Medexpert CBPM24 User manual

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TableofContents
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1.Introduction ...............................................................................................................................................4
1.1.Contentsofthemanual ......................................................................................................................5
1.2.SupplementaryInformationandHelpfulHints ..................................................................................5
1.3.Warranty.............................................................................................................................................6
1.4.GeneralInformation ...........................................................................................................................6
2.TheMedexpertCBPM24device ................................................................................................................8
2.1.Explanationofsymbols.......................................................................................................................8
2.2.Accessories........................................................................................................................................10
2.3.InstallingtheDevice..........................................................................................................................11
2.4.OperationsInstructions ....................................................................................................................12
2.4.1.Functionsofthebuttononthedevice ......................................................................................12
2.4.1.1.Oneshortpushofthebutton.............................................................................................12
2.4.1.2.Twoshortpushesonthebutton ........................................................................................13
2.4.1.3.Threeshortpushesonthebutton......................................................................................14
2.4.1.4.Fourshortpushesonthebutton........................................................................................14
2.4.2.Datatransmission ......................................................................................................................14
2.4.3.Errorcodesforusers..................................................................................................................15
2.4.4.Soundsignals .............................................................................................................................16
2.4.5.Usingthedeviceforambulatorybloodpressuremonitoring ...................................................16
3.Specifications ...........................................................................................................................................17
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4
1.Introduction

ThankyouforchoosingMedexpertCBPM24.TheMedexpertCBPM24,ambulatory
bloodpressuremonitorisaprofessionaldevice,forclinicalandambulatory
requirements,validatedaccordingtotheBritishHypertensionSocietyandthe
AssociationfortheAdvancementofMedicalInstrumentationstandards.Thedeviceuses
oscillometricmethodforbloodpressuredetermination.Itcanalsobeusedfor
conventionalhomemeasurements,executedbythepatients,offeringahighlevel
measuringqualityandadditionalfeatures.
MedexpertCBPM24deviceiscontrolledbytheMedexpertTensioWin™software.
Themeasurementscheduleandthebloodpressurereadingsareloadedviainfrared
communicationfromandtothephysician'sPC,respectively.
Automaticmeasurementscanbesetforupto48hours,withfrequenciesranging
from10to90minutes.Separatemeasurementfrequenciescanbesetforthe“active”
daytime,“passive”night‐time,andforathird“special”period.
Fourdifferenttypesofbloodpressuremeasuringplanswithdifferentmeasuring
frequenciescanbeprogrammedevenbypressingthebuttonofthedevicewithoutusing
acomputer.Thismeasuringplancoversa24‐hourperiodfromthetimeofprogramming.
Themeasureddata,namelythesystolicanddiastolicBPvalue,thepulserate,the
dateandtimeofthemeasurementwillbestoredintheEEPROMofthedevice.
 Apartfromtheprogrammedmeasurements,thepatientmaystartamanual
measurement(e.g.:heshowssymptomsorfeelssick).Thiscanbedonebyasimplepush
buttonoperation.Allmanuallyinitiatedmeasurementsarestoredanddisplayedonthe
softwarereport.
TheMedexpertCBPM24canbeusedwithoutthesoftwareprogram,for
conventional,manuallystartedBPhomemonitoring.Thehighaccuracyofthe
measurementsandthestorageofthemeasureddataoffergreaterflexibility.Thestorage
capacityofthedeviceis1000measurements.


5
Copyright©2011MedexpertLtd.,Budapest,Hungary.Allrightsreserved.Underthe
copyrightlaws,thismanualcannotbereproducedinanyformwithoutpriorwritten
permissionofMedexpertLtd.

Everyefforthasbeenmadetoensurethattheinformationinthismanualisaccurate.
Succeedingmodelsandmanualsaresubjecttochangewithoutnotice.

Medexpertisnotresponsibleforprintingorclericalerrors.

ThisManualisproducedontheassumptionthattheoperatorisanexperienceduserof
theWindows2000/XP/VistaoperatingSystems.
IftheoperatorisnotfamiliarwithWindowsoperations,pleaserefertotheOn‐lineHelp
ofWindowsortheWindowsUserManual.

MedexpertCBPM24isanunregisteredtrademarkofMedexpertLtd.
Othercompanyandproductnamesmentionedhereinmaybetrademarksoftheir
respectivecompanies.


1.1.Contentsofthemanual

ThismanualhelpsyouinsettingupandstartingtousetheMedexpertCBPM24device.

!
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Attention!Beforefirstuse,pleasereadandunderstandthis
documentcarefully.


