Oregon Scientific BPU321OS User manual

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WARNING
•Thismonitorisforhomedailyuseonlyandisnotmeant
toreplaceanymedicaldevice.
•Themonitorshouldbeusedbyadultswhoseageisat
least18orabove.
•Nomodicationofthisequipmentisallowed.
•Donotmodifythisequipmentwithoutauthorizationof
themanufacturer.
•Ifthisequipmentismodied,appropriateinspectionand
testingmustbeconductedtoensurecontinuedsafeuse
oftheequipment.
•Removethebatterieswheneveryouareplanningtostore
theunitforalongperiodoftime.
Ssmart Talking Blood Pressure Monitor
Model: BPU321OS
User Manual
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CONTENTS
Introduction................................................................. 3
Packagecontents....................................................... 3
Accessories........................................................ 3
Productview/keyfeatures........................................ 4
Settingupthemonitor................................................ 4
Assembletheunit................................................ 4
Installingandreplacingthebatteries................... 5
Monitorsettings.......................................................... 5
Positioningthearmcuff.............................................. 6
Preparingtotakebloodpressuremeasurement........ 6
Takingameasurement............................................... 7
Poweroff.................................................................... 7
Understandingthereading .................................................. 7
Display................................................................. 7
Hypertension........................................................ 8
Irregularheartbeat/arrhythmia........................... 8
Movement/readingerror.................................... 8
Voiceannouncement........................................... 8
Viewrecords............................................................... 9
Recallingmeasurementsstoredinmemory........ 9
Clearrecords.............................................................. 9
Deletingasinglerecord....................................... 9
Deletingallrecords............................................ 10
Application................................................................ 10
Connectwithyourmobiledevice.............................. 10
Startdatatransmission...................................... 10
Reviewtherecords............................................ 11
UniquedeviceID...................................................... 12
Troubleshooting........................................................ 12
Safetyandcareinstructions..................................... 12
Safetyprecautions............................................. 12
Caringforyourbloodpressuremonitor............. 13
Usefulreference....................................................... 14
Aboutbloodpressure......................................... 14
Howthebloodpressuremonitorworks............. 15
Operationfrequency................................................. 15
Specications........................................................... 15
Electromagneticcompatibilitydescriptions............... 16
AboutOregonScientic............................................ 21
Authorizedrepresentative......................................... 21
EU-Declarationofconformity.................................... 22
Symboldescription(s)............................................... 22
FCCstatement......................................................... 22
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INTRODUCTION
ThankyouforselectingtheOregonScienticTMSsmart
Talking Blood Pressure Monitor (BPU321OS). The
BPU321OSfeaturesmulti-languagevoiceannouncement
andplaybackofbloodpressuremeasurementsforadded
convenienceandhasbeendesignedtoprovideyouwith
manyyearsofreliableservice.Themonitorcanhelpyou
measureandtrackthefollowingmetrics:
• Systolicpressure
• Diastolicpressure
• Averagemorning/eveningbloodpressure
• Heartrate
Our BPU321OS product is able to store up to 100
measurements per user (maximum 2 users). The
monitorcarriesBluetoothSmarttechnology(Bluetooth
Low Energy, SMART ) that is compatible with your
SmartPhoneandtabletPC.Nowyoucaneasilyview
andsystematicallymanageyourbloodpressuredata
through ourApp “Ssmart Blood Pressure Monitor”,
whichisnotonlyavailableinAppleAppStore,butalso
inGooglePlayStore.
Readings taken by the blood pressure monitor are
equivalent to those obtained by a trained observer
using the cuff and stethoscope auscultation method.
ClinicalperformancewassuccessfullydoneagainstISO
81060-2:2009andinternationalprotocol.The B.H.S.
(BritishHypertension Society) has rated this product
“recommendedforclinicalandhomeuse”,thehighest
gradingavailableforbloodpressuremonitors.
NOTE Please keep this manual handy as you use
yournew product. It contains practicalstep-by-step
instructions,as well as technical specications and
warningsyoushouldknowabout.
PACKAGING CONTENTS
Thispackageshouldincludethefollowingitems:
• 1xBPU321OSBloodPressureMonitor
• 1xCuffwrap
• 1xCuffholder
• 4xAA(1.5V)batteries
ACCESSORIES
This product comes with below optional accessories
which can be purchased separately. For more
information,pleasecontactyourlocalretailer.﹡
-ReplacementArmcuff
-Storagepouch
-6Vadaptor
﹡Featuresandaccessorieswillnotbeavailablein
allcountries.
NOTE If you want to use a power adaptor for this
BloodPressure Monitor (BPU321OS), use ONLYthe
poweradaptorpurchasedfromOregonScienticthat
approvedbythestrictmedicalgradetest.Toorderan
adaptor,visitourwebsiteatwww.oregonscientic.com.
