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Version: 1.0 User Manual Arm Blood Pressure Monitor Model: TMB-1491-BHJ Arm Type Guangdong Transtek Medical Electronics Co., Ltd. Zone B, No.105, Dongli Road, Torch Development District, Zhongshan, 528437, Guangdong, China Thank you for selecng Transtek Blood Pressure Monitor. Please read the user manual carefully and thoroughly so as to ensure the safe usage of this product. Keep this manual for further reference in case any issues arise. INTRODUCTION.......................................................................................................................................2 Table of Contents CATALOGUE BEFORE YOU START..................................................................................................................................9 General Descripon Indicaons for Use Contraindicaons Measurement Principle Safety Informaon LCD Display Signal Monitor Components List The Choice of Power Supply Installing and Replacing the Baeries Seng Date and Time Select the user ID Install the App and Pair-Up Search your Test Informaon Tie the Cu Start the Measurement Recall the Records Delete the Records Tips for measurement Maintenance MEASUREMENT.....................................................................................................................................16 DATA MANAGEMENT.............................................................................................................................19 INFORMATION FOR USER......................................................................................................................21 ABOUT BLOOD PRESSURE.....................................................................................................................23 What are systolic pressure and diastolic pressure?
What is the standard blood pressure classicaon?
Irregular heartbeat detector Why does my blood pressure uctuate throughout the day?
Why do I get a dierent blood pressure at home compared to the hospital?
Is the result the same if measuring on the right arm?
TROUBLE SHOOTING.............................................................................................................................25 SPECIFICATIONS.....................................................................................................................................26 AUTHORIZED COMPONENT ..................................................................................................................27 CONTACT INFORMATION.......................................................................................................................27 FCC STATEMENT.....................................................................................................................................28 COMPLIED STANDARDS LIST..................................................................................................................29 EMC GUIDANCE.....................................................................................................................................30 1 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 Indicates the need for the user to consult the instrucons for use for important cauonary informaon such as warnings and precauons that cannot, for a variety of reasons , be presented on the medical device itself. Symbol for ENVIRONMENT PROTECTION - Electrical waste products should not be disposed of with household waste. Please recycle where facilies exist. Check with your local authority or retailer for recycling advice SN Symbol for SERIAL NUMBER Symbol for Recycle Symbol for DIRECT CURRENT For indoor use only F1 T1A/250V 3.6*10CCC Symbol for Class II Equipment Symbol for MANUFACTURER Symbol for MANUFACTURE DATE General Description This product features blood pressure measurement, pulse rate measurement and the result storage. The design provides you with two years of reliable service. Readings taken by this blood pressure monitor TMB-1491-BHJ is equivalent to those obtained by a trained observer using the cu and stethoscope auscultaon method. This manual contains important safety and care informaon, and provides step by step instrucons for using this blood pressure monitor. Read the manual thoroughly before using this product. Features:
60 mm 40.5 mm Digital LCD display Maximum storage of 60 records per user Up-to-date measuring-during-inaon technology Indications for Use This Blood Pressure Monitor TMB-2080 is a digital monitor intended for use in measuring blood pressure and heartbeat rate with arm circumference ranging from 22 cm to 32 cm (about 8-12), 22 cm to 42 cm (about 8-16). It is intended for indoor, adult use only. Contraindications 1. The device is not suitable for use on the women who are or may be pregnant. 2. The device is not suitable for use on paents with implanted, electrical devices, such as cardiac pacemakers, debrillators. 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 inang the arm cu, meanwhile, the unit detects pressure oscillaons generated by beat-to-beat pulsale, which is used to determine the systolic and diastolic pressure, and also pulse rate. 2 3 INTRODUCTION CAUTION
* This device is intended for adult use in homes only.
* The device is not suitable for use on neonatal patients, pregnant women, patients with 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.
* The device is not suitable for measuring the blood pressure of children. Ask your doctor before using it on older children.
* The device is not intended for patient transport outside a healthcare facility.
* The device is not intended for public use.
