Microlife BP3MW1-4B Upper Arm Automatic Digital Blood Presure Monitor User Manual MLU3AC1 JAN05 2

Microlife Corporation Upper Arm Automatic Digital Blood Presure Monitor MLU3AC1 JAN05 2

User manual

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Professional Blood Pressure MonitorInstruction ManualTable of contents1. Introduction1.1. Features of your professional automatic blood pressure monitor1.2. Important information about self-measurement2. Important information on blood pressure and its measurement2.1. How does high/low blood pressure arise?2.2. Which values are normal? 2.3. What can be done if regular high/low values are obtained?3. Components of your blood pressure monitor4. Using your blood pressure monitor for the first time4.1. Inserting the batteries4.2. Using the touch pad4.3. Setting the date and time4.4. Using the AC power adapter4.5. Cuff tube connection4.6. Select the user4.7. Select the measuring mode: standard or measurement averaging mode4.8. Measurement averaging mode technology5. Measurement procedure5.1. Before measurement5.2. Common sources of error5.3. Fitting the cuff5.4. Measuring procedure5.5. Memory – displaying the last 120 measurements5.6 Morning / Evening Hypertension Average5.7. Discontinuing a measurement5.8. Setting the medication reminder5.9. Hypertension risk indicator5.10. Irregular heartbeat detector5.11. Battery charge indicator6. Software functions6.1. Installation and data transmission7. CVS Application1
28. Error messages / troubleshooting9.Care and maintenance10.Warranty11. Certifications12. Technical specifications13. How to contact us
31. Introduction1.1. Features of your Professional Blood Pressure MonitorYour blood pressure monitor is a fully automatic digital blood pressure measuringdevice for use by adults on the upper arm at home or in your doctor’s/nurse’s office. Itenables very fast and reliable measurement of the systolic and diastolic blood pressureas well as the pulse by way of the oscillometric method. This device offers clinicallyproven accuracy and has been designed to be user friendly.Up to 20% of women develop hypertension during pregnancy. This disease (preeclamp-siaor toxemia) affects the final outcome of about 5% of all pregnancies. Preeclampsiais a disorder that occurs only during pregnancy. It can be recognized by a clearincrease in blood pressure and high protein levels in the urine. The measurementprecision of this device has been proven clinically in a comprehensive study carried outby Professor Andrew Shennan at St. Thomas’ Hospital, London. This study proved thereading reliability of this monitor during pregnancy and in the presence of preeclamp-sia, making it the first such home-use monitor that is clinically validated for such useand especially suitable for preganant women. Of course, this device can be used alsoafter the pregnancy or by other family members.The memory data can be transferred to the PC (personal computer) running theMicrolife Blood Pressure Analyzer (BPA) software by connecting the monitor via cable.The device can also be used in connection with smart mobile devices running the APPand via Bluetooth. Before using, please read this instruction manual carefully and then keep it in a safeplace. Please contact your doctor for further questions on the subject of blood pressureand its measurement.Attention!1.2. Important information about self-measurement• Self-measurement means control, not diagnosis or treatment. Unusual values mustalways be discussed with your doctor. Under no circumstances should you alter the
4dosages of any drugs prescribed by your doctor.• The pulse display is not suitable for checking the frequency of heart pacemakers.• In cases of irregular heartbeat, measurements made with this instrument shouldonly be evaluated after consultation with your doctor.Electromagnetic interference:The device contains sensitive electronic components. Avoid strong electrical or electro-magnetic fields in the direct vicinity of the device (e.g., mobile telephones, microwaveovens). These can lead to temporary impairment of the measuring accuracy.2. Important information on blood pressure and its measurement2.1. How does high/low blood pressure arise?Your level of blood pressure is determined in the circulatory center of the brain andadjusts to a variety of situations through feedback from the nervous system. To adjustblood pressure, the strength and frequency of the heart (pulse), as well as the width ofcirculatory blood vessels is altered. Blood vessel width is affected by fine muscles inthe blood vessel walls.Your level of arterial blood pressure changes periodically during heart activity. Duringthe "blood ejection" (Systole), the value is highest (systolic blood pressure value). Atthe end of the heart’s "rest period" (Diastole), pressure is lowest (diastolic bloodpressure value).Blood pressure values must lie within certain normal ranges in order toprevent particular diseases.2.2. Which values are normal?Blood pressure is too high if your diastolic pressure is above 100 mmHg and/or yoursystolic blood pressure is over 160 mmHg, while at rest. In this case, please consultyour physician immediately. Long-term values at this level endanger your health due tocontinual damage to the blood vessels in your body.If your systolic blood pressure values are between 140 mmHg and 159 mmHg and/orthe diastolic blood pressure values are between 90 mmHg and 99 mmHg, consult your
