Attachment 11-Annex 1. Predicate Device User Manual

Wrist Fully Automatic Blood Pressure Meter User ManualWrist Fully Automatic Blood Pressure Meter(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: FT-B11W, FT-B12W, FT-B13W, FT-B14W, FT-B21Y, FT-B22Y, FT-B11W-V, FT-B12W-V, FT-B13W-V, FT-B14W-V, FT-B21Y-V and FT-B22Y-VTable of Contents(I) General Information(II) Precaution for Use and Maintenance(III) Name of Each Part(IV) Measure Procedure(V) Troubleshooting(VI) Model ListI. General Informationn Intended UseFudakang Wrist Fully Automatic Blood Pressure Meter 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 UseFudakang Wrist Fully Automatic Blood Pressure Meter 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 6.1023 inches to 9.8425 inches.n SpecificationProduct Name Wrist Fully Automatic Blood Pressure MeterApplied ModelsFT-B11W, FT-B12W, FT-B13W, FT-B14W, FT-B21Y, FT-B22Y, FT-B11W-V, FT-B12W-V, FT-B13W-V, FT-B14W-V, FT-B21Y-V and FT-B22Y-VMeasurement PrincipleOscillographyCuffSoft cuffCuff size290mm72mm (+/- 5mm)Measurable Wrist Circumference RangeAbout 135195mmMeasurement RangePressure: 0300mmHgPulse: 30180 times/minuteAccuracyPressure: 3mmHgPulse: 5%Power Supply3V DC (2 “AAA” batteries)Battery LifeApprox. 300 times (180mmHg, 1 time/day, 22C)Working EnvironmentTemperature: 540CHumidity: 90%RHStorage Environment Temperature: -2060CHumidity: 95%RHEnvironmental Pressure Atmosphere pressureElectric Shock ProtectionInternal power unitSafety Classification Type B EquipmentMemory Capacity60 sets or 90 sets of data including date and timeSee VI. Model ListInflationAutomatic 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 NumberSwitch2 (ON/OFF, Memory)SizeSee VI. Model ListWeight (not including battery)See VI. Model Listn Contraindications:1. Contra-indicated for the NIBP measurement for analysis with heart disease2. Contra-indicated for the NIBP measurement at injured wristn Patient Populations:The device is intended to use for adults. DO NOT use this device on infants.n Cleaning Information:1. If the device is very dirty, wipe it clean with a sterilizing cloth moistened with a neutral detergent. Then wipe it again with a sterilizing cloth moistened with 75% Ethanol for 60s. Then wipe it with a dry cloth.2. To clean the cuff, wipe it with a moist cloth first before conducting the above cleaning method. Avoid hard rubbing, as this will cause air leakages. Take care also not to get water into the air hose.3. NEVER clean the blood pressure meter with thinners or benzene, as they may damage it.n Nature and Frequency of Maintenance:This 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 Environment:Please 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 60C), 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 - Appearancev “MEMORY” Button / Clock Settingv “ON/OFF” Button / Clock Adjustingv LCDv Systolicv Diastolicv PulseFigure 2 Display of LCDNote for LCD display:(1) Date: Month - Day(2) Time: Hour - Minute(3) Systolic Blood Pressure (unit: mmHg)(4) Diastolic Blood Pressure (unit: mmHg)(5) Pulse (unit: beat/minute)(6) WHO BP Classification Indicating Bar(7) Inflation / Deflation Indicator(8) Blood Pressure Unit(9) Low Battery Icon(10) Heart Icon (Twinkle when measuring)(11) Memory Record NumberIV. Measure Proceduren Battery LoadingOpen the battery cover at the back of the machine.Load two “AAA” size batteries. Please pay attention to the polarity.Close the battery cover. See Figure 3.Note： When 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 AdjustingWhen the machine is turned off, press the button “ON/OFF” and “MEMORY” at the same time, the number of month will twinkle on LCD. Press button “ON/OFF” continuously, the numbers of month, date, hour, minute, and unit will twinkle in sequence. While the number is twinkling, press button “MEMORY” and the corresponding number will increase by one. Hold on pressing the button “MEMORY” the number will increase fast.After pressing “ON/OFF” button the fifth time, numbers on LCD will not twinkle, then you exit the time adjusting mode. 