START/STOP button to confirm user ID , the display will show User ID + dOnE and then the monitor will turn off.
BEFORE YOU START BEFORE YOU START Install the App and Pair-Up Download the Transtek Health app from APP Store or Google Play. Install the APP, and register an account. Search your test information After binding the app, back to the beginning page and click Blood Pressure to search your test information. kk Click ,click My setting, choose the device and then bind the device and app
MEASUREMENT 2~3cm RF Frequency Range: 2402 MHz to 2480 MHz Output Power Range: 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 11.0 or more. For Android devices:
The operating system must be Android 8.0 or more. CAUTION Interference may occur in the vicinity of equipment marked with the following symbol . And TMB-2084-T may interfering vicinity electrical equipment. Sensitive people, including pregnant women pre-eclamptic and those who implanted medical electronic instruments, should avoid using the unit whenever possible. Keep the monitor at least 20 centimeters away from the human body
after measurement. To enable the data transmission function, this product should be paired to Bluetooth end at 2.4 GHz. How to mitigate possible interference?
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. To avoid interference, other electronic devices (particularly those with
meter away from the monitor. 1. 2. Tie the cuff 1. 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. 2. Roll or push up your sleeve to expose the skin. Make sure your sleeve is not too tight. 3. Hold your arm with your palm facing up and tie the cuff on your upper arm, then position the tube off-center toward the inner side of arm in line with the little finger. Or position the artery mark over the main artery (on the
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. This is your main artery. 4. The cuff should be snug but not too tight. You should be able to insert one finger between the cuff and your arm. 5. Sit comfortably with your tested arm 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. 6. Helpful tips for Patients, especially for Patients with Hypertension:
Rest for 5 minutes before first 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. Please sit comfortably. Do not cross your legs and keep your feet flat 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 arm, or as directed by a physician.
MEASUREMENT Start the Measurement Before you start the measurement,Download the Transtek Health app from APP Store or Google Play,and turn on the Bluetooth. Install the APP, and register an account. Then set your personal information (Gender, Birthday, Height, Weight, Name and so on). 1.Please switch the User button to select the user between User 1 and User 2. When the monitor is off,press the START/STOP button to turn on the monitor, and it will finish the whole measurement,save and transmit the measurement data for the desired user. (Take User 1 for
LCD display Adjust the zero. DATA MANAGEMENT After the measurement was finished, the symbol will start blinking, and the data will start transmitting. ( Please connect the app during the
3. If the data transmits successful, the symbol and symblo will disappear, and then the monitor will turn off. 4. If the data transmition fails, the monitor will turn off automatically. 5.Press the START/STOP to power off. Tips: Maximum 120 records are both for User 1 and User 2. Inflating and measuring. Display and save the measurement results.
DATA MANAGEMENT Recall the Records 1. When the monitor is off, please hold press the MEM,it will display the latest record first when the records are less than three groups. When there are three or more than three groups ,it will display the average value of the latest three records first. 2. Press the MEM or SET to get the record you want. Year, date and time will display alternately. The current No. is No 1. The corresponding yeat is 2020. The corresponding date is January 1 .st The corresponding time is A.M. 09:00. CAUTION
dropped from the list. DATA MANAGEMENT Delete the Records If you did not get the correct measurement, you can delete all results for the selected user by following steps below. 1. Long press MEM, when the monitor is in the memory recall mode, the flash displayYES will show. 2.Press SET or MEM,the flash display ON or YES will show alternatively,choose YES to confirm deleting. 3.Press START/STOP button to confirm delete the records, the display will show User ID + dOnE and then the monitor will turn off. 4.If there is no record, press both START/STOP and MEM button to confirm delete all the records, the following display will show and then the monitor will turn off.
INFORMATION FOR USER INFORMATION FOR USER Tips for Measurement Measurements may be inaccurate if taken in the following circumstances. Maintenance instructions below. In order to get the best performance, please follow the Within 1 hour after dinner or drinking Immediate measurement after tea, coffee, smoking Put in a dry place and avoid the sunshine Avoid touching water, clean it with a dry cloth in case. Within 20 minutes after taking a bath When talking or moving your fingers In a very cold environment When you want to discharge urine Avoid intense shaking and collisions Avoid dusty and unstable temperature environment Using wet cloths to remove dirt Do not attempt to clean the reusable cuff with water and never immerse the cuff in water.