1.2.SupplementaryInformationandHelpfulHints
•Thisdevicedoesnotproduceelectromagneticdisturbancesduringitsoperation
anditsimmunitytotheenvironmentaldisturbancesisalsogood.Thedownloadof
themeasureddatatothephysician'sPCisdonebyinfraredcommunication.The
electromagneticcompatibilitybetweenthedeviceandthePCisguaranteed.EMC
classification:A.
•Regularserviceisrecommendedbyanapprovedagentatleasteverytwoyearsto
maintainoptimumperformanceandaccuracy.
•Thecleaningofthecuffisbywipingoverwithadampclothonly.
•Thehandling,storage,wrapping,substance‐conservationandtransportationofthe
producer'sdevicesaredefinedinaccordancewiththegeneralQualityControl
Requirements.
•Thedevicemeetsthefollowingrequirements:

6

EN60601‐1:1995+A1:1993+A2:1995+A13:1996
EN60601‐1‐2:2001
EN1060‐1:1995+A1:2002
EN1060‐3:1997
MSZEN1060‐4:2005
ENISO14971:2000
93/42/EEC:1993
ESHInternationalProtocol2002

1.3.Warranty

MedexpertLtdundertakes2yearsofwarrantyforthedevice(12monthsforthe
accessories).TherepairsaredonebyMedexpertLtdattheplacebelow.

Headofficeandservice:

MedexpertLtd.
Törökkőu.5‐7.
BudapestH‐1037
Hungary
Phone:+36‐12504490
Fax:+3614333795
Web: www.medexpert.hu
E‐mail:[email protected]


1.4.GeneralInformation,warningsandprecautions

WestronglysuggestthatyoucarefullystudytheOperatingInstructionsofthis
multipurposebloodpressuremonitoringdeviceandthatyounotethelistedprecautions.
ForoptimumperformanceitisrecommendedtouseNickel‐MetalHybrid(Ni‐MH)
rechargeablebatteries,orNickelCadmium(NiCd)rechargeablebatteries,with1500mAh
capacity,sizeAA.
TheMedexpertCBPM24canalsobeusedwith1.5Vlonglifebatteries,sizeAA.


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Attention!
Attention!Ifthedeviceisnotusedforalongerperiod,removethebatteries
fromthebatterycompartment.Furthermore,please,keepthedeviceoutof
reachofchildrenifitisoutofuse.

PayspecialattentionwhenapplyingtheambulatoryBPMdevicetopatients
withseriousmobilityorotherimpairments,alsounconsciousorotherwise
incapablepatientsandpatientswithcoagulationdisturbances.Forchildrenit
isalsorecommendedtoapplytheunitwithspecialcare.Childrenshouldnot
usethedeviceontheirown!

Donotremovetheoutercoverofthedevice.TheMedexpertCBPM2424‐hour
BPMdeviceissophisticated,multipurpose,softwarecontrolledmeasuring
apparatus.Incaseofanyproblem,turntoaqualifiedservice.

OnlyusewithcuffssuppliedbyMedexpertLtd.Useofcuffssuppliedbyathird
partycanleadtoerroneousmeasurementresults.

Confirmbloodpressuremeasurementwithauscultationwhenerroneous
resultsaresuspected.

Donotuseamicrowavedevice(e.g.mobilephone)neartheunitduring
measurement.

Donotusethedevicewhenitisexposedtomechanicalvibration(e.g.in
vehicles).

Preventthedevicetobeexposedtodirectsunlight,togetincontactwith
liquidorfromexcessivemechanicalimpact.

Donotdisassemblethedevice.

Patientsafety
Thedevicehasanintegratedsafetymechanism,whichpreventsthecuff
pressuretoexceed300mmHg.Ifhowevertheinflationcontinuesabovethis
valueorthepressurizationlaststoolong,unplugthepneumaticconnectorof
thecufffromthedeviceandremovethecufffromthesubject.

Donotusethedeviceonanarm,whichisbeinginjectedwithintravenous
injection.
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Donotuseonneonates.


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2.TheMedexpertCBPM24device

2.1.Explanationofsymbols

1Nameofthedevice
2Functionbutton(Offeringfivemenuoptions,seesection2.4.1.)
3Commandsymbols(seesection2.4.1.)
4LCDdisplay
5Airconnector





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

Figure1.

1
4
32
5

9
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ThesymbolsonthebottomofthedevicearesowninFigure2.

