Transtek Medical Electronics TMB1014BT BLOOD PRESSURE MONITOR User Manual

Guangdong Transtek Medical Electronics Co.,Ltd BLOOD PRESSURE MONITOR

Contents

User Manual

User ManualBlood Pressure Monitor TMB-1014-BTTo use the monitor correctly and safely, please read the manual thoroughly.Thank you very much for selecting TRANSTEK Blood Pressure Monitor TMB-1014-BT.Please well keep this manual in order to reference in future.Zhongshan Transtek Electronics Co., LtdJin’an Road, Minzhong, Zhongshan 528441, Guangdong, ChinaWrist TypeVersion:1.0
CATALOGUE INTRODUCTIONINTRODUCTION  1Safety informationLCD display signalMonitor componentsBEFORE YOU START  4The Choice of power supplyInstalling and replacing the batteriesSetting Date, time and measurement unitMEASUREMENT  7Tie the cuffStrat a measurementTHE OPERATION OF RECALLING RECORDS 9Recall the recordsDelete the recordsINFORMATION FOR USER  11Tips for operationMaintenancesABOUT BLOOD PRESSURE 13What are systolic pressure and diastolic pressure?What is the standard blood pressure classification?Why does my blood pressure fluctuate throughout the day?Why the blood pressure I get from the hospital is different from home?If the result is the same if measuring on the right wrist?TROUBLESHOOTING  15SPECIFICATIONS  16CONTACT INFORMATION 17The below signs might be in the user manual, labeling or other component. They are the requirement of standard and using.Safety informationThis 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 wrist 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 based solely 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.This unit is not suitable for continuous monitoring during medical emergencies or operations.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 wrist and press the START/STOP button to stop inflation.To avoid measurement errors, carefully read this manual before using the product.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 the battery and the patient simultaneously.The user must check that the equipment functions safely and see that it is in proper working condition before being used.The manufacturer does not require such preventive inspections by other persons.The Max. temperature of apply part can be achieved is 42.5℃ under the environmental temperature of 40℃.Manufacture will make available on request circuit diagrams, component part list, etc.CAUTIONCaution:Consult accompanying documentsCE Mark: conforms to essential requirements of the Medical Device Directive 93/42/EEC.ManufacturerSpecifies serial numberType B applied partDirect currentDI SP OS AL: Do n ot d is p os e th is product as unsorted municipal waste. Collection of such waste separately for special treatment is necessary.Authorized Representative in the European CommunityEC REPThank you for selecting TRANSTEK wrist blood pressure Monitor (TMB-1014-BT). The monitor features blood pressure measurement, pulse rate measurement and auto-save the result. The design provides you with many years of reliable service.Reading taken by the TMB-1014-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 instruction for using the product.Read the manual thoroughly before using the product.Features:Systolic blood pressureDiastolic blood pressurePulse rateHistoric record of up to 60 measurements
LCD DISPLAYSYSTOLICDIASTOLICMEM/UPBUTTONSET/DOWNBUTTONSTART/OFF BUTTONCUFF(Type B applied part)PULSE RATEGRADETIMEBATTERYCOMPARTMENTINTRODUCTION INTRODUCTIONMonitor componentsLCD display signal6 < 0 % 2 / ' ( 6 & 5 ,3 7 ,2 1 ( ; 3 /$ 1 $ 7 ,2 1Systolicblood pressure High pressure resultDiastolicblood pressure Low pressure resultPulse Pulse/minutemmHg Measurement unit the blood pressure Time Currently timeLow batteryBatteries are low and need to be replacedErrorUserRecallingBlood pressure monitor has detected errorThe current selected userThe erecords will be showedBluetooth Bluetooth is in an open positionGrade The grade of the blood pressureFor instructions,refer to Page 13Arrhythmia Arrhythmia is detected
BEFORE YOU STARTBEFORE YOU STARTSlide off the battery cover.Install the batteries by matching the correct polarity, as shownbelow. Always use the correct battery type (2 alkaline LR03AAA-size). Replace the cover.The installment and replacement of battery 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. In sure the “lock” key is glided to the unlock mode.(year :2010—2050; time:24 H))Remove batteries if the device is not likely to be used for some time.The old battery is harmful to the environment, so please disposal with other daily trash.Remove the old battery from the device and follow your local recycling guidelines.CAUTIONReplace the batteries whenever the below happenThe showsThe display dimsThe display does not light up2.Press the “MEM” to change the [Hour].1.Pressing “SET” for 3 seconds to enter the mode for [Hour] setting.3.When you get the right [Hour], press “SET” to set down and turn to next step automatically.MEMSETMEMSETMEMSET