DoNOTattempttouseotherbrandinthemarketfor
thisproductthatmaycauseunpredictableharmtothe
productortheuser.OregonScienticisnotliablefor
anymisuseoftheadapter.
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PRODUCT VIEW / KEY FEATURES
A.:starttakingbloodpressureforuser1;viewuser1
measurementrecords,viewadditional/olderrecords;
increasevalueofthesetting;togglesettingoptions
B.:turnmonitoron/off;entersettingmode;
conrm
settings;starttakingmeasurementforguest(norecord
stored); cancel measurement; conrm deletion of
individualoralldataforuser(1or2).
C.:starttakingbloodpressureforuser2;viewuser2
measurementrecords,viewadditional/olderrecords;
decreasevalueofthesetting;togglesettingoptions.
1.:indicateswhichuser(1or2)hasbeenselected
(noiconappearsforguest).
2.Pairingstatus(bLE/Err /donE);Clock;calendar;
dateandtimestamp.
3.:Averagemorning/eveningbloodpressure
4.:memoryisfull;memorymodeselected.
5. Systolicpressure
6. Airoutlet
7. Diastolicpressure
8.:monitorbatterylow
9.:voiceactivation
10.Synchronizingstatusindicatorlight
11.Bloodpressureclassicationbar
12.Heartratecounter
13.:irregularheartbeatdetected
SETTING UP THE MONITOR
ASSEMBLE THE UNIT
1. Insertthesmallendoftheairtubeintotheairoutlet
onthemonitor.
2.
Snapcuffholderintoplaceatthebackofthemonitor.
3. Placecuffintoholder.
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BCA
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INSTALLING AND REPLACING
THE BATTERIES
Thismonitorcanworkwitha6Vadaptorwhichhastobe
purchasedseparately.
1. Slideoffthebatterycover.
2.
Installthebatteriesbymatchingthecorrectpolarities.
Alwaysusethecorrectbattery
3. Alignthecoveratagainstthebatterycompartment,
andthenslideitupwards.
Abovediagramdisplays:
1.Airoutlet
2.Batterycompartment
NOTE Flashingindicatesmonitorbatteriesarelow.
NOTE Replacebatteriespromptlytoensureaccurate
readings.Replaceallthebatteriesatthesametime;itis
dangeroustomixoldandnewbatteries.
NOTE Contactyourlocalwastedisposalauthorityfor
instructionsonhowtodisposeofusedbatteries.Used
batteriescanbeharmfultotheenvironment,andshould
notbethrownoutwithhouseholdtrash.
MONITOR SETTINGS
IMPORTANTAs blood pressure measurements are
recordedinthememorywithdateandtimestampfor
easyanalysis,setthemonitorpriortorstusetoensure
measurementsarecorrectlymarked.
Tosetthemonitor:
• Whenmonitor is off,press and hold to enter
settingmode.
Settings
Settingoptions(Press or
toadjustthevalue,andpress
toconrm)
Date Year,month,date
Time Hourformat,hour,minute
Audio
function
On/off
Volumecontrol(HI/Lo)when
functionenabled
Language:
(En)English
(Fr)French
(CH)Putonghua
(CHHk)Cantonese
(SP)Spanish
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2
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POSITIONING THE ARM CUFF
Thecuffcircumferenceisabout22-32cm.Ifyour
arm’scircumferenceis
biggerthanthis,the
cuffcannotbeused
tightlyandcause
inaccuratereading.
Ensurethearmcuff
iscorrectlyplacedtoobtain
anaccuratereading.
NOTE Ifyourphysicianhasdiagnosedyouwith poor
circulationinyourleftarm,useyourrightarm.
1. Choosethepositionfromwhichyouwishtomeasure,
sittingorlyingdown.
2. Rollorpushupyoursleevetoexposetheskin.
3. Putarmthroughthecuffloop.
4. Placecuffaboutaninch(2-3cm)aboveyourelbow.
Usecushionsorothersupportsifnecessarytoadjust.
Theairtubeshouldrundown,betweentheinsideof
yourforearmandthesideofyourchest,inlinewith
yourmiddlenger.
5. Fastenthearmcuffsoittssnugly.Ifthecuffistoo
loose,themeasurementwillnotbeaccurate.
PREPARING TO TAKE BLOOD PRESSURE
MEASUREMENT
Youcanchoosetotakebloodpressurewhilesittingorlying
down.Belowaresomehelpfultipsfortakingameasurement.
• Besure to set the clockbefore taking your first
measurement,orwheneveryoureplacethebatteries,so
thatthedateandtimearestoredinthememorywithyour
history.Forinstructions,refertoMonitor Settingssection.
• Itisimportanttorelaxwhentakingyourbloodpressure.
Trytotakea15-minuterestbeforeyoubegin.
• Donotleanbackwardorbendyourupperarminward
whiletakingameasurement.
• Donotsitcross-leggedandavoidtalkingormovingyour
ngersandhandwhiletakingameasurement.Rapid
movementsorotheractivitiesmayalteryourreading.
