Transtek Medical Electronics TMB1591-B Blood Pressure Monitor, Automated Blood Pressure System User Manual

Guangdong Transtek Medical Electronics Co.,Ltd Blood Pressure Monitor, Automated Blood Pressure System

User Manual

User ManualBlood Pressure Monitor TMB-1591To use the monitor correctly and safely, please read the manual thoroughly.Thank you very much for selecting TRANSTEK Blood Pressure Monitor TMB-1591.Please keep this manual well in order to reference in future.Arm TypeGuangdong Transtek Medical Electronics Co., Ltd.Zone A, No.105 ,Dongli Road, Torch Development District, Zhongshan,528437,Guangdong,China version:1.0
Table of ContentsINTRODUCTION........................................................................................2General DescriptionSafety InformationIndications for UseLCD Display SignalMonitor Components BEFORE YOU START................................................................................7The Choice of Power SupplyInstalling and Replacing the BatteriesMEASUREMENT.......................................................................................8PairingTie the CuffStart the MeasurementINFORMATION FOR USER......................................................................13Tips for measurementMaintenancesABOUT BLOOD PRESSURE....................................................................15What 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..............................................................................17SPECIFICATIONS.....................................................................................18AUTHORIZED COMPONENT ..................................................................19CONTACT INFORMATION........................................................................19COMPLIED STANDARDS LIST.................................................................20FCC STATEMENT......................................................................................21IC STATEMENT..........................................................................................22EMC GUIDANCE.......................................................................................23CATALOGUE CATALOGUE1
Thank you for selecting TRANSTEK arm type blood pressure monitor (TMB-1591). 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-1591 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.The signs below might be in the user manual, labeling or other component. They are the requirement of standard and using.Safety InformationFeatures:68mm*90mm Digital LCD display with White backlightMaximum 99 records Measuring during inflation technologyT1A/250V Φ3.6*10CCCF1For indoor use onlySymbol for “MANUFACTURER”Symbol for “TYPE BF APPLIED PARTS”Symbol for “ENVIRONMENT PROTECTION – Electrical waste products should not be disposed of with household waste. Please followlocal guidelines.”Symbol for “DIRECT CURRENT”Symbol for “Class II Equipment”Symbol for “THE OPERATION GUIDE MUST BE READ”General DescriptionThe Bluetooth Combination MarkCaution: These notes must be observed to prevent any damage to the device.Indications for UseThe Transtek Blood Pressure Monitor is digital monitors intended for use in measuring blood pressure and heartbeat rate with arm circumference ranging from 22cm to 42cm(about 8¾˝-16½˝). It is intended for adult indoor use only.IP22The ingress protection: the device could protected against solid foreign objects of 12.5mm and greater, and against vertically falling water drops when ENCLOSURE tilted up to 15° WARNING:These warning notes must be observed to preventany injury to the user.1. The device is not suitable for measuring the blood pressure of children. Ask your doctor before using it on older children. 2. The device is not suitable for use on pregnant women, patients with implanted, electrocical devices, patients with pre-elcampsia, premature ventricular beats, atrial fibrillation, peripheral, arterial disease and patients undergoing intravascular therapy or arterio-venous shunt or people who received a mastectomy. Please consult your doctor prior to using the unit if you suffer from illnesses3.Do not take any therapeutic measures on the basis of a self measurement. Never alter the dose of a medicine prescribed by a doctor. Consult your doctor if you have any question about your blood pressure.4.Please keep the unit out of reach of infants, children or pets, since inhalation or swallowing of small parts is dangerous or even fata.5. Do not dispose of batteries in fire. Batteries may explode or leak.WARNINGMeasurement 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%.Symbol for “KEEP DRY”INTRODUCTION INTRODUCTION32Symbol for “SERIAL NUMBER”SN
