User manual

FCC ID: OU9TMB1490BS

Users Manual

Download: PDF
FCCID_3907665

Document No.: LS-INS-TMB-1490-BS-2 Version: A0 version:1.0 User Manual Blood Pressure Monitor TMB-1490-BS Arm Type FCC ID:OU9TMB1490BS Thank you very much for selecting TRANSTEK Blood Pressure Monitor TMB-1490-BS. Guangdong Transtek Medical Electronics Co., Ltd. Zone B, No.105 ,Dongli Road, Torch Development District, Please do read the user manual carefully and thoroughtly so as to ensure Zhongshan,528437,Guangdong,China the safe usage of this product, and keep the manual well for further reference in case you have problems.

CATALOGUE Table of Contents INTRODUCTION..................................................................................................................2 General Description Indications for Use Contraindications Safety Information LCD Display Signal Monitor Components List BEFORE YOU START..........................................................................................................8 The Choice of Power Supply Installing and Replacing the Batteries Measurement Principle Setting Date, Time and Measurement Unit MEASUREMENT................................................................................................................12 Tie the Cuff Start the Measurement DATA MANAGEMENT........................................................................................................15 Recall the Records Delete the Records INFORMATION FOR USER...............................................................................................17 Tips for measurement Maintenances ABOUT BLOOD PRESSURE.............................................................................................19 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.......................................................................................................21 SPECIFICATIONS..............................................................................................................22 AUTHORIZED COMPONENT ...........................................................................................23 CONTACT INFORMATION.................................................................................................23 FCC STATEMENT...............................................................................................................24 COMPLIED STANDARDS LIST..........................................................................................25 EMC GUIDANCE................................................................................................................26 

INTRODUCTION INTRODUCTION General Description Safety Information The signs below might be in the user manual, labeling or other component. Thank you for selecting TRANSTEK arm type blood pressure monitor They are the requirement of standard and using. (TMB-1490-BS). The monitor features blood pressure measurement, pulse rate measurement and the result storage. The design provides you with Symbol for “THE OPERATION Symbol for “TYPE BF APPLIED GUIDE MUST BE READ” PARTS” two years of reliable service. Symbol for “ENVIRONMENT Readings taken by the TMB-1490-BS are equivalent to those obtained by Symbol for “MANUFACTURE PROTECTION - Electrical waste DATE” a trained observer using the cuff and stethoscope auscultation method. products should not be disposed of with household waste. Please recycle This manual contains important safety and care information, and Symbol for “MANUFACTURER” where facilities exist. Check with your provides step by step instructions for using the product. local authority or retailer for recycling Symbol for “SERIAL NUMBER” advice” Read the manual thoroughly before using the product. SN Symbol for “Class II Equipment” Features: Symbol for “DIRECT CURRENT” 60.5 mm×92.5 mm Digital LCD display F1 7$9ĭ &&& For indoor use only Maximum 250 records per each user 3rd technonoly: Measuring during inflation Caution: These notes must be (The updated technology in the world) observed to prevent any damage Symbol for “Recycle” to the device. Indications for Use The Green Dot is the license symbol of a European network of industry-funded systems for The Transtek Blood Pressure Monitor is digital monitors intended for use in recycling the packaging materials measuring blood pressure and heartbeat rate with arm circumference ranging of consumer goods. IURPFPWRFP DERXWôÝòÝ RUFPWRFP DERXWôÝòÝ  It is intended for adult indoor use only. CAUTION * 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 Contraindications 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; 1.The device is not suitable for use on may be pregnant women or pregnant women. * Wireless communications equipment such as wireless home network devices, mobile phones, cordless 2.The device is not suitable for use on patients with implanted,electrical devices, telephones and their base stations, walkie-talkies can affect this equipment and should be kept at least a distance d away from the equipment. The distance d is calculated by the MANUFACTURER from the 80 such as cardiac pacemakers, defibrillators. MHz to 5.8 GHz column of Table 4 and Table 9 of IEC 60601-1-2:2014, as appropriate. * Please use ACCESSORIES and detachable partes specified/ authorised 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.  