• Waitatleastanhourbeforetakingyourbloodpressure
ifyouhavejusteatenalargemeal.
• Do not smoke or drink alcohol before taking your
bloodpressure.
• Donotmeasureyourbloodpressureifyouareunderstress.
• Removeallaccessoriesfromyourarm.
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• Waitatleast3minutesbetweenmeasurements.This
allowsyourbloodcirculationtorecover.
For a meaningful comparison, try to measure under
similarconditions.Forexample,takedailymeasurements
atapproximatelythesametime,onthesamearm,oras
directedbyaphysician.
TAKING A MEASUREMENT
Ifyouwantthemonitortosynchronizewiththeapplication
ofyour mobile device. Pleasedo preparation before
startingameasurement.
1. Turn on the application and ensure the Bluetooth
connectiononyoursmartdeviceisgood.
2. Relaxyourarm.
3. Press toturnontheunit.
4. Select user, then a voice prompts you to sit in the
correctpositionandtoremainstill:
Button User Memory
Guest Norecordsstored
1RecordstoredunderUser1
2RecordstoredunderUser2
5. Armcuffwillbegininatingautomatically.Digitswill
appearonthescreen.
6. Oncethepressurereachesacertainlevel,itwillslowly
deateuntiltheresultsaredisplayedontheLCD.
7. The monitor automatically attempts to send the
record wirelessly to your mobile device. If data
transmissionsuccesses,bLEwilldisplayonthetop
ofthemonitorscreen.
8. Toconservebatterylife,monitorwillturnoff1minute
after taking a measurement.Alternatively, press to
manuallyturnoffmonitor.
NOTE Pleasesanitizethemonitorandmainaccessories
foravoidcrossinfection.
POWER OFF
Tostopthemeasurementprocessatanytime,press.
UNDERSTANDING THE READING
Forreferencematerial,pleaserefertoUseful Reference
sectionwhichcanbefoundattheendofthismanual.
DISPLAY
Example:
1. Date/Timestamp(automaticallytoggles)
2.Userselected
3.Systolicpressure
6
7
1
2
3
4
5
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4.Diastolicpressure
5.Heartrate
6.Bloodpressureclassicationsegments
7.Hypertensionindicatorbar
HYPERTENSION
Themonitorwillvisuallydisplaybysegmentsunderwhich
WHOclassicationthemeasurementfallsunder.
Bar Classication Reading
Grade3Hypertension
Grade2Hypertension High
Grade1Hypertension Slightlyhigh
HighNormal
Normal
Optimal
Normal
IRREGULAR HEARTBEAT / ARRHYTHMIA
Apartfrombloodpressureandheartrate,heartbeatis
alsoanindicatorofyourgeneralhealthcondition.
With a normal heartbeat, the beats are steady at
regularintervals.
Anirregularheartbeatisonewherethereisavariance
andtheintervalsvary.
NOTE Ifanirregularheartbeathasbeendetecteddur
ingthemeasurement, willbedisplayed.Wehighly
recommendyouconsultyourphysician.
MOVEMENT / READING ERROR
IfErr 1isdisplayed,pleasetake2-3minutesandthen
refastenthecuffbeforetakinganothermeasurement.
Refer again to Preparing to Take Blood Pressure
MeasurementsectionandPositioning the Arm Cuff
sectionifrequired.
VOICE ANNOUNCEMENT
Ifaudiofunctionisenabled,thefollowingwillbeannounced:
• Measurementresults(Systolic,Diastolic,Heartrate);
• WHOclassication;
• Lowbattery;
• Errordetection
• displayswhenaudiofunctionisenable
Pulse
Blood
pressure
Pulse
Short Long
Blood
pressure
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CLEAR RECORDS
Whenmemoryisfull, ashes.
Apartfromdeletinganentiremeasurementhistory,there
isalsoanoptiontodeletethelatestmeasurementrecord.
Thisisusefulifmeasurementshavenotbeenaccurately
recordedandneedtoberecordedagain.
DELETING A SINGLE RECORD
1. Whenmonitorisoff,press or toselectuser.
2. Pressthecorrespondinguserbuttonrepeatedly
( or )tonavigatetotherecordtobedeleted.
NOTE Themostrecentrecord(1)isshownrst.
3. Pressandhold .dEL ONEdisplaysandashes.
•Press toexittothedeletionmode.
•Pressandhold againtoconrmdeletion.
4. doNE dELindicatestherecordhasbeendeleted.
VIEW RECORDS
Thismonitorcanstoreupto100recordsperuser.Themost
recentrecord(1)isshownrst.Eachnewmeasurementis
assignedtotherst(1)entryintheuserrecordselected.All
otherrecordsarepushedbackonedigit(e.g.,2becomes3
andsoon),andthelastrecord(100)isdroppedfromthelist.