BEFORE YOU START BEFORE YOU STARTBluetooth phones’ test software1.Open the Bluetooth 4.0 special test mobile phones after electrify blood pressure monitor.2.After operating Bluetooth Test program (It is about 8 m from mobile to blood pressure monitor), the “discovered device” column will remind “searching for device”...3.Long press the "START" button after power off the blood pressure monitor, it’ll show moving "o”.4.At this moment, the “discovered device” column of mobile will display devices list.5.Choose detected device from the list. 7KHUHLV³¥´RQWKHULJKW4.Repeat the 2 and 3 to set the [Minute].5.Repeat the 2 and 3 to set th e [ YEA R], [MONTH] and [DAY].7.After the unit is set, the right picture will show, then it turn off automatically.MEMSETMEMSETMEMSET
Positioning the wrist cuff1.Remove all accessories (watch, bracelet, etc) from your left wrist. If your physician has diagnosed you with poor circulation in your left wrist, use your right wrist.2.Roll or push up your sleeve to expose the skin.3.Apply the cuff to your left wrist with your palm facing up.4.Position the edge of the cuff about 1-1.5cm.5.Fasten the wrist cuff around your wrist, leaving no extra room between the cuff and your skin. If the cuff is too loose, the measurement will not be accurate.6.When the blood pressure monitor show “[ ]”, it means matching successfully; When it display”E1”, it indicates matching unsuccessfully.7.If matching successfully, it will show the lately measuring record on the “receive data” column.8.Choose “Bloodpressure Record” to view the history record.9.Click “back” to return main interface of testing software and go on testing next blood pressure monitor.Resting 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, on the same wrist, or as directed by a physician.BEFORE YOU START MEASUREMENT
STARTSTOPSTARTSTOP1.Press the START/STOP, it will finish the whole measurement automatically.Adjust the zero automatically. Please press the SET to choose the user 1 or user 2 when the blood pressure monitor turn offInflating and measuring automatically.Display and save the results automatically.Start the Measurement4.Press the ST AR T/S TO P t opower off, otherwise it will turnoff automatically within 1 minute.2.After meas uring ，it’ll disp lay t he movin g “o” and send data at the same time.3.If da ta is sent succ essfu lly, go ba ck to disp lay t he inter face of me asuri ng resul ts.If the data failed to send，go back to display the interface of measuring results after display “E9”.MEASUREMENT MEASUREMENT
THE OPERATION OF RECALLING RECORDSRecalling the records1.Press the “MEM” to show the last 3 average of the record.2. Press the “MEM” or “SET” to get the 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.CAUTIONUPDOWNMEMSETMEMSETIf you did not get the correct measurement, you can delete all results by following below steps.Deleting a measurement record from memory1.Hold pressing “MEM” for 3 seconds, when the memory is shown.2.When flash “Delete all”, press the “SET” to delete the memory.3.If you don’t want to delete the records, press “START /STOP ” to escape.4.If there is no record. the right display will show.MEMSETTHE OPERATION OF RECALLING RECORDSMEMSET
Tips for measurementINFORMATION FOR USERWait at least 1 hour after dinner or drinkingWait at least 20 minutes after taking a bathIn a very cold enviromentImmediate measurement after tea, coffee, smoking When talking or moving your fingersWhen you want to discharge urineINFORMATIONIt can cause incorrectness if the measurement are taken in the following circumstances.MaintenanceIn order to get the best performance, please follow the below instructions.Put in a dry place and avoid the sunshineAvoid the intense shakingand collisionUsing the wet clothing to remove the dirtAvoid touching water,clean it with a dry cloth in case.Avoid the dusty and unstable-temperature environmentAvoid washing the cuffClean the cuff with a soft dry cloth. Do not use any abrasive or volatile cleaners.In order to reduce the pollution of the environment, please return to themanufacture when the product is close to the end of life.Instructions for correct replacement of interchangeable or detachable partsspecified by MANUFACTURER as replaceable by SERVICE PERSONNEL.Please calibrate the blood pressure monitor in specific institute once everytwo years to ensure the precise measurement。In order to get the bestperformance, please follow the below instructions for storage.