6Themanufacturer’slabel
7Thenameoftheapparatus
8Thetypenumberoftheapparatus
9MDDcertificationofdevice(IIa)
10 Thenominalvoltagerangeapplicablewithbatteries
11 Theclassificationoftheprotectionagainstelectricshock
Classification:patient'sside:CF
12 CallingtheattentiontoreadthoroughlythepresentUser'sManual
13 Certificationmarkguaranteeingthattheapparatuscomplieswiththeprescriptions
andrequirementsoftheEuropeanUnion.
14 Serialnumber
15 Operatingambienttemperaturerange
16 Yearofmanufacturing
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







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Figure2.

17 Infraredcommunicationwindow
5
6
7
8
9
10
13
12
11
14
15
16

10


Figure3.
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2.2.Accessories

MedexpertCBPM24ambulatorybloodpressuremonitoringdevice(Figure1),is
suppliedwiththefollowingaccessories:

-pouchforthedevicewithbelt
-four,AAsizebatteries
-3differentcuffs
-MedexpertTensioWin™softwareonCD
-Usermanual
-IrDAadapter

Forthe3differentsizecuffsthedimensionsare:


Bladder
Dimensions
Sleeve
Dimensions
Arm
Circumference
Cuff0134×8cm62×9cm34‐43cm
Cuff0226×8cm52×9cm26‐32cm
Cuff0318x6cm38x7cm18‐22cm

Note:Correctcuffdimensionsareimportanttoachieveoptimalperformanceand
accuracy.

17

11
2.3.InstallingtheDevice

MedexpertCBPM24isabatteryoperateddevice.
•Insert4durablealkalineAAbatteriesintotheDevicewithtakingcareoftheright
polarity(seeFigure4)
•Orinsert4AAsizedrechargeableNi‐MHorNiCdbatteriesaspertheabove
instruction.(Pleasenotethatnewbatteriesmustbepre‐charged.)
oForproblem‐freeoperationminimum1,500mAhchargeableNi‐MHorNiCd
batteriesarerecommended.


Figure4.

TheNi‐MH,NiCdbatteriesarerechargeableapproximatelyonethousandtimes.If
thecapacityoftherechargeablebatteriesislow,itisshownontheLCDautomatically.In
thiscaseplease,changeallthefourbatteriesnotonlytheonesyouthinkareweak.
TheclockcircuitsofthedevicearepoweredbyatypeNi‐CdHA35storagebattery
anditiscontinuouslychargedbytheAAbatteries,thereforetheclocktimeisheldand
resettingthetimeisunnecessarybetweenbatterychanges.
Ifyoudonotintendtousethedeviceforalongperiodoftime,removethebatteries
andstoretheminacoolanddryplace.Donotapplyheattothebatteries,oraninternal
shortcircuitmayoccur.Disposeofspentbatteriesimmediatelyinanenvironmentally‐
safeway.ThebatteriesandchargingapplianceshavetheirownInstructionsforuse,we
suggestyoustudythemandfollowmanufacturers’guidelines.
Incaseyoudonothaveainfraredcommunicationadapterorabuilt‐ininfraredinyour
PC,connecttheinfraredcommunicationadaptertoyourPCanddothesetting.Ifyou
finditnecessary,askforthehelpofyoursystemsupervisorwhoisresponsibleforyour
computer.AllowtheinfraredcommunicationinyourPC.Thenifthedeviceiswithin1m
fromtheinfraredadapter,thecomputerwillgetintoconnectionwiththedeviceviathe
software.Totransmitdata,itisnecessarytousetheMedexpertTensioWin™program,of
course.

12
2.4.OperationInstructions

Tosetupthe24‐hourautomaticBPMinoperatingmodefirstcheckpowersupply.
ThefrequencyofmeasurementswillbedownloadedfromthephysiciansPCviainfrared
communication.
Tooperatethedevice,thereisonesinglebutton.Themeasureddataand
informationaboutthestatusofthedeviceappearontheLCDisplay.
Thepatient,bytheonesinglebuttoncangivefourdifferentcommandstothe
device.


2.4.1.Functionsofthebuttononthedevice

Afterswitchingon,thedevicefirstperformsthe
controllingmeasurementasfollows:
‐  Thevoltagecontrolofthebatteries.Themeasured
valueappearsonthedisplay.Ifthebatteriesarewell
charged,themeasuredpotentialwillbebetween5,4V‐
4,4V.(Thenominalpotentialis4,8V)
Ifthevoltageisunder4,4Vthebatteriesneedreplacing.
Thereplacebatterymessagewillbedisplayed.
Iflonglifebatteriesareusedtopowerthedevicethe
measurednominalvoltagewillbe6V.Thebatterychange
symbolwillbethesameasabove.

