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version:1.0 User Manual Blood Pressure Monitor TMB-2266 Arm Type Guangdong Transtek Medical Electronics Co., Ltd. Zone A, No.105 ,Dongli Road, Torch Development District, 528437 Zhongshan, Guangdong,China Thank you very much for selecting TRANSTEK Blood Pressure Monitor TMB-2266 Please do read the user manual carefully and thoroughtly so as to ensure the safe usage of this product, and keep the manual well for further reference in case you have problems. Table of Contents INTRODUCTION..................................................................................................................2 CATALOGUE General Description Indications for Use Contraindications Measurement Principle Safety Information LCD Display Signal Monitor Components List BEFORE YOU START..........................................................................................................8 The Choice of Power Supply Installing and Replacing the Batteries Setting Date, Time and Voice Pair a smart device with the monitor MEASUREMENT................................................................................................................15 Applying the Cuff Start the Measurement DATA MANAGEMENT........................................................................................................20 Recall the Records Delete the Records INFORMATION FOR USER...............................................................................................24 Tips for measurement Maintenances 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 EMC GUIDANCE................................................................................................................31 FCC STATEMENT..............................................................................................................34 1 INTRODUCTION General Description Thank you for selecting TRANSTEK blood pressure monitor (TMB-2266). 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-2266 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:
71mm82 mm Digital LCD display with white backlight Maximum 199 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 from 22cm to 32cm, 22cm to 42cm, 22cm to 45cm. It is intended for adult indoor use only. 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 Safety Information The signs below might be in the user manual, labeling or other component. They are the requirement of standard and using. Refer to instruction manual/booklet To signify that the instruction manual/
booklet must be read. Type BF applied part Direct Current Serial Number Date and Country of manufacture Manufacturer Recyclable For indoor use only Symbol for Class II Equipment MR Unsafe To identify an item which poses unacceptable risks to the patient, medical staff or other persons within the MR environment. Caution Indicates that caution is necessary when operating the device or control close to where the symbol is placed, or that the current situation needs operator awareness or operator action in order to avoid undesirable consequences. The symbol indicates that the product should not be discarded as unsorted waste but must be sent to separate collection facilities for recovery and recycling. 2 3 INTRODUCTION CAUTION
* This device is intended for indoor, home use.
* This device is not intended for public use.
* This device is portable, but it is not intended for use during patient transport.
* This device is not suitable for continuous monitoring during medical emergencies or operations.
* This device is intended for no-invasive measuring and monitoring of arterial blood pressure. It is not intended for use on extremities other than the arm, or for any purpose other than obtaining a blood pressure measurement.
* This device is for adults. Do not use this device on neonates or infants. Do not use it on children unless otherwise instructed by a medical professional.
* Do not use on the women in pregnant, including pre-eclamptic, patients.
* The device is not suitable for use on patients with implanted, electrical devices, such as cardiac pacemakers, defibrillators.
* The effectiveness of this device has not been established for use:
-on users with common arrhythmias such as atrial or ventricular premature beats or atrial fibrillation,
-on users with peripheral arterial disease,
-on users undergoing intravascular therapy, or with arteriovenous (AV) shunt. Consult a medical professional before use.
* Do not use this device for diagnosis or treatment of any health problem or disease. Contact your physician if you have or suspect any medical problem. Do not change your medications without the advice of your physician or health care professional.
* If you are taking medication, consult your physician to determine the proper time to measure your blood pressure.
* This device may be used only for the intended use described in this manual, the manufacturer shall have no liability for any incidental, consequential, or special damages caused by misuse or abuse.
* Report any unexpected operation or events to the manufacturer.
* Do not apply the cuff on an arm that has an intravenous drip or a blood transfusion attached.
* Warning: Do not kink, fold, stretch, compress, or otherwise deform the tube during measuring, as the cuff pressure might continuously increase, which could prevent blood flow and result injury.
* Warning: Taking blood pressure measurements too frequently could disrupt blood circulation and cause injuries.
* Warning: Do not apply cuff to areas on patient where skin is delicate or damaged. Check cuff site frequently for irritation.
* Warning: Do not place the cuff on the arm of a person whose arteries or veins are undergoing medical treatment, i.e. intra-vascular access or intra-vascular therapy or an arteriovenous (A-V) shunt, which could disrupt blood circulation and cause injuries.
* Do not place the cuff on the arm on the same side of a mastectomy (especially when lymph nodes have been removed). it is recommended to take measurements on the unaffected side.
