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Welch Allyn ProBP 2400 digital blood pressure device

IB ProBP 2400 EN_FDA 1615

© 2014 Welch Allyn. All rights are reserved. To support the intended use of the product described in this publication, the purchaser 

of the product is permitted to copy this publication, for internal distribution only, from the media provided by Welch Allyn. No other 

use, reproduction, or distribution of this publication, or any part of it, is permitted without written permission from Welch Allyn.
For the addresses and phone numbers of all Welch Allyn regional locations, visit: welchallyn.com/locations.

Содержание ProBP 2400

Страница 1: ...digitalbloodpressuredevice EN 1 ProBP 2400 Digital Blood Pressure Device Directions for use AdvancingFrontlineCare poweredby CAUTIONFederallawrestrictsthisdevicetosalebyorontheorderofaphysicianorlicensedhealthcareprovider ...

Страница 2: ...detectstheappearanceofirregularheartbeatduringmeasurement andgivesawarningsignalwiththereading oncetheirregularheartbeatisdetected Thedevicecanaccuratelymeasurebloodpressureinpregnantpatientsincludingthosewithknownorsuspected preeclampsia TheProBP2400combinestheadvantagesofanautomaticbloodpressuredeviceandauscultatorysphygmomanometer It isdesignedtoprovideconvenient accurateandreliableofficebloodp...

Страница 3: ...ent JHypertens2005 23 697 701 E AsmarR BeilinL ImaiY etal EuropeanSocietyofHypertensionrecommendationsforconventional ambulatory andhomebloodpressuremeasurement EuropeanSocietyofHypertensionWorkingGrouponBloodPressureMonitoring JHypertens2005 23 697 701 2003 21 1983 1992 Pregnancy Approximately20 ofwomendevelophypertensionduringpregnancy Pre eclampsiaorToxemia whichmayaffect pregnancy Pre eclampsi...

Страница 4: ...4 ...

Страница 5: ...ittingthecuffproperly 16 17 TakingmeasurementsinSingleReading 1x ManualandThree ReadingAverage Mode 1x Mode 18 Manual Mode 19 20 Mode 21 SpecialFunctions MAP MeanArterialPressure 22 Irregularheartbeatdetectorin 1x Mode 22 Settingmaximuminflationpressure 23 Takingfewerthanthreemeasurements 24 Skippingthecountdowntime 24 Settingmeasurementintervaltimesin Mode 25 Viewingthestoredvalues 26 Appendix Re...

Страница 6: ...ultoperatinginstructions directionsforuse DFU Acopyofthe DFUisavailableonthiswebsite AprintedcopyoftheDFUcanbe orderedfromWelchAllynfordeliverywithin7calendardays F Helpfulnotes Shipping storing andenvironmentsymbols Fragile handlewithcare Recovery Recyclable Recycletheproductseparatefromotherdisposables Keepdry Controlsymbols Poweron Poweroff Start Stop Memory Adjustmeasurementintervaltimes Adjus...

Страница 7: ...surecuffandother accessoriesforfrayingorotherdamage Replaceasnecessary WARNINGInaccuratemeasurementrisk Donotusethedeviceonpatientswho areconnectedtoheart lungmachines WARNINGElectricshockhazard Donotopenthedeviceorattemptrepairs There arenouser serviceablepartsinsideProBP2400otherthanbatteryreplacement Onlyperformroutinecleaningandmaintenanceproceduresspecifically describedinthisdirectionsforuse ...

Страница 8: ...adtoheatgeneration smoke bursting orfire WARNINGDonotdisassemble modify orsolderthebattery WARNINGForproperpatientelectricalisolationandbatterycharging useonlythe providedexternalpowersupplytochargethedevice WARNINGElectricshockhazard Beforecleaningthedevice disconnectthepower cordfromthepowersourceandthedevice WARNINGTakecaretopreventwaterorotherfluidfromenteringanyconnectors onthedevice Shouldth...

Страница 9: ...onWelchAllyn bloodpressuretubing Usingtheseconnectorsonbloodpressurecufftubing createstheriskofmistakenlyconnectingthistubingtoapatient sintravenousline andintroducingairintothepatient scirculatorysystem WARNINGNIBPmeasurementsmaybeinaccurateinthepresenceofexcessive motionartefact Minimizeextremityandcuffmotionduringbloodpressurereadings WARNINGThepositionandphysiologicconditionofthesubjectcanaffe...

Страница 10: ...10 3 sec 1x 3x 3 sec On OffSwitch PowerAdapterSocket BatteryCompartment CuffSocket Recharge Indicator Display M Button Memory Mode Switch Start Stop Button Productdescription Nameofparts ...