* This device is intended for no-invasive measuring and monitoring of arterial blood pressure. It is not intended for use on extremities other than the arm or for functions other than obtaining a blood pressure measurement.
* Do not confuse self-monitoring with self-diagnosis. This unit allows you to monitor your blood pressure. Do not begin or end medical treatment without asking a physician for treatment advice.
* If you are taking medication, consult your physician to determine the most appropriate time to measure your blood pressure. Never change a prescribed medication without consulting your physician.
* Do not take any therapeutic measures on the basis of a self measurement. Never alter the dose of a medicine prescribed by a doctor. Consult your doctor if you have any question about your blood pressure.
* When the device was used to measure patients who have common arrhythmias such as atrial or ventricular premature beats or atrial fibrillation, the best result may occur with deviation. Please consult your physician about the result.
* Don't kink the connection tube during use, otherwise, the cuff pressure may continuously increase which can prevent blood flow and result in harmful injury to the PATIENT.
* When using this device, please pay attention to the following situation which may interrupt 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 therapy, or an arterio-venous (A-V) shunt, is present; inflating the cuff on the side of a mastectomy.
* Warning: Do not apply the cuff over a wound, otherwise it can cause further injury.
* Do not inflate the cuff on the same limb which other monitoring ME equipment is applied around simultaneously, because this could cause temporary loss of function of those simultaneously-used monitoring ME equipment.
* On the rare occasion of a fault causing the cuff to remain fully inflated during measurement, open the cuff immediately. Prolonged high pressure (cuff pressure >
300mmHg or constant pressure >15mmHg for more than 3 minutes) applied to the arm may lead to an ecchymosis. patient blood circulation.
* When measurement, please avoid compression or restriction of the connection tubing. 4 INTRODUCTION CAUTION
* The device cannot be used with HF surgical equipment at the same time.
* The ACCOMPANYING DOCUMENT shall disclose that the SPHYGMOMANOMETER was clinically investigated according to the requirements of ISO 81060-2:2018.
* To verify the calibration of the AUTOMATED SPHYGMOMANOMETER, please contact the manufacturer.
* This device is contraindicated for any female who may be suspected of, or is pregnant. Besides providing inaccurate readings, the effects of this device on the fetus are unknown.
* Too frequent and consecutive measurements could cause disturbances in blood circulation and injuries.
* This unit is not suitable for continuous monitoring during medical emergencies or operations. Otherwise, the patients arm and fingers will become anaesthetic, swollen and even purple due to a lack of blood.
* When not in use, store the device with the adapter in a dry room and protect it against extreme moisture, heat, lint, dust and direct sunlight. Never place any heavy objects on the storage case.
* This device may be used only for the purpose described in this booklet. The manufacturer cannot be held liable for damage caused by incorrect application.
* This device comprises sensitive components and must be treated with caution. Observe the storage and operating conditions described in this booklet.
* The equipment is not AP/APG equipment and not suitable for use in the presence of a flammable anesthetic mixture with air of with oxygen or nitrous oxide.
* Warning: No servicing/maintenance while the ME equipment is in use.
* The patient is an intended operator.
* The patient can measure, transmit data and change batteries under normal circumstances and maintain the device and its accessories according to the user manual.
* To avoid measurement errors, please avoid the condition of strong electromagnetic field radiated interference signal or electrical fast transient/burst signal.
* The blood pressure monitor, its adapter, and the cuff are suitable for use within the patient environment. If you are allergic to polyester, nylon or plastic, please don't use this device.
* During use, the patient will be in contact with the cuff. The materials of the cuff have been tested and found to comply with requirements of ISO 10993-5:2009 and ISO 10993-10:2010. It will not cause any potential sensitization or irritation reaction.
* Adapter is specified as a part of ME EQUIPMENT.
* If you experience discomfort during a measurement, such as pain in the arm or other complaints, press the START/STOP button to release the air immediately from the cuff. Loosen the cuff and remove it from your arm.
