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Attachment 3 AGE Automatic Wrist Blood Pressure Monitor - User ManualAGE Automatic Wrist Blood Pressure Monitor (Electronic Sphygmomanometer)User Manual Thank your to purchase our product. Please read this manual carefully before using the product. Please keep the manual appropriately for future reference. This User Manual is suitable to the following models: BW-601, BW-602, BW-603, BW-605, BW-606, BW-611, BW-612, BW-613Table of Contents(I) General Information(II) Precaution for Use and Maintenance(III) Name of Each Part(IV) Measure Procedure(V) Troubleshooting(VI) Model List(VII) Symbol Form(VIII) Guidance and Manufacturers DeclarationI. General Informationn Intended UseAGE Automatic Wrist Blood Pressure Monitor is intended for use by medical professionals or at home to monitor and display diastolic, systolic blood pressure and pulse rate on adult each time, with an air cuff buckled around ones wrist according to the instruction in the users guide manual.n Indications For UseAGE Automatic Wrist Blood Pressure Monitor is for use by medical professionals or at home and is a non-invasive blood pressure measurement system intended to measure the diastolic and systolic blood pressures and pulse rate of an adult individual by using a non-invasive technique in which an inflatable cuff is wrapped around the wrist. The cuff circumference is limited to 13.5cm 19.5cm.n SpecificationProduct Name AGE Automatic Wrist Blood Pressure MonitorModelsBW-601, BW-602, BW-603, BW-605, BW-606, BW-611, BW-612, BW-613Measurement PrincipleOscillometryCuffSoft cuffCuff Size290mm x 70mm (+/- 5mm)Measurable Wrist Circumference RangeAbout 13.519.5cmMeasurement RangePressure: 0280 mmHg Pulse: 40199 beats/minuteAccuracyPressure: 3mmHgPulse: 5%Power Supply3Vdc (2 “AAA” batteries)Battery LifeApprox. 250 timesWorking EnvironmentTemperature: 5C 40CHumidity: 1090%RHStorage EnvironmentTemperature: -20C +65CHumidity: 1095%RHElectric Shock ProtectionInternally powered equipment这里有问题,应为II类仪器,无接地Applied Part Classification Type B applied partMemory Capacity2 x 90 sets of data including date and timeSee Part VI - “Model List Form”InflationAutomatic inflation by internal pumpDeflationAutomatic speed deflation system controlled by internal electromagnetic valve.DisplayBlood Pressure (Systolic and Diastolic), Pulse, Date, Time, WHO BP Classification Indicating Bar, Low Battery Icon, Heart Icon, Memory Record NumberSwitch3 switches: POWER (START/STOP), MEMORY, SETSizeSee Part VI - “Model List Form”Weight (not including battery)See Part VI - “Model List Form”n Contraindications1. Contra-indicated for the NIBP measurement for analysis with heart disease2. Contra-indicated for the NIBP measurement at injured wristn Patient PopulationsThis Blood Pressure Monitor is intended for use by adults. Children should not use this monitor unless it is under the supervision of an adult.n Warning1. Keep the device away from high temperatures or high humidity, and direct sunlight.2. Keep sharp objects away from the cuff.3. Do not press the Start/Stop button without the cuff around your wrist to avoid excess pressure build up that may damage the cuff.4. Use the device at a sufficient distance from devices with strong electrical fields, such as television, microwave ovens, X-ray equipment, etc.5. Do not subject the device to strong impacts or drop it on the floor.6. Do not disassemble or modify the device or the cuff.7. Remove the batteries when the device is to be stored for extended periods of time.n Nature and Frequency of MaintenanceThis product is designed for use over an extended period of time; however, it is generally recommended that it be inspected every two years to ensure proper function and performance.n Protect the Nature EnvironmentPlease help to protect natural environment by respecting national and/or local recycling regulations when disposing of the battery and the product at the end of their useful live.II. PRECAUTION FOR USE AND MAINTENANCE n Precautions for Use:1. If you suffer from heart disease, high blood pressure or other circulatory disease, consult your physician before