This device is intended only for adult use in homes.This device is intended for non-invasive measuring and monitoring of arterial blood pressure. It is not intended for use on extremities other than arm or for functions other than obtaining a blood pressure measurement.If you experience discomfort during a measurement, such as pain in the arm or other complaints, press the START/STOP button to release the air immediately from the cuff. Loosen the cuff and remove it from your arm. On the rare occasion of a fault causing the cuff to remain fully inflated during measurement, open the cuff immediately. Prolonged high pressure (cuff pressure >300mmHg or constant pressure >15mmHg for more than 3 minutes) applied to the arm may lead to an ecchymosis.Too frequent and consecutive measurements could cause disturbances in blood circulation and injuries.Do not wrap the cuff on the same arm which other monitoring ME EQUIPMENT is applied simultaneously, because this could cause temporary loss of function of those simultaneously-used monitoring ME EQUIPMENT.Don’t kink the connection tube during use, otherwise, the cuff pressure may continuously increase which can prevent blood flow and result in harmful injury to the PATIENT.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.This unit is not suitable for continuous monitoring during medical emergencies or operations. This device cannot be used with HF surgical equipment at the same time.This device is not intended for patient transports outside a healthcare facility.To avoid measurement errors, please avoid the condition of strong electromagnetic field radiated interference signal or electrical fast transient/burst signal.The operator shall not touch output of batteries/adapter and the patient simultaneously.Manufacturer will make available on request circuit diagrams, component parts list etc.The materials of the cuff have been tested and found to comply with requirements of ISO 10993-5:2009 and ISO 10993-10:2010. It will not cause any potential sensization or irritation reaction.Never apply the cuff over hurt skin.Do not use the unit in case of existing polyester resp. synthetic allergies.Be careful to strangulation due to cables and hoses, particularly due to excessive length.Do not connect the air hose to other medical equipment, as this could cause air to be pumped into intravascular systems or high pressure, what could lead to dangerous injuries.Before use, make sure the device functions safely and is in proper working condition.Please use the device under the environment which was provided in the user manual. Otherwise, the performance and lifetime of the device will been impacted and reduced.Please use ACCESSORIES and detachable partes specified/ authorised by MANUFACTURE. Otherwise, it may cause damage to the unit or danger to the user/patients.Please dispose of ACCESSORIES, detachable parts, and the ME EQUIPMENT according to the local guidelines.Please do not attempt to repair the unit yourself in the event of malfunctions. Only have repairs carried out by authorized service centers. Please report to Manufacturer if any unexpected operation or events occur.The device doesn’t need to be calibrated in two years of reliable service.Please use the soft cloth to clean the whole unit. Don’t use any abrasive or volatile cleaners.The patient is an intended operator.The patient can measure and change battery under normal circumstances and maintain the device and its accessories according to the user manual.Don't press or restrict the connection tubing during measurement. The device is not intended for public use.CAUTION LCD Display SignalSYMBOL DESCRIPTIONSystolic blood pressure High pressure resultDiastolic blood pressure Low pressure resultEXPLANATIONPulse Pulse/minutemmHg Measurement Unit of the blood pressureBattery Indicator Indicate the current battery Irregular heartbeat detectionIrregular heartbeatGradeHeartbeat Heartbeat dectetion during measurementThe grade of the blood pressureData transmission errorShocking reminder Shocking will result in inaccurateSYSmmHgPULSE /MINmmHgDIAData transmission errorINTRODUCTIONINTRODUCTION54
Component list of pressure measuring system1 Cuff 2 Air pipe3 PCBA4 Pump5 ValveMonitor ComponentsBATTERY COMPARTMENTON/STANDBY BUTTONLCD DISPLAY AIR HOSEAIR CONNECTOR PLUGCUFFList1. Blood Pressure Monitor (TMB-1591)4. User manual3. 4*AA alkaline Batteries2. Cuff (22cm~42cm) (Type BF applied part)5. AC adaptor (UE08WCP-060100SPA)DC POWER SOCKETThe Choice of Power SupplyIn order to get the best effect and protect your monitor,please use the right battery and special power adaptor. The power adapter is a part of the device. After using, please pull out the adaptor plug insulates from the main supply. Do not position the device in a position where it is difficult to disconnect from the supply mains. １.Slide off the battery cover.２.Install the batteries by matching the correct polarity, as shown.３.Replace the cover.1.Battery powered mode: 6VDC 4*AA alkaline batteries (Notes: A groups of new batteries can be used about 750 times.2.AC adaptor powered mode: 6V 1A(Can be supplied by AC adaptor model UE08WCP-060100SPA !) Right picture is the hole in for power adaptor.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 upINTRODUCTION BEFORE YOU START76