5physician. Regular self-checks are necessary. If you have blood pressure values that are too low (i.e., systolic values under 105mmHg and/or diastolic values under 60 mmHg), consult your physician. Even with normal blood pressure values, a regular self-check with your blood pressuremonitor is recommended. You can detect possible changes in your values early andreact appropriately. If you are undergoing medical treatment to control your blood pressure, keep a recordof values along with time of day and date. Show these values to your physician. Neveruse the results of your measurements to independently alter the drug dosesprescribed by your physician.Which values are normal?The following standards for assessing high blood pressure (in adults) have beenestablished by the National Institutes of Health JNC7, 2003.☞Further information• If your values are mostly normal under resting conditions but exceptionally highunder conditions of physical or psychological stress, it is possible that you aresuffering from so-called "labile hypertension." Consult your doctor.• Correctly measured diastolic blood pressure values above 120 mmHg requireimmediate medical treatment.This device is not intended for use on children 12 years of age or younger.2.3. What can be done if regular high or low values are obtained?Category Systolic Diastolic (mmHg) (mmHg)Normal <120 and <80Pre-Hypertension 120-139 or 80-89HypertensionStage 1 Hypertension 140-159 or 90-99Stage 2 Hypertension ≥160 or ≥100
6a) Consult your doctor.b) Increased blood pressure values (various forms of hypertension) are associated withconsiderable health risks over time. Arterial blood vessels in your body areendangered due to constriction caused by deposits in the vessel walls (arteriosclero-sis). A deficient supply of blood to important organs (heart, brain, muscles) can resultfrom arteriosclerosis. Furthermore, the heart will become structurally damaged withincreased blood pressure values.c) There are many different causes of high blood pressure. We differentiate betweenthe common primary (essential) hypertension and secondary hypertension. The lattergroup can be ascribed to specific organ malfunctions. Please consult your doctor forinformation about the possible origins of your own increased blood pressure values.d) There are measures which you can take to reduce and even prevent high blood pressure. These measures must be permane nt lifestyle changes.1) Eating habits• Strive for a normal weight corresponding to your age. See your doctor for your ideal weight.• Avoid excessive consumption of common salt.• Avoid fatty foods.2) Previous illnesses• Consistently follow all medical instructions for treating illness such as:• Diabetes (diabetes mellitus)• Fat metabolism disorder• Gout3) Habits• Give up smoking completely.• Drink only moderate amounts of alcohol.• Restrict your caffeine consumption (e.g., coffee).4) Physical constitution• After a preliminary medical examination, do regular exercise.
7• Choose sports which require stamina and avoid those which require strength.• Avoid reaching the limit of your performance.• With previous illnesses and/or an age of over 40 years, please consult your doctorbefore beginning your exercise routine. You must receive advice regarding the typeand extent of exercise that is appropriate for you.3. Components of your blood pressure monitora) Measuring unitb) Wide Range Soft Cuff:For arm circumference 22 cm - 42 cm (8.7” - 16.5”) If you ever need to buy a replacement cuff, call CVS/pharmacy®Blood Pressure Support toll-free at 1-866-464-6184. STARTSTOPMCuff SocketTime/DateButtonON/OFF/START/STOPMode SwitchSelect ON or OFFMeasurementsUSB PortMemory Recall ButtonAC AdapterHypertensionRisk Indicator
8Please Note:Arm circumference should be measured with a measuring tape in the middle of therelaxed upper arm. Do not force cuff connection into the opening. Make sure the cuffconnection is not pushed into the AC adapter port. If the cuff is too small, call 1-866-464-6184 for further information.4. Using your blood pressure monitor for the first time4.1. Inserting the batteriesAfter you have unpacked your device, insert the batteries.The battery compartment is located on the bottom of thedevice.a) Remove the battery cover.b) Insert the batteries (4 x size AA 1.5 V), observing theindicated polarity. c) If a battery warning appears in the display, the batteriesare discharged and must be replaced. Attention!• After the low battery indicator appears, the device won’tfunction until the batteries have been replaced.• Please use "AA" Long-Life or Alkaline 1.5 V batteries. • If the blood pressure monitor is not used for longperiods, remove the batteries from the device.4.2. Using the touch padThis monitor features three touch pad "buttons" whichoperate similarly to traditional buttons, but require only alight touch of the finger to operate.• The buttons are MEMORY, START/STOP, and TIME.Low Battery IndicatorSTARTSTOPM
94.3. Setting the date and time1. After the new batteries are activated, the year numberflashes in the display. You can advance the year bypressing the "M" button. To confirm and then set themonth, press the TIME button.2. You can now set the month using the "M" button. Toconfirm and then set the day, press the TIME button.3. Please follow the instructions above to set the day, hourand minutes.4. Once you have set the last minute and pressed the TIMEbutton, the date and time are set and the time isdisplayed.5. If you want to change the date and time, press and holdthe TIME button down for approximately 3 seconds untilthe year number starts to flash. Now you can enter thenew values as described above.4.4. Using the AC power adapterYou may also operate this monitor using the included ACadapter.Use only the included AC adapter to avoiddamaging the unit. a) Ensure that the AC adapter and cable are not damaged.b) Plug the adapter cable into the AC adapter port on theright side of monitor.c) Plug the AC adapter into a 110 V power socket (U.S. orCanada).d) Test that power is available by pressing the START/STOPbutton.Note:STARTSTOPM MemoryTime/DateButtonTIME PM