ABOUT BLOOD PRESSURE1. Individual blood pressure varies every in one day, it also affected by the w ay y o u t i e you r cuf f and t he y o u r measurement position, so please take the measurement at the same condition.2.The varies of the pressure is greater if the person take medicine.3.Waiting at least 4-5 minutes for another measurement.Why my blood pressure is varies even in one day?If the result is the same i f m e a s u r i n g o n t h e right wrist?It is ok for both wrists, but there will be some different results for different person, so suggest you measure the same wrist every time.Why the blood pressure I get from the hospital is different from home?The blood pressure is different even during 24 hour because of the weather,emotion , exercise etc, specially the “white coat” in hospital which makes the results are higher than the ones at home.The attention need to pay when you measure you 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 wrist.If you feel anxious pressured.You had better take deep breath 2-3 times before beginning.Advice:adjust yourself for 4-5 minutes until you calm down. ABOUT BLOOD PRESSURESYSDIA12080120~12980~84130~13985~89140~15990~99160~179100~109!180!110green light yellowlight red light/HYHO%ORRG3UHVVXUHPP+JWhen ventricles contract and pump blood out of the heart, blood pressure reaches its maximum value, the highest pressure in the cycle is known as systolic pressure. When the heart relaxes between heartbeats, the lowest blood pressure is diastolic pressure.What are systolic pressure and diastolic pressure?Below illustrates the blood pressure classification mode by World Health Organization (WHO) and International Society of Hypertension(ISH) in 1999. What is the standard blood pressureclassification?Only a physician can tell you your normal blood pressure range and the point at which you are at risk. Consult your physician to obtain these values.If the measurements taken with these products fall outside the range, consulty.CAUTIONpressartery veinblood dischargingSystolicrelaxblood enteringDiastolic
TROUBLESHOOTING SPECIFICATIONSPower supply 2*AAA alkaline batteriesDisplay moder Digital LCD V.A.36x41mmMeasurement mode Oscillographic testing modeMeasurement rangeAccuracyNormal working conditionStorage & transportationconditionMeasurement perimeterof the wrist About 13.5cm-19.5cmWeight Approx.120g(Excluding the dry cells)External dimensionsAttachmentApprox.80×65×22mm2*AAA alkaline batteries,user manualMode of operation Continuous operationDegree of protection Type B applied partProtection against ingress of water IPXOSoftware versionDevice classificationV01Internally Powered ME EquipmentWARNING: No modification of this equipment is allowed.Pressure: 0kpa-40kpa（0mmHg-300mmHg）pulse value:(40-199)times/minutePressure:15ć-25ćwithin±0.4kpa(3mmHg)10ć-40ć(out of 15ć-25ć)vithin±0.8kpa(6mmHg)pulse value:±5%Temperature:-20ć to 60ćRelative humidity:10% to 93%Temperature:5ć to 40ć5HODWLYHKXPLGLW\Atmospheric pressure: 86kPa to 106kPaThis 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 is dim orwill not light up.Batteries are exhausted. Replace with new batteriesInsert the batteries correctlyReplace with new batteriesBatteries are insertedincorrectly.Show onthe display Batteries are low.E 1 shows Data communication has failedMake sure that phone’s Bluetooth is on or within the distance rangeE 2 shows The cuff is very tight Refasten the cuff and thenmeasure again.E 3 shows The pressure of thecuff is excess.Relax for a momentand then measure again.E 9 shows Product has not been activated. ReactivatedE 10 or E 11 showsThe monitor detectedmotion while measuring.movement can affect themeasurement.Relax for a moment and then measure again.E 20 showsE 21 shows Relax for a moment andthen measure again.EExx,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.The measurement process does not detect the pulse signal.Loosen the clothing on the arm and thenmeasure again.Measure incorrectly.