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
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
SYS DIA Optimal Normal High-normal Mild Moderate Severe
<120 120-129 130-139 140-159 160-179
<80 80-84 85-89 90-99 100-109
Irregular Heartbeat Detector An irregular heartbeat is detected when a heartbeat rhythm varies while the unit is measuring the systolic and diastolic blood pressure.During each measurement, the monitor records all the pulse intervals and calculate the average ; 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%,the irregular heartbeat symbol appears on the display when the measurement results are appeared. CAUTION The appearance of the IHB icon indicates that a pulse irregularity consistent with an irregular heart-beat 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.
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.
TROUBLESHOOTING SPECIFICATIONS Low batteries Batteries are low. Replace with new batteries Accuracy This section includes a list of error messages and frequently asked questions for problems you may encounter with your blood pressure monitor. If the products not operating as you think it should, check here before arranging for servicing. PROBLEM SYMPTOM CHECK THIS REMEDY No power Display will not light up. Batteries are exhausted. Replace with new batteries Batteries are inserted incorrectly. AC adaptor is inserted incorrectly. Insert the batteries correctly tightly Insert the AC adaptor Display is dim or show E01 shows E02 shows E03 shows E04 shows H bAt shows E+ ,shows on the display. The cuff is too tight or too loose. Refasten the cuff and then measure again. The monitor detected motion or talking during measuring. The measurement process does not detect the pulse signal. The treatment of the measurement failed. Adaptor voltage is higher than 7.5V Movement can affect the measurement.Relax for a moment and then measure again Loosen the clothing on the arm and then measure again. Relax for a moment and then measure again. Replace with new adaptor Matching failure or transmission timeout. Reconnect to the bluetooth and re-upload data Error message EEx,shows on the display. Hardware error 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. Warning message
Power supply Display mode Measurement mode Measurement range Normal working condition Storage & transportation condition Measurement perimeter of the upper arm Weight External dimensions Attachment Mode of operation Degree of protection Protection against ingress of water Device Classification Battery powered mode:
AC adaptor powered mode:
(Please only use the recommended AC
5V 1A 6VDC 4AAA batteries Digital LCD V.A.61mm 74mm Oscillographic testing mode Rated cuff pressure:
Measurement pressure:
Pressure:
5-40 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
at a water vapour pressure up to 50hPa About 22 cm ~ 32 cm, 22cm ~ 42cm, 22cm ~ 45cm
Approx.100.2mm138.2mm51mm 4AAA batteries,user manual,AC adapter Continuous operation Type BF applied part IP21 It means the device could protected against solid foreign objects of 12.5mm and greater, and protect against vertically falling water drops. Battery Powered Mode:
Internally Powered ME Equipment AC Adaptor Powered Mode: Class II ME Equipment WARNING: No modification of this equipment is allowed.
out shows Out of measurement range Software Version A01 COMPLIED STANDARDS LIST AUTHORIZED COMPONENT Authorized Component 1please use the TRANSTEK authorized adapter. Adapter ModelBLJ06L050100U-V BLJ06L050100U-S BLJ06L050100U-B BLJ06L050100U-U InputAC 100-240V 50/60Hz 0.2A Max Output5V 1000mA Contact Information For more information about our products, please visit www.transtek.cn.you can get customer service, usual problems and customer download, transtek will serve you anytime. Manufactured by:
Company:
Address:
Guangdong Transtek Medical Electronics Co., Ltd. Guangdong Transtek Medical Electronics Co., Ltd. Zone B, No.105 ,Dongli Road, Torch Development District, Zhongshan,528437,Guangdong,China Authorized European Representative:
Company: MDSS - Medical Device Safety Service GmbH Address: Schiffgraben 41, 30175 Hannover, Germany FCC Statement FCC ID: OU9TMB2080-B This device complies with Part 15 of the FCC Rules. Operation issubject 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. 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.