* Do not wrap the cuff on the same arm to which another monitoring device is applied. One or both devices could temporarily stop functioning if you try to use them at the same time.
* Please check that the operation of the device do not result in prolonged impairment of patient blood circulation.
* Warning: On the rare occasion of a fault causing the cuff to remain fully inflated during measurement, loosen and remove the cuff immediately. Prolonged high pressure applied to the arm (cuff pressure >300 mmHg or constant pressure >15 mmHg for more than 3 minutes) might lead to bruising and discolored skin.
* Warning: Do not use this device with high-frequency (HF) surgical equipment at the same time. INTRODUCTION CAUTION
* Warning: This device is not AP/APG equipment. Do not use the device where flammable anesthetic are present, or in environments mixture with air of with oxygen or nitrous oxide.
* The device contains sensitive electronic components.To avoid measurement errors, avoid taking blood pressure measurements near a strong electromagnetic field radiated interference signal or electrical fast transient/burst signal.
* Wireless communication equipment, such as wireless home network devices, mobile phones, cordless telephones and their base stations, walkie-talkies may cause interference that may affect the accuracy of measurements. A minimum distance of 1 foot (30 cm) should be kept from such devices during a measurement.
* You can use this device to take your own measurement, no third-party operator is required.
* Please use the device under the environment which is provided in the user manual. Otherwise, the performance and lifetime of the device will be impacted and reduced.
* The device may require up to 30 minutes to warm up / cool down from the minimum / maximum storage temperature before it is ready for use.
* Warning: Excessive cuff tube lengths could cause strangulation if you don't manage them properly.
* Warning: Do not touch output of the batteries/adapter and the user simultaneously.
* Adapter is specified as a part of ME EQUIPMENT.
* Warning: The power cord is considered the disconnect device for isolating this equipment from supply mains. Do not position the equipment so that it is difficult to reach or disconnect.
* The blood pressure monitor, its adapter, and the cuff are suitable for use within the patient environment.
* Warning: Do not use this device if you are allergic to polyester, nylon, or plastic.
* Warning: Only use accessories approved by manufacturer. Using unapproved accessories might cause damage to the unit and injure users.
* Warning: If you experience discomfort during a measurement, such as pain in the arm or other complaints, press the Power button immediately to release the air from the cuff.
* No calibration is required within two years of reliable service.
* Do not attempt to repair the unit yourself if it malfunctions. Only have repairs carried out by authorized service centers.
* At the request of authorized service personnel, circuit diagrams, component part lists, descriptions, and calibration procedures will be made available by the manufacturer or distributor.
* It is recommended that the performance should be checked after repair, maintenance, and every two years of use, by retesting the requirements in limits of the error of the cuff pressure indication and air leakage (testing at least at 50 mmHg and 200 mmHg).
* Warning: Do not use the device while under maintenance, or being serviced.
* Store your device, cuff and adapter in a clean and dry place, protect it against extreme moisture, heat, lint, dust and direct sunlight. Never place any heavy objects on it.
* Make sure the rubber tube of the cuff is not squeezed, stretched, or kinked during storage.
* Warning: Keep the device, cuff, and batteries away from children as they may pose a risk of choking or strangulation if used improperly.
* Clean both device and cuff with a soft, dry cloth. If necessary use a dampened cloth and natural detergent. Do not use alcohol, benzene, or other harsh chemicals.
* Do not wash the cuff in a washing machine or dishwasher!
* 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.
