Transtek Medical Electronics LS802-E01 BLOOD PRESSURE MONITOR User Manual LS 802

Guangdong Transtek Medical Electronics Co.,Ltd BLOOD PRESSURE MONITOR LS 802

User 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.ZHONGSHAN TRANSTEKELECTRONICES CO.,LTDArm TypeJin’an Road, Minzhong, Zhongshan,528441,Guangdong, ChinaVersion:1.0
CATALOGUE INTRODUCTION1INTRODUCTION ............................................................... 1Safety informationLCD display signalMonitor componentsBEFORE YOU START .......................................................... 4The Choice of power supplyMEASUREMENT ............................................................... 5Tie the cuffStart a measurementINFORMATION FOR USER...................................................... 7Tips for measurementMaintenanceABOUT BLOOD PRESSURE..................................................... 9What 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?The result is different that you measuring on the different arm.TROUBLESHOOTING ......................................................... 11SPECIFICATIONS ............................................................. 12AUTHORIZED COPMONENT ................................................... 13COMPLIED EUROPEAN STANDARDS LIST...................................... 13ELECTROMAGNETIC COMPATIBILITY DESCRIPTIONS .......................... 14The below signs might be in the user manual, labeling or other component. they are the requirement of standard and using.Safety informationCaution:Consult accompanying documentsCE Mark: conforms to essential requirements of the Medical Device Directive 93/42/EEC.ManufacturerSpecifies serial numberThis 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 homologous 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 output of AC 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 when using the AC adaptor.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.CAUTIONType B applied partDirect currentDISPOSAL: Do not dispose this 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 arm type blood pressure Monitor (LS802-E). 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 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:93.5*79mm Bright LCD display with blue backlightMaximum 60 records per userCharging measuring technology
INTRODUCTION INTRODUCTION2 3CUFF AIR HOSEAIR CONNECTOR PLUGLCD DISPLAYDC POWER SOCKETUser AGuestUser BBATTERY COMPARTMENTMonitor componentsLCD display signalList1.Blood Pressure Monitor (LS802-E)4.User manual3. 4*AA alkaline batteries2.Cuff (Type B applied part) (AC2232-01)Component list of pressure measuring system1.Cuff 2.Micro Control Unit3.Amplifier4.Air pipe5.Pump6.ValveUser A User BGuestSYMBOL DESCRIPTIONSystolic blood pressure High pressure resultDiastolic blood pressure Low pressure resultEXPLANATIONPulse Pulse/minuteUser A provide measurement for user A, and then save the measure date automaticallyGuest provide measurement for guests,but not save the measurement data.User B provide measurement for user B, and then save the measure date automaticallyData storage to remind the users that the measurement dates 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 deflating
AC adaptorBEFORE YOU START54The Choice of BatteryIn order to get the best effect and protect you monitor,please use the right battery and special power adapter.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 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.The installment and replacement of batteryCAUTIONRemove 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 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 left arm resting on a flat surface. 2~3cm
BEFORE YOU START76Tips for measurementINFORMATION FOR USERIn a very cold enviromentImmediate 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.LCD displayTips:Inflating and measuring automatically.Ｓｔａｒｔ　ｔｈｅ　Ｍｅａｒｓｕｒｅｍｅｎｔ2.In this manual, the measurement of user A as an example.Press the (User A) to turn on the monitor and it will finish the whole measurement automatically, and then save the measure date for User A. The same to the (User B).Adjust the zero automatically. If the measure date don’t upload to the bridge in time, the icon will display.Press the to power off , otherwise it will turn off automatically within one minute.Display and save the results will transmit to the bridge through the wireless.Press the (Guests) to turn on the monitor and it will finish the whole measurement automatically for Guests, 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 A and user B.1. Press the to turn on the monitor. User AUser AUser AUser AImmediate measurement after taking a bathImmediate measurement after dinner or drinking
98ABOUT BLOOD PRESSUREWhen 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.LevelBlood Pressure(mmHg)SYSDIA<120<80120~12980~84130~13985~89140~15990~99160~179100~109>180>110Optimal Normal High-normal Mild Moderate SevereCAUTIONINFORMATIONMaintenanceIn 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 cuffpressartery veinblood dischargingSystolicrelaxblood enteringDiastolic Instructions for correct replacement of interchangeable or detachable parts specified by MANUFACTURER as replaceable by SERVICE PERSONNEL.