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, on the same 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 arm resting on a flat surface. 2~3cm4.Correct position: - Bare your arm or wear tights only when starting measurement. - Sit comfortably with legs uncrossed, feet flat on the floor, back and arm supported. The center of the cuff should be at the same level as the right atrium of the heart.When the blood pressure monitor is off, press On/Standby button for 2 full seconds to enter bluetooth pairing mode. The symbol flashes, indicating the pairing is proceeding. Turn on Bluetooth and APP. Make sure both are ON when pairing is proceeding.Then please select the user ID you want to connect with your smartphone on the app to continute the pair-up.If succeed, symbol will be shown. Then blood pressure monitor will turn off.If fail, symbol will flash all the time until the blood pressure turns off. PairingBluetooth Module No.: AW2540MV1RF Frequency Range: 2402 MHz to 2480 MHzOutput Power Range: -1 dBmSupply Voltage: 2V-3.6 VTransmitting Distance: 10 metersMEASUREMENT MEASUREMENT98
Start MeasurementWhen the blood pressure monitor is off, press On/Standby button to turn it on, it will finish the whole measurement.LCD display Adjust to zero.Inflating and Measuring Display and save the result.The blood pressure monitor will proceed to data transmission after measurement. The bluetooth symbol flashes on the LCD indicates data is transmitting.Segments Pressure1 >= 02 >= 403 >= 804 >= 120Segments Pressure5 >= 1406 >= 1607 >= 1808 >= 200Notes: During inflation, the heart icon in the upper left blinks in accordance with the user’s pulse rate.Additionally, during inflation the progress metre to the right of the digits builds vertically up as the pressure increases according to the table below.After successful transfer, the device powers off the Bluetooth radio and the icon (and rectangle) are removed.If the user presses and releases the On/Standby button, another reading is initiated.If the user presses and holds the On/Standby button for 2 seconds, the device powers down.Or if there is no operation, after a 10 seconds of inactivity, the device powers down.MEASUREMENT MEASUREMENT1110
Tips for Measurementwait at least 1 hour after dinner or drinkingWait at least 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 urineMeasurements may be inaccurate if taken in the following circumstances.During the measurement, if you press the On/Standby button to stop the measurement, the numerics are cleared. It will display as below:If you press and release the On/Standby button, another reading is initiated.If you press and hold the On/Standby button for 2 seconds, the device powers down.Or if there is no operation, after a 10 seconds of inactivity, the device powers down.MEASUREMENT INFORMATION FOR USER1312The 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 oldest record (99) is dropped from the list. CAUTION
MaintenanceIn 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 environmentAvoid washing the cuffWhat are systolic pressure and diastolic pressure? pressartery veinblood dischargingSystolicrelaxblood enteringDiastolic What is the standard blood pressure classification?Irregular Heartbeat DetectorCAUTIONCAUTIONBlood 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 HgWhen 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.The chart on the right is the standard blood pressure classification published by American Heart Association (AHA).The appearance of the IHB icon indicates that a pulse irregularity consistent with an irregular heartbeat 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.An 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.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.INFORMATION FOR USER ABOUT BLOOD PRESSURE1514