* Dispose of accessories, detachable parts, and the device according to the local guidelines. 4 5 INTRODUCTION LCD display signal SYMBOL DESCRIPTION EXPLANATION Systolic blood pressure High pressure result Diastolic blood pressure Low pressure result Pulse display Pulse in beats per minute Blood pressure level Indicate blood pressure level User ID User 1/2/G Current Time Time(year:month:day:hour:minute) 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 Memory Query Indicate it is in the memory mode and which group of memory it is. Cuff wearing The cuff is secured Bluetooth icon Indicate the bluetooth is working Voice Broadcast The funcon of Voice Broadcast is o. Triple Mode Connous measurement for three mes and then display the average of three mes measurement result. Monitor Components CUFF AIR CONNECTOR PLUG AIR HOSE INTRODUCTION pressure measuring system Component list of 1 Cuff 2 Air Hose 3 PCBA 4 Pump 5 Valve LCD DISPLAY USER SWITCH DC POWER SOCKET MEMORY BUTTON TRIPLE MODE BUTTON USER BUTTON START/ STOP BUTTON BATTERY COMPARTMENT List 1.Blood Pressure Monitor
(TMB-2266) 2.Cuff (Type BF applied part)
(22cm~32cm or 22cm~42cm or 22cm~45cm) 3. 4AAA batteries 4.User manual 6 7 BEFORE YOU START BEFORE YOU START The Choice of Power Supply 1. Battery powered mode:
6VDC 4AAA batteries 2. 5V 1A AC adaptor powered mode:
(Please only use the recommended AC adaptor model). Please unplug the adaptor to depart from the using utility power. CAUTION AC adaptor Setting Date,Time and Voice It is important to set the clock before using your blood pressure monitor, so that a time stamp can be assigned to each record that is stored in the memory. (The setting range of the year :20222052 time format: 12H/24H) 1. When the monitor is off, press and hold the USER button, it will display the bluetooth symbol first, then press the START/STOP button to enter the
[year] setting, press the USER or MEMORY button to change the year. Type-C cable Press and hold the USER button to quickly advance the years. Press and hold the MEMORY button to quickly go backwards through the years. In order to get the best effect and protect your monitor,please use the the right batteries and special power adaptor which complies with local safety standard. Installing and Replacing the Batteries Open the battery cover. Install the batteries by matching the correct polarity, as shown. Replace the battery cover. Replace the batteries whenever the below happen The bAt Lo 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. 2. Press the START/STOP button to confirm the year, then the [date format]
will flash. Press the USER or MEMORY button to switch the date format between [month/day] and [day/month]. 8
[month/day] format
[day/month] format 9 BEFORE YOU START BEFORE YOU START 3. Press the START/STOP button to confirm the date format, then the month will flash. Repeat the same steps to change the month, day, time format, hour and minute. Voice volume 2, broadcast Voice on Voice volume 1 broadcast Voice on Month Day Time format Hour Minute 4. After the minute is set, it will enter the vocie setting. It will speak Voice on Voice off or Voice off, press the USER or MEMORY button to change the Vioce volume. Each press USER button will increase the voice volume by one in a cycling manner (voice volume 2 - OFF - 1 - 2 ...). Each press MEMORY button will decrease the volume by one in a cycling manner (voice volume 2 -1 - OFF - 2 ...). 5. Press the START/STOP button to confirm the voice setting. The LCD will display do nE and then turn off after several seconds. 10 11 BEFORE YOU START BEFORE YOU START Pair a smart device with the monitor You are the intended operator of this blood pressure monitor. You can measure your blood pressure and then save and send measurement data to a smart device (such as smartphone or tablet) with Bluetooth wireless connectivity and application. 1. Turn on the Bluetooth and the app on your smart device. Make sure both are ON when pair-up is proceeding. 2. When the monitor is off, press and hold the START/STOP button to start pair-up, the bluetooth symbol will flash. If unsuccessful within 60 seconds, it is judged timeout and the monitor will shut off. RF Frequency Range: 2402 MHz to 2480 MHz Output Power Range: -1.57dBm Supply Voltage: 1.8-3.6 V Transmitting Distance: 10 meters List of compatible devices:
For iOS devices:
The operating system must be iOS 13.0 or more. For Android devices:
The operating system must be Android 5.0 or more. CAUTION 3. If successful, the bluetooth symbol will not flash any more and the monitor will automatically shut off after several seconds. BEFORE YOU START Note The date and time on your monitor will automatically be set after paired with your smart device successfully. Interference may occur in the vicinity of equipment marked with the following symbol . And TMB-2266 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
(especially the head) when the data transmission is proceeding 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 wireless transmission / Transmitter) should be kept at least 1 meter away from the monitor. 1. 2. 12 13 BEFORE YOU START Setting a user ID There are 3 user ID available. The user and , each with 199 memory spaces, are designed for 2 different people to save the measured values separately. The user , no memory space, is reserved for guest. 1. When the monitor is off, press the USER button to display the current user ID and flash. Press the USER button to switch the user ID between the user , and . 2. Press the START/STOP button to confirm the selected user ID, the User ID will not flash any more and the monitor will enter the measurement automatically. MEASUREMENTT 2~3cm Applying the cuff 1. 2. 3. Remove all jewelry, such as watches and bracelets from your left arm. Note: If your doctor has diagnosed you with poor circulation in your left arm, use your right arm. Roll or push up your sleeve to expose the skin. Make sure your sleeve is not too tight. Hold your arm with your palm facing up and tie the cuff on your upper arm, align the Artery indicator with the main Artery (on the inside of your arm). Note: Locate the main Artery by pressing with 2 fingers approximately 2 cm above the bend of your elbow on the inside of your left arm. Identify where the pulse can be felt the strongest, that is your main Artery 4. Make sure the bottom edge of the 5. arm cuff 2 to 3 cm above the inside elbow. Then wrap the cuff securely. Note: The cuff should be snug but not too tight. You should be able to insert one finger between the cuff and your arm. Sit upright in a comfortable chair with your back against the backrest of the chair. Keep your feet flat and your legs uncrossed. Place your arm resting comfortably on a flat table. The cuff worn on your arm should be placed at the same level as your right atrium of the heart. 6. Take 5-6 deep breaths and let's start measuring!