INTRODUCTION INTRODUCTION CAUTION CAUTION * This device is intended for adult use in homes only. * The equipment is not AP/APG equipment and not suitable for use in the presence of a flammable * The device is not suitable for use on neonatal patients, pregnant women,patients with implanted, anesthetic mixture with air of with oxygen or nitrous oxide. electronical devices, patients with pre-eclampsia, premature ventricular beats, atrial fibrillation, peripheral, * Warning: No servicing/maintenance while the ME equipment is in use. arterial disease and patients undergoing intravascular therapy or arterio-venous shunt or people who * The patient is an intended operator. received a mastectomy. Please consult your doctor prior to using the unit if you suffer from illnesses. * The patient can measure, transmit data and change batteries under normal circumstances and maintain * The device is not suitable for measuring the blood pressure of children. Ask your doctor before using it on the device and its accessories according to the user manual. older children. * To avoid measurement errors, please avoid the condition of strong electromagnetic field radiated * The device is not intended for patient transport outside a healthcare facility. interference signal or electrical fast transient/burst signal. * The device is not intended for public use. *The blood pressure monitor, its adaptor, and the cuff are suitable for use within the patient environment. * This device is intended for no-invasive measuring and monitoring of arterial blood pressure. If you are allergic to polyester, nylon or plastic, please don't use this device. It is not intended for use on extremities other than the arm or for functions other than obtaining a blood * During use, the patient will be in contact with the cuff. The materials of the cuff have been tested and pressure measurement. found to comply with requirements of ISO 10993-5:2009 and ISO 10993-10:2010. It will not cause any * Do not confuse self-monitoring with self-diagnosis. This unit allows you to monitor your blood pressure.Do potential sensization or irritation reaction. not begin or end medical treatment without asking a physician for treatment advice. * Adaptor is specified as a part of ME EQUIPMENT. * If you are taking medication,consult your physician to determine the most appropriate time to measure your * If you experience discomfort during a measurement, such as pain in the arm or other complaints, press blood pressure. Never change a prescribed medication without consulting your physician. the START/STOP button to release the air immediately from the cuff. Loosen the cuff and remove it from * Do not take any therapeutic measures on the basis of a self measurement. Never alter the dose of a your arm. medicine prescribed by a doctor. Consult your doctor if you have any question about your blood pressure. * If the cuff pressure reaches 40 kPa (300 mmHg), the unit will automatically deflate. Should the cuff not * When the device was used to measure patients who have common arrhythmias such as atrial or ventricular deflate when pressures reaches 40 kPa (300 mmHg), detach the cuff from the arm and press the premature beats or atrial fibrillation, the best result may occur with deviation. Please consult your physician START/STOP button to stop inflation. about the result. * Before use, make sure the device functions safely and is in proper working condition. Check the device, * Don't kink the connection tube during use, otherwise, the cuff pressure may continuously increase which do not use the device if it is damaged in any way. The continuous use of a damaged unit may cause can prevent blood flow and result in harmful injury to the PATIENT. injury, improper results, or serious danger. * When using this device, please pay attention to the following situation which may interrupt blood flow and * Do not wash the cuff in a washing machine or dishwasher! influence blood circulation of the patient, thus cause harmful injury to the patient: connection tubing kinking * The service life of the cuff may vary by the frequency of washing, skin condition, and storage state. The too frequent and consecutive multiple measurements; the application of the cuff and its pressurization on any typical service life is 10000 times. arm where intravascular access or therapy, or an arterio-venous (A-V) shunt, is present; inflating the cuff on * It is recommended that the performance should be checked every 2 years and after maintenance and the side of a mastectomy. repair, by retesting at least the requirements in limits of the error of the cuff pressure indication and air * Warning: Do not apply the cuff over a wound;otherwise it can cause further injury. leakage (testing at least at 50mmHg and 200mmHg). *Do not inflate the cuff on the same limb which other monitoring ME equipment is applied around * Please dispose of ACCESSORIES, detachable parts, and the ME EQUIPMENT according to the local simultaneously, because this could cause temporary loss of function of those simultaneously-used monitoring guidelines. ME equipment. * Manufacturer will make available on request circuit diagrams, component part lists, descriptions, *On the rare occasion of a fault causing the cuff to remain fully inflated during measurement, open the cuff calibration instructions,etc., to assist to service personnel in parts repair. immediately. Prolonged high pressure (cuff pressure ＞ 300mmHg or constant pressure ＞ 15mmHg for more * The plug/adapter plug pins insulates the device from the main supply. Do not position the device in a than 3 minutes) applied to the arm may lead to an ecchymosis. position where it is difficult to disconnect from the supply mains to safely terminate operation of ME *Please check that operation of the device does not result in prolonged impairment of patient blood equipment. circulation. * The operator shall not touch output of batteries /adapter and the patient simultaneously. * When measurement, please avoid compression or restriction of the connection tubing. * Cleaning :Dust environment may affect the performance of the unit. Please use the soft cloth to clean * The device cannot be used with HF surgical equipment at the same time. the whole unit before and after use. Don’t use any abrasive or volatile cleaners. * The ACCOMPANYING DOCUMENT shall disclose that the SPHYGMOMANOMETER was clinically * The device doesn’t need to be calibrated within two years of reliable service. investigated according to the requirements of ISO 81060-2:2013. * If you have any problems with this device, such as setting up, maintaining or using, please contact the * To verify the calibration of the AUTOMATED SPHYGMOMANOMETER, please contact the manufacturer. SERVICE PERSONNEL of Transtek. Don’t open or repair the device by yourself in the event of * This device is contraindicated for any female who may be suspected of, or is pregnant. Besides providing malfunctions. The device must only be serviced, repaired and opened by individuals at authorized inaccurate readings, the effects of this device on the fetus are unknown. sales/service centers. * Too frequent and consecutive measurements could cause disturbances in blood circulation and injuries. * Please report to Transtek if any unexpected operation or events occur. * This unit is not suitable for continuous monitoring during medical emergencies or operations.Otherwise, the * Keep the unit out of reach of infants, young children or pets to avoid inhalation or swallowing of small patient’s arm and fingers will become anaesthetic, swollen and even purple due to a lack of blood. parts. It is dangerous or even fatal. * 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.  