Why does my blood pressure fluctuate throughout the day?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?1. Individual blood pressure varies multiple times everyday. It is also affected by the way you tie your cuff and your measurement position, so please take the measurement under the same conditions.2.If the person takes medicine, the pressure will vary more.3.Wait at least 3 minutes for another measurement.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.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.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. 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 powerLowbatteriesErrormassageDisplaywill not light up.Batteries are exhausted. Replace with new batteriesInsert the batteries correctlyReplace with new batteriesBatteries are insertedincorrectly.Batteries are low.showsUnsuccessful pairing.Check if both the APP and Bluetooth are on, operateand send the data again.E 01 shows The cuff is not secure.Readjust the cuff and relax for a momentand then measure again.AC adaptor is insertedincorrectly.Insert the AC adaptor tightlyThe display indicates the “BAT LO”message, pauses for 3 seconds.The battery icon shows empty (does not flash.)E 02 shows The cuff is too tight orthe inflation is too fast.E 03 shows The pressure of thecuff is excess.E 10 or E 11 showsMovement can affect themeasurement.Relax for a moment and then measure again.E 20 shows The measurement process does not detect the pulse signal.Loosen the clothing onthe arm and then measure again. E 21 shows Relax for a moment andthen measure again.Measure incorrectly.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.Refasten the cuff and thenmeasure again.Refasten the cuff and thenmeasure again.The monitor detectedmotion,talking or thepluse is too poor while measuring.ABOUT BLOOD PRESSURE TROUBLESHOOTING1716
Power supplyBattery powered mode: 6VDC 4*AA alkaline batteriesAC adaptor powered mode:6V 1A(Can be supplied by AC adaptor model UE08WCP-060100SPA !)Display mode Digital LCD V.A.68mm*90mmMeasurement mode Oscillographic testing modeMeasurement rangeAccuracyNormal working conditionStorage & transportationconditionMeasurement perimeterof the upper arm About 22cm~42cmNet Weight Approx.300g(Excluding the dry cells)External dimensionsAttachmentApprox.92mm*140mm*46mm4*AA alkaline batteries,user manual Mode of operation Continuous operationDegree of protectionSoftware VersionType BF applied partProtection against ingress of waterV01WARNING: No modification of this equipment is allowed.IP20Rated cuff pressure: 0mmHg-300mmHgMeasurement pressure: SYS:60mmHg-230mmHgDIA: 40mmHg-130mmHg pulse value:(40-199)beat/minutePressure:5℃-40℃ within±3mmHg pulse value:±5%Temperature:-20℃to 60℃Relative Humidity: 10%RH to 93%RHAtmospheric Pressure: 50kPa to 106 kPaTemperature:5℃ to 40℃ Relative humidity ≤85%RHAtmospheric pressure: 86kPa to 106kPaAuthorized Component１.please use the TRANSTEK authorized adapter.Ｃｏｎｔａｃｔ　ＩｎｆｏｒｍａｔｉｏｎAdapterInput：100~240V，50~60Hz,400mAOutput：6V 1AType： UE08WCP-060100SPA( Conforms to UL certificate )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.Manufactured by:Company:Address:Guangdong Transtek Medical Electronics Co., Ltd.Zone A, No.105 ,Dongli Road, Torch Development District, Zhongshan,528437,Guangdong,China Guangdong Transtek Medical Electronics Co., Ltd.SPECIFICATIONS AUTHORIZED COMPONENT1918
Complied Standards List 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: OU9TMB1591-BRisk 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 60601-1-11 Medical electrical equipment - Part 1-11: General requirements for basic safety and essential performance - Collateral standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environmentIEC60601-1-11:2010IEC/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+A1:2013 Medical electrical equipment- Part 2-30: Particular requirements for the basic safety and essential performance of automated non-invasive sphygmomanometersIEC/EN 62304:2006+AC: 2008 Medical device software - Software life cycle processesUsabilityIEC 62366 Medical devices - Application of usability engineering to medical devices (IEC 62366:2007)IEC 62366:2007+A1:2014IEC 60601-1-6:2010+A1:2013 Medical electrical equipment - Part 1 -6 : General requirements for basic safety and essential performance - collateral standard : UsabilityISO81060-2 Non-invasive sphygmomanometers —Part 2: Clinical validation of automatedmeasurement typeCOMPLIED STANDARDS LIST FCC STATEMENT2120
EMC Guidance1) This equipment needs to be installed and put into service in accordance with the information provided in the user manual;2) 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) IC Statement This device complies with Industry Canada license-exempt RSS standard(s). Operation is subject to the following two conditions: (1) this device may not cause interference, and (2) this device must accept any interference, including interference that may cause undesired operation of the device.Le présent appareil est conforme aux CNR d'Industrie Canada applicables aux appareils radio exempts de licence. L'exploitation est autorisée aux deux conditions suivantes : (1) l'appareil ne doit pas produire de brouillage, et (2) l'utilisateur de l'appareil doit accepter tout brouillage radioélectrique subi, même si le brouillage est susceptible d'en compromettre le fonctionnement.IC ID：12725A-TMB1591BIC STATEMENT EMC GUIDANCE2322

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