5.6
V

Ifthebatteryvoltageisadequate,thedevicewillbe
readyformeasuringandthecurrentcomputertimewill
bedisplayed.MedexpertCBPM24isreadyforoperation:


2.4.1.1.Oneshortpushofthebuttonstartsa
manualmeasurement.

Duringtheambulatorymeasuringmode,theremightbeaneedformanual
measurements,forexamplewhenthepatientfeelsunwell.Oneshortpushofthe
buttonsetsupthemeasurement.Theexacttimedisappearsonthedisplayandthen:

•thetestfigureofthedisplayappears(seeadjacent
figure)
•thevoltageofthebatteriesarechecked(see
adjacentfigure)

5.6

13
•calibrationtakesplace,settingthezeropressure
(seeadjacentfigure)

CAL
0
Afterthat,themeasurementstartsbytheinflationofthe
cuff,signaledonthedisplay(seeadjacentfigure).
8
7


Thedevicecheckstheplacementofthecuffduring
inflating.Ifthecuffonthearmistoolooseornotthe
propersizeofcuffhasbeenchosen(e.g.itisbigger),the
followingsignwillbeonthedisplayaccompaniedbya
beepingsignal.Checkthecuffanditstightnessandrepeat
thebloodpressuremeasurement.

CUF
F
Thedeflationofthecuffisshownbytheadjacentfigure


6
9
Afterthisprocessthedeviceshowsthesystolicand
diastolicBPvalues
Thenthepulserateisshownonthedisplay,andthe
devicestoresallthemeasureddata,includingthedate
andexacttime.

128/9
6
PUL 6
8
Atanytimeduringareadingthepatientcanterminatea
readingbypressingoncethesinglebutton.Atermination
symbolwillappearonthedisplayfor10sec(seeadjacent
figure).Thenthetimewillappearandtheunitsreadyfor
measurement,formanualandprogrammedmode.

OF
F

2.4.1.2.Twoshortpushesonthebutton(Pill):allowsthe
patienttokeephis"electronicdiary"concerningtaking
his(antihypertensive)medication.
Aftertakinghismedicine,twoshortpushesonthebutton
storesthedateandtimeinthememory.Duringaday,it
ispossibletostoreadditionalpillconsumptions.By
downloadingallthedatafromthedevicetothe
physician'sPC,hewillbeabletomonitorthemedication
intakeandthereforethecomplianceofthepatient.

Pill
Ifthememoryofthedeviceisfull,thiswillappearonthe
display.

FULL

14
2.4.1.3.Threeshortpushesonthebuttonallowsthe
patienttoindicatethetimeofgoingtobedandwaking
upinthetabulatedlistofmeasurements.Thedevice
indicatesthewakingupbyatriangleshowingupwards
andbyatriangleshowingdownwardswhenthepatient
goestobed.


2.4.1.4.Byfourshortpushesonthebutton,thedevice
canbeswitchedoff.Youwillseethen“OFF”onthe
display.Inthisstatetheserieswrittenabovecannotbe
appliedandthemeasuringplanyousetinthedevicewill
beinterrupted.Ifyouintendtousethedeviceagain,
pressthebuttonagainfivetimes.Then“OFF”will
disappearfromthedisplay,allfunctionsofthedevice
canbeusedagainandthesetmeasuringplanwillbe
continued.
OF
F



2.4.2.Datatransmission

Thedevicedownloadsallthestoreddatatothephysician'sPCviainfrared
communication.Theinformationloadedconsistsof:
- thesystolicanddiastolicbloodpressurevalues(inmmHg)
- thepulserateperminute
- thedistinctionbetweenprogrammedandmanualmeasurements
- thedateandtimeofthemeasurement
- theactiveorpassiveperiod
- thediaryofmedicationintake.

Ifainfraredcommunicationadapterisplacedwithinthe
rangeofthedeviceanditworks‐asitsoperationis
permitted‐thedeviceandthePCwillconnect
automatically.ThissignwillappearontheLCDdisplay.
Theactualdatatransmissiondoesnothappen,yetthis
canbestartedbytheMedexpertCBPM24program.

IrD
A
Duringtheoperationoftheinfraredcommunication
betweenthedeviceandthePC,whentheactualdata
transmissionison,thefollowingsignwillappearonthe
LCDdisplay.
CO P
C



15
2.4.3.Errorcodesforusers

Theerrorcodes,whichappearontheLCDdisplay,andtheirmeaningsaredescribed
below.Please,notethatyoushouldnotmakeanyconclusionsifanerrorappearsonce
becausethemovementsofthepatientcanimitateseveraltypesoferrors.Ifthedevice
cannotmeasurethebloodpressure(e.g.becauseofmovement),themeasurementwill
beinterrupted.WiththeMedexpertTensioWin™program‐incaseofafaulty
measurement‐itispossibletosetthedevicetorepeatitaccordingtothemeasuring
planafter1minute.