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 1-2cm 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 “ON/OFF” button. The device will verify itself, and LCD will twinkle automatically.After about two seconds, LCD shows one “00”. See Figure 8.If the device has voice function, it will speak out the prompt that “keep silent and place cuff at the same level as your heart”.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.If the device has voice function, it will speak out the displayed blood pressure, heart rate. See Figure 9.Press “ON/OFF” 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 “OFF” 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.If the device has voice function, it will speak out the last time displayed memory blood pressure and heart rate.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 “ON/OFF” 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 “ON/OFF”, 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 “ON/OFF” to turn off the device. The device will be automatically power off after 1 minute of none use.n Voice FunctionThe device with voice function can speak out in the following state: The device will speak out the prompt that “keep silent and place cuff at the same level as your heart” when the measure begin. The device will speak out the displayed blood pressure (systolic and diastolic blood pressure), heart rate after each measurement finish. The device will speak out the last time displayed memory blood pressure (systolic and diastolic blood pressure), and heart rate when reading memory result.Note:The voice function is ONLY for models FT-B11W-V, FT-B12W-V, FT-B13W-V, FT-B14W-V, FT-B21Y-V and FT-B22Y-V.V. TroubleshootingAbnormalityReasonCheckoutLCD shows Low Battery icon Batteries are low.Change new batteries.Shows abnormal resultCuff is not tightened properly or its position is incorrect.Tighten cuff correctly and refer to “Wrist Cuff Connecting”.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.Shows abnormal resultSpeaking, frightened nervous or excited measurementDo not speak, take deep breath 23 times to relax yourself.Wrong positionAdjust position; refer to “Wrist Cuff Swathing”.Some interference in inflation or wrong operation during measuringRefer to the inflation step in “Measuring process”.LCD shows “Er U”Insufficient inflationMeasure again.LCD shows “Er H”Inflation over 305 mmHgSBP is higher than 300 mmHg. Measure again.LCD shows “Er 1”Undetectable the pulse Measure again.LCD shows “Er 2”Radiation interferenceAway the radiation source.LCD shows “Er 3” Measured result wrongMeasure again.Note: 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 CapacityFT-B11W725mm(L)620mm(W)305mm(H)73gNO60 setsFT-B12W655mm(L)635mm(W)250mm(H)72gNO60 setsFT-B13W730mm(L)635mm(W)250mm(H)82gNO60 setsFT-B14W725mm(L)780mm(W)300mm(H)75gNO60 setsFT-B21Y725mm(L)780mm(W)300mm(H)73gNO60 setsFT-B22Y720mm(L)570mm(W)285mm(H)74gNO90 setsFT-B11W-V725mm(L)620mm(W)305mm(H)76gYES60 setsFT-B12W-V655mm(L)635mm(W)250mm(H)75gYES60 setsFT-B13W-V730mm(L)635mm(W)250mm(H)85gYES60 setsFT-B14W-V725mm(L)780mm(W)300mm(H)78gYES60 setsFT-B21Y-V725mm(L)780mm(W)300mm(H)76gYES60 setsFT-B22Y-V720mm(L)570mm(W)285mm(H)77gYES90 sets- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - Manufacturer: Fudakang Industrial Co., LtdAddress: No.8 Yinghe Road, Yuanjiangyuan Management Zone, Changping Town, Dongguan, Guangdong, ChinaPhone: +86-769-81098181Fax: +86-769-81098187Website: www.fudakang.com- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - Manual Version: V1.0Issue Date: 2010-9-8Page 17 of 17