ABOUT BLOOD PRESSURE1. 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 4-5 minutes for another measurement.TROUBLESHOOTING 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.Why my blood pressure is varies even in one day?1110The result is different that you measuring on the different arm.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.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 The cuff is not secure. Refasten the cuff and thenmeasure again.E 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.The monitor detectedmotion while measuring.movement can affect themeasurement.Relax for a moment and then measure again.Measure incorrectly. Relax for a moment andthen measure again.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.E 10 or E 11 showsE 20 or E 21 showsEexx,shows on the display.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.
AUTHORIZED COPMONENT13The matched components１.Please use the TRANSTEK authorized adapter.2.Storage bag.12SPECIFICATIONSComplied European Standards listAdapterType：UE08WCP-060100SPAInput：100~240V，50~60Hz,400mAOutput：6V 1APower 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 moder Digital LCD V.A.93.5*79mmMeasurement mode Oscillographic testing modeMeasurement range Pressure: 0~40kpa(0~300mmHg)pulse value:(40~199)times/minuteAccuracyPressure:5℃~40℃within±0.5kpa(4mmHg) pulse value:±5%Normal working condition Temperature:5℃~40℃ Relative humidity ≤80%RHStorage & transportationconditionTemperature:-20℃~60℃Relative humidity:10%~93%RHMeasurement perimeterof the upper armAbout 22cm~42cmWeight Approx.424g(Excluding the dry cells)External dimensionsAttachmentApprox.138*110*60mm4*AA alkaline batteries,user manual Mode of operation Continuous operationDegree of protection Type B applied partProtection against ingress of waterIPX-0Risk management is the application of medical devices EN/ISO 14971:2007 Graphical symbols for labeling medical devices EN 980: 2008 Medical equipment manufacturers to provide information EN 1041: 2008 Medical electrical equipment Part 1-1: General Requirements for Safety Collateral Standard: Safety requirements for medical electrical systems EN 60601-1:1990+A1+A2+A13 Non-invasive blood pressure Part 1: General requirements EN 1060-1:2001/A1:2002 Non-invasive blood pressure Part 3: Supplementary requirements for electromechanical blood pressure measuring system EN 1060-3:1997/A1:2005 Automatic Blood Pressure Monitor overall system Interventional accuracy of the testing process EN 1060-4: 2004 Medical electrical equipment Part 1-2: Basic safety and essential performance of the general requirements Collateral Standard: Electromagnetic compatibility requirements and tests EN 60601-1-2:2001+A1：2006 WARNING: No modification of this equipment is allowed.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.Contact InformationAuthorized European Representative:Manufactured by: ZHONGSHAN TRANSTEK ELECTRONICES CO.,LTDConpany: ZHONGSHAN TRANSTEK ELECTRONICES CO.,LTDAddress: JinanRoad,Jinbiao,Minzhong,Zhongshan,Guangdong,ChinaConpany: MDSS - Medical Device Safety Service GmbHAddress: Schiffgraben 41,30175 Hannover, Germany
1514 Table 1 Guidance and manufacture’s declaration – electromagnetic emissions- for all EQUIPMENT and SYSTEMS Guidance and manufacture’s declaration – electromagnetic emissionEmission test Electromagnetic environment – guidanceRF emissions CISPR 11 Group 1 Class B Not applicable Not applicable ComplianceThe LS802-E is intended for use in the electromagnetic environment specified below. The customer of the user of the LS802-E should assure that it is used in such and environment. Harmonic emissions IEC 61000-3-2Voltage fluctuations/ flicker emissions IEC 61000-3-3 RF emission CISPR 11The LS802-E is intended for use in the electromagnetic environment specified below. The customer or the user of LS802-E should assure that it is used in such an environment. Guidance and manufacture’s declaration – electromagnetic immunity Immunity test ±6 kV contact±8 kV air ±6 kV contact±8 kV air ±2 kV for power supply lines ±2kV for power supply lines±1 kV line(s) to line(s)±1 kV differential 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 UT is 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 levelElectrostatic discharge (ESD) IEC 61000-4-2 Electromagnetic environment - guidance Floors should be wood, concrete or ceramic tile. If floor are covered with synthetic material, the relative humidity should be at least 30%. Mains power quality should be that of a typical commercial or hospital environment. Mains power quality should be that of a typical commercial or hospital environment. Mains power quality should be that of a typical commercial or hospital environment. If the user of the LS802-E requires continued operation during power mains interruptions, it is recommended that the LS802-E be powered from an uninterruptible power supply or a battery. Power frequency magnetic fields should be at levels characteristic of a typical location in a typical commercial or hospital environment. 