10• No power is taken from the batteries while the ACadapter is connected to the instrument.• If the power is interrupted during a measurement (e.g., byremoval of the adapter from the wall socket), the instru-ment must be reset by removing the plug from the instru-ment.If you have any questions regarding the AC adapter, callCVS/pharmacy®Blood Pressure Support at 1-866-464-6184.4.5. Cuff tube connectionInsert the cuff tube into the opening on the left side of theinstrument.4.6. Select the userThis blood pressure monitor is designed to store 120measurements for each of two users. In addition, there is aguest mode in which results are not stored.Before taking a measurement, be certain that thecorrect user has been selected.a) With the unit off, press and release the TIME button tocycle through users ("1,""2" or “OFF” (guest mode)).b) Press the START/STOP button to make your selection.4.7. Select the measuring mode: standard or measurement averaging mode (MAM) This instrument enables you to select either standard (singlemeasurement) or measurement averaging mode (automatictriple measurement). With the unit off, press the Time button for 3 seconds andthen the screen will show the current MAM mode. You canSTARTSTOPMGuest Mode
11click M button to switch between Standard mode andAverage mode. To select Standard mode, please choose OFF To select Average mode, please choose On If you select OFF, then only one measurement will be taken. Ifyou select ON, the unit will inflate and deflate three timesresulting in one final average. 4.8. Measurement averaging mode technology (MAM)• In Measurement Averaging Mode (MAM), three measurements are automaticallytaken in succession and the result is then automatically analyzed and displayed.Because your blood pressure constantly fluctuates, a result determined in this way ismore reliable than one produced by a single measurement.• After pressing the START/STOP button the selected Measurement Averaging Modeappears in the display as the MAM symbol.• The bottom, right-hand section of the display shows a 1, 2 or 3 to indicate which ofthe 3 measurements is currently being taken.5. Measurement procedurePlease note: You should always be seated before and during measurement.5.1. Before measurement:•Avoid eating and smoking as well as all forms of exertion directly before measure-ment. These factors influence the measurement result. Find time to relax by sitting inan armchair in a quiet atmosphere for about ten minutes before your measurement.• Remove any garment that fits closely to your upper arm.• Always measure on the same arm (normally left).• Compare measurements at the same time of day, since blood pressure changesduring the course of the day (as much as 20–40 mmHg).5.2. Common sources of error
12Note: Comparable blood pressure measurements always require the sameconditions. Conditions should always be quiet.• All efforts by the user to support the arm can increase blood pressure. Make sureyou are in a comfortable, relaxed position and do not flex any of the muscles in themeasurement arm during the measurement. Use a cushion for support if necessary.• If the arm artery lies considerably lower or higher than the heart, an erroneouslyhigh or low blood pressure will be measured. Each 15 cm (6”) difference in heightbetween your heart and the cuff results in a measurement error of 10 mmHg.• Cuffs that are too narrow or too short result in false measurement values. Selectingthe correct cuff is extremely important. Cuff size is dependent upon the circumfer-ence of the arm (measured in the center). The permissible range is printed on thecuff. If this is not suitable for your use, please call 1-866-464-6184. • A loose cuff or a sideways protruding air pocket causes false measurement values.• With repeated measurements, blood accumulates in the arm, which can lead tofalse results. Consecutive blood pressure measurements should be repeated after a1 minute pause or after your arm has been held up in order to allow the accumulat-ed blood to flow away.5.3. Fitting the cuffa) The cuff is wide rang and soft for easier use. Pleaseremove tight or bulky clothing from your upper arm.b) Wrap the cuff around your upper left arm. The rubber tubeshould be on the inside of your arm extending downwardto your hand. Make certain the cuff lies approximately1/2” to 3/4” (1 to 2 cm) above the elbow.IMPORTANT: The red strip on the edge of the cuff(Artery Mark) must lie over the artery which runs downthe inner side of the arm.TIP: Align red artery mark to pinky finger.c) To secure the cuff, wrap it around your arm and press the½”-¾”8.7” - 18.1”