Страница 11: ...e Pulse Rate Pulse Detected Mode Selection Single Reading Manual Three Reading Average Power Low Battery Unit of Measure Auto Inflation Maximum Inflation Pressure Rest Count Down Irregular Heart Beat IHB Power LowBattery ModeSelection SingleReading Manual ThreeReadingAverage UnitofMeasure MaximumInflationPressure Rest CountDown AutoInflation Memory SystolicValue DiastolicValue MeanArterialPressure...

Страница 12: ... Version 1 01 DESCRIPTION PART NO TITLE AW CD LABEL DFU PROBP 3400 ML 1 03 DRAWING NO SHEET 1 OF 1 DATE 2014 12 24 DRW BY Microlife SCALE 1 1 VER CHANGE NUMBER APVD DESCRIPTION OF CHANGE A RELEASE TO PRODUCTION D D SEE SAP DIR FOR CHANGE NUMBER APPROVER NAME AND DATE OF APPROVAL 408263 CD DFU PROBP 2400 ML 1 01 103701 DFU PROBP 2400 NOTES 1 USE CMYK COLOR MODE AND WHITE FLOOD FOR PRINTING ONTO THE...

Страница 13: ...epoweradapter Selectaproperpowerplugandattachtothepoweradapteras shownbelow Chargethebatterycompletely Whenusingforthefirsttime chargethebatteryuntilthe rechargeindicatoronthedeviceturnstogreen F Refertopage27forthesectionof Usingapoweradapter F Refertopage27forthesection RechargeableBattery ...

Страница 14: ...ReleasetheMButtonwhenbacklightilluminates 4 PresstheStart StopButtontoselectthepreferred pressureunit mmHgorkPa 5 PressMButtontoconfirmtheselection Units MAPor PAM 1 mmHg MAP 2 mmHg PAM 3 kPa MAP F MAPistheabbreviationofMeanArterialPressure F PAMorMAPischosendependingonlanguagepreference Initialsetup cont F Factorydefaultsetting ...

Страница 15: ...andlargeadultlongcuffsarenotavailableintheUSA Checkyourlocalrepresentativeforavailability Reusable ProBP 2400 Blood Pressure Cuff 14 22cm CHILD www welchallyn com Reusable ProBP 2400 Blood Pressure Cuff 32 52cm LARGE ADULT LONG www welchallyn com LATEX LATEX PVC DEHP LATEX PVC DEHP Reusable ProBP 2400 Blood Pressure Cuff 32 42cm LARGE ADULT www welchallyn com LATEX LATEX Reusable ProBP 2400 Blood ...

Страница 16: ...d Pressure Cuff 22 32cm ADULT 3 Wrapandtightenthecuffaroundthearm 4 Leavefreespacewiththesizeof2fingersbetween thearmofthepatientandthecuff Excessivetightness maycausevenouscongestionanddiscolorationof thelimb Ifthecuffiswrappedtooloosely itcannot beinflatedproperlyandthemeasuredvaluesmaybe inaccurate Removeallclothingcoveringorconstricting themeasurementarm Clothingmayinterferewith measurementacc...

Страница 17: ...00 Blood Pressure Cuff 22 32cm ADULT www welchallyn com LATEX 5 Cuffsthatdonotfitproperlymayleadtoinaccurate readings Useadifferentsizecuffiftherangeindexatthe endofthecuffdoesnotfallintotherangespecifiedbythe rangestripes F Therangeindexofthecuff shouldfallintothisrange ...

Страница 18: ...detheswitchtoselect1x standardsinglemeasurement Manualor Mode automaticthreereadingaverage Turnonthepower TurnonthedevicebypressingtheOn OffSwitchattheback ofthedevicetotheONposition Connectthecufftothedevice Connectthecufftothedevicebyinsertingthecuffconnector intothecuffconnectorsocket 3 sec 1x 3x 3 sec 1x 3x 1x 3x 1x 3x FRefertopage22forthesectionof Setmaximuminflation pressure ...

Страница 19: ...digitalbloodpressuredevice 1x Mode standardsinglemeasurement Select 1x Modethenpressthe Start Stop Button toperformasinglebloodpressuremeasurement The measurementreadingisdisplayedandsavedafterthe measurement 1x 3x 1x 3x 1x 3x ...