INTRODUCTION INTRODUCTION LCD display signal MEMORY Monitor Components M CUFF Component list of pressure measuring S system AIR HOSE START 1 Cuff STOP 2 Air pipe TIME/DATE Pul/min 3 PCBA 4 Pump SYMBOL DESCRIPTION EXPLANATION 5 Valve Systolic blood pressure High blood pressure AIR CONNECTOR PLUG DC POWER SOCKET Diastolic blood pressure Low blood pressure USER SWITCH Pul/min Pulse display Pulse in beats per minute MEM BUTTON SET BUTTON Deflation symbol The cuff is deflating. 67$57‡6723%87721 Memory Indicate it is in the memory mode and which group of memory it is. LCD DISPLAY kPa kPa Measurement Unit of the blood pressure BATTERY COMPARTMENT (1kPa=7.5mmHg) Measurement Unit of the blood pressure mmHg mmHg (1mmHg=0.133kPa) Low battery Batteries are low and need to be replaced Blood pressure monitor is detecting an Irregular heartbeat irregular heartbeat during measurement. Blood pressure Indicate the blood pressure level List level indicator 1.Blood Pressure Monitor 2.Cuff (Type BF applied part) Current Time Month/Day/Year, Hour/Minute (TMB-1490-BS) (22cm~32cm or 22cm~42cm) Start measurement,save and transmit the User A measuring results for User A Start measurement,save and transmit the User B measuring results for User B Blood pressure monitor is detecting a 3. 4×AAA batteries 4.User manual 5. AC Adaptor Heartbeat heartbeat during measurement. (BLJ06L060100P-U) The average value The average value of the latest three records Bluetooth icon The bluetooth icon blinks when the bluetooth is working  

BEFORE YOU START BEFORE YOU START The Choice of Power Supply Measurement Principle This product uses the Oscillometric Measuring method to detect blood pressure. 1.Battery powered mode: 6VDC 4×AAA batteries Before every measurement, the unit establishes a “zero pressure” equivalent to the air 2.AC adaptor powered mode: pressure. Then it starts inflating the arm cuff, meanwhile, the unit detects pressure 6V 1A oscillations generated by beat-to-beat pulsatile, which is used to determine the systolic (Please only use the recommended AC and diastolic pressure, and also pulse rate. adaptor model). Please unplug the adaptor to depart from the using utility power. Setting Date, Time and Measurement Unit AC adaptor CAUTION 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 In order to get the best effect and protect your monitor,please use the the right batteries and special power adapter which complies with local is stored in the memory. (The setting range of the year :2017—2057 safety standard. time format:12 H/24H) 1.When the monitor is off, MEMORY Installing and Replacing the Batteries press “SET”button,it will display the time.Then ‡ Open the battery cover. press and hold “ SET ” M ‡ Install the batteries by matching button to enter the the correct polarity, as shown. mode for year setting. S ‡ Replace the battery cover. START STOP TIME/DATE Pul/min Replace the batteries whenever the below happen MEMORY The shows 2.Press the “MEM” to M The display is dim. change the [YEAR]. Each press will increase S The display does not light up the numeral by one in a cycling manner. START CAUTION STOP Do not use new and used batteries together. TIME/DATE Pul/min Do not use different types of batteries together. Do not dispose the batteries in fire. Batteries may explode or leak. Remove batteries if the device is not likely to be used for some time. Worn batteries are harmful to the environment. Do not dispose with daily garbage. Remove the old batteries from the device following your local recycling guidelines.  

BEFORE YOU START BEFORE YOU START 3.When you get the right MEMORY 6.Repeat steps 2 and 3 to set the [HOUR] year, press “SET” to set and [MINUTE]. down and turn to next M step. MEMORY MEMORY S START M M STOP 4.Repeat steps 2 and 3 to set S TIME/DATE Pul/min S the [MONTH] and [DAY]. START START STOP STOP TIME/DATE Pul/min TIME/DATE Pul/min MEMORY MEMORY M M 7.Repeat steps 2 and 3 to set the [UNIT]. S S MEMORY MEMORY START START STOP STOP TIME/DATE Pul/min TIME/DATE Pul/min M M S S START 5.Repeat steps 2 and 3 to set the [TIME FORMAT] STOP START STOP between 12h and 24h. TIME/DATE Pul/min TIME/DATE Pul/min MEMORY MEMORY 8.After the unit is set,the LCD will display MEMORY “dOnE”first,then display all the settings you M M have done and then it will turn off. S S M S START START STOP STOP START TIME/DATE Pul/min TIME/DATE Pul/min STOP TIME/DATE Pul/min  

