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
Version:1.0 User Manual Blood Pressure Monitor LS802-E Arm Type ZHONGSHAN TRANSTEKELECTRONICES CO.,LTD Jin’an Road, Minzhong, Zhongshan,528441,Guangdong, China Thank you very much for selecting TRANSTEK Blood Pressure Monitor LS802-E. To use the monitor correctly and safely, please read the manual thoroughly. please keep well this manual in order to reference in future. CATALOGUE INTRODUCTION ............................................................... 1 Safety information LCD display signal Monitor components BEFORE YOU START .......................................................... 4 The Choice of power supply MEASUREMENT ............................................................... 5 Tie the cuff Start a measurement INFORMATION FOR USER ...................................................... 7 Tips for measurement Maintenance ABOUT BLOOD PRESSURE..................................................... 9 What 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 ......................................................... 11 SPECIFICATIONS ............................................................. 12 AUTHORIZED COPMONENT ................................................... 13 COMPLIED EUROPEAN STANDARDS LIST ...................................... 13 ELECTROMAGNETIC COMPATIBILITY DESCRIPTIONS .......................... 14 Thank 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. INTRODUCTION Features: 93.5*79mm Bright LCD display with blue backlight Maximum 60 records per user Charging measuring technology Safety information The below signs might be in the user manual, labeling or other component. they are the requirement of standard and using. Caution:Consult accompanying documents Type B applied part CE Mark: conforms to essential requirements of the Medical Device Directive 93/42/EEC. DISPOSAL: Do not dispose this product as unsorted municipal waste. Collection of such waste separately for special treatment is necessary. Manufacturer Specifies serial number Direct current EC REP Authorized Representative in the European Community CAUTION 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 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. INTRODUCTION INTRODUCTION LCD display signal Monitor components CUFF AIR HOSE AIR CONNECTOR PLUG User A SYMBOL Guest User B DESCRIPTION EXPLANATION Systolic blood pressure High pressure result LCD DISPLAY DC POWER SOCKET Diastolic blood pressure Low pressure result Pulse Pulse/minute User A provide measurement for user A, and then save the measure date automatically Guest provide measurement for guests, but not save the measurement data. User B provide measurement for user B, and then save the measure date automatically Data storage to remind the users that the measurement dates don’t upload to bridge in time Wireless transmitter the blood monitor and Bridge in communication Network connection the bridge not connect the network Shocking remainding Shocking will result in inaccurate Low battery Batteries are low and need to be replaced Unit Measurement Unit of the blood pressure date (hour:minute) Currently time Deflating CUFF air is exhausting of deflating User B Guest User A Component list of pressure measuring system 1.Cuff 2.Micro Control Unit 3.Amplifier 4.Air pipe 5.Pump 6.Valve BATTERY COMPARTMENT List 1.Blood Pressure Monitor (LS802-E) 2.Cuff (Type B applied part) (AC2232-01) 3. 4*AA alkaline batteries 4.User manual MEASUREMENT BEFORE YOU START Tie the cuff The Choice of Battery 1.Battery powered mode: 1.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. 6VDC 4*AA alkaline batteries 2.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. AC adaptor CAUTION In order to get the best effect and protect you monitor,please use the right battery and special power adapter. The installment and replacement of battery 1.Slide off the battery cover. 2.Install the batteries by matching the correct polarity, as shown. 3.Replace the cover. 2.The cuff should be sung but not too tight. You should be able to insert one finger between the cuff and your arm. 2~3cm 3.Sit comfortably with your left arm resting on a flat surface. Replace the batteries whenever the below happen The shows The display dims The display does not light up CAUTION 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. 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 arm, or as directed by a physician. INFORMATION FOR USER BEFORE YOU START Start the Mearsurement 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). Press the (Guests) to turn on the monitor and it will finish the whole measurement automatically for Guests, but not save the measurement data. In this manual, the measurement of user A as an example. 1. Press the Tips for measurement It can cause incorrectness if the measurement are taken in the following circumstances. to turn on the monitor. LCD display User A Inflating and measuring automatically. User A Adjust the zero automatically. If the measure date don’t upload to the bridge in time, the icon will display. Immediate measurement after dinner or drinking Immediate measurement after tea, coffee, smoking Immediate measurement after taking a bath When talking or moving your fingers In a very cold enviroment When you want to discharge urine User A Display and save the results will transmit to the bridge through the wireless. User A 2. Press the to power off , otherwise it will turn off automatically within one minute. Tips: 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. INFORMATION ABOUT BLOOD PRESSURE Maintenance In order to get the best performance, please follow the below instructions. Put in a dry place and avoid the sunshine Avoid touching water, clean it with a dry cloth in case. What are systolic pressure and diastolic pressure? 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. Systolic blood discharging artery Diastolic blood entering vein press relax What is the standard blood pressure classification? Below illustrates the blood pressure classification mode by World Health Organization (WHO) and International Society of Hypertension(ISH) in 1999. Avoid the intense shaking and collision Avoid the dusty and unstabletemperature environment Level Optimal Normal High-normal Mild Moderate Severe SYS <120 120~129 130~139 140~159 160~179 >180 DIA <80 80~84 85~89 90~99 100~109 >110 Blood Pressure(mmHg) CAUTION Using the wet clothing to remove the dirt Avoid washing the cuff Instructions for correct replacement of interchangeable or detachable parts specified by MANUFACTURER as replaceable by SERVICE PERSONNEL. 