Foraveragemorning/eveningbloodpressurereadingstobe
displayed,bloodpressurehastomeasureforthreeconsecutive
daysatleasttwiceineachtimeperiod(morning/evening).
For ease of reference, the date and time when the
measurement was taken is shown with each record.
Memory is kept even when the batteries become
exhaustedandsubsequentlyreplaced.
RECALLING MEASUREMENTS STORED IN
MEMORY
Ensurethemonitorisoff.
Selectuser:
• Press toviewahistoryofUser1’srecords
• Press toviewahistoryofUser2’srecords
Viewmorerecordsforthesameuser:
• Pressthecorrespondinguserbuttonrepeatedly
( or )toseeadditionalrecords(average
morning/eveningifavailableornextrecord).
TIP Pressandholdcorrespondinguserbutton
( or )toquicklytogglethroughalltheentries.
Toalternatebetweendifferentuser’srecords:
Press or .
Press & hold
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DELETING ALL RECORDS
1. Whenmonitorisoff,press or toselectuser.
2. Pressandhold .dEL ONEwillbedisplayed.
3. Press or totoggletodEL ALL
4. Pressandhold againtoconrmdeletion.
Thisscreenindicatesallrecordshavebeensuccessfully
deletedandtherearenorecordsleftforthatuser.
5.Pressor tonavigatetotheotheruser’srecords.
APPLICATION
Youcanndtheinstructionsintheapplicationor
contactyourlocalretaileroftheproduct.
CONNECT WITH YOUR MOBILE DEVICE
Tohelpuserkeeptrackoftheirresults,themeasurements
recordedby the monitor can be easily uploaded and
reviewedthrough an application by
BluetoothLow Energy. Download the
application“Ssmart Blood Pressure
Monitor” inApple Store through your
mobiledevice.
Turn on Bluetooth:
PleaseensuretoturnontheBluetooth
onyourmobiledevicebeforeusingthe
application.
START DATA TRANSMISSION
YouneedtobuildupUser’sProlebefore
startingthetransmission.
Edit user’s prole:
1. Tap toaddupauser.
2. In New User screen, tap on the
prolepictureforuploadingaphoto;
tapon each row to inputGender,
Date of birth,WeightandHeight.
3. Tap Donewhenyounish.
NOTE
• Ifyouwanttoediteachprole,youcanalsotap to
modifytheinformation.
• Toremoveauser,tapEdit inUserscreen,tapthe
iconoftheuseryouwanttoremove.Deletedisplays
anditmeansthedeletionissuccessful.
Press & hold
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Start data transmission:
Foraddedconvenience,theunitisprogrammedtosend
dataautomatically:
• Atthesametimeastakingmeasurement
• Aftertaking measurement and unit detects there is
datawhichwasnotsentsuccessfully.
Read a measurement on the app:
1. InUserscreen,selectauser.
2. Thescreensimultaneouslydisplays
the measuring value exactly the
same as your blood pressure
monitor.Connecting… and icon
appearsandashesonthescreen.
3. Once the connection is done, the
icon stops flashing and BLE
Donedisplaysonthescreenofthe
monitor.Youcanstartmeasurement
and the record is automatically
savedtotheapplication.
4. Swipe the screen to right;you
can view your measurement in
graphview.Rotatethescreentobe
horizontal,andthenyoucanreview
thedatahistoryinbarview.
NOTE
• Ifthe icondisappearsthatmeanstheconnectionis
notsuccessful.
• IfthereisanerrorduringtheBluetoothconnection,animated
BLE Err displaysonthetopofthemonitorscreen.
Manually send data:
1.Selectadesireddatahistoryfromuser1 oruser2 .
2.Pressandhold and atthesametime.
3. Thescreendisplaywillturnoffoncesynchronization
attempt(whether successful or not) has been
completedinaminute.Synchronizingstatusindicator
light(locatedabovethetoprightcornerofthescreen)
variesasshownbelow:
Description Meaning
Flashinggreen Communicating
Continuousred Noconnectivity
IMPORTANT Duringtransmission,pressingdoesnothave
anyfunction.Trytopressthebuttoninaminute.
REVIEW THE RECORDS
Youcanviewtherecordsfromthe
applicationbytapping .
1. You can view the records by List
VieworCalendar View.
2. Onceyouviewtheexactdatahistory,
youwillview yourmeasurement in
graphview.Rotatethescreentobe
horizontal,andthenyoucanreview
thedatahistoryinbarview.
Successful
transmission
Unsuccessful
transmission
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Delete a record:
1. Swipetoleftonarecord, displaysontherecord.
2. Tapon toconrmthedeletion.
UNIQUE DEVICE ID
EachunithasauniquedeviceIDwhichcanbefoundon
thedevice.Youcannditonthebatterycompartment.
