Transtek Medical Electronics LS802-E02 Blood Pressure Monitor User Manual

Guangdong Transtek Medical Electronics Co.,Ltd Blood Pressure Monitor Users Manual

Users Manual

User ManualBlood Pressure Monitor LS802-ETo use the monitor correctly and safely, please read the manual thoroughly.Thank you very much for selecting TRANSTEK Blood Pressure Monitor LS802-E.please keep well this manual in order to reference in future.Arm TypeVersion:1.0FCC ID:OU9LS802-E02GUANGDONG TRANSTEK MEDICAL ELECTRONICS CO.,LTDZone A, 5/F., Investment Building, No. 12, Huizhan East Rd., Torch Development District, Zhongshan, Guangdong, 528437, China
CATALOGUE1Table of ContentsCATALOGUEINTRODUCTION..............................................................................................................................2General DescriptionSafety InformationLCD Display SignalMonitor Components BEFORE YOU START......................................................................................................................6The Choice of Power SupplyInstalling and Replacing the BatteriesMEASUREMENT..............................................................................................................................8Tie the CuffStart the MeasurementINFORMATION FOR USER...........................................................................................................10Tips for measurementMaintenancesABOUT BLOOD PRESSURE.........................................................................................................12What are systolic pressure and diastolic pressure?What is the standard blood pressure classification?Why my blood pressure is varies even in one 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 arm?TROUBLESHOOTING ...................................................................................................................14SPECIFICATIONS..........................................................................................................................15AUTHORIZED COMPONENTS ....................................................................................................16CONTACT INFORMATION.............................................................................................................16FCC STATEMENT...........................................................................................................................17COMPLIED STANDARDS LIST.....................................................................................................18EMC GUIDANCE............................................................................................................................19
The below signs might be in the user manual, labeling or other component. they are the requirement of standard and using.Safety InformationINTRODUCTION INTRODUCTION2 3Thank you for selecting TRANSTEK arm type blood pressure Monitor (LS802-E). The monitor features blood pressure measurement, pulse rate measurement and the the result storage. The design provides you with two years of reliable service.Reading taken by the LS802-E 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:92*78mm Blue LCD display with white backlightMaximum 60 records per each userMeasuring during inflation technologyGeneral DescriptionT1A/250V Φ3.6*10CCCF1For indoor use onlySymbol for “MANUFACTURER”Symbol for “SERIAL NUMBER”Symbol for “TYPE BF APPLIED PARTS”Symbol for “ENVIRONMENT PROTECTION – Waste electrical 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”Symbol for “MANUFACTUREDATE”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 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.When the device was used to measure patients who have common arrhythmias such as atrial or ventricular premature beats or artrial fibrillation, the best result may occure 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 armand 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 /adapter and the patient simultaneously.To avoid measurement errors, please avoid the condition of strong electromagnetic field radiated interference signal or electrical fast transient/burst signal.The user must check that the equipment functions safely and see that it is in proper working condition before being used.This device is contraindicated for any female who may be suspected of, or is pregnant. Besides provided inaccurate readings, the affects 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 been impacted and reduced.During using, the patient will 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.Please 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 in two years of reliable service.Please dispose of ACCESSORIES, detachable parts, and the ME EQUIPMENT according to the local guidelines.If you have any problems with this device, such as setting up, maintaining or using, please contact with 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.The device has been evaluated clinically used manual cuff/stethoscope ausculation 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.” CAUTIONWireless Transmission
CUFF AIR PIPEAIR CONNECTOR PLUGLCD DISPLAYDC POWER SOCKETUser 1GuestUser 2BATTERY COMPARTMENTMonitor ComponentsLCD Display Signal54List1.Blood Pressure Monitor (LS802-E)4.User manual3. 4*AA alkaline batteries2.Cuff (Type BF applied part) SYMBOL DESCRIPTIONSystolic blood pressure High pressure resultDiastolic blood pressure Low pressure resultEXPLANATIONPulse Pulse/minuteUser 1 Provide measurement for user 1, and then save the measure dataGuest Provide measurement for guests,but not save the measurement data.User 2 Provide measurement for user 2, and then save the measure dataData storage To remind the users that the measurement data don’t upload to bridge in timeWireless transmitter The blood monitor and Bridge in communicationNetwork connection The bridge not connect the networkShocking remainding Shocking will result in inaccurateLow battery Batteries are low and need to be replacedMeasurement Unit of the blood pressureUnitdate (hour:minute) Currently timeDeflating CUFF air is exhausting of deflatingComponent list of pressure measuring system1 Cuff 2 Air pipe3 PCBA4 Pump5 ValveArrhythmia Irregular heartbeatHeartbeat Heartbeat detection during the measurementINTRODUCTION INTRODUCTION(22~32cm or 22cm~42cm)5. AC Adaptor (UE08WCP-060100SPA only!)