Страница 20: ... P 2 4 0 0 B l o o d P r e s s u r e C u f f 2 2 3 2 c m A D U L T Takingmeasurementsin1x Manualand Mode cont R eu sa b le P ro B P 2 4 0 0 B lo o d P re ss u re C u ff 22 3 2c m A D U LT Startinflation PresstheStart StopButtontostartinflation ofthecuff Whenmaximuminflationpressureisreached theProBP 2400willautomaticallybeginlineardeflationatarateof 3mmHg sec Re inflate PushandHoldtheMButtonduring...

Страница 21: ...beforethefirstmeasurementissetat60 seconds Theintervaltimesbetweenmeasurementsisuseradjustableto 15 30 45or60seconds Theaveragemeasurementreadingis displayedandsavedafterthemeasurementsarecomplete 15 30 45 or 60 sec 15 30 45 or 60 sec 1 2 3 60 sec 1x 3x 1x 3x 1x 3x Whenthecuffpressurereaches20mmHgduringthe deflationcycle theremainingpressureisventedandthe ProBP2400goesintotheStandbymode Pushthe St...

Страница 22: ...alue Irregularheartbeatdetectorin 1x Mode Thedevicedetectsirregularheartbeatin 1x Mode Theirregularheartbeatsymbolshowsupifduringa bloodpressuremeasurementtheheartratehasvaried bymorethan25 Incaseofanirregularheartbeatthe bloodpressuremeasurementmightbeaffected Itis recommendedtorepeatthemeasurementortochoose the Manual Modeforverification FTheMeanArterialPressure MAPisdeterminedfrom themaximumpea...

Страница 23: ...UTO atthebottomofthelist 3 PresstheMButtontoconfirmtheselectedvalue Pushandholdfor3 seconds 3 sec 3 sec Ifthemaximuminflationpressureselected orthe maximuminflationpressureasdeterminedwhilein AUTOmode isnotadequatetodeterminesystolic pressure thedevicewillreinflatetoapressure30 mmHghigherthanthepreviousinflationpressureand attemptanothercycle Thiscanberepeatedincreasing themaximuminflationby30mmHg...

Страница 24: ...de Thecountdownbeforeandbetweenmeasurementsin ModecanbeskippedbypressingtheStart StopButton When theStart StopButtonispressedduringcountdown thedevice willimmediatelybeginthenextmeasurement FThedevicecanbesetin Standby ModebypressingtheStart StopButtonaftercompletionofmeasurements Thedevicewill automaticallyswitchto Standby Modeifleftunattendedfor1 minute Cancelremaining measurementsat anytimeduri...

Страница 25: ...efaultmeasurementintervaltimeis60seconds The intervaltimescanbesetas15 30 45or60seconds 1 PressandholdtheStart StopButtonfor3seconds Pressandholdfor3 seconds 2 PresstheMButtontoadjustthemeasurementinterval time thenpresstheStart StopButtontoconfirm The devicewillgobackto Standby 15 30 60 45 3 sec ...

Страница 26: ...ngtheMButtonto reviewindividualmeasurements Viewingstoredvalues Thedeviceonlystoresbloodpressurevaluesofthelast measurementprocedurein 1x and Mode Pressthe MButtontoreviewthestoredreadingswhenthedeviceis in Standby mode FThedevicestoresonlythelastmeasurementcompletedin 1x Modeandthelastthreemeasurementscompletedin Mode ...

Страница 27: ...1 Plugtheadaptercableintothepowersocketofthedevice 2 Plugtheadapterplugintothewallsocket Thebattery willberechargedaslongasthedeviceisattached toan ACpowersource Afterthebatteryisfully recharged the chargingwillstop Nobatterypowerwillbeusedaslong astheadapterispluggedin Thebatteryhastoremainin theProBP2400alsowhenusingtheACpower 3 Ifthebatterystartslosing capacity contactyourlocal dealerforreplace...

Страница 28: ... Rechargetherechargeablebatterybyplugginginthe powersupply Cuffdoesnotinflateproperly Looseconnectionofthetube Makesurethetubeofthecuffissecurelyconnectedtothe device Leakageofthetube bladder Checkforcracksonthetubeorthebladder Replacethe bloodpressurecuffifnecessary Noresultdisplayedafter measurements DeviceisinManualMode Switchto 1x or Modeandrepeatthe measurements ...

Страница 29: ...r isdisplayed Error Description Potentialcauseand remedy Err1 Signaltoo weak Thepulsesignalsonthe cuffaretooweak Re positionthecuffandrepeat themeasurement Err2 Errorsignal Duringthemeasurement errorsignalsweredetected bythecuffcaused for instance bymovementor muscletension Repeat themeasurementkeeping patient sarmstill Errormessages ...