TROUBLESHOOTING
This section includes a list of error messages and
frequentlyasked questions for problems you may
encounterwithyourbloodpressuremonitor.Iftheproduct
isnotoperatingasyouthinkitshould,checkherebefore
arrangingforservicing.
ERROR
CODE Message Reason/Suggestion
Err
Thereisan
errorduring
synchronization
Repeatthe
synchronization
procedure
Err1
Theupperarmcuff
isnotappropriately
secured.
Refastenthecuffandthen
takeameasurementagain
Err4
Themonitordetects
motionduring
meausrement.
Donotmoveortalkduring
measurement.Pleasetry
again.
Err5 Pressureisover
300mmhg
Relaxforamomentand
thentakeameasurement
again
EE(3-20)Internalsoftware/
hardwareerror
Pleaseremovethebatteries
andthenre-installthem
forreset.Iftheerrorcode
stilldisplaysonthescreen,
pleasecontactourCustomer
Serviceforasolution.
BLE Err
(animatedand
displayed
onthetopof
screen)
Thereisanerror
duringthe
connection.
BLE DoneTheconnectionis
successfullydone.
frequentlyasked questions for problems you may
encounterwithyourbloodpressuremonitor.Iftheproduct
isnotoperatingasyouthinkitshould,checkherebefore
arrangingforservicing.
SAFETY AND CARE INSTRUCTIONS
SAFETY PRECAUTIONS
Pleaseobservethefollowingsafetyprecautionswhen
settingupandusingyourbloodpressuremonitor.
• Thisdeviceisintendedforadultuseonly.
• Thisdeviceisintendedfornon-invasivemeasuring
andmonitoringofarterialbloodpressure.Itisnot
intendedfor use on extremities otherthan the
upperarmorforfunctionsotherthanobtaininga
bloodpressuremeasurement.
• Donotconfuseself-monitoringwithself-diagnosis.This
unitallowsyoutomonitoryourbloodpressure.Donot
beginorendmedicaltreatmentbasedsolelyonthe
measurementsofthisdevice.Consultaphyscianfor
treatmentadvice.
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• Ifyouaretakingmedication,consultyourphysician
todeterminethemostappropriatetimetomeasure
yourbloodpressure.Neverchangeaprescribedmedi
cationwithoutconsultingyourphysician.
• This unit is not suitable for continuous monitoring
duringmedicalemergenciesoroperations.
• Ifthecuffpressureexceeds40kPa(300mmHg),the
unitwillautomaticallydeate.Shouldthecuffnotdef
late when pressures exceeds 40 kPa (300mmHg),
detachthe cuff from the upperarm and press the
buttontostopination.
• To avoid measurement errors, carefully read this
manualbeforeusingtheproduct.
• Thecontinuouscuffpressureduetoconnectiontubing
kinkingmaycausebloodowinterferenceandharmful
injurytothepatient.
• Frequentmeasurementscancauseinjurytothepatient
duetobloodowinterference.
• Donotapplyacuffoverawound,asthiscancause
furtherinjury.
• The application of the cuff on any limb where
intravascularaccessortherapy,oranarterio-venous
(A-V)shuntmaycausetemporaryinterferencetoblood
owandcouldresultininjurytothepatient.
• Theapplicationofthecuffanditspressurizationon
thearmshouldbeonthesideofamastectomy;
• Pressurizationofthecuffcantemporarilycauseloss
of function of simultaneously used monitoring ME
EQUIPMENTonthesamelimb.
• Youneedtocheckthatoperationofthebloodpressure
monitordoes not result in prolonged impairment of
patientbloodcirculation
• Do not use this monitor close to any magnetic
resonanceimaging(MRI)equipment.IfMRIistobe
performed,removecufffromthearm.
CARING FOR YOUR BLOOD PRESSURE
MONITOR
Toensureyoureceivethemaximumbenetfromusing
thisproduct,pleaseobservethefollowingcareguidelines.
• Whennotinuse,storetheunitinadryplaceaway
fromdirectsunlight.
• Donotimmersetheunitinwater.Ifitcomesincontact
withwater,dryitimmediatelywithasoftlint-freecloth.
• Carefully remove dirt from the unit or cuff with a
soft,slightlymoistenedcloth.Donotuseabrasiveor
corrosivecleaningdetergent,suchaspetrol,thinners
orsimilarsolvents,asthesemaycausedamage.
• Do not wash the arm cuff or immerse it in water.
Positionthearmcuffinventilatedanddryplace,not
underdirectsunlight.
• Carefullyremovespotsonthecuffwithadampcloth
andsoapsuds.
• Removethebatterieswheneveryouareplanningto
storetheunitforalongperiodoftime.
• Whenreplacingbatteries,usenewbatteriesasspecied
inthisusermanual.Donotmixnewandoldbatteries.
• Donotplaceobjectssuchasstickersontheupperarm
cufforunit,asthesemayimpairthemeasurement.