3A/mPower frequency (50Hz) magnetic field IEC 61000-4-8 Voltage dips, short interruptions and voltage variations on power supply input lines IEC 61000-4-11 Electrical fast transient/burst IEC 61000-4-4 Surge IEC 61000-4-5The LS802-E uses RF energy only for its internal function. Therefore, its RF emissions are very low and are not likely to cause any interference in nearby electronic equipment. The LS802-E 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.
1716Table 4 Guidance and manufacture’s declaration – electromagnetic immunity –for ME EQUIPMENT and ME SYSTEMS that are not LIFE-SUPPORTING Guidance and manufacture’s declaration – electromagnetic immunityImmunity test3 Vrms 3 V/m The LS802-E is intended for use in the electromagnetic environment specified below. The customer or the user should assure that it is used in such an environment.Compliance level IEC 60601 test level Conducted RF IEC 61000-4-6 Radiated RF IEC 61000-4-3 3 V/m 80 MHz to 2.5 GHz3 Vrms150 kHz to 80 MHz Electromagnetic environment - guidancePortable and mobile RF communications equipment should be used no closer to any part of the YS-6100, including cables, than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter. Portable and mobile RF communications equipment should be used no closer to any part of the including cables, than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter. Recommended separation distanced = 1.167d = 1.167 80 MHz to 800 MHzd = 2.333 800 MHz to 2.5 GHzwhere P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer and d is the recommended separation distance in metres (m). Field strengths from fixed RF transmitters, as determined by an electromagnetic site survey,a should be less than the compliance level in each frequency range. Interference may occur in the vicinity of equipment marked with the following symbol: NOTE 1 At 80 MHz and 800 MHz, the higher frequency range applies. NOTE 2 These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects and people. a Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones and land mobile radios, amateur radio, AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with accuracy. To assess the electromagnetic environment due to fixed RF transmitters, an electromagnetic site survey should be considered. If the measured field strength in the location in which the ELE007839V1 is used exceeds the applicable RF compliance level above, the ELE007839V1 should be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, 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.
19180,010.167 0.167 0.233 0,10.369 0.369 0.738 761.1 761.1 333.21 883.7 096.3 096.3 0111.67 11.67 23.330 150 kHz to 80 MHz d = 1.167 80 MHz to 800 MHz d = 1.167 800 MHz to 2,5 GHz d = 2.333Table 6 Recommended separation distances between portable and mobile RF communications equipment and the EQUIPMENT or SYSTEM –for ME EQUIPMENT or ME SYSTEM that are not LIFE-SUPPORTING Recommended separation distances between portable and mobile RF communica-tions equipment and the ELE007839V1 Fitness Equipment. The LS802-E is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of the LS802-E can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the LS802-E as recommended below, according to the maximum output power of the communica-tions equipment. Rated maximum output power of transmitter WSeparation distance according to frequency of transmitter m100For transmitters rated at a maximum output power not listed above, the recommended separation distance d in meters (m) can be estimated using the equation applicable to the frequency of the transmitter, where P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer.NOTE 1 At 80 MHz and 800 MHz, the separation distance for the higher frequency range applies. NOTE 2 These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects and people.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 turningthe 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.

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