Страница 30: ...pulseistoolow less than40beatsperminute Repeatthemeasurement Err3 Nopressurein thecuff Anadequatepressure cannotbegeneratedin thecuff Aleakmayhave occurred Replacethe bloodpressurecuffif necessary Repeatthe measurement Err5 Novalid results Themeasuringsignalsare inaccuratethereforeno resultcan bedisplayed SwitchtoManual Modeanddetermine bloodpressurewith astethoscopeusing traditionalKorotkoff meth...

Страница 31: ...otection Thisdevicemaybeusedonlyforthepurposedescribed inthisdirectionsforusemanual Thedevicecomprisesof sensitivecomponentsandmustbetreatedwithcare The manufacturercannotbeheldliablefordamagecausedby incorrectapplication Observethestorageandoperatingconditionsdescribedin the Technicalspecifications sectionofthisdirectionsfor usemanual Onlyactivatethepumpwhenthecuffisconnectedto thedevice Donotuse...

Страница 32: ...ffcoverin75 C 167 F hot waterfor30minutes Airdrythecuff DONOTironthecuffcover Reusable ProBP 2400 Blood Pressure Cuff 22 32cm ADULT www welchallyn com LATEX Devicecare Useasoftclothwithoneofthefollowingrecommended cleaningsolutionstowipetheexteriorofthedevice 1 Mildsoapandwater 2 Hydrogenperoxidesolution 3 dilutedwithwater 3 Sodiumhypochloritesolution 1 10dilutionof householdchloridebleachinwater ...

Страница 33: ...curacyevery2 yearsoraftermechanicalimpact e g beendropped 1 Setupforaccuracytest 2 Pushandhold Start Stop Buttonandturnthepoweron thenreleasethe Start Stop Button Waituntil CA 0 then 0 0 isdisplayed 350 500 ml Vessel 350 500 ml Vessel Air release valve Calibrated reference manometer ProBP 2400 T pieces Squeeze bulb or Pressure source ...

Страница 34: ...ssuretonearly200mmHg Comparethe pressuredisplayedonthescreensofthedeviceand thereferencemanometer Forexample the 201 0 displayedonthedevicestandsfor 201 0mmHg 5 Pumpthepressuretonearly300mmHg Comparethe pressuredisplayedonthescreensofthedeviceand thereferencemanometer Forexample the 301 2 displayedonthedevicestandsfor 301 2mmHg 6 Ifthedifferencebetweenthedeviceandthereference manometeratanycalibra...

Страница 35: ...servestherighttoaltertechnicalspecificationswithoutpriorwrittennotice ProBP 2400 ProBP 2400 Digital Blood Pressure Monitor www welchallyn com BOM number Color CMYK 901096 2400 DIGITAL BLOOD PRESSURE DEVICE ML Distributed by Welch Allyn Inc 4341 State Street Road Skaeateles Falls NY 13153 Microlife Corporation 9F 431 RuiGuang Road NeiHu Taipei 11492 Taiwan R O C Microlife AG Espenstrasse 139 9443 W...

Страница 36: ...vice should assure that it is used in such an environment Immunity test IEC 60601 test level Compliance level Electromagnetic environment guidance Electrostatic discharge ESD IEC 61000 4 2 6 kV contact 8 kV air 6 kV contact 8 kV air Floors should be wood concrete or ceramic tile If floors are covered with synthetic material the relative humidity should be at least 30 Electrostatic transient burst ...

Страница 37: ...ectromagnetic site survey should be considered If the measured field strength in the location in which the ProBP 2400 Digital Blood Pressure Device is used exceeds the applicable RF compliance level above the ProBP 2400 Digital Blood Pressure Device should be observed to verify normal operation If abnormal performance is observed additional measures may be necessary such as re orienting or relocat...

Страница 38: ...sedby 1 handlingduringshipping 2 useormaintenancecontraryto labeledinstructions 3 alterationorrepairbyanyonenotauthorizedbyWelchAllyn and4 accidents Theproductwarrantyisalsosubjecttothefollowingtermsandlimitations ShippingcosttoreturnadevicetoaWelchAllynServicecenterisnotincluded AservicenotificationnumbermustbeobtainedfromWelchAllynpriortoreturninganyproductsoraccessoriesto WelchAllyn sdesignated...

Страница 39: ...bed inthispublication thepurchaser oftheproductispermittedtocopythispublication forinternaldistributiononly fromthemediaprovided byWelchAllyn Noother use reproduction ordistributionofthispublication oranypartofit ispermittedwithoutwrittenpermission fromWelchAllyn Fortheaddresses andphonenumbersofallWelchAllynregionallocations visit welchallyn com locations ...

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