• Do not subject the unit to excessive force, shock,
dust, temperature changes, or humidity. Such treat
mentmayresultinmalfunction,ashorterelectronic
lifespan,damagedbatteries,ordistortedparts.
• Donottamperwiththeinternalcomponents.Doing
so will terminate the product warranty and may
causedamage.
• Theunitcontainsnouser-serviceableparts.
• Ifyounolongerneedtousethisproduct,protectthe
environmentbybringingittoyourdealerordesignated
collectionpointforproperdisposal.
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Referencematerial:1999WorldHealthOrganization-
InternationalSocietyofHypertensionGuidelinesforthe
managementofhypertension,JournalofHypertension,
1999,17(2): 151-183.This is used asthe basis for
thecolouredhypertensionindicationbartotheright
ofthescreen.
NOTE
• Blood pressure is considered high when either the
diastolicorsystolicbloodpressurevalueexceedsthe
normalrange.Whenapatient’ssystolicanddiastolic
bloodpressuresfallintodifferentcategories,thehigher
categoryshouldapply.
• Onlya physician can tell youyour normal blood
pressurerangeandthepointatwhichyouareatrisk.
Consultyourphysiciantoobtainthesevalues.Ifthe
measurementstakenwiththeseproductsfalloutside
therange,consultyourphysician.Whydoesmyblood
pressureuctuatethroughouttheday?Individualblood
pressurevariesgreatlybothonadailyandaseasonal
USEFUL REFERENCE
ABOUT BLOOD PRESSURE
Whatisbloodpressure?
Blood pressure is the force generated by the blood
againstthewallsofarteriesduringcardiaccontraction
andrelaxation(e.g.,thepumpingactionoftheheart).
Whataresystolicpressureanddiastolicpressure?When
ventriclescontract and pump bloodout of the heart,
bloodpressurereachesitsmaximumvalue.Thishighest
pressureinthecycleisknownassystolicpressure.When
theheartrelaxesbetweenheartbeats,thelowestblood
pressureisdiastolicpressure.
Whymeasureyourbloodpressure?
Blood pressure measurement can highly reect one’s
healthcondition.Highbloodpressureispotentiallylinked
toseriousillnessessuchasstroke,heartdiseaseand
kidneyfailure.Sincethereis nosymptommostofthe
time,manyhypertensivepeopledonotrealizetheyare
atriskuntiltheirhealthisseriouslythreatened.
Whatisthestandardbloodpressureclassication?
Thegure illustrates the blood pressure classication
madeby WorldHealth Organization (WHO) and
InternationalSocietyofHypertension(ISH)in1999.
120 130 140 150 160 180
Systolic Blood Pressure(mmHg)
)gHmm(erusserPdoolBcilotsaiD
110
100
95
90
85
80
Grade 3 hypertension(severe)
Grade 2 hypertension(moderate)
High-normal Blood Pressure
Normal Blood Pressure
Optimal Blood
Pressure
Grade 1 hypertension(mild)
Subgroup:borderline
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ortemperaturebasis.Thesevariationsmaybemore
pronounced in hypertensive patients. Normally the
bloodpressureriseswhileatworkandisatitslowest
duringsleep.Thegraphbelowillustratesthevariations
over a single day with measurement taken every 5
minutes.The thick line represents sleep time. The
risesinbloodpressureat4PM(Ainthegraph)and1
2AM(Binthegraph)correspondtoanattackofpain
andsexualintercourse(Beven,Honour&Stott,Clin.Sci.
36:329,1969).
HOW THE BLOOD PRESSURE
MONITOR WORKS
ThisproductusestheOscillometricMeasuringmethodto
detectyourbloodpressure.Beforeeverymeasurement,
theunitestablishesa“zeropressure”equivalenttothe
airpressure.
Thenitstartsinatingthearmcuffto180mmHgorhigher
untilitsensesthatithasblockedyourbloodintheartery.
Afterthat,thedeationprocessstarts,duringwhichtimethe
unitdetectspressureoscillationsgeneratedbybeat-to-beat
pulsatile,whichisusedtodeterminethesystolic,meanand
diastolicpressure, and also yourpulse rate.Any motion
duringthisperiodwillresultinanincorrectmeasurement.
Afterallreadingsaredeterminedanddisplayedonthe
LCD, the measurement is nished and the arm cuff
automaticallydeates.
OPERATION FREQUENCY
Thedevice’soperationfrequencyisbetween2.40GHzto
2.4835GHz,thisisaunlicensedfrequencybandunder
CFR47,Part15ofFCCrules,thereis40RFchannels,
consists of 37 data channels for communication
betweenconnecteddevicesand3advertisingchannels
fordiscoveringdevices,thecommunicationuseGFSK
modulation mode with Frequency-hopping spread
Spectrumtechnology,theMaximumpeakoutputpower
is99.25dBuV/mbyFCCtestreport(ReportreferenceNo.:
TRE1204008401-Section4.2:RadiatedEmission),the
effectiveconnectiondistanceisuptotenmetersindoor.