Themeaningsoftheerrorcodesshownbythedeviceareasfollows:

1Thedevicecouldnotmeasurethepatient’sbloodpressurewithinthemeasuringtime
3Themeasurementwasinterruptedduetotheweaknessofthebattery
31Thecuffisnotconnectedtothedevice
32Thecufftubeisbrokenorsomethinggotintothetube(e.g.water).
33Thecuff(ordevice)isleaking
34Thecuffisnotonthepatient‘sarm
35Themeasurementwasinterruptedforsomereason(e.g.becausethepatientpressedthe
button).
91‐97TheBPmeasurementwasnotsuccessfulduetothefailureofthedeviceorthebatteries
areweak
100ThemeasuredresultcannotbeconsideredasarealBPvalueorthepatienthasarrhythmia
101Themeasuringcircumstancese.g.themovingofthepatient,disturbsthemeasurement
102ThedevicecannotsensetheHR
110ThemeasuredresultcannotbeconsideredasarealBPvaluebecauseofsomemovement
orarrhythmia
111systole>max.inflation
115TheHRcannotbecalculatedorcannotbeconsideredasarealHRvalue
116Notenoughevaluableresultseitherfromsysorfromdia.




16
2.4.4.Soundsignals
- Ifthedeviceisworking,beepingsignalscanbeheardwhenpressingitsbutton.

2.4.5.Usingthedeviceforambulatorybloodpressuremonitoring
- placethecuffonthenon‐dominantarm
- placethecuffwiththetubeexitingthecuffupwardintheregionofthebrachial
artery.Makesurethatthehosingallowsforfreeambulation
- toavoidskinirritationathinshirtmightbeusedbelowthecuff
- thetubeofthecuffshouldbeinsertedintotheblackopeningontheleftsideof
thedevice.Attention!Please,takecareoftheconnectionofthecuffbecauseit
shouldnotbetooloose,itshouldnotleak.Youcanconnectitproperlyifyou
inserttheplugwithatwistingmotionuntilitstops
- duringmeasurementsavoidexcessivemusclemovement,particularlyinthearm,
asthismayleadtolongermeasurementormeasurementerroranditmay
decreasetheaccuracyofthemeasurement
- Askthepatienttokeepadiaryonhis/herdailyactivities,symptoms,andthetime
ofgoingtobedandwakingupinthemorning




17
3.Specifications

PowerSource:
4longlifebatteries,sizeAA
Themodetopreventelectricshock:
Thedeviceispoweredbyinside,lowvoltagesource
Thecategorytopreventelectricshock:
CFtypepatient‐part
Display:
LiquidCrystalDisplay
DataStorage:
EEPROM,Flashmemory
DataTransmission:
Infrared
PCinterface:
IrDAcommunicationadapter
Computerrequirements:
WindowsXP+servicepack3
Operatingenvironment:
10‐40°C
Humidity:
30‐85%
Size:
128x77,5x45,5mm
Weight:
310g(includingbatteries)
BloodPressuremeasurementmethod:
Oscillometric
DataStorage:
Max1000measurements
BloodPressuremeasurementsrange:
30‐280mmHg
Staticaccuracy:
±3mmHg,or±2%ofthemeasuredvalue
Measuringaccuracy:
Systolic:
94outof99comparisonswerewithin5mmHg(95%),
incaseof33outof33patients,2comparisonsoutof3werewithin5mmHg,
0outof33patients,wherenoneofthemeasurementsoutof3werewithin5mmHg
Diastolic:
93outof99comparisonswerewithin5mmHg(94%),
incaseof32outof33patients,2comparisonsoutof3werewithin5mmHg,
0outof33patients,wherenoneofthemeasurementsoutof3werewithin5mmHg
Averagedifferencefromtheauscultatic(Korotkov)measurements:
(systolic/diastolic):0.5/‐0.4mmHg
Therangeofthedifference(systolic/diastolic):2.8/2.8mmHg
Pressuresensor:
Piezo‐resistive
Inflation:
Automaticallycontrolledpump
Safety:
Maximuminflation280mmHg
Deflation:
Automatic
Workingmodeofthedevice:
Continuous

18

19

20
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