AC adaptor76The Choice of Power Supply１.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 batteries2.AC adaptor powered mode: 100-240V~, 50-60HZ,400mA(Can be supplied by AC adaptor model UE08WCP-060100SPA only!)Please unplug the adaptor to depart from the using utility power.Installing and Replacing the BatteriesCAUTIONRemove 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.Do not dispose of batteries in fire. Batteries may explode or leak.CAUTIONReplace the batteries whenever the below happenThe + showsThe display dimsThe display does not light upMEASUREMENTResting 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 arm, or as directed by a physician.Tie the Cuff1.Tie the cuff on your upper arm, the position the tube off-center toward the inner side of arm in line with the little finger.2.The cuff should be sung 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. 2~3cmNote:The adaptor interface is located on the right side of the monitor. Place NO obstacles on the right for easy pull-off adaptor.In order to get the best effect and protect you monitor,please use the right battery and special power adapter which complies with U.S. safety standard.BEFORE YOU START4.Correct Posture for Patients with Hypertension, especially for Hypertension patient - 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 central of the cuff should maintain at the same level as the right atrium of the heart.
98LCD displayTips:Inflating and measuring.Start the Measurement2.In this manual, the measurement of User 1 as an example.Press the User 1 button to turn on the monitor and it will finish the whole measurement, and then save the measure data for User 1. The same to the User 2.Adjust the zero . If the measure data don’t upload to the bridge in time, the icon will display.Press the User 1 to power off , otherwise it will turn off within one minute.Display and save the results will transmit to the bridge through the wireless.Press the Guest button to turn on the monitor and it will finish the whole measurement for Guest, but not save the measurement data.A.when finish the whole measurement, press another button ,the blood monitor will begin measure again.B.If the blood monitor not connect with bridge, the icon of will display. Maximum 60 records are both for User 1 and User 2.1. When the monitor is off, press the User 1 button to turn on the monitor. 3Please proceed to activate/synchronize before initial use of this equipment or when the measurement unit is changed. When the equipment is OFF, press and hold “GUEST” button to enter Activation / Synchronization Interface. After successful activation/synchronization, the equipment will display and transmit the measuring results after each measurement.Activation /synchronization is proceedingThe measureme-nt data is uploadingThe data has been uploaded successfullyCAUTIONInterference may occur in the vicinity of equipment marked with the following symbol . And LS802-E may interfering vicinity electrical equipment.Sensitive people, including pregnant women and those who implanted medical elec-tronic instruments, should avoid using the unit whenever possible.Keep the monitor at least 20 centimeters away from the human body (especially the head) when the data transmission is proceeding after measurement.To enable the data transmission function, this product should be interconnected with Bridge in RF 915 MHz network.How to mitigate possible interference?1. The range between the device and the Bridge should be reasonably close, from 1 meter to 10 meters. Please ensure no obstacles between the device and the Bridgeso as to obtain quality connection and to lower the RF output range.2. To avoid interference, other electronic devices (particularly those with wireless transmission / Transmitter) should be kept at least 1 meter away from the monitor.Wireless Transmission Module No.Frequency Range Output Power RangeSupply VoltageAW4431_915915 - 918.5 MHz +1 dBm3.3VWhen there is no recordMEASUREMENT MEASUREMENT
INFORMATION FOR USERMaintenanceIn 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 cuff1110Tips for measurementIn a very cold environmentImmediate measurement after tea, coffee, smoking When talking or moving your fingersWhen you want to discharge urineIt can cause incorrectness if the measurement are taken in the following circumstances.Within 20 minutesafter taking a bathWithin 1 hourafter dinner or drinkingINFORMATION FOR USER