SPECIFICATIONS
Application
Measuringmethod Oscillometric/non-invasive
Application Foradultuseonly
Measurementlocation Upperarm
Maximumnumber
ofusers 2andguest
Memory Maximum100peruser
160 A B
TimePM
BLOOD PRESSURE
(mmHg)
AM
Sleep
140
120
100
80
60
40
20
12 13 14 15 16 17 18 19 20 21 22 23 24 1 2 3 45 6 7 8 9 10 11
BPU321OS_UM_EN_R20.indd 15 13-12-5 ��1:46

EN
16
ELECTROMAGNETIC COMPATIBILITY
DESCRIPTIONS
TABLE1: GUIDANCE AND MANUFACTURER’S
DECLARATION – ELECTROMAGNETIC EMISSION –
FOR ALL EQUIPMENT AND SYSTEMS
1Guidance and manufacturer’s declaration –
electromagnetic emission
2
TheBPU321OSBloodPressureMonitorisintended
foruseintheelectromagneticenvironmentspecied
below.ThecustomerortheuserofBPU321OS
BloodPressureMonitorshouldassurethatitisused
insuchanenvironment.
3Emissionstest Compliance Electromagnetic
environment-guidance
4
RFemissions
CISPR11
Group1
TheBPU321OSBlood
PressureMonitoruses
RFenergyonlyfor
itsinternalfunction.
Therefore,itsRF
emissionsareverylow
andarenotlikelyto
causeanyinterference
innearbyelectronic
equipment.
Dimensions
Dimensions
LxWxH 148x103x75mm
(5.8x4.1x3.0in)
Weight 450g
Cuffcircumference 22-32cm
Transmissionrange 6meters(19.7feet)
Measuring range
Pressure 30to280mmHg
(4.0to37.3kPa)
Pulse 40to199pulse/min
Power
Powersupply 4xUM-3(AA)1.5Vbatteries
6Vadaptor(separate
purchaserequired)
Powersave Autopoweroffafter1minute
ofnokeypressorafter
synchronisationattempt
Operating environment
Operation 10°Cto40°C
(50°Fto104°F)
Storage -20°Cto60°C
(-4°Fto140°F)
Humidity 10%to83%relativehumidity
BPU321OS_UM_EN_R20.indd 16 13-12-5 ��1:46

EN
17
5RFemissions
CISPR11 ClassB TheBPU321Blood
PressureMonitoris
suitableforuseinall
establishments,
including
domestic
establishments
andthosedirectly
connectedtothepublic
low-voltagepower
supplynetworkthat
suppliesbuildingsused
fordomesticpurposes.
6
Harmonic
emissions
IEC61000-3-2
ClassA
7
Voltage
uctuations/
icker
emissions
IEC61000-3-3
Complies
TABLE 2: GUIDANCE AND MANUFACTURER’S
DECLARATION – ELECTROMAGNETIC IMMUNITY –
FOR ALL EQUIPMENT AND SYSTEMS
Guidance and manufacturer’s declaration –
electromagnetic immunity
TheBPU321OSBloodPressureMonitorisintendedfor
useintheelectromagneticenvironmentspeciedbelow.
ThecustomerortheuseroftheBPU321OSBlood
PressureMonitorshouldassurethatitisusedinsuch
anenvironment.
Immunity
test
IEC
60601
testlevel
Compliance
level
Electromagnetic
environment-
guidance
Electrostatic
discharge
(ESD)
IEC
61000-4-2
±6kV
contact
±8kV
air
±6kV
contact
±8kVair
Floorsshouldbe
wood,concreteor
ceramictile.If
oorsarecovered
withsynthetic
material,the
relativehumidity
shouldbeatleast
30%.
Electrostatic
transient/
burst
IEC
61000-4-4
±2kV
forpower
supply
lines
±1kVfor
input/
output
lines
±2kVfor
power
supply
lines
±1kVfor
input/
output
lines
Mainspower
qualityshouldbe
thatofatypical
commercialor
hospital
environment.
Surge
IEC
61000-4-5
±1kV
differential
mode
±2kV
common
mode
±1kV
differential
mode
±2kV
common
mode
Mainspower
qualityshouldbe
thatofa
typical
commercialor
hospital
environment.
BPU321OS_UM_EN_R20.indd 17 13-12-5 ��1:46

EN
18
Voltage
dips,
short
interruptions
andvoltage
variations
onpower
supply
inputlines
IEC
61000-4-11
<5%UT
(>95%
dipinUT)
for0.5
cycle
40%UT
(60%
dipinUT)
for5
cycles
70%UT
(30%
dipinUT)
for25
cycles
<5%UT
(>95%
dipinUT)
for5sec
<5%UT
(>95%dip
inUT)
for0.5
cycle
40%UT
(60%
dipinUT)
for5
cycles
70%UT
(30%
dipinUT)
for25
cycles
<5%UT
(>95%
dipinUT)
for5sec
Mainspower
qualityshouldbe
thatofatypical
commercial
orhospital
environment.If
theuserofthe
BPU321OS
BloodPressure
Monitorrequires
continued
operationduring
powermains
interruptions,it
isrecommended
thatthe
BPU321OSBlood
PressureMonitor
bepoweredfrom
anuninterruptible
powersupplyora
battery.