14 Helpful tips:
Take the measurement in a silent room. Rest for 5 minutes before a measurement. Wait at least 3 minutes before another measurement. This allows your blood circulation to recover. Be relax and do not move and talk during the measurement procedure. For a meaningful comparison, try to measure under similar conditions. For example, take daily measurements at approximately the same time, on the same arm, or as directed by a physician. 15 MEASUREMENT Start the Measurement A. Single measurement 1. When the monitor is OFF, press the START/STOP button, it will finish the whole measurement automatically, save and transmit the measurement data for the selected user. (Take User 1 with voice on for example.) MEASUREMENT B. Triple mode measurement 1. When the monitor is OFF, press the TRIPLE MODE button, it will finish the whole measurement automatically, save and transmit the measurement data for the selected user. (Take User 1 with voice on for example.) After the first and second measurements are completed, there will be no results. After all three measurement is completed, the average results of the three measurements will be displayed. Display the latest measurement record. Adjust the zero. It will read starting measurement, please remain still and quiet Cuff wrap detection. symbol flash Display the latest measurement record. Adjust the zero. It will read starting measurement, please remain still and quiet Cuff wrap ok. Inflating and measuring. Display, save and read the measurement result your blood pressure is 116 over 78, pulse is 80 Cuff wrap detection. symbol flash Cuff wrap ok. Inflating and measuring. 16 17 MEASUREMENT MEASUREMENT 3. Press START/ STOP button to turn off, otherwise it will turn off automatically. Note 1. Any time if you want to stop the measurement, you can press the START/ STOP button manually. 2. When the selected user has history memory record, the monitor will display its last measurement record first before starting measurement. 4. About the irregular heartbeat and excessive body motion during the measurement. During a measurement, If an irregular heartbeat is detected, the symbol will display in the measurement result. See page 26 for more information. During a measurement, when the excessive body motion, especially of the arm the cuff is worn is detected, the symbol will flash about 5 seconds and detect again. If it is no longer detected, the symbol will disappear; If still detected, the symbol will final display in the measurement result. Note The measured blood pressure reading may not be accurate if this symbol is displayed. The second measurement
(60 seconds countdown display) The third measurement
(60 seconds countdown display) Display, save and read the measurement result your blood pressure is 120 over 80, pulse is 90 2. After the measurement was finished, the bluetooth symbol blinks and data transmission starts. (Please connect the app during the transmission) If data transmission successful, the symbol will not blink and will disappear, after sevral seconds, will also disappear, and then the monitor will turn off automatically after about 1 minute. If unsuccessful within 60 seconds, it is judged timeout and the monitor will shut off. 18 19 Transmission successful. DATA MANAGEMENT Recall the Records 1.When the monitor is off, press the MEMORY button, the user ID will blink, you can press the USER or MEMORY button to switch the user ID between user and . DATA MANAGEMENT Note The most recent record (1) is shown first. Each new measurement is assigned to the first (1) record. All other records are pushed back one digit (e.g., 2 becomes 3, and so on), and the last record (199) is dropped from the list. 3. Press the USER or MEM button to display the next record. 2. Press the START/STOP button to confirm the selected user ID. Then the LCD will display the latest record. (Example shown below for User 1) When the voice is on, it will read the memory value for you at the same time.