using the device.2. If the cuff pressure feels abnormal or you experience any other irregularity while using the cuff, reduce the pressure immediately by pressing the “START/STOP” switch and then consult the sales outlet where you purchased the device.3. If you think the measurement is abnormal or if measurement makes you feel unwell, discontinue use and consult your physician.4. Blood pressure measurement may not be possible for anyone with a weak pulse or arrhythmia.5. Repeated blood pressure measurement may cause problems such as congestion or swelling in some people.6. Frequently repeated blood pressure measurements will not give accurate results. Allow an interval of about 3 minutes between measurements.7. If you suffer from a severe problem with blood circulation in your arms, consult your physician before using the device. Failure to do so could be hazardous to your health.8. Measurement may not be possible for anyone with insufficient blood flow to the area where measurements will be taken or who suffers from a frequent irregular heartbeat. Consult your physician for advice on whether to use the device.9. DO NOT wrap the cuff around an injured wrist.10. DO NOT wrap the wrist cuff around a wrist in which a drip (intravenous infusion) is inserted or which is being used for blood transfusion as part of medical treatment. Doing so could result in an injury or a serious accident.11. DO NOT use the device in the vicinity of flammable gases such as those used for anaesthesia. Doing so could ignite the gases and cause an explosion.12. DO NOT use the device in enriched oxygen environments such as a hospitals hyperbaric chamber or oxygen tent. Doing so could ignite the oxygen and cause a fire.13. DO NOT use mobile phones near the device as this could result in a malfunction.14. If you use a cardiac pacemaker, consult your physician before using the device.15. Be sure to use this device only for measuring blood pressure. DO NOT use it for any other purpose.16. DO NOT use this device on infants.17. Blood pressure measurement may not be possible for anyone with common arrhythmias such as atrial or ventricular premature beats or atrial fibrillation.n Precautions for Maintenance:1. DO NOT store the blood pressure monitor in locations exposed to direct sunlight, high temperatures (over 65C), low temperatures (below -20C), high relative humidity (over 95%) or excessive amounts of dust.2. DO NOT drop the blood pressure monitor or subject it to other shocks or vibration.3. Remove the batteries if the device will be left unused for a long period.4. DO NOT attempt to disassemble the device.5. DO NOT bend the cuff or air hose excessively.6. NEVER clean the blood pressure meter with thinners or benzene, as they may damage it.7. DO NOT hard rub when clean the cuff. Take care not to get water into the air hose.III. Name of Each PartFigure 1 AppearanceNote for Appearance:(1) LCD Display(2) “MEMORY” Button(3) “START/STOP” Button (“POWER” button)(4) “SET” Button(5) CuffFigure 2 Display of LCDNote for LCD Display Panel:(1) Date: Month - Day(2) Time: Hour - Minute(3) Systolic Blood Pressure (unit: mmHg)(4) Diastolic Blood Pressure (unit: mmHg)(5) Arrhythmia Detection Function(6) Memory Record Number(7) 2x90 Sets Memory(8) Voice Function(9) WHO BP Classification Indicating Bar(10) Inflation/Deflation Indicator(11) Low Battery Icon(12) Blood Pressure Unit(13) Pulse (unit: beat/minute)(14) Heart Icon (Twinkle when measuring)IV. Measure Proceduren Battery LoadingSlide the battery cover in the direction of the arrow.Load two alkaline “AAA” size batteries. Please pay attention to the polarity.Close the battery coveen the battery voltage is lower than 2.1V, the LCD shows “Low Battery” icon . It means you must change the batteries at once. See Figure 4. Rechargeable batteries with a voltage of 1.2V are not suitable for this product. Take out all the batteries if the device will be not used for a long time to avoid battery leakage and relevant damage. Figure 3 Figure 4n Clock AdjustingPress the SET button repeatedly, and the individual figure will start blinking sequentially from month, date, hour to minute. Press