MEASUREMENT MEASUREMENT Tie the cuff Start the Measurement 1.Before you start the measurement, switch the User button to select the user 1. Remove all jewelry, such as watches and between User A and User B. Switch to right to select User A, switch to left to bracelets from your left arm. VHOHFW8VHU%:KHQWKHPRQLWRULVRIISUHVVWKH³67$57‡6723EXWWRQWRWXUQ Note: If your doctor has diagnosed you with on the monitor, and it will finish the whole measurement,save and transmit the poor circulation in your left arm, use your right measurement data for the desired user. (Take User A for example.) arm. 2. Roll or push up your sleeve to expose the LCD display Adjust the zero. skin. Make sure your sleeve is not too tight. MEMORY MEMORY 3. Hold your arm with your palm facing up and tie the cuff on your upper arm, then position the tube off-center toward the inner side of arm in line with the little finger. Or position the M M artery mark over the main artery (on the inside of your arm). Note: Locate the main S S artery by pressing with 2 fingers approximately 2 cm above the bend of your START elbow on the inside of your left arm. Identify START STOP where the pulse can be felt the strongest. STOP This is your main artery. TIME/DATE Pul/min TIME/DATE Pul/min 4. The cuff should be snug but not too tight. 2~3cm You should be able to insert one finger between the cuff and your arm. Inflating and measuring. Display and save the 5. Sit comfortably with your tested arm resting on a measurement result. flat surface. Place your elbow on a table so that MEMORY the cuff is at the same level as your heart. Turn MEMORY your palm upwards. Sit upright in a chair, and take 5-6 deep breaths. 6. Helpful tips for Patients, especially for Patients with M Hypertension: M Rest for 5 minutes before first measuring. S S Wait at least 3 minutes between measurements. This allows your blood circulation to recover. START Take the measurement in a silent room. STOP START The patient must relax as much as possible and do STOP TIME/DATE not move and talk during the measurement procedure. Pul/min TIME/DATE Pul/min The cuff should maintain at the same level as the right atrium of the heart. Bluetooth Module No.: LS51802 Please sit comfortably. Do not cross your legs and RF Frequency Range: 2402 MHz to 2480 MHz keep your feet flat on the ground. Keep your back against the backrest of the chair. Output Power Range: 0 dBm Supply Voltage: 2V-3.6 V For a meaningful comparison, try to measure under similar conditions. For example, take daily Transmitting Distance: 10 meters measurements at approximately the same time, on the same arm, or as directed by a physician. List of compatible devices: For iOS devices: The operating system must be iOS 8 or more, such as iPhone 4S, iPhone 5/5C/5S, iPhone 6/6 Plus and so on. For Android devices:  The operating system must be 4.3 or more. 

DATA MANAGEMENT MEASUREMENT MEMORY 2.This device will proceed MEMORY to data transmission Recall the Records after measurement. 1. When the monitor is off, The Bluetooth symbol M please press the “MEM”,it will display the M blinks on the LCD S latest record first when the records are less than S indicates data is three groups. When there are three or more than transmitting. START three groups ,it will display the average value of START Pul/min STOP the latest three records first. STOP TIME/DATE TIME/DATE Pul/min MEMORY 2. Press the “MEM” or “SET” to get the record you 3.If the data is successfully want. transmitted, the Bluetooth MEMORY symbol doesn’t blink any more, M MEMORY and then it will turn off within 5 seconds. S M M START If the data transmission fails, STOP S it will turn off within 3 minutes. S TIME/DATE Pul/min START START STOP STOP TIME/DATE Pul/min 43UHVVWKH³67$57‡6723´WRSRZHU TIME/DATE Pul/min off. START STOP The date and time of the record Tips: Maximum 250 records are both for User A and User B. will be shown alternately. The current No. is No 2. The corresponding The corresponding CAUTION date is January 6th. time is P.M. 10:08. Interference may occur in the vicinity of equipment marked with the following symbol . And TMB-1490-BS may interfering vicinity electrical equipment. Sensitive people, including pregnant women pre-eclamptic and those who implanted medical electronic instruments, should avoid using the unit 3. If you want to look over another user’s data, switch the User button to select whenever possible. the desired user. Then you can look over its historical records. Keep the monitor at least 20 centimeters away from the human body (especially the head) when the data transmission is proceeding after measurement. CAUTION To enable the data transmission function, this product should be paired to Bluetooth end at 2.4 GHz. The most recent record (1) is shown first. Each new measurement is How to mitigate possible interference? assigned to the first (1) record. All other records are pushed back one 1. The range between the device and BT end should be reasonably close, from 1 meter to 10 meters. Please ensure no obstacles between the device and digit (e.g., 2 becomes 3, and so on), and the last record (60) is BT end so as to obtain quality connection and to lower the RF output range. dropped from the list. 2. To avoid interference, other electronic devices (particularly those with wireless transmission / Transmitter) should be kept at least 1 meter away from the monitor.  