13hook and loop material together.d) There should be little free space between the arm and thecuff. You should be able to fit 2 fingers between your armand the cuff. Clothing must not restrict the arm. Any pieceof clothing which does must be removed. Cuffs that don’tfit properly result in false measurement values. Measureyour arm circumference if you are not sure of proper fit. e) Lay your arm on a table so the cuff is at the same heightas your heart. Make sure the tube is not kinked.f) Remain seated quietly for two minutes before you beginthe measurement. CommentIf it is not possible to fit the cuff to your left arm, it can alsobe placed on your right arm. However, all measurementsshould be made using the same arm.Comparable blood pressure measurements always require thesame conditions (relax for several minutes before a reading).5.4. Measuring procedureAfter the cuff has been appropriately positioned the measurement can begin:a) Press the START/STOP button. After a series of shortbeeps, the pump begins to inflate the cuff. On the display,the increasing cuff pressure is continually shown.b) After automatically reaching an individual pressure, thepump stops and the pressure slowly falls. The cuff pressure is displayed during the measurement.Cuff onright armPumpingPressure
14c) When the device has detected your pulse, the heart symbol in the display begins to blink.d) When the measurement has been concluded, the air willautomatically release from the cuff. The measured systolicand diastolic blood pressure values, as well as the pulse,are now displayed.e) The measurement results are displayed until you switchthe device off. If no button is pressed for 1 minute, thedevice switches off automatically.f) When the unit is set to the MAM (Measurement AveragingMode) setting, 3 separate measurements will take place insuccession, after which your result is calculated anddisplayed as a single, averaged measurement. There is a 15second resting time between each measurement. A count-down indicates the remaining time and a beep will soundfor 5 seconds before the 2nd and 3rd readings begin. If one of the measurements causes an error message, it willbe repeated one more time. If any additional error occurs, themeasurement will be discontinued and error code displayed.Expanding the averaged measurement to see the threeindividual readings:This function allows you to view the three individualmeasurements used to calculate the MeasurementAveraging Mode (MAM) reading.a) After taking an averaging mode measurement, hold the memory button for 3 secondsuntil you hear a short beep. (Do not hold the button longer than 7 seconds or youwill delete all the readings in the memory.) b) Release the button and watch the screen. It will automatically scroll through the 3measurements used in the reading.MeasurementCompleteSystolicDiastolic PulseMeasuring
155.5. Memory – displaying the last 120 measurementsAt the end of a measurement, this monitor automatically stores each result with dateand time. This unit stores 120 memories for each of 2 users.Viewing the stored valuesWith the unit off, press the "M" button. The display first shows "A," then shows anaverage of all measurements stored in the unit. Please note: Measurements for eachuser are averaged and stored separately. Be certain that you are viewing the measure-ments for the correct user. Pressing the "M" button again displays the previous value. To view a particular storedmemory, press and hold the "M" button to scroll to that stored reading.Memory fullWhen the memory has stored 120 results, a new, measured value is stored byoverwriting the oldest value.Clear all valuesIf you are sure that you want to permanently remove all stored values,hold down the "M" button (the instrument must have been switched offbeforehand) until "CL" appears and then release the button. If you do notwant to clear the values, press the START/STOP button. To permanentlyclear the memory, press the "M" button while "CL" is flashing. Individual values cannot be cleared.5.6 Morning / Evening Hypertension AverageMorning Hypertension usually occurs as a surge in blood pressure upon waking up, thisBlood Pressure Monitor (BPM) will average readings taken between 4:00 A.M. and11:50 A.M.. Evening hypertension, sometimes called nocturnal hypertension, is charac-terized by high blood pressure that persists from night time until early morning; this BPmonitor will average reading taken between 6:00 P.M. and 11:59 P.M..With the unit off, press the M (Memory) pad to display the average reading for the1
16current user.Press the M pad again, the screen will show the average of all reading taken between4:00 A.M. and 11:50 P.M. The screen will display the sun icon.When you press the M (Memory) pad a third time, the screen will show the average ofall readings taken between 6:00 P.M. and 11:59 P.M.. The screen will display the moonicon.After 30 seconds, the screen will display the last taken value. You can continuouslypress the M (Memory) pad to view each value individually.5.7.Discontinuing a measurementIf it is necessary to interrupt a blood pressure measurement for any reason (e.g., thepatient feels unwell), the START/STOP button can be pressed at any time. The devicethen immediately lowers the cuff pressure automatically and enters sleep mode.5.8. Setting the medication reminderThis instrument allows you to set two alarm times at which an alarm signal will thenbe triggered. This can be a useful aid, for instance as a reminder totake medication or to remind you to take your blood pressure at thesame time each day.1. To set an alarm time, press the TIME button (the instrument must have been switched off beforehand), and immediatelyafterwards the "M" button, and hold both down until the bellsymbol appears in the bottom left of the display. Then releaseboth buttons. The flashing "1" in the display indicates that thefirst alarm time can now be set.2. Press the TIME button to set the hours – the hours displayflashes and pressing the "M" button allows you to set the alarmhour. To confirm, press the TIME button.
