Transtek Medical Electronics TMB1491-B Blood Pressure Monitor User Manual TMB 1491 BT

Guangdong Transtek Medical Electronics Co.,Ltd Blood Pressure Monitor TMB 1491 BT

TMB-1491-BT User Manual

version:1.0User ManualBlood Pressure Monitor TMB-1491-BTArm TypeThank you very much for selecting TRANSTEK Blood Pressure MonitorTMB-1491-BT.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.Guangdong Transtek Medical Electronics Co., Ltd.Zone A, No.105 ,Dongli Road, Torch Development District, Zhongshan,528437,Guangdong,China
Table of ContentsCATALOGUE CATALOGUEINTRODUCTION...................................................................................................................2General DescriptionIndications for UseSafety InformationLCD Display SignalMonitor Components BEFORE YOU START...........................................................................................................6The Choice of Power SupplyInstalling and Replacing the BatteriesMeasurement PrincipleSetting Date, Time and Measurement UnitSelect the UserPair-up the Blood Pressure Monitor with Your DeviceMEASUREMENT...................................................................................................................13Tie the CuffStart the MeasurementDATA MANAGEMENT..........................................................................................................16Recall the RecordsDelete the RecordsINFORMATION FOR USER................................................................................................18Tips for measurementMaintenancesABOUT BLOOD PRESSURE..............................................................................................20What are systolic pressure and diastolic pressure?What is the standard blood pressure classification?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........................................................................................................22SPECIFICATIONS..............................................................................................................23AUTHORIZED COMPONENT ...........................................................................................24CONTACT INFORMATION.................................................................................................24COMPLIED STANDARDS LIST..........................................................................................25FCC STATEMENT...............................................................................................................26EMC GUIDANCE................................................................................................................27
 INTRODUCTION INTRODUCTIONSafety InformationThe signs below might be in the user manual, labeling or other component. They are the requirement of standard and using.Symbol for “THE OPERATION GUIDE MUST BE READ”Symbol for “MANUFACTURER”Symbol for “SERIAL NUMBER”Symbol for “TYPE BF APPLIED PARTS”Symbol for “DIRECT CURRENT”Symbol for “ENVIRONMENT PROTECTION - Electrical waste products should not be disposed of with household waste. Please recycle where facilities exist. Check with your local authority or retailer for recycling advice”Symbol for “MANUFACTURE DATE”Thank you for selecting TRANSTEK arm type blood pressure Monitor (TMB-1491-BT). 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-1491-BT are equivalent to those obtained by a trained observer using the cuff and stethoscope auscultation method.This manual contains important safety and care information, and provides step by step instructions for using the product.Read the manual thoroughly before using the product.Features: Maximum 60 recordsGeneral DescriptionFor indoor use onlyF17$9ĭ&&& Symbol for “Class II Equipment”3rd technonoly: Measuring during inflation (The updated technology in the world)60mm×40.5 mm Digital LCD display The Bluetooth Combination MarkSymbol for “Including RFtransmitter”This device is intended for adult use only.This device is intended for no-invasive measuring and monitoring of arterial blood pressure. It is not intended for use on extremities other than the arm or for functions other than obtaining a blood pressure measurement.Do not confuse self-monitoring with self-diagnosis. This unit allows you to monitor your blood pressure.Do not begin or end medical treatment without asking a physician for treatment advice.If you are taking medication,consult your physician to determine the most appropriate time to measure your blood pressure. Never change a prescribed medication without consulting your Physician.When the device was used to measure patients who have common arrhythmias such as atrial or ventricular premature beats or atrial fibrillation, the best result may occur with deviation. Please consult your physician about the result.If the cuff pressure exceeds 40 kPa (300 mmHg), the unit will automatically deflate. Should the cuff not deflate when pressures exceeds 40 kPa (300 mmHg), detach the cuff from the arm and press the START/STOP button to stop inflation.The equipment is not AP/APG equipment and not suitable for use in the presence of a flammable