* If the cuff pressure reaches 40 kPa (300 mmHg), the unit will automatically deflate. Should the cuff not deflate when pressures reaches 40 kPa (300 mmHg), detach the cuff 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.
* Do not wash the cuff in a washing machine or dishwasher!
5
* Please check that operation of the device does not result in prolonged impairment of
* Before use, make sure the device functions safely and is in proper working condition. INTRODUCTION CAUTION
* The service life of the cuff may vary by the frequency of washing, skin condition, and storage state. The typical service life is 10000 times.
* It is recommended that the performance should be checked every 2 years and after maintenance and repair, by retesting at least the requirements in limits of the error of the cuff pressure indication and air leakage (testing at least at 50mmHg and 200mmHg).
* Please dispose of ACCESSORIES, detachable parts, and the ME EQUIPMENT according to the local guidelines.
* Manufacturer will make available on request circuit diagrams, component part lists, descriptions, calibration instructions, etc., to assist to service personnel in parts repair.
* The plug/adapter plug pins insulates the device from the main supply. Do not position the device in a position where it is difficult to disconnect from the supply mains to safely terminate operation of ME equipment.
* The operator shall not touch output of batteries/adapter and the patient simultaneously.
* Cleaning: Dust environment may affect the performance of the unit. Please use the soft cloth to clean the whole unit before and after use. Dont use any abrasive or volatile cleaners.
* The device doesnt need to be calibrated within two years of reliable service.
* If you have any problems with this device, such as setting up, maintaining or using, 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.
* Please report to Transtek if any unexpected operation or events occur.
* Keep the unit out of reach of infants, young children or pets to avoid inhalation or swallowing of small parts. It is dangerous or even fatal.
* Be careful to strangulation due to cables and hoses, particularly due to excessive length.
* At least 30 min required for ME equipment to warm from the minimum storage temperature between 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.
* This equipment needs to be installed and put into service in accordance with the information provided in the ACCOMPANYING DOCUMENTS.
* Wireless communications equipment such as wireless home network devices, mobile phones, cordless telephones and their base stations, walkie-talkies can affect this equipment and should be kept at least a distance away from the equipment. The distance d is calculated by the MANUFACTURER from the 80MHz to 5.8 GHz column of Table 4 and Table 9 of IEC 60601-1-2:2014, as appropriate.
* Please use ACCESSORIES and detachable parts specified/authorized by MANUFACTURE. Otherwise, it may cause damage to the unit or danger to the user/patients.
* There is no luer lock connectors are used in the construction of tubing, there is a possibility that they might be inadvertently connected to intravascular fluid systems, allowing air to be pumped into a blood vessel.
* Please use the device under the environment which was provided in the user manual. Otherwise, the performance and lifetime of the device will be impacted and reduced.
* Adapter is specified as a part of ME EQUIPMENT. 6 LCD display signal INTRODUCTION SYMBOL DESCRIPTION Systolic blood pressure EXPLANATION The high pressure measured. Diastolic blood pressure The low pressure measured. mmHg KPa Measurement Unit of the blood pressure. (1 kPa=7.5 mmHg) Measurement Unit of the blood pressure. (1 mmHg = 0.133 kPa) Pulse/minute Measurement Unit of Heart Rate. Heartbeat Heart rate decteted during measurement. Irregular heartbeat Irregular heartbeat detected during measurement. User ID appears when the monitor is operated by User 1. appears when the monitor is operated by User 2. appears when the monitor is operated by guest User G. NOTE: User 1 and User 2, each with 60 memory spaces;