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.& R Q WDFW,Q IR UP DWLR QAuthorized European Representative:Manufactured by: ZHONGSHAN TRANSTEK ELECTRONICES CO.,LTDConpany: ZHONGSHAN TRANSTEK ELECTRONICES CO.,LTDAddress: Jin’an Road, Minzhong, Zhongshan,528441,Guangdong, ChinaConpany: MDSS - Medical Device Safety Service GmbHAddress: Schiffgraben 41, 30175 Hannover, GermanyComplied European Standards listRisk management EN/ISO 14971:2007Labelling EN 980: 2008User manual EN 1041: 2008General requirementsfor safetyEN 60601-1:1990+A1+A2+A13Non-invasivesphygmomanometersGeneral requirementsEN 1060-1:2001/A1:2002EN 1060-3:1997/A1:2005EN 1060-4: 2004ElectromagneticcompatibilityEN 60601-1-2:2001+A1˖2006Table 1 Guidance and manufacture’s declaration – electromagnetic emissions-for all EQUIPMENT and SYSTEMSGuidance and manufacture’s declaration – electromagnetic emissionEmission test Electromagnetic environment – guidanceRF emissionsCISPR 11 Group 1Class BNot applicableNot applicableComplianceThe TMB-1014-BT is intended for use in the electromagnetic environmentspecified below. The customer of the user of the TMB-1014-BT should assurethat it is used in such and environment.Harmonic emissionsIEC 61000-3-2Voltage fluctuations/flicker emissions IEC61000-3-3RF emissionCISPR 11TheTMB-1014-BTuses RF energy only forits internal function. Therefore, its RFemissions are very low and are not likely tocause any interference in nearby electronicequipment.The TMB-1014-BT is suitable for use in all establishments other than domestic and those directly connected to the public low-voltage power supply network that supplies buildings used for domestic purposes.1) Caution: This unit has been thoroughly tested and inspected to assure proper performance and operation!2) Caution: this machine should not be used adjacent to or stacked with other equipment and that if adjacent or stacked use is necessary, this machine should be observed to verify normal operation in the configuration in which it will be used3) This product needs special precautions regarding EMC and needs to be installed and put into service according to the EMC information provided, and this unit can be affected by portable and mobile RF communications equipment.4) The guidelines for avoiding or identifying and resolving adverse electromagnetic effects on other equipment that may result from operation of the ME EQUIPMENT or ME SYSTEM.5) Each frequency or frequency band of reception; the preferred frequency or frequency band, if applicable, and the bandwidth of the receiving section of the ME EQUIPMENT or ME SYSTEM in those bands;6) Warning: the TMB-1014-BT may be interfered with by other equipment, even if that other equipment complies with CISPR EMISSION requirements.7) Each frequency or frequency band of transmission, the type and frequency characteristics of the modulation and the EFFECTIVE RADIATED POWER.
The TMB-1014-BTis intended for use in the electromagnetic environment specifiedbelow. The customer or the user of TMB-1014-BTshould assure that it is used insuch an environment.Guidance and manufacture’s declaration – electromagnetic immunityImmunity test±6 kV contact±8 kV air±6 kV contact±8 kV air±2 kV forpower supply lines±2kV forpower supply lines±1 kV line(s)to line(s)±1 kVdifferential mode<5% UT(>95% dip in UT)for 0.5 cycle40% UT(60% dip in UT)for 5 cycles70% UT(30% dip in UT)for 25 cycles<5% UT(>95% dip in UT)for 5 sec<5% UT(>95% dip in UT)for 0.5 cycle40% UT)(60% dip in UT)for 5 cycles70% UT(30% dip in UT)for 25 cycles<5% UT(>95% dip in UT)for 5 sec3A/mNOTE UTis the a.c. mains voltage prior to application of the test level.Table 2 Guidance and manufacture’s declaration – electromagnetic immunity –for all ME EQUIPMENT and ME SYSTEMSIEC 60601 test level Compliance levelElectrostaticdischarge (ESD)IEC 61000-4-2Electromagneticenvironment - guidanceFloors should be wood,concrete or ceramic tile. Iffloor are covered withsynthetic material, therelative humidity should beat least 30%.Mains power quality shouldbe that of a typicalcommercial or hospitalenvironment.Mains power quality shouldbe that of a typicalcommercial or hospitalenvironment.Mains power quality shouldbe that of a typicalcommercial or hospitalenvironment. If the user ofthe TMB-1014-BTrequirescontinued operation duringpower mains interruptions,it is recommended that theTMB-1014-BTbe poweredfrom an uninterruptiblepower supply or a battery.Power frequency magneticfields should be at levelscharacteristic of a typicallocation in a typicalcommercial or hospitalenvironment.3A/mPower frequency(50Hz) magneticfield IEC61000-4-8Voltage dips,shortinterruptions andvoltage variationson