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. TROUBLESHOOTING ABOUT BLOOD PRESSURE Why my blood pressure is varies even in one day? 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. 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. PROBLEM SYMPTOM No power Low batteries 3.Waiting at least 4-5 minutes for another measurement. 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 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. 10 Error massage REMEDY Batteries are exhausted. Replace with new batteries Batteries are inserted incorrectly. Show on Batteries are low. the display E 1 shows 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. Display is dim or will not light up. CHECK THIS The cuff is not secure. Insert the batteries correctly Replace with new batteries Refasten the cuff and then measure again. E 2 shows The cuff is very tight Refasten the cuff and then measure again. E 3 shows The pressure of the cuff is excess. Relax for a moment and then measure again. E 10 or E 11 shows movement can affect the The monitor detected measurement.Relax for a motion while measuring. moment and then measure again. E 20 or E 21 shows Measure incorrectly. Eexx,shows on the display. A calibration error occurred. Relax for a moment and then measure again. Retake the measurement. If the problem persists, contact the retailer or our customer service department for further assistance.Refer to the warranty for contact information and return instructions. 11 SPECIFICATIONS AUTHORIZED COPMONENT Power supply Battery powered mode: 6VDC 4*AA alkaline batteries AC 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*79mm Measurement mode Oscillographic testing mode Measurement range Pressure: 0~40kpa(0~300mmHg) pulse value:(40~199)times/minute Accuracy Normal working condition Pressure: 5℃~40℃within±0.5kpa(4mmHg) pulse value:±5% Temperature:5℃~40℃ Relative humidity ≤80%RH Storage & transportation condition Temperature:-20℃~60℃ Relative humidity:10%~93%RH Measurement perimeter of the upper arm About 22cm~42cm Weight External dimensions Attachment Mode of operation Degree of protection Protection against ingress of water Approx.424g(Excluding the dry cells) Approx.138*110*60mm 4*AA alkaline batteries,user manual Continuous operation Type B applied part IPX-0 The matched components 1.Please use the TRANSTEK authorized adapter. Adapter Type:UE08WCP-060100SPA Input:100~240V,50~60Hz,400mA Output:6V 1A Contact Information 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: ZHONGSHAN TRANSTEK ELECTRONICES CO.,LTD Conpany: ZHONGSHAN TRANSTEK ELECTRONICES CO.,LTD Address: JinanRoad,Jinbiao,Minzhong,Zhongshan,Guangdong,China Authorized European Representative: Conpany: MDSS - Medical Device Safety Service GmbH Address: Schiffgraben 41,30175 Hannover, Germany Complied European Standards list Risk 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 EN 60601-1:1990+A1+A2+A13 for Safety Collateral Standard: Safety requirements for medical electrical systems 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 Medical electrical equipment Part 1-2: Basic safety and essential performance of the general requirements Collateral Standard: Electromagnetic compatibility requirements and tests 12 WARNING: No modification of this equipment is allowed. 2.Storage bag. EN 1060-4: 2004 EN 60601-1-2:2001+A1:2006 13 Table 1 Guidance and manufacture’s declaration – electromagnetic emissionsfor all EQUIPMENT and SYSTEMS Guidance and manufacture’s declaration – electromagnetic emission The 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. Emission test Compliance Electromagnetic environment – guidance RF emissions CISPR 11 Group 1 The 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. RF emission CISPR 11 Class B Harmonic emissions IEC 61000-3-2 Not applicable Voltage fluctuations/ flicker emissions IEC 61000-3-3 Not applicable 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. Table 2 Guidance and manufacture’s declaration – electromagnetic immunity – for all ME EQUIPMENT and ME SYSTEMS Guidance and manufacture’s declaration – electromagnetic immunity The 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. Immunity test IEC 60601 test level Compliance level Electrostatic discharge (ESD) IEC 61000-4-2 ±6 kV contact ±8 kV air Electrical fast transient/burst IEC 61000-4-4 ±2 kV for power supply lines Surge IEC 61000-4-5 ±1 kV line(s) to line(s) Voltage dips, short interruptions and voltage variations on power supply input lines IEC 61000-4-11 <5% UT (>95% dip in UT) for 0.5 cycle <5% UT (>95% dip in UT) for 0.5 cycle 40% UT (60% dip in UT) for 5 cycles 40% UT) (60% dip in UT) for 5 cycles 70% UT (30% dip in UT) for 25 cycles 70% UT (30% dip in UT) for 25 cycles <5% UT (>95% dip in UT) for 5 sec Power frequency 3A/m (50Hz) magnetic field IEC 61000-4-8 14 NOTE 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 ±2kV for power supply lines be that of a typical commercial or hospital environment. Mains power quality should ±1 kV be that of a typical differential mode commercial or hospital environment. ±6 kV contact ±8 kV air <5% UT (>95% dip in UT) for 5 sec 3A/m 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. UT is the a.c. mains voltage prior to application of the test level. 15 Table 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 immunity 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. Immunity test IEC 60601 test level Compliance level Conducted RF 3 Vrms IEC 61000-4-6 150 kHz to 80 MHz 3 Vrms Radiated RF 3 V/m 80 MHz IEC 61000-4-3 to 2.5 GHz 3 V/m Electromagnetic environment guidance Portable 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 distance d = 1.167 d = 1.167 80 MHz to 800 MHz d = 2.333 800 MHz to 2.5 GHz 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. where 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: 16 17 Table 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 communications 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 communications equipment. Rated maximum output Separation distance according to frequency of transmitter power of transmitter 150 kHz to 80 MHz 80 MHz to 800 MHz 800 MHz to 2,5 GHz d = 2.333 d = 1.167 d = 1.167 0,01 0.167 0.167 0.233 0,1 0.369 0.369 0.738 10 1.167 1.167 2.333 3.690 3.690 7.388 100 11.67 11.67 23.330 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. For 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. 18 19
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