173. The minute display will now flash. The minutes can be set usingthe "M" button. To confirm, press the TIME button again.4. The bell symbol will now flash. Use the "M" button to selectwhether the alarm time is to be active (bell) or inactive (crossed-out bell). To confirm, press the TIME button.To set a second alarm time, proceed as above but if the "1" flashes,press the "M" button to select "2" and confirm with the TIMEbutton.• An active alarm time is indicated by the bell symbol in the display.• The alarm sounds at the set time every day.• To switch off the alarm when it is sounding, press the START/STOP button.• To permanently switch off the alarm, proceed as above (steps 1-4) and select thecrossed-out bell symbol. This will then disappear from the display.• The alarm times must be re-entered each time the batteries are replaced.5.9. Hypertension risk indicatorThe bars on the left-hand edge of the display show you the range within which theindicated blood pressure value lies. Depending on the height of the bar, the readoutvalue is either within the normal (green), borderline (yellow) or danger (orange, red)range.The classification is based on standards established by the National Institutes ofHealth JNC7, 2003.Refer to the chart in section 2.2 of this instruction manual for details of the classifications.Indication of a"Normal" BloodPressureIndication of a "Pre-Hypertension" BloodPressureIndication of a "Stage 1Hypertension" BloodPressureIndication of a "Stage 2Hypertension" BloodPressureTIME PM TIME PM
18The traffic light bar illuminates according to your measurement.• If your measurement has only the green bar,your measurement is "Normal," accordingto NIH standards.• If your measurement shows the yellow bar, your measurement is "Pre-Hypertension."• If your measurement shows the orange bar, it is "Stage 1 Hypertension."• If your measurement shows the red bar, it is "Stage 2 Hypertension."5.10.Irregular heartbeat detectorThe appearance of this symbol indicates that certain pulseirregularities were detected during the measurement. In this case,the result may deviate from your normal basal blood pressure –repeat the measurement. In most cases, this is no cause for concern.However, if the symbol appears on a regular basis (e.g., several timesa week with measurements taken daily), we advise you to tell yourdoctor. Please show your doctor the following explanation:Information on frequent appearance of the irregular heartbeat symbolThis instrument is an oscillometric blood pressure monitor device that also analyzespulse frequency during measurement. The instrument is clinically tested.If pulse irregularities occur during the measurement, the irregular heartbeat symbol isdisplayed with the measurement.If the symbol appears frequently or if it suddenly appears more often than usual, werecommend the patient seek medical advice. The instrument does not replace a cardiacexamination but serves to detect pulse irregularities at an early stage.