power supplyinput lines IEC61000-4-11Electrical fasttransient/burstIEC 61000-4-4Surge IEC61000-4-5Table 4 Guidance and manufacture’s declaration – electromagnetic immunity –for ME EQUIPMENT and ME SYSTEMS that are not LIFE-SUPPORTINGGuidance and manufacture’s declaration – electromagnetic immunityImmunity test3 Vrms3 V/mThe TMB-1014-BTis intended for use in the electromagnetic environment specifiedbelow. The customer or the user should assure that it is used in such an environment.CompliancelevelIEC 60601test levelConducted RFIEC 61000-4-6Radiated RFIEC 61000-4-33 V/m 80 MHzto 2.5 GHz3 Vrms150 kHz to80 MHzElectromagnetic environment -guidancePortable and mobile RF communicationsequipment should be used no closer toany part of theYS-6100, includingcables, than the recommendedseparation distance calculated from theequation applicable to the frequency ofthe transmitter.Portable and mobile RF communicationsequipment should be used no closer toany part of the including cables, than therecommended separation distancecalculated from the equation applicableto the frequency of the transmitter.Recommended separation distanced = 1.167d = 1.16780 MHz to 800 MHzd= 2.333800 MHz to 2.5 GHzwhere Pis the maximum output powerrating of the transmitter in watts (W)according to the transmitter manufac-turer and d is the recommendedseparation distance in metres (m).Field strengths from fixed RFtransmitters, as determined by anelectromagnetic site survey,ashould beless than the compliance level in eachfrequency range.Interference may occur in the vicinity ofequipment marked with the followingsymbol:
NOTE 1 At 80 MHz and 800 MHz, the higher frequency range applies.NOTE 2 These guidelines may not apply in all situations. Electromagneticpropagation is affected by absorption and reflection from structures, objects andpeople.a Field strengths from fixed transmitters, such as base stations for radio(cellular/cordless) telephones and land mobile radios, amateur radio, AM and FMradio broadcast and TV broadcast cannot be predicted theoretically with accuracy.To assess the electromagnetic environment due to fixed RF transmitters, anelectromagnetic site survey should be considered. If the measured field strength inthe location in which the ELE007839V1 is used exceeds the applicable RFcompliance level above, the ELE007839V1 should be observed to verify normaloperation. If abnormal performance is observed, additional measures may benecessary, such as reorienting or relocating the ELE007839V1.b Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m. 0,010,1761.1 761.11096.3096.301150 kHz to 80 MHzd = 1.16780 MHz to 800 MHzd = 1.167800 MHz to 2,5 GHzd = 2.333Table 6 Recommended separation distances between portable and mobileRF communications equipment and the EQUIPMENT or SYSTEM –for ME EQUIPMENT or ME SYSTEM that are not LIFE-SUPPORTINGRecommended separation distances between portable and mobile RF communica-tions equipment and the ELE007839V1 Fitness Equipment.TheTMB-1014-BT is intended for use in an electromagnetic environment in whichradiated RF disturbances are controlled. The customer or the user of theTMB-1014-BT can help prevent electromagnetic interference by maintaining a minimum distancebetween portable and mobile RF communications equipment (transmitters) and theTMB-1014-BT as recommended below, according to the maximum output power of thecommunications equipment.Rated maximum outputpower of transmitterWSeparation distance according to frequency of transmitterm100For transmitters rated at a maximum output power not listed above, the recommendedseparation distance din meters (m) can be estimated using the equation applicable tothe frequency of the transmitter, where Pis the maximum output power rating of thetransmitter in watts (W) according to the transmitter manufacturer.NOTE 1 At 80 MHz and 800 MHz, the separation distance for the higher frequencyrange applies.NOTE 2 These guidelines may not apply in all situations. Electromagnetic propagationis affected by absorption and reflection from structures, objects and people.0.167 0.167 0.2330.369 0.369 0.738333.2883.711.67 11.67 23.330
This device complies with Part 15 and Part 18 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 and Part 18 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 equipment complies with FCC and IC radiation exposure limits set forth for an uncontrolled environment. End user must follow the specific operating instructions for satisfying RF exposure compliance. This transmitter must not be co-located or operating in conjunction with any other antenna or transmitter.

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