anesthetic mixture with air of with oxygen or nitrous oxide.The operator shall not touch output of batteries/AC adaptor and the patient simultaneously.To avoid measurement errors, please avoid the condition of strong electromagnetic field radiatedinterference signal or electrical fast transient/burst signal.The user must check that the equipment functions safely and see that it is in proper workingcondition before being used.This device is contraindicated for any female who may be suspected of, or is pregnant. Besides providing inaccurate readings, the effects of this device on the fetus are unknown.Manufacturer will make available on request circuit diagrams, component parts list etc.This unit is not suitable for continuous monitoring during medical emergencies or operations. Otherwise, the patient’s arm and fingers will become anaesthetic, swollen and even purple due to a lack of blood.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.During use, the patient will be in contact with the cuff. The materials of the cuff have been tested andfound to comply with requirements of ISO 10993-5:2009 and ISO 10993-10:2010. It will not cause any potential sensization or irritation reaction.The device has been evaluated clinically using manual cuff/stethoscope auscultation as the reference. Blood pressure measurements determined with this device are equivalent to those obtained by a trained observer using the cuff/stethoscope auscultatory method, within the limits prescribed by the American National Standard, Manual, electronic, or automated sphygmomanometers.”The patient is an intended operator. The patient can measure under normal circumstances and maintain the device and its accessories according to the user manual.The blood pressure monitor, and the cuff are suitable for use within the patient environment. If you are allergic to dacron or plastic, please don’t use this device.Please keep the unit out of reach of infants, children or pets, since inhalation or swallowing of small parts is dangerous or even fata.If 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.The device is not suitable for public use.The device is not intended for PATIENT transport outside a healthcare facility.This device cannot be used with HF surgical equipment at the same time.Be careful to strangulation due to cables and hoses, particularly due to excessive length.CAUTIONIndications for UseThe Transtek Blood Pressure Monitor is digital monitors intended for use in measuring blood pressure and heartbeat rate with arm circumference ranging IURPFPWRFPDERXWôÝòÝRUFPWRFPDERXWôÝòÝIt is intended for adult indoor use only.SN
 INTRODUCTION INTRODUCTIONLCD display signalSYMBOL DESCRIPTIONSystolic blood pressure High pressure resultDiastolic blood pressure Low pressure resultEXPLANATIONPulse per minute Beats per minute, BPMDeflating CUFF air is exhausting of deflatingMemory The displayed measurement values is from the memory. mmHgkPaMeasurement Unit of the blood pressureMeasurement Unit of the blood pressureLow battery Batteries are low and need to be replacedIrregular heartbeatArrhythmiaGrade The grade of the blood pressureCurrent Time Year/Month/Day, Hour/MinuteMonitor ComponentsList1.Blood Pressure Monitor (TMB-1491-BT)4.User manual2.Cuff (Type BF applied part) (22~32cm or 22~42cm)Component list of pressure measuring system1 Cuff 2 Air pipe3 PCBA4 Pump5 Valve5. AC Adaptor(Model : KH0601000UW)3. 4×AAA alkaline batteriesBATTERY COMPARTMENT(1kPa=7.5mmHg)(1mmHg=0.133kPa)Heartbeat Heartbeat detection during the measurementUser 1 Start measurement,save and transmit themeasuring results for User 1User 2 Start measurement,save and transmit themeasuring results for User 2Bluetooth icon The bluetooth icon blinks when thebluetooth is workingMEM BUTTONSTART/STOP BUTTONSET BUTTONCUFF AIR HOSELCD DISPLAYAIR CONNECTOR PLUG
BEFORE YOU START BEFORE YOU STARTIn order to get the best effect and protect your monitor,please use the right battery and special power adaptor which complies with U.S. safety standard.Open the battery cover.Install the batteries by matching the correct polarity, as shown.Replace the cover.Installing and Replacing the BatteriesCAUTIONRemove batteries if the device is not likely to be used for some time.The old batteries are harmful to the environment, do not dispose with other daily trash.Remove the old batteries from the device and follow your local recycling guidelines.CAUTIONReplace the batteries whenever the below happenThe showsThe display dimsThe display does not light upDo not dispose of batteries in fire. Batteries may explode or leak. AC adaptorThe Choice of Power Supply1.Battery powered mode: 6VDC 4×AAA alkaline batteries2.AC adaptor powered mode: 6V 1A(Please only use the recommended AC adaptor model). Please unplug the adaptor to depart fromthe using utility power.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 air 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. The device also compares the longest and the shortest time intervals of detected pulse waves to mean time interval then calculates standard deviation. The device will display a warning signal with the reading to indicate the detection of irregular heartbeat when the difference of the time intervals is over 25%. 