195.11. Battery charge indicatorBatteries almost dischargedWhen the batteries are approximately 75% used, the batterysymbol will flash a few times as soon as the instrument isswitched on (if at least one of the batteries still has somecharge). Although the instrument will continue to measure reliably, you should obtainreplacement batteries. Batteries discharged – replacements requiredWhen the batteries are discharged, the battery symbol willappear, unblinking, as soon as the instrument is switched on.You cannot take any further measurements and must replace thebatteries.1. Open the battery compartment on the bottom of the instrument.2. Replace the batteries – ensure they are correctly connected, as shown on thesymbols in the compartment.3. The memory retains all values although date and time (and possibly also set alarmtimes) must be reset – the year number will flash automatically after the batteriesare replaced.4. To set date and time, follow the procedure described in Section 4.3.Note:Use four new, Long-Life 1.5 V AA batteries. Do not use batteries beyond their expira-tion date. If the monitor is not going to be used for a prolonged period, the batteriesshould be removed.Using rechargeable batteriesYou can also operate this instrument using rechargeable batteries.• Please use only type "NiMH" reusable batteries.• If the battery symbol ( ) appears, the batteries must be removed and
20recharged. They must not remain inside the instrument, as they may becomedamaged through total discharge even when switched off. The batteries must NOTbe discharged in the blood pressure monitor. If you do not intend to use the instru-ment for a week or more, always remove the rechargeable batteries.• Recharge these batteries using an external charger and follow manufacturer’sinstructions carefully.6. Software functionsThis unit can be used in connection with your compu-er (PC / MAC) running the PC Link blood pressureanalyzer software. Your computer will allow acapacity of monitoring 80 patients, each with 1000data (note: overuse will lower system efficiency). Thememorydata can be transferred to the computer by connect-ing the monitor via the included USB cable. User canget the BPA (Blood Pressure Analyzer) softwareeither the providedCD or download the BPA on Microlife web site:http://www.microlife.com/support/software/6.1. Installation and data transmissiona) install the BPA software on your PC or MACcomputer, users can choose BPArevision 3.2.5 or higher revision.b) Connect the monitor via USB cable with the PC.Three horizontal bars will appear on the display andlast for 3 seconds.Blood Pressure Analyzer Rev.: 3.2.5 or higher Blood Pressure Analyzer Rev.: 3.2.5 or higher Blood Pressure Analyzer Rev.: 3.2.5 or higher
21c) The bars will then flash to indicate that the connec-tion between computer and device is successfullymade. As long as the cable is plugged, the bars willkeep flashing and the buttons are disabled.During the connection, the device is completelycontrolled by the computer. Please refer to the "Help"file in the software for detailed instructions or call1-866-464-6184.7. CVS Application Please download Microlife BPM Application from the App Store or Google Play beforeattempting to pair your devices. Microlife BPM Applications can be executed on amobile platform, which comply with the required compatibility as the following:Compatibility:- Paring your device running iOS 6.0 or higher on iPhone, iPad, and iPodtouch.- Paring your device running Android 2.3.3 or higher on Android Phone andAndroid TabletsConnection between Blood Pressure Monitor and Mobile Device:a). Please switch the slide switch to “On” to turn on Bluetooth function onyour device.Next, press the I/O for 8 sec until the BT icon appears on the screen.b). The BT icon will flash on the screen for 60 sec for users to pairdevices, if there isno any operations implemented in 1 min, then the BT function will beturned off.c). Turn Bluetooth “On” under the setting Menu on the iOS or Androiddevice.d). Open Microlife BPM APP to pare and connect your Blood Pressure1
22Monitor.Data Transmission:Please make sure your Blood Pressure Monitor and your iOS / Androiddevice are in connecting status before you do data transmissiona). Open Microlife BPM APP on your iOS or Android mobile device.b). When you choose “Download all data”, the App will show a datatransmitting display on the screen as below:c). After finishing data transmitting, the App will directly enter asummary page.Microlife BPM Application can transfer, store and convert formats anddisplay medical device data on your mobile device without modifyingthe data. So, you can record, collect and track your data from a mobiledevice to eventually share with others. 8.Error messages/troubleshootingIf an error occurs during a measurement, the measurement is discontinuedand a corresponding error code is displayed (example: Error no. 2).Error No. Possible cause(s)/SolutionsERR 1 The tube may have loosened, or no pulse was detected.* Ensurecuff connections are tight with proper cuff placement. See section 5.3.ERR 2 Unnatural pressure impulses influenced the measurement result.Reason: The arm was moved during the measurement (artefact).Repeat measurement, keeping still and quiet.ERR 3 Inflation of the cuff takes too long. The cuff is not correctly seatedor the hose connection is not tight. Re-position cuff and repeat themeasurement.ERR 5 The measured readings indicated an unacceptable differencebetween systolic and diastolic pressures. Take another readingfollowing directions carefully. Contact your doctor if you continue to
23get unusual readings.HI The cuff pressure is too high. Relax for 5 minutes and repeat themeasurement.*LO Thepulse is too low (less than 40). Repeat the measurement.**If this or any other problem occurs repeatedly, please consult your doctor.Other possible errors and their solutionsIf problems occur when using the device, the following points should be checked and,if necessary, the corresponding measures are to be taken: Malfunction Remedy1. Check batteries for the correct polarity. 2. If the display is unusual, remove the batteries and exchange them for new ones.Check the connection of the cuff tube andconnect properly. 1.Check the positioning of the cuff. 2.Measure blood pressure again in peace and quiet, carefully following the detailsin Section 5.The display remains blank when the instru-ment is switched on although the batteriesare in place.The pressure does not rise although thepump is running.The device frequently fails to measure bloodpressure values or the values measured aretoo low or high.Please read the following information andpoints listed in Section 5.2 "Commonsources of error." Repeat the measurement.Please note: Blood pressure fluctuatescontinually so successive measurementswill show some variability.Record the daily development of themeasured values and consult your doctor.Please note: Individuals visiting theirdoctor frequently experience anxietywhich can result in a higher readingthan at home under resting conditions.Every measurement results in a differentvalue, although the device functions normally and normal values are displayed.Blood pressure values differ from thosemeasured by my doctor.