User G, no momery space. Deaon symbol The cu is deang. Bluetooth transfer icon The bluetooth transfer icon blinks when the bluetooth is working. Low baery Baeries are low and need to be replaced Blood pressure level Indicates the blood pressure level. Memory display Indicate it is in the memory mode and which group of memory it is. Current Time Time and date (year/month/day; hour:minute) 7 INTRODUCTION Monitor Components Component list of pressure measuring system 1 Cu 2 Air pipe 3 PCBA 4 Pump 5 Valve CUFF AIR HOSE LCD DISPLAY AIR CONNECTOR PLUG DC POWER SOCKET MEM BUTTON SET BUTTON START/STOP BUTTON BATTERY COMPARTMENT BEFORE YOU START The Choice of Power Supply 1. Baery powered mode:
6V DC 4 AAA baeries 2. AC adapter powered mode:
6V 1A
(Please only use the recommended AC adapter) Please unplug the adapter to depart from the using ulity power, when you nish the measurement. CAUTION In order to get the best eect and protect your monitor, please use the right baeries and special power adapter which complies with local safety standard. AC adaptor Installing and Replacing the Batteries Open the baery cover. Install the baeries by matching the correct polarity, as shown. Replace the baery cover. List 1. Blood Pressure Monitor
(TMB-1491-BHJ) 2. Cu (Type BF applied part) 22 cm ~ 32 cm 22 cm ~ 42 cm Replace the baeries whenever the below happen. when shows. The display is dim. The display does not light up. 3. 4 AAA baeries 4. AC Adapter 5. User manual BLJ06L060100P-U 8 CAUTION Do not use new and used baeries together. Do not use dierent types of baeries together. Do not dispose the baeries in re. Baeries may explode or leak. Remove baeries if the device is not likely to be used for some me. Worn baeries are harmful to the environment. Do not dispose with dailygarbage. Remove the old baeries from the device following your local recycling guidelines. 9 BEFORE YOU START BEFORE YOU START 4. Repeat steps 2 and 3 to set the [MONTH] and [DAY]. Setting Date and Time It is important to set the Date and Time before using your blood pressure monitor, so that a me stamp can be assigned to each record that is stored in the memory.
(The seng range of the year: 20172057, Time format: 12/24H) 1. When the monitor is o, hold press SET buon, the display will show a blinking number represenng the
[YEAR]. Or when the monitor is o, press SET buon shortly, it will display the me. Then hold press SET buon to enter the mode for year seng. 2. Change the [YEAR] by pressing MEM buon. Each press MEM buon will increase the number by one in a cycling manner. 3. When you get the right year, press SET buon to conrm the entry. The screen will then show a blinking number represenng the
[MONTH]
5. Repeat steps 2 and 3 to conrm the me format between
[12H] and [24h]. 6. Repeat steps 2 and 3 to set the [HOUR] and [MINUTE]. 10 11 BEFORE YOU START BEFORE YOU START 6. Repeat steps 2 and 3 to set the [UNIT]. Select the User ID 1. When the monitor is o, hold press MEM buon, the user ID will show. Then press MEM buon to switch the user ID between user 1, user 2 and USER G (guest). 7. Aer the UNIT is set, the LCD will display donE rst, then display all the sengs you have done and then it will turn o. 2. Press SET buon to ensure your choice, it will show User ID and donE and then turn o. 12 13 BEFORE YOU START BEFORE YOU START Pair-up the Blood Pressure Monitor with Your Device 1.Download the MedM Health app from APP Store or Google Play. Install the APP, and register an account. t urn on Bluetooth and the app. Make sure both are ON when pair-up is proceeding. 2.When the monitor is OFF, press and hold the START/STOP buon to start pair-up. The symbol and will be shown on the LCD alternavely, indicang pair-up is proceeding. 3.Then please select the user ID you want to connect with your smartphone on the app to connute the pair-up. If SUCCEED , symbol will be shown on the LCD. If FAIL, symbol will be shown on the LCD. 4.The monitor will shut o aer Pair-up process is complete. List of compable devices For iOS devices:
The operang system must be iOS 11.0 or more. For Android devices The operang system must be Android 8.0 or more CAUTION Interference may occur in the vicinity of equipment marked with the following symbol . And TMB-1491-BHJ may interfer the vicinity electrical equipment. Sensive people, including pregnant women, pre-eclampc and those who implanted medical electronic instruments, should avoid using the unit whenever possible. Keep the monitor at least 20 cenmeters away from the human body
(especially the head) when the data transmission is proceeding aer measurement. To enable the data transmission funcon, this product should be paired to Bluetooth end at 2.4 GHz. How to migate possible interference?