Power
frequency
(50/60Hz)
magnetic
eld
IEC
61000-4-8
3A/m 3A/m
Powerfrequency
magnetic
eldsshould
beatlevels
characteristicof
atypicallocation
inatypical
commercial
orhospital
environment.
NOTE UTisthea.c.mainsvoltagepriortoapplication
ofthetestlevel.
TABLE 3: GUIDANCE AND MANUFACTURER’S
DECLARATION – ELECTROMAGNETIC IMMUNITY –
FOR EQUIPMENT AND SYSTEM THAT ARE NOT
LIFE-SUPPORTING
Guidance and manufacturer’s declaration –
electromagnetic immunity
TheBPU321OSBloodPressureMonitorisintended
foruseintheelectromagneticenvironmentspecied
below.ThecustomerortheuseroftheBPU321OS
BloodPressureMonitorshouldassurethatitisusedin
suchanenvironment.
BPU321OS_UM_EN_R20.indd 18 13-12-5 ��1:46

EN
19
wherePisthemaximum
outputpowerratingof
thetransmitterinwatts(W)
accordingtothetransmitter
manufactureranddisthe
recommendedseparation
distanceinmetres(m).
Fieldstrengthsfrom
xedRFtransmitters,
asdeterminedbyan
electromagneticsite
survey,ashouldbeless
thanthecompliancelevel
ineachfrequencyrange.
Interferencemayoccurin
thevicinityofequipment
markedwiththefollowing
symbol:
Immunity
test
IEC60601
testlevel
Compliance
level
Electromagnetic
environment-
guidance
Conducted
RF
IEC
61000-4-6
Radiated
RF
IEC61000-
4-3
3Vrms
150kHzto
80MHz
3V/m
80MHzto
2.5GHz
3V
3V/m
Portableandmobile
RFcommunications
equipmentshould
beusednocloser
toanypartof
theBPU321OS
BloodPressure
Monitor,including
cables,thanthe
recommended
separationdistance
calculatedfromthe
equationapplicable
tothefrequencyof
thetransmitter.
Recommended
separationdistance
P
V
d]
5.3
[
1
=
P
E
d]
5.3
[
1
=
80MHzto800MHz
P
E
d]
7
[
1
=
800MHzto2.5GHz
BPU321OS_UM_EN_R20.indd 19 13-12-5 ��1:46

EN
20
NOTE At 80MHzand800MHz, thehigherfrequency
rangeapplies.
NOTE Theseguidelinesmaynotapplyinallsituations.
Electromagneticisaffectedbyabsorptionandreection
fromstructures,objectsandpeople.
aField strengths fromxed transmitters, such as base
stationsforradio(cellular/cordless)telephonesandland
mobileradios,amateurradio,AMandFMradiobroadcast
andTVbroadcastcannotbepredictedtheoreticallywith
accuracy. To assess the electromagnetic environment
due to xed RF transmitters, an electromagnetic site
survey should be considered. If the measured eld
strengthin the locationin whichthe BPU321OSBlood
Pressure Monitor is used exceeds the applicable RF
compliancelevelabove,theBPU321OSBloodPressure
Monitorshouldbeobservedtoverifynormaloperation.If
abnormalperformanceisobserved,additionalmeasures
maybenecessary,suchasreorientingorrelocatingthe
BPU321OSBloodPressureMonitor.
b Over the frequency range 150 kHz to 80 MHz, eld
strengthsshouldbelessthan3V/m.
TABLE 4: RECOMMENDED SEPARATION
DISTANCES BETWEEN PORTABLE AND MOBILE
RF COMMUNICATIONS EQUIPMENT
AND THE EQUIPMENT OR SYSTEM -
FOR EQUIPMENT AND SYSTEMS
THAT ARE NOT LIFE-SUPPORTING
Recommended separation distances between
portable and mobile RF communications equipment
and the BPU321OS Blood Pressure Monitor
TheBPU321OSBloodPressureMonitorisintendedfor
useinanelectromagneticenvironmentinwhichradiated
RF disturbances are controlled. The customer or the
useroftheBPU321OSBloodPressureMonitorcanhelp
prevent electromagnetic interference by maintaining
a minimum distance between portable and mobile
RF communications equipment (transmitters) and the
BPU321OSBloodPressureMonitorasrecommended
below, according to the maximum output power of the
communicationsequipment
BPU321OS_UM_EN_R20.indd 20 13-12-5 ��1:46
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