DATA MANAGEMENT INFORMATION FOR USER Delete the Records Tips for Measurement If you did not get the correct measurement, you can delete all Measurements may be inaccurate if taken in the following results for the selected user by following steps below. circumstances. MEMORY 1.Hold pressing “SET” for 3 seconds when the monitor is in the memory M recall mode ,the S flash display “dEL ALL” will show. START STOP TIME/DATE Pul/min MEMORY Within 1 hour Immediate measurement 2.Press “SET” to after dinner or drinking after tea, coffee, smoking confirm deleting and the monitor will turn M off. S START STOP TIME/DATE 3.If you don’t want to delete the Pul/min records, press “START/STOP” Within 20 minutes to escape. START STOP after taking a bath When talking or moving your fingers 4. If there is no record, MEMORY press “MEM” button, the right display will show. M S START In a very cold environment When you want to discharge urine STOP TIME/DATE Pul/min  

INFORMATION FOR USER ABOUT BLOOD PRESSURE What are systolic pressure and diastolic pressure? Maintenance When ventricles contract and pump blood out of the Systolic Diastolic In order to get the best performance, please follow the heart, the blood pressure reaches its maximum value blood discharging blood entering artery vein instructions below. in the cycle, which is called systolic pressure. When the ventricles relax, the blood pressure reaches its press relax minimum value in the cycle, which is called diastolic pressure. What is the standard blood pressure classification? The chart on the right is the This chart reflects blood pressure categories defined by American Heart Association. standard blood pressure classifi- Blood Pressure Category Systolic Diastolic mmHg (upper#) mmHg (lower#) cation published by American Put in a dry place and Avoid touching water, Heart Association (AHA). Normal less than 120 and less than 80 avoid the sunshine clean it with a dry cloth in case. Elevated 120-129 and less than 80 High Blood Pressure 130-139 or 80-89 (Hypertension) Stage 1 High Blood Pressure 140 or higher or 90 or higher (Hypertension) Stage 2 Hypertensive Crisis Higher than 180 and/or Higher than 120 (Consult your doctor immediately) CAUTION Avoid intense shaking Avoid dusty and unstable Please consult a physician if your measuring result falls outside the range. and collisions temperature environment 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 Using wet cloths to Do not attempt to clean the reusable pulse intervals and calculate the average ; if there are two or more pulse intervals ,the difference cuff with water and never immerse between each interval and the average is more than the average value of ±25% , or there are four remove dirt the cuff in water. 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 appear. 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. 

ABOUT BLOOD PRESSURE TROUBLESHOOTING This section includes a list of error messages and frequently Why does my blood pressure asked questions for problems you may encounter with your blood pressure monitor. If the products not operating as you think it fluctuate throughout the should, check here before arranging for servicing. day? 1. Individual blood pressure varies PROBLEM SYMPTOM CHECK THIS REMEDY multiple times everyday. It is also affected Batteries are exhausted. Replace with new batteries by the way you tie your cuff and your Display will not measurement position, so please take the No power Batteries are inserted Insert the batteries light up. measurement under the same conditions. incorrectly. correctly 2.If the person takes medicine, the AC adaptor is inserted Insert the AC adaptor incorrectly. tightly pressure will vary more. Low Display is dim or 3.Wait at least 3 minutes for another Batteries are low. show Replace with new batteries measurement. batteries E 01 shows The cuff is too tight Refasten the cuff and then Why do I get a different What you need to pay or too loose. measure again. E 02 shows Movement can affect the blood pressure at home attention to when you measure The monitor detected motion measurement.Relax for a compared to the hospital? your blood pressure at home: If the cuff is tied properly. while measuring. moment and then measure again. The blood pressure is different even If the cuff is too tight or too loose. Loosen the clothing on E 03 shows The measurement If the cuff is tied on the upper arm. the arm and then throughout the day due to weather, Error process does not If you feel anxious. detect the pulse measure again. emotion, exercise etc, Also, there is the message Taking 2-3 deep breaths before signal. “white coat” effect, which means blood beginning will be better for measuring. pressure usually increases in clinical Advice: Relax yourself for 4-5 The treatment of the Relax for a moment and E 04 shows settings. minutes until you calm down. measurement failed. then measure again. Retake the measurement. Is the result the same EExx,shows on the display. A calibration error occurred. (XX can If the problem persists, contact the retailer or our if measuring on the be some digital symbol, customer service such as 01, 02,etc., if right arm? this similar situation department for further assistance.Refer to the appear, all belong to calibration error.) warranty for contact It is ok for both arms, but there information and return will be some different results for instructions. different people. We suggest you Relax for a moment. measure the same arm every time. Warning Out of measurement Refasten the cuff and then “out ” shows range measure again. If the message problem persists, contact your physician.  