1: When using this device, please pay attention to the following situation which may interrupt blood flow and influence blood circulation of the patient, thus cause harmful injury to the patient: too frequent and consecutive multiple measurements; the application of the CUFF and its pressurization on any arm where intravascular access or therapy, or an arterio-venous (A-V) shunt, is present; Inflating the cuff on the upper arm on the side of a mastectomy.2. Do not apply the cuff over a wound, otherwise it can cause further injury.3. Do not inflate the cuff on the same limb which other monitoring ME EQUIPMENT is applied around simultaneously, because this could cause temporary loss of function of those simultaneously-used monitoring ME EQUIPMENT.4. Using it in case to result in prolonged impairment of the circulation of the blood of the PATIENT.5: Don’t kink the connection tube, otherwise, the cuff pressure may continuously increase which can prevent blood flow and result in harmful injury to the PATIENT.CAUTION
Setting Date, Time and Measurement Unit It is important to set the clock before using your blood pressure monitor, so that a time stamp can be assigned to each record that is stored in the memory. (The setting range of the year :2014—2054 time format:12H / 24H)1.When the monitor is off, hold pressing “SET” buttonfor 3 seconds to enter the mode for year setting.Or when the monitor is off,press “SET” button shortly,it will display the time. Thenhold pressing “SET” buttonto enter the mode for yearsetting.2.Press the “MEM” button to change the [YEAR].3.When you get the right year, press “SET” button to set down and turn to next step.BEFORE YOU START4.Repeat steps 2 and 3 to set the [MONTH] and [DAY].5.Repeat steps 2 and 3 to set the [TIME FORMAT]. BEFORE YOU START
6.Repeat steps 2 and 3 to set the [HOUR] and [MINUTE]. 8.After the unit is set,the LCD will display“done” and then turn off.7.Repeat steps 2 and 3 to set the [UNIT].Select the User1.When the monitor is off , press and hold the MEM button to enter user setting mode. The user ID will blink.2.Then press MEM button again, select the user ID between user 1 and user 2.3. After selecting the suitable user ID, press SET button to confirm. Then the LCD will turn off.BEFORE YOU START BEFORE YOU START
Rest for 5 minutes before measuring.Wait at least 3 minutes between measurements. This allows your blood circulation to recover.For a meaningful comparison, try to measure under similar conditions. For example, take daily measurements at approximately the same time, position of upper arm, or as directed by a physician.Tie the cuff1.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.2.The cuff should be snug but not too tight. You should be able to insert one finger between the cuff and your arm.3.Sit comfortably with your tested arm resting on a flat surface. 2~3cmSTARTSTOP.Patients with Hypertension:The middle of the cuff should be at the level of the right atrium of the heart;Before starting measurement, please sit comfortably with legs uncrossed,feet flat on the floor, back and arm supported.4Pair-up the Blood Pressure Monitor with Your Device1.Turn on Bluetooth and the app. Make sure both are ON when pair-up is proceeding.2.When the monitor is OFF, press and hold the START/STOP button to start pair-up. The symbol and will be shown on the LCD alternatively,indicating pair-up is proceeding. If SUCCEED, symbol will be shown on the LCD.If FAIL, only bluetooth symbolwill be shown on the LCD.4.The monitor will shut off after Pair-up process is complete.3.Then please select the user ID you want to connect with yoursmartphone on the app to continute the pair-up.MEASUREMENTBEFORE YOU STARTBluetooth Module No.: AW8001RF Frequency Range: 2402 MHz to 2480 MHzOutput Power Range: 0 dBmSupply Voltage: 1.8-3.6 VTransmitting Distance: 10 meters
1.When the monitor is off, press the “START/STOP” button to turn on the monitor, and it will finish the whole measurement .Adjust to zero. LCD displayInflating and measuring. Display and save the results. The device will proceed to data transmission after measurement.The Bluetooth symbol blinks on the LCD indicates data is transmitting.Start the Measurement2.Press the “START/STOP” button to power off, otherwise it will turnoff within 1 minute.STARTSTOPSTARTSTOPIf the data transmission fails, the Bluetooth symbol blinks all the time until it turns off.If the data transmission succeeds, the Bluetooth symbol will disappear.MEASUREMENT MEASUREMENT
Recall the Records1. When the monitor is off, please press “MEM” buttonto show the average value of the latest three records.2. Press “MEM” buttonor “SET” button to getthe record you want.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 (60) is dropped from the list.The current No. is No. 4. The corresponding time is P.M. 10:00.The corresponding date is March 20th.CAUTIONDOWNUPThe date and time of the record will be shown alternately.If you did not get the correct measurement, you can delete all results by following steps below.Delete the Records1.Hold pressing “MEM” button for 3 seconds when themonitor is in the memory recall mode ,the flash display will show. 2.Press “SET” button to confirm deleting and the monitor will turn off.3.If you don’t want to delete the records, press “START/STOP” button to escape.4. If there is no record. the right display will show.STARTSTOPDATA MANAGEMENT DATA MANAGEMENT