Memory button once will cause the display to advance by one digit. See Figure 5.After you change the batteries, you have to readjust the date and time.Figure 5n Unit ChangeFor the unit change, you can select the mmHg or Kpa; and the mmHg is definition unit.When the device is turned off, press the button “ON/OFF” more than 5 seconds, then mmHg will be automatically changed to Kpa, or Kpa will be automatically changed to mmHg.n Wrist Cuff ConnectingBe sure to place the wrist cuff on bare skin of left wrist, and place device on the center of wrist. Place the wrist cuff 1cm above wrist joint. See Figure 6.Note: Wrist cuff connecting should make wrist feel no much tension. Dont connect too tense (otherwise the measurement will be not precise). Keep up right position on the same level of heart. When the cuff is dirty, detach it from the equipment, wash the cuff by hand with proper detergent and rinse it in the enough cold water, dry in air. Never iron it.Figure 6n Measuring ProcessFigure 7After your body is in a comfortable position, press the “Start / Stop” button. The device will verify itself, and LCD will twinkle automatically.After about two seconds, LCD shows one “00”. See Figure 8.Then the machine begins to pressurize automatically.After measurement, the result of systolic blood pressure, diastolic blood pressure, pulse rate and level of WHO BP classification will be all displayed on LCD. The result will be automatically memorized by itself.See Figure 9.Press “Start/stop” button after measuring, the device will be turned off.The device will be automatically power off after 1 minute of none use. Figure 8 Figure 9n Assessing High Blood Pressure for AdultsThe follow standards for assessing high blood pressure (without regard to age or gender) have been established as a guideline according to WHO (World Health Organization) standard. See Figure 10. Please note that other risk factors (e.g. diabetes, obesity, smoking, etc.) need to be taken into consideration and may affect these figures. Consult with your physician for accurate assessment.Figure 10From the above figure, we can see the classification of blood pressure for adults is as below. The WHO BP Classification Indicating Bar would show out the blood pressure level by the length.Blood Pressure ClassificationSBP (mmHg)DBP (mmHg)Length of WHO BP Classification BarOptimal120801 gridNormal120-12980-842 gridsHigh-Normal130-13985-893 gridsStage 1 Hypertension140-15990-994 gridsStage 2 Hypertension160-179100-1095 gridsStage 3 Hypertension1801106 gridsNote:1. The graph is not exact, but may be used as a guide in understanding non-invasive blood pressure measurements. The device is only intended for use with adults.2. 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.n Reading Memory ResultsUnder the “Stop” condition, press button “MEMORY” and enter the mode of reading results. LCD will show how many results it has, and then the latest result will be displayed, which is 01 for memory number. See Figure 11. Continuously press the “MEMORY” button; the memory number will increase by one.Press “MEMORY” button again after the last memory, the machine will power off. Under the memory-displaying mode, it will be automatically power off after ten seconds of none use. Or you can press “Start/stop” button to shut down the device.If it has no memory, then LCD will show “00” for systolic, diastolic, and pulse rate, and show “00” for the number of memory. While press the “MEMORY” or “START/STOP”, the device will power off.Figure 11n Delete for all MemoriesUnder the mode of reading memories, holding on pressing “MEMORY” button for three seconds, all memories will be deleted. LCD will show the Figure 12 for two seconds.Figure 12n Shut DownAfter measurement, press button “Start/stop” to turn off the device. The device will be automatically power off after 1 minute of none use.V. Troubleshooting3.这里问题太少。