SPECIFICATIONS AUTHORIZED COMPONENT Battery powered mode: 6VDC 4×AAA batteries Authorized Component AC adaptor powered mode: 6V 1A 1please use the TRANSTEK Power supply (Please only use the recommended AC authorized adapter. adaptor model). Display mode Digital LCD V.A.60mm × 92mm Measurement mode Oscillographic testing mode Rated cuff pressure: Measurement range 0mmHg~299mmHg(0kPa ~ 39.9kPa) Measurement pressure: SYS: 60mmHg~230mmHg (8.0kPa~30.7kPa) DIA: 40mmHg~130mmHg (5.3kPa~17.3kPa) Pulse value: (40-199)beat/minute Adapter Pressure: Model：BLJ06L060100P-U Accuracy 5℃-40℃within±3mmHg(0.4kPa) Input：AC 100-240V Pulse value:±5% 50/60Hz 0.2A Max A temperature range of :+5°C to +40°C Output：6V 1000mA Normal working condition A relative humidity range of 15% to 90%, non-condensing, but not requiring a water vapour partial pressure greater than 50 hPa An atmospheric pressure range of : 700 hPa to 1060 hPa Temperature:-20°C to +60°C Storage & transportation $UHODWLYHKXPLGLW\UDQJHRI”QRQFRQGHQVLQJ Contact Information condition at a water vapour pressure up to 50hPa For more information about our products, please visit www.transtek.cn.you can get customer service, usual problems and customer download, transtek will serve you anytime. Measurement perimeter About 22cm~32cm or 22cm~42cm of the upper arm Manufactured by: Guangdong Transtek Medical Electronics Co., Ltd. Company: Guangdong Transtek Medical Electronics Co., Ltd. Weight Approx.250g(Excluding the batteries and cuff) Address: Zone B, No.105 ,Dongli Road, Torch Development District, Zhongshan,528437,Guangdong,China External dimensions Approx.140mm×130mm×49.7mm Attachment 4×AAA batteries,user manual,AC adapter Mode of operation Continuous operation Degree of protection Type BF applied part Protection against IP21 It means the device could protected against ingress of water solid foreign objects of 12.5mm and greater, and protect against vertically falling water drops. Battery Powered Mode: Device Classification Internally Powered ME Equipment AC Adaptor Powered Mode: Class II ME Equipment Software Version A01  WARNING: No modification of this equipment is allowed. 

FCC STATEMENT COMPLIED STANDARDS LIST FCC Statement Complied Standards List FCC ID:OU9TMB1490BS EN ISO 14971:2012 / ISO 14971:2007 Medical devices - This device complies with Part 15 of the FCC Rules. Operation is subject Risk management Application of risk management to medical devices to the following two conditions: (1) this device may not cause harmful EN ISO 15223-1:2016 / ISO 15223-1:2016 Medical devices. Symbols to be used with medical device labels, labelling and interference, and (2) this device must accept any interference received, Labeling information to be supplied. Part 1 : General requirements including interference that may cause undesired operation. Caution: The user is cautioned that changes or modifications not EN 1041:2008 Information supplied by the manufacturer of medical User manual devices expressly approved by the party responsible for compliance could void EN 60601-1:2006/ IEC 60601-1:2005+A1:2012 Medical electrical the user's authority to operate the equipment. General Requirements equipment - Part 1: General requirements for basic safety and NOTE: This equipment has been tested and found to comply with the for Safety essential performance EN 60601-1-11:2015/ IEC 60601-1-11:2015 Medical electrical limits for a Class B digital device, pursuant to Part 15 of the FCC Rules. equipment - Part 1-11: General requirements for basic safety and essential performance - Collateral standard: Requirements for medical These limits are designed to provide reasonable protection against electrical equipment and medical electrical systems used in the home harmful interference in a residential installation. This equipment generates, healthcare environment uses and can radiate radio frequency energy and, if not installed and used in EN 60601-1-2:2015/ IEC 60601-1-2:2014 Medical electrical Electromagnetic accordance with the instructions, may cause harmful interference to equipment - Part 1-2: General requirements for basic safety and compatibility essential performance - Collateral standard: Electromagnetic radio communications. However, there is no guarantee that interference will disturbances - Requirements and tests not occur in a particular installation. Performance EN ISO 81060-1:2012 Non-invasive sphygmomanometers - Part 1: If this equipment does cause harmful interference to radio or television Requirements and test methods for non-automated measurement type requirements EN 1060-3:1997+A2:2009 Non-invasive sphygmomanometers - reception, which can be determined by turning the equipment off and on, Part 3: Supplementary requirements for electro-mechanical blood the user is encouraged to try to correct the interference by one or more pressure measuring systems of the following measures: IEC 80601-2-30:2013 Medical electrical equipment- Part 2-30: Particular requirements for the basic safety and essential -- Reorient or relocate the receiving antenna. performance of automated non-invasive sphygmomanometers -- Increase the separation between the equipment and receiver. EN 1060-4:2004 Non-invasive sphygmomanometers - Part 4: Test -- Connect the equipment into an outlet on a circuit different from that to procedures to determine the overall system accuracy of automated which the receiver is connected. Clinical investigation non-invasive sphygmomanometers -- Consult the dealer or an experienced radio/TV technician for help. ISO 81060-2:2013 Non-invasive sphygmomanometers - Part 2: Clinical validation of automated measurement type FCC Radiation Exposure Statement: EN 60601-1-6:2010/IEC 60601-1-6:2010+A1:2013 Medical This equipment complies with FCC radiation exposure limits set forth for electrical equipment - Part 1-6: General requirements for basic safety an uncontrolled environment. Usability and essential performance - Collateral standard: Usability This transmitter must not be co-located or operating in conjunction with EN 62366-1:2015/ IEC 62366-1:2015 Medical devices - Part 1: Application of usability engineering to medical devices any other antenna or transmitter. Software life-cycle EN 62304:2006/AC: 2008 / IEC 62304:2006 Medical device software - Software life-cycle processes processes ISO 10993-1:2009 Biological evaluation of medical devices- Part 1: Evaluation and testing within a risk management process ISO 10993-5:2009 Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity Bio-compatibility ISO 10993-10:2010 Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization  