EMC GUIDANCE Complied Standards List EMC Guidance EMC GUIDANCE Risk management EN ISO 14971:2012 / ISO 14971:2007 Medical devices -
Application of risk management to medical devices The ME EQUIPMENT or ME SYSTEM is suitable for home healthcare environments Labeling User manual General Requirements for Safety Electromagnetic compatibility Performance requirements EN ISO 15223-1:2016 / ISO 15223-1:2016 Medical devices. Symbols to be used with medical device labels, labelling and information to be supplied. Part 1 : General requirements EN 1041:2008 +A1:2013 Information supplied by the manufacturer of medical devices EN 60601-1:2006+A1:2013/ IEC 60601-1:2005+A1:2012 Medical electrical equipment - Part 1: General requirements for basic safety and essential performance EN 60601-1-11:2015/ IEC 60601-1-11:2015 Medical electrical equipment - Part 1-11: General requirements for basic safety and essential performance - Collateral standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment EN 60601-1-2:2015/ IEC 60601-1-2:2014 Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic disturbances - Requirements and tests EN ISO 81060-1:2012 Non-invasive sphygmomanometers - Part 1:
Requirements and test methods for non-automated measurement type WarningDont near 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. WarningPortable RF communications equipment (including peripherals such as antenna cables and external
including cables specified by the manufacturer. Otherwise, degradation of the performance of this equipment could result. Technical description 1all necessary instructions for maintaining BASIC SAFETY and ESSENTIAL PERFORMANCE with regard to electromagnetic disturbances for the excepted service life. 2Guidance and manufacturers declaration -electromagnetic emissions and Immunity IEC 80601-2-30:2009+A1:2013 Medical electrical equipment- Part 2-30: Particular requirements for the basic safety and essential performance of automated non-invasive sphygmomanometers Table 1 Clinical investigation Usability Software life-cycle processes Bio-compatibility
EN 1060-4:2004 Non-invasive sphygmomanometers - Part 4: Test procedures to determine the overall system accuracy of automated non-invasive sphygmomanometers ISO 81060-2:2018 Non-invasive sphygmomanometers - Part 2:
Clinical validation of intermittent automated measurement type EN 60601-1-6:2010+A1:2015/IEC 60601-1-6:2010+A1:2013 Medical electrical equipment - Part 1-6: General requirements for basic safety and essential performance - Collateral standard: Usability IEC 62366-1:2015 Medical devices - Part 1: Application of usability engineering to medical devices EN 62304:2006/AC: 2008 / IEC 62304: 2006+A1:2015 Medical device software - Software life-cycle processes ISO 10993-1:2018 Biological evaluation of medical devices- Part 1: Evaluation and testing within a risk management process ISO 10993-5:2009 Biological evaluation of medical devices -
Part 5: Tests for in vitro cytotoxicity ISO 10993-10:2010 Biological evaluation of medical devices -
Part 10: Tests for irritation and skin sensitization 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
Guidance and manufacturers declaration electromagnetic Immunity Immunity Test IEC 60601-1-2 Test level Electrostatic discharge IEC 61000-4-2 8 kV contact 2 kV, 4kV, 8 kV, 15 kV air Compliance level 8 kV contact 2 kV, 4kV, 8 kV, 15 kV air Guidance and manufacturers declaration - electromagnetic Immunity Test Frequency
Band
Service Modulation
IMMUNITY Modulation
1.8 0.3 EMC GUIDANCE Table 2 Electrical fast transient/burst IEC 61000-4-4 Surge IEC61000-4-5 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
2 kV for power supply lines 1 kV signal input/output 100 kHz repetition frequency 2 kV for power supply lines 1 kV signal input/output 100 kHz repetition frequency 0.5 kV, 1 kV differential mode 0.5 kV, 1 kV differential mode 0.5 kV, 1 kV,2 kV common mode 0.5 kV, 1 kV,2 kV common mode 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 30 A/m 50Hz/60Hz 30 A/m 50Hz/60Hz 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 UT is the a.c. mains voltage prior to application of the test level. Table 3 Radiated RF IEC61000-4-3
(Test specifications for ENCLOSURE PORT IMMUNITY to RF wireless communica-