1. 2. 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 connecon and to lower the RF output range. To avoid interference, other electronic devices (parcularly those with wireless transmission/Transmier) should be kept at least 1 meter away from the monitor. And BT end so as to obtain quality connecon and to lower the RF output range. 14 15 MEASUREMENT Tie the cuff 1. Remove all jewelry, such as watches and bracelets from your le arm. Note: If your doctor has diagnosed you with poor circulaon in your le arm, use your right arm. 2. Roll or push up your sleeve to expose the skin. Make sure your sleeve is not too ght. Hold your arm with your palm facing up and e the cu on your upper arm, then posion the tube o-center toward the inner side of arm in line with the lile nger. Or posion the artery mark over the main artery (on the inside of your arm). Note:
Locate the main artery by pressing with 2 ngers approximately 2 cm above the bend of your elbow on the inside of your le arm. Idenfy where the pulse can be felt the strongest. This is your main artery. The cu should be snug but not too ght. You should be able to insert one nger between the cu and your arm. 5. Sit comfortably with your tested arm resng on a at surface. Place your elbow on a table so that the cu is at the same level as your heart. Turn your palm upwards. Sit upright in a chair, and take 5-6 deep breaths. 3. 4. 6. Helpful ps for Paents, especially for Paents with Hypertension:
Rest for 5 minutes before rst measuring. Wait at least 3 minutes between measurements. This allows your blood circulaon to recover. Take the measurement in a silent room. The paent must relax as much as possible and do not move and talk during the measurement procedure. The cu 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 at on the ground. Keep your back against the backrest of the chair. For a meaningful comparison, try to measure under similar condions. For example, take daily measurements at approximately the same me, on the same arm, or as directed by a physician. 16 2~3cm STOP START MEASUREMENT Start the Measurement Before you start the measurement, Download the MedM Health app from APP Store or Google Play, and turn on the Bluetooth. Install the APP, and register an account. Then set your personal informaon
(Gender, Birthday, Height, Weight, Name and so on). 1. When the monitor is o, press START/STOP buon, it will nish the whole measurement automacally, save and transmit the measurement data for the desired user. (Take User 1 for example.) LCD display Adjust the zero. Inang and measuring. Display and save the measurement result. 17 MEASUREMENT DATA MANAGEMENT If the data transmission fails, the Bluetooth symbol blinks all the me unl it turns o. Recall the Records 1. When the monitor is o, press MEM buon, it will display the latest record rst 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 rst. If the data transmission succeeds, the Bluetooth symbol will light up for several seconds then the device will turn o. 2 2. Each press MEM or SET buon again will show next record. Date, Time will display alternately. The current record is Group 2. The corresponding date is January 1st. The corresponding me is 12:00. CAUTION The most recent record (1) is shown rst. Each new measurement is assigned to the rst (1) record. All other records are pushed back one digit (e.g., 2 becomes 3, and so on), and the last record (60) is dropped from the list. 18 19 If you did not get the correct measurement, you can delete all results for the selected user by following steps. (Take User 1 for example.) DATA MANAGEMENT Delete the Records 1. Hold press MEM buon, when the monitor is in the memory recall mode, the display will show dEL ALL + User ID. INFORMATION FOR USER Tips for Measurement Measurements may be inaccurate if taken in the following circumstances. 2. Press SET buon to conrm deleng, the LCD will display dEL do nE + User ID and then turn o. If you dont want to delete the records, press START/STOP buon to escape. 3. If there is no record, when you press MEM buon to check the record, the right display will be shown. Within 1 hour aer dinner or drinking Immediate measurement aer tea, coee, smoking Within 20 minutes aer taking a bath When talking or moving your ngers In a very cold environment When you want to discharge urine 20 21 INFORMATION FOR USER Maintenance In order to get the best performance, please follow the instrucons below. Put in a dry place and avoid the sunshine Avoid touching water, clean it with a dry cloth in case. Avoid intense shaking and collisions Avoid dusty and unstable temperature environment Using wet cloths to remove dirt Do not aempt to clean the reusable cu with water and never immerse the cu in water. 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. Diastolic blood entering vein Systolic blood discharging press relax artery What is the standard blood pressure classification?