Tips for MeasurementWithin 1 hour after dinner or drinkingWithin 20 minutes after taking a bathIn a very cold environmentImmediate measurement after tea, coffee, smoking When talking or moving your fingersWhen you want to discharge urineMaintenanceIn order to get the best performance, please follow the instructions below.Put in a dry place and avoid the sunshineAvoid intense shakingand collisionsUsing wet cloths to remove dirtAvoid touching water,clean it with a dry cloth in case.Avoid dusty and unstabletemperature environmentDo not attempt to clean the reusable cuff with water and never immerse the cuff in water.Measurements may be inaccurate if taken in the following circumstances.INFORMATION FOR USERINFORMATION FOR USERPlease use ACCESSORIES and detachable partes specified/ authorised by MANUFACTURE. Otherwise, it may cause damage to the unit or danger to the user/patients.The device doesn’t need to be calibrated within the two years of reliable service.Please dispose of ACCESSORIES, detachable parts, and the ME EQUIPMENT according to thelocal guidelines.If you have any problems with this device, such as setting up, maintaining or using, please contact the SERVICE PERSONNEL of Transtek. Don’t open or repair the device by yourself. Please report to Transtek if any unexpected operation or events occur.Please use the soft cloth to clean the whole unit. Don’t use any abrasive or volatile cleaners.CAUTION
What are systolic pressure and diastolic pressure? pressartery veinblood dischargingSystolicrelaxblood enteringDiastolic 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.What is the standard blood pressure classification?Irregular Heartbeat DetectorCAUTIONThe 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.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.The chart on the right is the standard blood pressure classification published by American Heart Association (AHA).CAUTIONBlood Pressure CategoryNormalPrehypertensionHigh Blood Pressure(Hypertension) Stage 1High Blood Pressure(Hypertension) Stage 2Hypertensive Crisis(Emergency care needed)SystolicmmHg (upper#)DiastolicmmHg (lower#)less than 120120-139140-159160 or higherHigher than 180andororororless than 8080-8990-99100 or higherHigher than 110This chart reflects blood pressure categories defined by American Heart Association.AHA Home Guideline for Upper Limit of Normal BPSYS 135 mm HgDIA 85 mm HgAn irregular heartbeat is detected when a heartbeat rhythm varies while the unit is measuring the systolic and diastolic blood pressure.During each measurement, this equipment records the heartbeat intervals and works out the standard deviation. If the calculated value is larger than or equal to 15,the irregular heartbeat symbol appears on the symbol when the measurement results are displayed.Why does my blood pressure fluctuate throughout theday?Is the result the same if measuring on the right arm?Why do I get a different blood pressure at home compared to the hospital?STARTSTOPSTARTSTOP1. 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.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 yourself for 4-5 minutes until you calm down.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.ABOUT BLOOD PRESSUREABOUT BLOOD PRESSURE
  This section includes a list of error messages and frequently asked questions for problems you may encounter with your blood pressure monitor. If the products not operating as you think it should, check here before arranging for servicing.PROBLEM SYMPTOM CHECK THIS REMEDYNo powerLowbatteriesErrormassageDisplay will not light up.Batteries are exhausted. Replace with new batteriesInsert the batteries correctlyReplace with new batteriesBatteries are insertedincorrectly.Display is dim or show Batteries are low.E 1 showsThe cuff is not secure. Refasten the cuff and thenmeasure again.E 3 showsE10 or E11 showsE20 shows The measurement process does not detectthe pulse signal.Loosen the clothing on thearm and then measure againEExx,shows on the display.A calibration erroroccurred.Retake the measurement.If the problem persists,contact the retailer or ourcustomer service department for further assistance.Refer to the warranty for contact information and return instructions.E21 shows The treatment of themeasurement failed.Relax for a moment andthen measure again.AC adaptor is insertedincorrectly.Insert the AC adaptor tightlyThe monitor detectedmotion,talking or thepluse is too poor while measuring.Relax for a moment and then measure again.About 22cm~32cm or 22cm~42cmType BF applied partWARNING: No modification of this equipment is allowed.Temperature:-20℃-60℃Relative Humidity: 10%RH-93%RHAtmospheric Pressure: 50kPa-106 kPaTemperature:5ć to 40ć 5HODWLYHKXPLGLW\5+Atmospheric pressure: 86kPa to 106kPaPower