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?1. Individual blood pressure varies every in one day, it also affected by the way you tie your cuff and the your 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 3 minutes for another measurement.1312Why does my blood pressure fluctuate throughout the day?pressartery veinblood dischargingSystolicrelaxblood enteringDiastolic It is ok for both arms, but there will be some different results for different arm, so suggest you measure the same arm 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 upper arm.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. What is the standard blood pressureclassification?ABOUT BLOOD PRESSUREIf the result is the same if measuring on the right arm?ABOUT BLOOD PRESSUREIrregular Heartbeat DetectorThis Blood Pressure Monitor is equipped with an intelligent function of Irregular Heartbeat (IHB) Detector. 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, this equipment will light up the IHB symbol on the screen when displaying the measuring result.CAUTIONThe 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.Only a physician can tell your normal BP range. Please contact a physician if your measuring result falls out of the range. Kindly note that only a physician could tell whether your blood pressure value has reached a dangerous point.The chart on the right is the standardblood pressure classification publishedby 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 Hg
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.Power supplyBattery powered mode: 6VDC 4*AA alkaline batteriesAC adaptor powered mode:100-240V~, 50-60HZ,400mA(Can be supplied by AC adaptor model UE08WCP-060100SPA only!)Display mode Digital LCD V.A.78*92mmMeasurement mode Oscillographic testing modeMeasurement rangeAccuracyNormal working conditionStorage & transportationconditionMeasurement perimeterof the upper arm About 22cm~32cm or 22cm~42cmNet Weight Approx.385g(Excluding the dry cells)External dimensionsAttachmentApprox.120*160*69mm4*AA alkaline batteries,user manual Mode of operation Continuous operationDegree of protection Type BF applied partProtection against ingress of waterIP21Device Classification Battery powered mode: Internally powered ME EquipmentAC adaptor powered mode: CLASS II ME EuipmentSoftware Version V011514SPECIFICATIONSTROUBLESHOOTINGPROBLEM 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 dimor show Batteries are low.E 1 shows RF communication failed. Check the database is power on or not. Or synchronize the data operation.E 3 showsE10 or E11 showsE20 showsExxx,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 showsAC adaptor is insertedincorrectly.Insert the AC adaptor tightlyThe cuff is not secure. Refasten the cuff and thenmeasure again.The monitor detectedmotion,talking or thepluse is too poor while measuring.Relax for a moment and then measure again.The measurement process does not detectthe pulse signal.Loosen the clothing on thearm and then measure againThe treatment of themeasurement failed. Relax for a moment andthen measure again.E 8 shows Failure of activating or synchronizing the networkCheck if the newwork isconnected normally or not.E 9 shows The device is not activated or registered.Activate or register thedevice again.Rated cuff pressure: 0kpa - 40kpa (0mmHg~300mmHg)Measurement pressure: 5.3kPa-30.7kPa(40mmHg-230mmHg)pulse value: (40-199) beat/minutePressure:5℃-40℃within±0.4kpa(3mmHg) pulse value:±5%Temperature:5℃ to 40℃ Relative humidity ≤85%Atmospheric pressure: 86kPa to 106kPaTemperature:-20℃-60℃Relative Humidity 10%-93%Atmospheric Pressure: 50-106 kPa
Authorized Components１.Please use the TRANSTEK authorized adaptor.2.Storage bag.AdaptorType：UE08WCP-060100SPAInput：100~240V，50~60Hz,400mAOutput：6V 1A1716Contact Information(Conforms to UL certificate)AUTHORIZED COMPONENTSFor 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: GUANGDONG TRANSTEK MEDICAL ELECTRONICS CO., LTDCompany: GUANGDONG TRANSTEK MEDICAL ELECTRONICS CO., LTDAddress: Zone A, 5/F., Investment Building , No. 12, Huizhan East Rd., Torch Development District, Zhongshan, Guangdong, 528437, ChinaFCC 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 encouragedto 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 thereceiver 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 Statement
Complied Standards list 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) Risk 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 processesCOMPLIED STANDARDS LIST18EMC GUIDANCE19

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