(Take the right memory record 01 for example, it will speak memory 1, your blood pressure is 120 over 80, pulse is 80) Date,Time and Year will display alternately. The current record is Group 2. The corresponding year is 2022. Latest memory record 01 The corresponding date is January 1st. The corresponding time is 08:38 (a.m.). 20 21 DATA MANAGEMENT Delete the Records If you did not get the correct measurement, you can delete results by following steps below. A: To delete a single measurement:
1. Enter the memory recall mode as described in section [Recall the Records]. Press the USER or MEMORY button to get the measurement you would like to erase. 2. Press and hold MEMORY button for about 5 seconds, and the display will show a blinking dEL y. 3. Use the USER or MEMORY button to switch between dEL y and dEL no, Press START/STOP to confirm the selection. If dEL y is selected, the unit will delete the record, after then it will return to last memory record and all the records are pushed forward one digit (e.g., 03 becomes 02, and so on) If dEL no is selected, it will stop the deletion. DATA MANAGEMENT B: To delete all measurements:
1. Enter the memory recall mode as described in section [Recall the Records]. 2. Press and hold USER and MEMORY button button for 5 seconds, and the display will show a blinking dEL AL along with the user ID. 3. Use the USER or MEMORY button to switch between dEL AL and dEL no, Press START/STOP to confirm the selection. If dEL AL is selected, the unit will display dEL do nE + User ID, and delete all the record of the current user. Several seconds later, it will display ---. If dEL no is selected, it will stop the deletion. dEL AL blinks dEL no blinks dEL y blinks dEL no blinks 22 23 Deletion is done No record INFORMATION FOR USER DATA MANAGEMENT Tips for Measurement Measurements may be inaccurate if taken in the following circumstances. INFORMATION FOR USER Maintenance In order to get the best performance, please follow the instructions below. Within 1 hour after dinner or drinking Immediate measurement after tea, coffee, smoking 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 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. In a very cold environment When you want to discharge urine 24 25 ABOUT BLOOD PRESSURE ABOUT BLOOD PRESSURE What are systolic pressure and diastolic pressure?
When ventricles contract and pump blood out of the heart, the blood pressure reaches its maximum value in the cycle, which is called systolic pressure. When the ventricles relax, the blood pressure reaches its minimum value in the cycle, which is called diastolic pressure. Systolic blood discharging artery Diastolic blood entering vein press relax What is the standard blood pressure classification?
The blood pressure classification published by World Health Organization (WHO) and International Society of Hypertension (ISH) in 1999 is as follows:
CAUTION Only a physician can tell your normal BP range. Please contact a physician if your measuring result falls out of the range. Please note that only a physician can tell whether your blood pressure value has reached a dangerous point. Level Blood Pressure (mm Hg) SYS DIA Optimal Normal High-normal Mild Moderate Severe
<120 120-129 130-139 140-159 160-179 180
<80 80-84 85-89 90-99 100-109 110 Irregular 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. 26 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. 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 for 4-5 minutes until 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 different results for different people. We suggest you measure the same arm every time. 27 TROUBLESHOOTING SPECIFICATIONS If any abnormality arises during use, please check the following points:
PROBLEM SYMPTOM CHECK THIS REMEDY No power Display can not light up. Batteries are depleted. Replace with new batteries. Batteries are inserted incorrectly. Insert the batteries correctly. Adapter is inserted incorrectly. Insert the AC adapter correctly. bAt H shows The battery is too high. Replace with the correct DC plug. High Battery Low Battery Error message bAt Lo&
shows E 1 shows E 2 or shows E 3 shows E 4 shows EExx shows The battery is too low. Replace with new batteries. The cuff is not wrapped or wrapped incorrectly, or the cuff air plug is loose. Excessive body motion
(such as shaking of the arm with the cuff on) or weak Pulse is detected. Refasten the cuff and insert air tube plug correctly then measure again. Relax for 5 minutes. and then keep still, measure again. Pulse is not detected during measuring. Loosen the clothing on the arm and measure again. The measurement failed. Relax for 5 minutes and measure again. A calibration error occurred (XX can be some digital symbol, such as 01, 02,etc., if this similar situation appear, all belong to calibration 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 i nstructions. Relax for a moment and then measure again. If the problem persists, contact your physician. Warning message out shows Out of measurement range Power supply Display mode Measurement mode Measurement range Accuracy Normal working condition Battery powered mode:
AC adaptor powered mode:
(Please only use the recommended AC adaptor model). 5V 1A 6VDC 4AAA batteries Digital LCD V.A.71mm 82mm Oscillographic testing mode Rated cuff pressure:
0mmHg~299mmHg Measurement pressure:
SYS: 60mmHg~230mmHg DIA: 40mmHg~130mmHg Pulse value: (40-199)beat/minute Pressure:
5-40within3mmHg Pulse value:5%
A temperature range of :+5C to +40C A relative humidity range of 15% to 90%, non-condensing An atmospheric pressure range of :
700 hPa to 1060 hPa Storage & transportation condition Temperature:-20C to +60C A relative humidity range of 93%, non-condensing Measurement perimeter of the upper arm Weight External dimensions Attachment Mode of operation Degree of protection Protection against ingress of water Device Classification About 22 cm ~ 32 cm, 22cm ~ 42cm, 22cm ~ 45cm Approx.278g (Excluding the batteries and cuff) Approx.100mmx138mmx51mm 4AAA batteries,user manual, Type-C cable 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 NOTE: If the product still does not work, contact Customer Service. Under no circumstance should you disassemble or attempt to repair the unit by yourself. Software Version A01 28 WARNING: No modification of this equipment is allowed. 29 AUTHORIZED COMPONENT Authorized Component 1.please use the TRANSTEK authorized adapter. Adapter Type: BLJ06L060100P-U Input: 100-240V, 50-60Hz, 0.2A max Output: 5V 1000 mA Contact Information For more information about our products, please visit www.transtekcorp.com. Manufactured by:
Guangdong Transtek Medical Electronics Co., Ltd. Company:
Guangdong Transtek Medical Electronics Co., Ltd. Address:
Zone A, No.105, Dongli Road, Torch Development District, 528437 Zhongshan, Guangdong, China EMC GUIDANCE 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-2266 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. Table 1 Guidance and manufacturers declaration - electromagnetic emissions Emissions test Compliance RF emissions CISPR 11 RF emissions CISPR 11 Harmonic emissions IEC 61000-3-2 Voltage fluctuations /
flicker emissions IEC 61000-3-3 Group 1 Class [ B ]
Class A Comply 30 31 EMC GUIDANCE Table 2 Table 3 EMC GUIDANCE Guidance and manufacturers declaration electromagnetic Immunity 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 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. Radiated RF IEC61000-4-3
(Test specifications for ENCLOSURE PORT IMMUNITY to RF wireless communicati-
ons equipment) Test Frequency
(MHz) Band
(MHz) Service Modulation 385 380-390 TETRA 400 450 430-470 GMRS 460, FRS 460 704-787 800-960 1700-
1990 710 745 780 810 870 930 1720 1845 1970 2450 2400-
2570 LTE Band 13, 17 GSM 800/900, TETRA 800, iDEN 820, CDMA 850, LTE Band 5 GSM 1800;
CDMA 1900;
GSM 1900;
DECT;
LTE Band 1, 3, 4,25;
UMTS Bluetooth, WLAN, 802.11 b/g/n, RFID 2450, LTE Band 7 Pulse modulation 18 Hz FM 5k Hz deviation 1 kHz sine Pulse modulation 217 Hz Pulse modulation 18 Hz Pulse modulation 217 Hz Pulse modulation 217 Hz 5100-
5800 WLAN 802.11 a/n Pulse modulation 217 Hz 5240 5500 5785 Maximum Power
(W) Distance
(m) IEC 60601-1-2 Test Level
(V/m) 1.8 0.3 27 2 0.3 28 0.2 0.3 9 Compliance level
(V/m) 27 28 9 2 2 2 0.3 28 28 0.3 28 28 0.3 28 28 0.2 0.3 9 9 32 33 FCC STATEMENT FCC Statement FCC ID: OU9-TMB-2266 FCC Regulatory Compliance Changes or modifications not expressly approved by the party responsible for compliance could void the users authority to operate the equipment. This equipment has been tested and found to comply with the limits for a Class B digital device, pursuant to Part 15 of the FCC Rules. These limits are designed to provide reasonable protection against harmful interference in a residential installation. This equipment generates, uses and can radiate radio frequency energy and, if not installed and used in accordance with the instructions, may cause harmful interference to radio communications. However, there is no guarantee that interference will not occur in a particular installation. If this equipment does cause harmful interference to radio or television reception, which can be determined by turning the equipment off and on, the user is encouraged to try to correct the interference by one or more of the following measures:
-- Reorient or relocate the receiving antenna.
-- Increase the separation between the equipment and receiver.
-- Connect the equipment into an outlet on a circuit different from that to which the receiver is connected.