249. Care and maintenancea) Do not expose the device to either extreme temperatures,humidity, dust or direct sunlight.b) The cuff contains a sensitive airtight bubble. Handle thiscuff carefully and avoid all types of stress through twistingor buckling.c) Clean the device with a soft, dry cloth. Do not usegasoline, thinners or similar solvents. Spots on the cuff canbe removed carefully with a damp cloth and soapsuds. Thecuff must not be washed in a dishwasher, clotheswasher or submerged in water.d) Handle the tube carefully. Do not pull on it. Do not allowthe tubing to kink and keep it away from sharp edges. e) Do not drop the monitor or treat it roughly in any way.Avoid strong vibrations.f) Never open the monitor. This invalidates the manufac-turer’s warranty.g) Batteries and electronic instruments must be disposed ofin accordance with the locally applicable regulations, notwith domestic waste. h) Please ensure that children do not use this devicesunsupervised; some prts are small enough to beswallowed. Be aware of the risk of strangulation in casethis device is supplied with cables or tubes. GasolineSTARTSTOPMSTARTSTOPMSTARTSTOPM1. Check cuff connections. 2.Ensure the unit has not been tampered with.After the instrument has inflated the cuffthe pressure falls very slowly, or not at all.(No reasonable measurement possible.)
25i) Please do not use the device if you think it is damaged or ifanything appears unusual.☞ Further informationBlood pressure is subject to fluctuations, even in healthy people.Comparable measurements always require the same conditions (quiet conditions)! If fluctuations in readings are larger than 15 mmHg, and/or youhear irregular pulse tones, consult your doctor. Never attempt to repair the instrument yourself.Any unauthorized opening of the instrument invalidates all warranty claims.10. WarrantyYour Professional Blood Pressure Monitor is guarante for a lifetime againstmanufacturer defects for the original purchaser only, from date of purchase. Thewarranty does not apply to damage caused by improper handling, accidents, profes-sional use, not following the operating instructions or alterations made to the instru-ment by third parties.Lifetime warranty only applies to the instrument. All accessories including the cuff, ACadapter and software are guaranteed for one year.There are no user serviceable parts inside. Batteries or damage from old batteries isnot covered by the warranty.Please note: According to international standards, your monitor should be checked foraccuracy every 2 years.11. CertificationsDevice standard: Device corresponds to the requirements ofthe standard for non-invasive bloodpressure monitors:
26AAMI/ ANSI/ IEC 80601-2-30IEC 60601-1IEC 60601-1-2IEC 60601-1-11- Bluetooth system to V4.0- FCC Part 15CElectromagnetic compatibility: Device fulfills the stipulations of theInternational standard IEC 60601-1-2Clinical testing: Clinical performance tests were carriedout in the US according to ANSI/AAMIstandard.The B.H.S. (British Hypertension Society) clinical protocol was used to measure theaccuracy of this product. Blood pressure units using the same measurement technologyare graded "AA" for systolic/diastolic accuracy by independent investigators using theBHS protocol. This is the highest grading available for blood pressure monitors. Pleasesee bhsoc.org for more information.