EMC GUIDANCE EMC GUIDANCE EMC Guidance Table 2 1)This product needs special precautions regarding EMC and needs to be Guidance and manufacturer’s declaration – electromagnetic immunity installed and put into service according to the EMC information provided, The device is intended for use in the electromagnetic environment specified below. The customer or the and this unit can be affected by portable and mobile RF communications user of the device should assure that it is used in such an environment. equipment. 2)* Do not use a mobile phone or other devices that emit electromagnetic Electromagnetic fields, near the unit. This may result in incorrect operation of the unit. Immunity test IEC 60601 test level Compliance level environment - guidance 3)Caution: This unit has been thoroughly tested and inspected to assure Floors should be wood, concrete proper performance and operation! Electrostatic or ceramic tile. If floors are ±8 kV contact 4)* Caution: This machine should not be used adjacent to or stacked with discharge (ESD) ±8 kV contact covered with synthetic material, ±15 kV air the relative humidity should be at other equipment and that if adjacent or stacked use is necessary, this IEC 61000-4-2 ±15 kV air least 30%. machine should be observed to verify normal operation in the configuration in which it will be used. Electrical fast power supply lines: power supply lines: Mains power quality should be transient/burst ±2 kV ±2 kV that of a typical commercial or IEC 61000-4-4 input/output lines: hospital environment. ±1 kV Table 1 Surge line(s) to line(s): ±1 kV line(s) to line(s): ±1 kV Mains power quality should be line(s) to earth: ±2 kV IEC61000-4-5 that of a typical commercial or Guidance and manufacturer’s declaration – electromagnetic emissions 100 kHz repetition 100 kHz repetition hospital environment. frequency frequency The device is intended for use in the electromagnetic environment specified below. The customer or the 0%UT; 0.5 cycle 0% UT ; 0.5 cycle Mains power quality should be user of the device should assure that it is used in such an environment. At 0°, 45°, 90°, 135°, At 0°, 45°, 90°, 135°, that of a typical commercial or Voltage dips, 180°,225°,270° and 315° 180°,225°,270° and hospital environment. short interruptions 0%UT ; 1 cycle 315° Emissions test Compliance Electromagnetic environment - guidance and 0% UT ; 1 cycle and voltage variations on 70%UT ; 25/30 cycles and The device uses RF energy only for its internal power supply Single phase: at 0° 70% UT ; 25/30 cycles RF emissions function. Therefore, its RF emissions are very low input lines 0% UT ; 300 cycle Single phase: at 0° Group 1 and are not likely to cause any interference in nearby 0% UT ;300 cycle CISPR 11 IEC 61000-4-11 electronic equipment. RF emissions The device is suitable for use in all establishments, Class B other than domestic and those directly connected to CISPR 11 the public low-voltage power supply network that supplies buildings used for domestic purposes. Harmonic emissions Class A Power frequency Power frequency magnetic fields IEC 61000-3-2 (50Hz/60Hz) should be at levels characteristic magnetic field 30 A/m 30 A/m of a typical location in a typical Voltage fluctuations/ 50Hz/60Hz 50Hz/60Hz commercial or hospital flicker emissions Complies IEC 61000-4-8 environment. IEC 61000-3-3 NOTE UT is the a.c. mains voltage prior to application of the test level.  