supplyBattery powered mode: 6VDC 4×AAA alkaline batteriesAC adaptor powered mode:6V 1A(Please only use the recommended AC adaptor model). Display modeMeasurement mode Oscillographic testing modeMeasurement rangeMeasurement perimeterof the upper armNet Weight Approx.180g(Excluding the dry cells)External dimensionsAttachmentMode of operation Continuous operationDegree of protectionProtection against ingress of water IP21AccuracyNormal working conditionStorage & transportationconditionSoftware Version V01Pressure:5ć-40ćwithin±0.4kPa(3mmHg) pulse value:±5%Digital LCD V.A.60mm×40.5mmApprox.110mm×110mm×41mm4×AAA alkaline batteries,user manual SPECIFICATIONSTROUBLESHOOTINGData communication is failed.Check if the App/Bluetoothis on or not,try datatransmission again.Rated cuff pressure: 0mmHg~300mmHg(0kPa ~ 40kPa)Measurement pressure: SYS: 60mmHg~230mmHg (8.0kPa~30.7kPa) DIA: 40mmHg~130mmHg (5.3kPa~17.3kPa)Pulse value: (40-199)beat/minute
 Contact InformationFor more information about our products, please visit www.transtek.cn.you can get customer service, usual problems and customer download, transtek will serve you anytime.Manufactured by:Company:Address:Authorized Component1please use the TRANSTEK authorized adapter.Complied Standards ListCOMPLIED STANDARDS LISTAUTHORIZED COMPONENTRisk managementLabelingUser manualGeneral Requirements for SafetyElectromagnetic compatibilityPerformance requirements and Clinical InvestigationSoftware life-cycle processesISO/EN 14971:2012 Medical devices — Application of risk management to medical devicesISO/EN 15223-1:2012 Medical devices. Symbols to be used with medical device labels, labelling and information to be supplied. General requirementsEN 1041: 2008 Medical equipment manufacturers to provide informationIEC 60601-1: 2005+A1：2012 Medical electrical equipment - Part 1: General requirements for basic safety and essential performanceIEC/EN 60601-1-2:2007 Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral standard:Electromagnetic compatibility - Requirements and testsIEC 80601-2-30:2009 Medical electrical equipment- Part 2-30: Particular requirements for the basic safety and essential performance of automated non-invasive sphygmomanometersANSI/AAMI SP10:2002/A2: 2008 Manual, electronic, or automated sphygmomanometers IEC/EN 62304:2006+AC: 2008 Medical device software - Software life cycle processesGuangdong Transtek Medical Electronics Co., Ltd.Zone A, No.105 ,Dongli Road, Torch Development District, Zhongshan,528437,Guangdong,China Guangdong Transtek Medical Electronics Co., Ltd.$GDSWHU7\SH˖KH0601000UW,QSXW˖100~240V~50/60Hz, 0.4A Max2XWSXW˖6V 1000mA
 EMC GuidanceFCC STATEMENT EMC GUIDANCE1. MEDICAL ELECTRICAL EQUIPMENT needs special precautions regarding EMC and needs to be installed and put into service according to the EMC information provided in the ACCOMPANYING DOCUMENTS2. Wireless communications equipment such as wireless home network devices, mobile phones, cordless telephones and their base stations, walkie-talkies can affect this equipment and should be kept at least a distance d=3, 3m away from the equipment.(Note: As indicated in Table 6 of IEC 60601-1-2:2007 for ME EQUIPMENT, a typical cell phone with a maximum output power of 2 W yields d=3, 3m at an IMMUNITY LEVEL of 3V/m) FCC StatementThis device complies with Part 15 of the FCC Rules. Operation is subject to the following two conditions: (1) this device may not cause harmful interference, and (2) this device must accept any interference received, including interference that may cause undesired operation. Caution: The user is cautioned that changes or modifications not expressly approved by the party responsible for compliance could void the user's authority to operate the equipment. NOTE: This equipment has been tested and found to comply with the limits for a Class B digital device, pursuant to Part 15 of the FCC Rules. These limits are designed to provide reasonable protection against harmful interference in a residential installation. This equipment generates, uses and can radiate radio frequency energy and, if not installed and used in accordance with the instructions, may cause harmful interference to radio communications. However, there is no guarantee that interference will not occur in a particular installation. If this equipment does cause harmful interference to radio or television reception, which can be determined by turning the equipment off and on,the user is encouraged to try to correct the interference by one or more of the following measures: -- Reorient or relocate the receiving antenna. -- Increase the separation between the equipment and receiver. -- Connect the equipment into an outlet on a circuit different from that to which the receiver is connected. -- Consult the dealer or an experienced radio/TV technician for help. FCC Radiation Exposure Statement: This equipment complies with FCC radiation exposure limits set forth for an uncontrolled environment. This transmitter must not be co-located or operating in conjunction with any other antenna or transmitter. FCC ID: OU9TMB1491-B

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