2712. Technical specifications:Weight: . . . . . . . . . . . . . . . . . . . . . . . . . . . 468 g (with batteries)Size: . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .110 (W) x 120 (L) x 85 (H) mmStorage temperature: . . . . . . . . . . . . . . . . .-20 to +55°C (-4° to +131°F)Humidity: . . . . . . . . . . . . . . . . . . . . . . . . . . 15 to 90% relative humidity maximumOperation temperature: . . . . . . . . . . . . . . . 10 to 40°C (50° to 104°F)Display: . . . . . . . . . . . . . . . . . . . . . .. . . . . .LCD (Liquid Crystal Display)Measuring method: . . . . . . . . . . . . . . . . . .OscillometricPressure sensor: . . . . . . . . . . . . . . . . . . . . .CapacitiveMeasuring range:SYS/DIA: . . . . . . . . . . . . . . . . . . . . . . . . . . 30 to 280 mmHgPulse: . . . . . . . . . . . . . . . . . . . . . . . . . . . . .40 to 200 per minuteCuff pressure display range: . . . . . . . . . . . .0-299 mmHgMemory: . . . . . . . . . . . . . . . . . . . . . . . . . .Automatically stores the last 120measurements for 2 users (total 240)Measuring resolution: . . . . . . . . . . . . . . . . 1 mmHgAccuracy: . . . . . . . . . . . . . . . . . . . . . . . . . .Pressure within ± 3 mmHg or 2% ofreading >200 mmHgPulse ± 5% of the readingPower source: . . . . . . . . . . . . . . . . . . . . . . . .a) 4 AA batteries, 1.5 Vb) AC adapter 6 V DC 600 mA(voltage 4.5 V DC to 6 V DC)Battery life: . . . . . . . . . . . . . . . . . . . . . . . . .Approximately 500 measurements.Expected service life: . . . . . . . . . . . . . . . . 5 years
28Cuff life: . . . . . . . . . . . . . . . . . . . . . . . . . . 2 yearsIP Classification . . . . . . . . . . . . . . . . . . . . . .IP20 Accessories: . . . . . . . . . . . . . . . . . . . . . . . . Cuff type: Wide range soft cuff for arm circumference 22-42 cm (8.7"-16.5")BP analyzer software CDUSB (A to mini B) cableStorage caseTechnical alterations reserved.The adapter was made by Dee Van Enterprise Co., Ltd, Model number is: DSA-6E-05 US 6006010 Made in ChinaRead the instructions carefully before using this device.Type BF applied part.IP20: Protected against solid foreign particles with a diameter of more than12.5 mm, no protection against water)Version of user's manual: BP3MW1-4BCVS IB-001Not for use on children 12 years of age or younger.
2913. How to contact usDistributed by: CVS Pharmacy, Inc.One CVS Drive, Woonsocket, RI 02895© 2012 CVS/pharmacywww.cvs.com 1-800-shop-CVSToll Free Customer Support Line: 1-866-464-6184Email: CVSbpsupport@microlifeusa.com
30Federal Communications Commission (FCC) Statement15.105(b)This equipment has been tested and found to comply with the limits for a Class Bdigital device, pursuant to part 15 of the FCC rules. These limits are designed toprovide reasonable protection against harmful interference in a residential installation.This equipment generates, uses and can radiate radio frequency energy and, if notinstalled and used in accordance with the instructions, may cause harmful interferenceto radio communications. However, there is no guarantee that interference will notoccur in a particular installation. If this equipment does cause harmful interference toradio or television reception, which can be determined by turning the equipment offand on, the user is encouraged to try to correct the interference by one or more of thefollowing 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.15.21You are cautioned that changes or modifications not expressly approved by the partresponsible for compliance could void the user’s authority to operate the equipment.FCC RF Radiation Exposure Statement:1. This Transmitter must not be co-located or operating in conjunction with anyother antenna or transmitter.
312. This equipment complies with FCC RF radiation exposure limits set forth for anuncontrolled environment. This equipment should be installed and operated with aminimum distance of 20 centimeters between the radiator and your body.15.19This 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 and2) this device must accept any interference received, including interference that maycause undesired operation of the device.Statements and TrademarksApple, the Apple logo, iPad, and iPhone are trademarks of Apple Inc., registered in theU.S. and other countries. App Store is a service mark of Apple Inc.Android and Google Play are both trademarks of Google Inc.Samsung and Galaxy S are both registered trademarks of Samsung Electronics Co., Ltd.Sony, Xperia M4 and Nexus 5 are registered trademarks of Sony Co., Ltd.
32Manufacturer’s declaration – Electro Magnetic Compatibility (EMC)
33Guidance and manufacturer’s declaration – electromagnetic immunity
34Guidance and manufacturer’s declaration – electromagnetic immunity
35Guidance and manufacturer’s declaration –

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