参考EN说明书AbnormalityReasonCheckoutNo displayBatteries are not in proper directionMake sure that the batteries are installed in the proper direction. (Polarity matches to the indication in the battery case.)Abnormal resultsCuff is not tightened properly or its position is incorrect.Check that the cuff is positioned properly, over the measurement procedure again.The arm is moved during measuring.Stay calm, arm remains steady. Do not move during measuring.Irregular heartbeatYou can test again for light irregular heartbeat patients. It is inappropriate for serious irregular heartbeat patients to use this device.Blood pressure readings are too high or too lowWrong positionCheck if the arm is positioned properly Position your arm on a table, so the cuff is at the same level as your heart.Wrong positionRemain seated during the entire measurement period.Some interference in inflation or wrong operation during measuringRefrain from hand and body movements during measurementNote: If you cannot resolve the problem, you can contact factory or service agent.VI. Model ListThe differences among all applied models are enclosure (including LCD and key button) and Voice Function. Please see the following table for detail.Model NameAppearance PictureSize and WeightVoice FunctionMemory CapacityKey NumberBW-60173.5mm(L)73.2mm(W)30.9mm(H)270gYES90x2 sets3BW-60273.5mm(L)73.2mm(W)30.9mm(H)270gNO90x2 sets3BW-60387mm(L)67.9mm(W)31mm(H)262gNO90x2 sets3BW-60587mm(L)64mm(W)31mm(H)265gNO90x2 sets3BW-60687mm(L)63.4mm(W)31mm(H)265gNO90x2 sets3BW-61187mm(L)62mm(W) 30mm(H)245gNO90x2 sets3BW-61278mm(L)72mm(W)29mm(H)255gNO90x2 sets3BW-61378mm(L)72mm(W)29.6mm(H)260gNO90x2 sets3VII. Symbol FormSymbolExplanationCautionManufacturerThis symbol indicates that the device includes IEC 60601-1 Type B Applied Part.The symbol indicates that the device should be sent to the special agencies according to local regulations for separate collection after its useful life.Refer to User Manual.VIII. Guidance and Manufacturers DeclarationGuidance and manufactures declaration-electromagnetic emissions-For all EQUIPMENT and SYSTEMSNOTE:To protect from EMI, please leave the AGE Automatic Wrist Blood Pressure Monitor away from the EMI sources. For the technical reasons, electromagnetic immunity is limited to 1 Vrms; otherwise, the interfaced images may affect the diagnosis and measurements.Guidance and manufactures declaration-electromagnetic emissionThe AGE Automatic Wrist Blood Pressure Monitor is intended for use in the electromagnetic environment specified below; The customer or the user of the AGE Automatic Wrist Blood Pressure Monitor should assure that it is used in such and environment.Emission test ComplianceElectromagnetic environment-guidanceRF emissionsCISPR 11Group 1The AGE Automatic Wrist Blood Pressure Monitor 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 emissionsCISPR 11Class BThe AGE Automatic Wrist Blood Pressure Monitor is suitable for use in all establishments, other than domestic and those directly connected to the public low-voltage power supply network that supplies building used for domestic purposes.Harmonic emissionsIEC 61000-3-2Class BVoltage fluctuations/flicker emissionsIEC 61000-3-3CompliesGuidance and manufactures declaration electromagnetic immunity for all EQUIPMENT and SYSTEMSGuidance and manufactures declaration electromagnetic immunity The AGE Automatic Wrist Blood Pressure Monitor is intended for use in the electromagnetic environment specified below. The customer or the user of AGE Automatic Wrist Blood Pressure Monitor should assure that it is used in such an environment. Immunity test IEC 60601 test level Compliance level Electromagnetic environment -guidance Electrostatic discharge (ESD) IEC 61000-4-2 6 kV contact 8 kV air 6 kV contact8 kV air Floors should be wood, concrete or ceramic tile. If floor are covered with synthetic material, the relative humidity should be at least 30%. Electrical fast transient/burstIEC 61000-4-4 2 kV for power supply lines 2KV for power supply lines Mains power quality should be that of a typical commercial or hospital environment. Surge IEC 61000-4-5 1 kV line to line 2 kV line to ground 1 kV line to line2 kV line to groundMains power quality should be that of a typical commercial or hospital environment. Power frequency (50/60Hz) magnetic field IEC61000-4-
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