tions
2 0.2 2 2 2 385 380-390 TETRA 400 Pulse
18Hz
deviation 1kHz sine GMRS 460 FRS 460 430-470 704-787 LTE Band 13, 17 Pulse
217Hz 800-960 GSM 1700-
1990 Pulse
18Hz Pulse
217Hz 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 2450 2400-
2570 Pulse modulation 217 Hz 450 710 745 780 810 870 930 1720 1845 1970 5240 5500 5785 5100-
5800 WLAN 802.11 a/n Pulse modulation 217 Hz 0.2 0.3 9 TEST LEVEL
27 28 9 28 0.3 0.3 0.3 0.3 28 0.3 28
1 | Label & label position | ID Label/Location Info | 156.85 KiB | April 09 2021 |
TMB-2080-A Model Rating: Battery powered mode: 4xAAA batteries, 6V AC adaptor powered mode: 5V 1A
(Please use the AC adaptor which authorized by the manufacturer!) IP Classification:IP21 SN BA5281201000001D Guangdong Transtek Medical Electronics Co., Ltd. Zone B , No.105 ,Dongli Road, Torch Development District,Zhongshan,528437,Guangdong,China FCC Statement FCC ID:OU9TMB2080-B This device com plies 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 m ay cause undesired operation. 2020-11 1 5.60.2 0.1 2 2 A b a tterie s , 6 a n V u fa D c t u re r!) 0 2 0 -1 1 2 A B d o e m 0 1 0 0 0 0 0 2 1 8 M d b y t h 1 d e : 4 x A o r ize o 8 0 - A er e d m A u t h V 1 B - 2 0 o., L td . h a 52 nt w A e : 5 h ic att ery p o m e nics C p t o r w p a e velo 2 0 8 0- B d m dical Ele ctro hin ad , To rch D g , C C a d B on n :I P 2 1 gd M p t o r p 9 T ns tek M e ngli R T 7 ,G I P C la s sific atio U C I D: O e u o 5 , D g T ra 8 an ,52 o.1 on C g sh e nt F e B , N on h D is tric t, Z C Stat e T g: B a as w o e t h e re e A ng on o 43 ua m s a n 0 u a d Z G C F M o R e l d atin d C a A
( P le TMB-2080 TMB-2080-AC-02 NA 50#
20201026 20201026 mm 1 1
<6 0.06 0.10 0.08 0.10 0.10 0.10 0.15 0.15 0.20 0.20 0.20 0.20 0.35 00 00
1 | Authorization Letter | Cover Letter(s) | 170.71 KiB | April 09 2021 |
Guangdong Transtek Medical Electronics Co.,Ltd Date: 2021-01-14 Federal Communications Commission 7435 Oakland Mills Road Columbia MD 21046 To whom it may concern:
I, the undersigned, hereby authorize UL Verification Services Inc. to act on our behalf in all manners relating to application for equipment authorization, including signing of all documents relating to these matters. Any and all acts carried out by UL Verification Services Inc. on our behalf shall have the same effect as acts of our own. I, 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). In authorizing UL Verification Services Inc. as our representative, we still recognize that we are responsible to:
a) comply with the relevant provisions of the certification program;
b) c) d) e) f) make all necessary arrangements for the conduct of the evaluation, including provision for examining documentation and access to all areas, records (including internal audit reports) and personnel for the purposes of evaluation (e.g. testing, inspection, assessment, surveillance, reassessment) and resolution of complaints;
make claims regarding certification only in respect of the scope for which certification has been granted;
do not use our product certification in such a manner as to bring the Certification Division into disrepute and not make any statement regarding our product certification which the Certification Division may consider misleading or unauthorized;
upon suspension or cancellation of certification, discontinue use of all advertising matter that contains any reference thereto and return any certification documents as required by the Certification Division;
use certification only to indicate the products are certified as being in conformity with specified standards;
g) h) i) j) endeavor to ensure that no certificate or report nor any part thereof is used in a misleading manner;
ensure that any reference to our product certification in communication media such as documents, brochures or advertising, complies with the requirements of the Certification Division;
keep a record of all complaints made known to us relating to the products compliance with requirements of the relevant standard and to make these records available to the when requested;
take appropriate action with respect to such complaints and any deficiencies found in products or services that affect compliance with the requirements for certification;