The chart on the right is the standard blood pressure classifi-
cation published by American Heart Association (AHA). This chart reflects blood pressure categories defined by American Heart Association. Blood Pressure Category Systolic mmHg (upper#) Diastolic mmHg (lower#) Normal Elevated High Blood Pressure
(Hypertension) Stage 1 High Blood Pressure
(Hypertension) Stage 2 less than 120 120-129 130-139 less than 80 less than 80 80-89 and and or or 140 or higher 90 or higher Hypertensive Crisis
(Consult your doctor immediately) Higher than 180 and/or Higher than 120 CAUTION Please consult a physician if your measuring result falls outside the range. Please note that only a physician can tell whether your blood pressure value has reached a dangerous point. 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 dierence between each interval and the average is more than the average value of 25%, or there are four or more pulse intervals, the dierence 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 oen, we recommend you seek medical advice. Please note that the device does not replace a cardiac examinaon, but serves to detect pulse irregularies at an early stage. 22 23 ABOUT BLOOD PRESSURE TROUBLE SHOOTING Why does my blood pressure fluctuate throughout the day?
1. Individual blood pressure varies mulple mes everyday. It is also aected by the way you e your cu and your measurement posion, so please take the measurement under the same condions. 2. If the person takes medicine, the pressure will vary more. 3. Wait at least 3 minutes for another measurement. STOP START Why do I get different blood pressure at home compared to the hospital?
The blood pressure is dierent even throughout the day due to weather, emoon, exercise etc. Also, there is the white coat eect, which means blood pressure usually increases in clinical sengs. What you need to pay aenon to when you measure your blood pressure at home:
If the cu is ed properly. If the cu is too ght or too loose. If the cu is ed on the upper arm. If you feel anxious. Taking 2-3 deep breaths before beginning will be beer for measuring. Advice: Relax yourself for 4-5 minutes unl you calm down. Is the result the same if measuring on the right arm?
It is ok for both arms, but there will be some dierent results for dierent people. We suggest you measure the same arm every me. If any abnormality arises during use, please check the following points:
PROBLEM SYMPTOM CHECK THIS REMEDY No power Display will not light up. Low batteries Display is dim or shows E 01 shows E 02 shows E 03 shows Error message Baeries are exhausted. Replace with new baeries. Baeries are inserted incorrectly. Insert the baeries correctly. AC adapter is inserted instrucons below. Insert the AC adapter ghtly. Baeries are low. Replace with new baeries. Incorrect cu placement or cu air plug is loose Hand shaking or talking or weak Pulse during measuring. Pulse signal is not detected during measuring. Refasten the cu and insert air tube plug correctly then measure again. Relax for 5 minutes. and then keep sll, measure again. Loosen the clothing on the arm and then measure again. E 04 shows The measurement failed. Relax for 5 minutes and measure again. EEx or E2x, shows on the display. Hardware error.