-- Consult the dealer or an experienced radio/TV technician for help. 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. RF Exposure Compliance This equipment complies with FCC radiation exposure limits set forth for an uncontrolled environment. This transmitter must not be co-located or operating in conjunction with any other antenna or transmitter. 34
1 | Internal Photos | Internal Photos | 548.81 KiB | September 27 2022 / March 27 2023 | delayed release |
1 | External Photos | External Photos | 592.57 KiB | September 27 2022 / March 27 2023 | delayed release |
1 | Label | ID Label/Location Info | 401.72 KiB | September 27 2022 |
Dimension50.0 x 19.0 mm Material60# paper with white background Colour Pantone Reflex Blue C TMB-2266 label SN2BS1096220700001-2BS1096220700050 Model: TMB-2266 Rating: Battery powered mode: 4x AAA batteries, 6V Blood Pressure Monitor IP Classification: IP21 AC adapter powered mode: 5V 1A
(Please use the AC adapter authorized by the manufacturer!) Guangdong Transtek Medical Electronics Co., Ltd. Zone A, No.105, Dongli Road, Torch Development District, 528437 Zhongshan, Guangdong, China FCC ID: OU9-TMB-2266 FCC Statement:
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. Made in China 2022-07
(01) xxxxxxxxxxxxxx SN (21) 2BS1096220700001 GS1 Datamatrix
(UDI) Location:
1 | Authorization Letter | Cover Letter(s) | 257.25 KiB | September 27 2022 |
Guangdong Transtek Medical Electronics Co.,Ltd Date: 2022/07/28 TO:
Federal Communication Commission Equipment Authorization Branch 7435 Oakland Mills Road Columbia, MID 21046 Regarding: FCC ID: OU9-TMB-2266 To whom it may concern:
We, the undersigned, hereby authorize Compliance Certification Services (Kunshan) Inc to act on our behalf in all manners relating to application for equipment authorization with respect to the FCC ID above, including signing of all documents relating to these matters. Any and all acts carried out by the agent on our behalf shall have the same effect as acts of our own. We, the undersigned, hereby certify that we are not subject to a denial of federal benefits, that includes FCC benefits, pursuant to Section 5301 of the Anti-Drug Abuse Act of 1988, 21 U.S.C. 853(a). Where our agent signs the application for certification on our behalf, I acknowledge that all responsibility for complying with the terms and conditions for Certification, as specified by SGS North America, Inc., still resides with Guangdong Transtek Medical Electronics Co., Ltd. This authorization is valid until further written notice from the applicant. Print Name: Jerry Fan Title: RA Manager Signature:
On behalf of Company: Guangdong Transtek Medical Electronics Co., Ltd. Telephone: +86-760-85166220 E-mail: gt-rateam@transtekcorp.com
1 | Confidentiality Letter | Cover Letter(s) | 76.23 KiB | September 27 2022 |
Guangdong Transtek Medical Electronics Co.,Ltd TO:
Federal Communication Commission Equipment Authorization Branch 7435 Oakland Mills Road Columbia, MID 21046 Regarding:
Confidentiality Request regarding application for FCC ID: OU9-TMB-2266 LONG TERM CONFIDENTIALITY Pursuant to 47 CFR Section 0.459 and 0.457 of the commissions rules, the applicant hereby request confidential treatment of the documents listed below, associated with the certification application referenced above. Schematic(s) Block Diagrams Operational Descriptions The documents above contain proprietary information not released to the public. Public disclosure of this information may prove harmful to the business of the applicant. SHORT TERM CONFIDENTIALITY Additionally, the applicant requests the following documents be held confidential until the device is marketed or 180 days from the grant date, whichever is less. period, the applicant will notify the TCB per FCC KDB 726920 D01 Confidentiality Request Procedures. If the device is marketed within confidential External Photos Internal Photos Test Setup Photos User manual(s) Sincerely, Print Name: Jerry Fan Title: RA Manager Signature:
On behalf of Company: Guangdong Transtek Medical Electronics Co.,Ltd Telephone: +86-760-85166220 E-mail: gt-rateam@transtekcorp.com
1 | Test Setup Photos | Test Setup Photos | 342.07 KiB | September 27 2022 / March 27 2023 | delayed release |
frequency | equipment class | purpose | ||