k) document the actions taken. This authorization is valid until further written notice from the applicant. Sincerely Yours, Signed by:
Company Name: Guangdong Transtek Medical Electronics Co.,Ltd Contact Name: Kevin Tan Title of PersonR&D Director Address: Zone A, No. 105 , Dongli Road, Torch Development District, Zhongshan,528437, Guangdong, China
1 | Confidentiality Request letter | Cover Letter(s) | 125.39 KiB | April 09 2021 |
Guangdong Transtek Medical Electronics Co.,Ltd OU9TMB2080-B Request for Confidentiality Federal Communications Commission 7435 Oakland Mills Road Columbia MD 21046 Subject:
FCC ID:
To Whom It May Concern:
Pursuant to the provisions of Sections 0.457 and 0.459 of the Commissions rules (47 CFR 0.457, 0.459), we are requesting the Commission to withhold the following attachments as confidential document from public disclosure indefinitely. Schematic Diagram Block Diagram Theory of Operation Above mentioned document contains detailed system and equipment description are considered as proprietary information in operation of the equipment. The public disclosure of above documents might be harmful to our company and would give competitor an unfair advantage in the market. It is our understanding that all measurement test reports, FCC ID label format and correspondent during certification review process cannot be granted as confidential documents and those information will be available for public review once the grant of equipment authorization is issued. Best Regards Company Name: Guangdong Transtek Medical Electronics Co.,Ltd Contact Name: Kevin Tan Title of PersonR&D Director Address: Zone A, No.105 , Dongli Road, Torch Development District, Zhongshan,528437, Guangdong ,China Date:2020-01-14
1 | Family Declaration | Cover Letter(s) | 224.69 KiB | April 09 2021 |
Guangdong Transtek Medical Electronics Co.,Ltd. Address: Zone B, No.105 ,Dongli Road, Torch Development District, Zhongshan,Guangdong,China 528437 Confirmation Letter We, Guangdong Transtek Medical Electronics Co.,Ltd. The product: Blood Pressure Monitor (product name) And model No.: TMB-2084-T TMB-2080, TMB-2080-A, TMB-2080-K, TMB-2083, TMB-2083-K, TMB-2084, TMB-2084-K, TMB-2084-KT, TMB-2084-A have the same technical construction including circuit diagram, PCB Layout, components and component layout, all electrical construction and mechanical construction with TMB-2084-T. The difference lies only the model name, Appearance and voice function. Contact name: Endless Chan Company n ame: Guangdong Transtek Medical Electronics Co.,Ltd.
frequency | equipment class | purpose | ||
---|---|---|---|---|
1 | 2021-04-09 | 2402 ~ 2480 | DTS - Digital Transmission System | Original Equipment |
app s | Applicant Information | |||||
---|---|---|---|---|---|---|
1 | Effective |
2021-04-09
|
||||
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 Torch Development District
|
||||
1 |
Zone A, No.105,Dongli Road
|
|||||
1 |
Zhongshan, Guangdong, N/A
|
|||||
1 |
China
|
|||||
app s | TCB Information | |||||
1 | TCB Application Email Address |
L******@ul.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 |
TMB2080-B
|
||||
app s | Person at the applicant's address to receive grant or for contact | |||||
1 | Name |
K**** T******
|
||||
1 | Title |
R&D Director
|
||||
1 | Telephone Number |
+86-7********
|
||||
1 | Fax Number |
+86-7********
|
||||
1 |
n******@transtekcorp.com
|
|||||
app s | Technical Contact | |||||
1 | Firm Name |
UL
|
||||
1 | Name |
E****** Y******
|
||||
1 | Physical Address |
Building 10
|
||||
1 |
Donguan, 523808
|
|||||
1 |
China
|
|||||
1 | Telephone Number |
86769********
|
||||
1 | Fax Number |
86769********
|
||||
1 |
e******@ul.com
|
|||||
app s | Non Technical Contact | |||||
n/a | ||||||
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?: | No | ||||
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 peak 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 |
UL Verification Services (Guangzhou) Co., Ltd.
|
||||
1 | Name |
S**** G********
|
||||
1 | Telephone Number |
+86 0********
|
||||
1 |
S******@ul.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 | 0.0007000 |
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