(X can be some digital symbol,such as 1, 2, etc.) Retake the measurement. If the problem persists, contact the retailer or ourcustomer service department for further assistance. Refer to the warranty for contact informaon and return. Relax for a moment. Refasten the cu and then measure again. If the problem persists, contact your physician. STOP START Warning message OUt shows Out of measurement range 24 NOTE: If the product sll does not work, contact Transtek Customer Service. Under no circumstance should you disassemble or aempt to repair the unit by yourself. 25 SPECIFICATIONS Power supply Display mode Measurement mode Measurement range Accuracy Normal working condition Baery powered mode: 6V DC 4 AAA baeries AC adapter powered mode: 6V 1A
(Please only use the recommended AC adapter). Digital LCD V.A. 60 mm 40.5 mm Oscillographic tesng mode Rated cu pressure:
0 mmHg ~ 299 mmHg (0 kPa ~ 39.9 kPa) Measurement pressure:
SYS: 60 mmHg ~ 230 mmHg (8.0 kPa ~ 30.7 kPa) DIA: 40 mmHg ~ 130 mmHg (5.3 kPa ~ 17.3 kPa) Pulse value: (40-199) beat/minute Pressure:
5C - 40C within 3 mmHg (0.4 kPa) Pulse value: 5%
A temperature range of: +5C to +40C A relave humidity range of 15% to 90%, non-condensing, but not requiring a water vapour paral pressure greater than 50 hPa An atmospheric pressure range of:
700 hPa to 1060 hPa Storage & transportation condition Temperature: -20C to +60C A relave humidity range of 93%, non-condensing, at a water vapour pressure up to 50 hPa Measurement perimeter of the upper arm About 22 cm to 32 cm (about 8-12) or 22 cm to 42 cm (about 8-16) Weight External dimensions Attachment Approx.179g (Excluding the baeries and cu) Approx.110 mm 110 mm 41 mm 4 AAA baeries, user manual, AC adapter Mode of operation Connuous operaon Degree of protection Type BF applied part Protection against ingress of water Device Classification Software Version Bluetooth Module information IP20 It means the device could protected against solid foreign objects of 12.5mm and greater, and there is no special protecon for water or moisture. Baery Powered Mode:
Internally Powered ME Equipment AC Adapter Powered Mode: Class II ME Equipment A01 Bluetooth Module No.: 1491-BHJ RF Frequency Range: 2402 MHz to 2480 MHz Output Power Range: -2.5 dBm Supply Voltage: 1.8-3.6 V Transming Distance: 10 meters Athorized Component Please use the TRANSTEK authorized adapter. AUTHORIZED COMPONENT Adapter Type: BLJ06L060100P-U Input: 100-240 V, 50-60 Hz, 0.2A max Output:
6V 1000 mA Contact Information For more informaon about our products, please visit www.transtekcorp.com. You can get customer service, usual problems and customer download, Transtek will serve you anyme. 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 26 WARNING: No modicaon of this equipment is allowed. 27 FCC STATEMENT FCC Statement FCC ID:OU9TMB1491BJ This device complies with Part 15 of the FCC Rules. Operation is subject to the following two conditions: (1) this device may not cause harmful interference, and (2) this device must accept any interference received, including interference that may cause undesired operation. Caution: The user is cautioned that changes or modifications not expressly approved by the party responsible for compliance could void the user's authority to operate the equipment. NOTE: This equipment has been tested and found to comply with the limits for a Class B digital device, pursuant to Part 15 of the FCC Rules. These limits are designed to provide reasonable protection against harmful interference in a residential installation. This equipment generates, uses and can radiate radio frequency energy and, if not installed and used in accordance with the instructions, may cause harmful interference to radio communications. However, there is no guarantee that interference will not occur in a particular installation. 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. COMPLIED STANDARDS LIST Complied Standards List Risk management EN ISO 14971:2019 / ISO 14971:2019 Medical devices - Application of risk management to medical devices Labeling User manual of medical devices 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 EN 60601-1:2006+A1:2013+A12:2014 / 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 IEC80601-2-30:2018 Medical electrical equipment - Part 2-30:
Particular requirements for the basic safety and essential performance of automated non-invasive sphygmomanometers General Requirements for Safety Electromagnetic compatibility Performance requirements Clinical investigation EN ISO 81060-2:2019/ISO 81060-2:2018, Non-invasive sphygmomanometers - Part 2: Clinical validation of automated measurement type Usability 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 Software life-cycle processes EN 62304:2006/AC: 2008 / IEC 62304: 2006+A1:2015 Medical device software - Software life-cycle processes Bio-compatibility Tests for in vitro cytotoxicity 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:
ISO 10993-10:2010 Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization 28 29 EMC GUIDANCE EMC Guidance The ME EQUIPMENT or ME SYSTEM is suitable for home healthcare environments. Warning: Dont be near the active HF surgical equipment and the RF shielded room of an ME system for magnetic resonance imaging, where the intensity of EM disturbances is high. Warning: Use of this equipment adjacent to or stacked with other equipment should be avoided because it could result in improper operation. If such use is necessary, this equipment and the other equipment should be observed to verify that they are operating normally. Warning: Use of accessories, transducers and cables other than those specified or provided by the manufacturer of this equipment could result in increased electromagnetic emissions or decreased electromagnetic immunity of this equipment and result in improper operation. Warning: Portable RF communications equipment (including peripherals such as antenna cables and external antennas) should be used no closer than 30 cm (12 inches) to any part of the equipment TMB-1491-BHJ including cables specified by the manufacturer. Otherwise, degradation of the performance of this equipment could result. Technical description 1. All necessary instructions for maintaining BASIC SAFETY and ESSENTIAL PERFORMANCE with regard to electromagnetic disturbances for the excepted service life. 2. Guidance and manufacturers declaration-electromagnetic emissions and Immunity. Guidance and manufacturers declaration - electromagnetic emissions Emissions test Compliance Table 1 RF emissions CISPR 11 RF emissions CISPR 11 Harmonic emissions IEC 61000-3-2 Voltage fluctuations /
flicker emissions IEC 61000-3-3 30 Group 1 Class [ B ]
Class A Comply 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. 31 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 Modulation
(W) Distance
(m) IMMUNITY TEST LEVEL
(V/m) 1.8 0.3 27 0.3 28 0.2 0.3 9 0.3 28 0.3 28 Pulse modulation b) 18 Hz FM c) 5k Hz deviation 1 kHz sine Pulse modulation b) 217 Hz Pulse modulation b) 18 Hz Pulse modulation b) 217 Hz 2 2 2 2 385 380-390 TETRA 400 450 430-470 GMRS 460, FRS 460 704-787 800-960 1700-
1990 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 7 710 745 780 810 870 930 1720 1845 1970 5240 5500 5785 2450 2400-
2570 Pulse modulation 217 Hz 0.3 28 5100-
5800 WLAN 802.11 a/n Pulse modulation 217 Hz 0.2 0.3 9 32
1 | Label format and location | ID Label/Location Info | 880.91 KiB | May 24 2021 |
PO#2BEBS0884 TMB-1491-BHJ FDA Dimension49.70X19.70mm,Thickness0.05mm 25#
+Pantone Reflex Blue SN:BS0884210500018D
: TMB-1491-BHJ Model AC adaptor powered mode: 6V 1A
(Please use the AC adaptor which authorized by the manufacturer!) Rating: 4AAA batteries, 6V Guangdong Transtek Medical Electronics Co., Ltd. Zone B, No.105, Dongli Road, Torch Development District, Zhongshan, 528437, Guangdong, China IP Degree: IP20 Made in China FCC ID OU9TMB1491BJ GS1 Datamatrix
(UDI) 2021-05
(01)XXXXXXXXXXXXXX
(21)BS0884210500018D SN 49.700.20 Location:
0 2
. 0 0 7
. 9 1
1 | Agent authorization | Cover Letter(s) | 199.99 KiB | May 24 2021 |
Guangdong Transtek Medical Electronics Co.,Ltd Date: 2021-04-20 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 | Request for confidentiality | Cover Letter(s) | 172.24 KiB | May 24 2021 |
Guangdong Transtek Medical Electronics Co.,Ltd OU9TMB1491BJ 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:2021-04-20
frequency | equipment class | purpose | ||
---|---|---|---|---|
1 | 2021-05-24 | 2402 ~ 2480 | DTS - Digital Transmission System | Original Equipment |
app s | Applicant Information | |||||
---|---|---|---|---|---|---|
1 | Effective |
2021-05-24
|
||||
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 |
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 |
TMB1491BJ
|
||||
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 | |||||
n/a | ||||||
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 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