EMC GUIDANCE EMC GUIDANCE Table 3 Table 4 Guidance and manufacturer’s declaration – electromagnetic immunity Recommended separation distances between portable and mobile RF communications The device is intended for use in the electromagnetic environment specified below. The customer or the equipment and the device. user of the device should assure that it is used in such an environment. The device is intended for use in an electromagnetic environment in which radiated RF disturbances are Immunity test IEC 60601 Compliance Electromagnetic environment - guidance controlled. The customer or the user of the device can help prevent electromagnetic interference by Test level level maintaining a minimum distance between portable and mobile RF communications equipment (transmittters) and the device as recommended below, according to the maximum output power of the Conducted RF 150 kHz to 150 kHz to Portable and mobile RF communications communications equipment. IEC 61000-4-6 80 MHz: 80 MHz: equipment should be used no closer to any part 3 Vrms 3 Vrms of the device, including cables, than the 6Vrms (in ISM 6Vrms (in ISM recommended separation distance calculated Rated maximum output Separation distance according to frequency of transmitter (m) and amateur and amateur from the equation appropriate for the frequency power of transmitter radio bands) radio bands) of the transmitter. (W) 80% Am at 1kHz 80% Am at 1kHz Recommended separation distances: d=0.35 P ; 150 kHz to 80 MHz 80 MHz to 800 MHz 800 MHz to 2.7 GHz d=1.2 P d = 3.5 P d = 1.2 P d = 2.3 P Radiated RF 10V/m, 80% Am 10V/m, 80% Am 80 MHz to 800 MHz: where, P is the maximum IEC 61000-4-3 at 1kHz at 1kHz d=1.2 P output power rating of the 0.01 0.12 0.12 0.23 800 MHz to 2.7 GHz: transmitter in watts (W) according to the 0.1 0.37 0.38 0.73 d=2.3 P transmitter manufacturer, 1 1.2 1.2 2.3 d is the recommended separation distance in 10 3.8 3.8 7.3 meters (m). Field 100 12 12 23 strengths from fixed RF transmitters, as For transmitters rated at a maximum output power not listed above, the recommended separation determined by an distance d in metres (m) can be estimated using the equation applicable to the frequency of the electromagnetic site transmitter, where P is the maximum output power rating of the transmitter in watts (W) according to the survey, should be less transmitter manufacturer. than the compliance level NOTE 1 At 80 MHz and 800 MHz, the separation distance for the higher frequency range applies. in each frequency range. NOTE 2 These guidelines may not apply in all situations. Electromagnetic propagation is affected by Interference may occur in absorption and reflection from structures, objects and people. the vicinity of equipment marked with the following symbol: NOTE 1 At 80 MHz and 800 MHz, the higher frequency range applies. NOTE 2 These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects and people. a Field strengths from fixed transmitters, such as base stations for radio (cellular / cordless) telephones and land mobile radios, amateur radio, AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with accuracy. To assess the electromagnetic environment due to fixed RF transmitters, an electromagnetic site survey should be considered. If the measured field strength in the location in which the device is used exceeds the applicable RF compliance level above, the device should be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as re-orienting or relocating the device. b Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3V/m.  

EMC GUIDANCE Table 5 Guidance and manufacturer’s declaration - electromagnetic immunity The device is intended for use in the electromagnetic environment specified below. The customer or the user of the device, should assure that it is used in such an environment. Radiated RF Test Band a) Service a) Modulation b) Modulation b) Distance (m) IMMUNITY IEC61000-4-3 Frequency (MHz) (W) TEST LEVEL (Test (MHz) (V/m) specifications for 385 380-390 TETRA Pulse 1.8 0.3 27 ENCLOSURE 400 modulation b) PORT 18Hz IMMUNITY to GMRS 460，FM c) ± 5kHz RF wireless 2 0.3 28 communicatio 450 380-390 FRS 460 deviation 1kHz sine ns equipment) 710 704-787 LTE Band Pulse 745 13, modulation b) 0.2 0.3 9 17 217Hz 780 GSM Pulse 2 810 800-960 0.3 28 800/900, modulation b) TETRA 800, 18Hz 870 iDEN 820, CDMA 850, 930 LTE Band 5 1720 1700- GSM 1800; Pulse CDMA 1900; modulation b) 2 0.3 28 1990 GSM 1900; 217Hz 1845 DECT; LTE Band 1, 1970 3, 4,25; UMTS 2450 2400- Bluetooth, Pulse 2 0.3 28 2570 WLAN, modulation b) 802.11 217 Hz b/g/n, RFID 2450, LTE Band 7 5240 5100- WLAN Pulse 0.2 0.3 9 5800 802.11 modulation b) 5240 a/n 217 Hz 5785 NOTE If necessary to achieve the IMMUNITY TEST LEVEL, the distance between the transmitting antenna and the ME EQUIPMENT or ME SYSTEM may be reduced to 1 m. The 1 m test distance is permitted by IEC 61000-4-3. a) For some services, only the uplink frequencies are included. b) The carrier shall be modulated using a 50% duty cycle square wave signal. c) As an alternative to FM modulation, 50% pulse modulation at 18 Hz may be used because while it does not represent actual modulation, it would be worst case. The MANUFACTURER should consider reducing the minimum separation distance, based on RISK MANAGEMENT, and using higher IMMUNITY TEST LEVELS that are appropriate for the reduced minimum separation distance. Minimum separation distances for higher IMMUNITY TEST LEVELS shall be calculated using the following equation: E= Where P is the maximum power in W, d is the minimum separation distance in m, and E is the IMMUNITY TEST LEVEL in V/m. 


Document Created: 2018-07-01 13:03:37
Document Modified: 2018-07-01 13:03:37
© 2024 FCC.report
This site is not affiliated with or endorsed by the FCC