---|---|---|---|---|
1 | 2022-09-27 | 2402 ~ 2480 | DTS - Digital Transmission System | Original Equipment |
app s | Applicant Information | |||||
---|---|---|---|---|---|---|
1 | Effective |
2022-09-27
|
||||
1 | Applicant's complete, legal business name |
Guangdong Transtek Medical Electronics Co.,Ltd
|
||||
1 | FCC Registration Number (FRN) |
0021999248
|
||||
1 | Physical Address |
Zone A, No.105,Dongli Road
|
||||
1 |
Zhongshan, Guangdong, N/A 528437
|
|||||
1 |
China
|
|||||
app s | TCB Information | |||||
1 | TCB Application Email Address |
U******@SGS.COM
|
||||
1 | TCB Scope |
A4: UNII devices & low power transmitters using spread spectrum techniques
|
||||
app s | FCC ID | |||||
1 | Grantee Code |
OU9
|
||||
1 | Equipment Product Code |
TMB-2266
|
||||
app s | Person at the applicant's address to receive grant or for contact | |||||
1 | Name |
J****** F****
|
||||
1 | Title |
RA Manager
|
||||
1 | Telephone Number |
+86-7********
|
||||
1 | Fax Number |
+86-7********
|
||||
1 |
g******@transtekcorp.com
|
|||||
app s | Technical Contact | |||||
1 | Firm Name |
Compliance Certification Services (Kunshan) Inc
|
||||
1 | Name |
W****** W****
|
||||
1 | Physical Address |
Fuyong Lab Xinlong Techno Park Fengtang Road
|
||||
1 |
Shenzhen
|
|||||
1 |
China
|
|||||
1 | Telephone Number |
+8613********
|
||||
1 | Fax Number |
N/A********
|
||||
1 |
w******@sgs.com
|
|||||
app s | Non Technical Contact | |||||
1 | Firm Name |
Compliance Certification Services (Kunshan) Inc
|
||||
1 | Name |
W******** W****
|
||||
1 | Physical Address |
Fuyong Lab Xinlong Techno Park Fengtang Road
|
||||
1 |
Shenzhen
|
|||||
1 |
China
|
|||||
1 | Telephone Number |
+8613********
|
||||
1 | Fax Number |
N/A********
|
||||
1 |
w******@sgs.com
|
|||||
app s | Confidentiality (long or short term) | |||||
1 | Does this application include a request for confidentiality for any portion(s) of the data contained in this application pursuant to 47 CFR § 0.459 of the Commission Rules?: | Yes | ||||
1 | Long-Term Confidentiality Does this application include a request for confidentiality for any portion(s) of the data contained in this application pursuant to 47 CFR § 0.459 of the Commission Rules?: | Yes | ||||
1 | If so, specify the short-term confidentiality release date (MM/DD/YYYY format) | 03/27/2023 | ||||
if no date is supplied, the release date will be set to 45 calendar days past the date of grant. | ||||||
app s | Cognitive Radio & Software Defined Radio, Class, etc | |||||
1 | Is this application for software defined/cognitive radio authorization? | No | ||||
1 | Equipment Class | DTS - Digital Transmission System | ||||
1 | Description of product as it is marketed: (NOTE: This text will appear below the equipment class on the grant) | Blood Pressure Monitor | ||||
1 | Related OET KnowledgeDataBase Inquiry: Is there a KDB inquiry associated with this application? | No | ||||
1 | Modular Equipment Type | Does not apply | ||||
1 | Purpose / Application is for | Original Equipment | ||||
1 | Composite Equipment: Is the equipment in this application a composite device subject to an additional equipment authorization? | No | ||||
1 | Related Equipment: Is the equipment in this application part of a system that operates with, or is marketed with, another device that requires an equipment authorization? | No | ||||
1 | Grant Comments | Output Power listed is conducted. | ||||
1 | Is there an equipment authorization waiver associated with this application? | No | ||||
1 | If there is an equipment authorization waiver associated with this application, has the associated waiver been approved and all information uploaded? | No | ||||
app s | Test Firm Name and Contact Information | |||||
1 | Firm Name |
Compliance Certification Services (Kunshan) Inc
|
||||
1 | Name |
A**** Z********
|
||||
1 | Telephone Number |
+86 7********
|
||||
1 |
A******@sgs.com
|
|||||
Equipment Specifications | |||||||||||||||||||||||||||||||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Line | Rule Parts | Grant Notes | Lower Frequency | Upper Frequency | Power Output | Tolerance | Emission Designator | Microprocessor Number | |||||||||||||||||||||||||||||||||
1 | 1 | 15C | 2402.00000000 | 2480.00000000 | 0.0007000 |
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