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LABORIE alpHaONE User & Service Manual
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LABORIE alpHaONE User & Service Manual

Including laborie's virtual instructor program (vip)
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FOR DIGNITY. FOR LIFE.
alpHaONE
™
User & Service Manual
GASTROENTEROLOGY
Including Laborie's Virtual Instructor Program (VIP)
laborie.com

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Summary of Contents for LABORIE alpHaONE

  • Page 1 FOR DIGNITY. FOR LIFE. alpHaONE ™ User & Service Manual GASTROENTEROLOGY Including Laborie’s Virtual Instructor Program (VIP) laborie.com...
  • Page 2 The Laborie products described herein are subject to change without prior notice. LaborieMedicalTechnologiesCorp.anditsAffiliates(“Laborie”)makenorepresentationsorwarrantieswithrespecttothismanual or with respect to the Laborie products described herein other than what is contained within our Global Terms and Conditions of Sale, also available on our website at www.laborie.com/terms-conditions/.
  • Page 3 Starting the Database Module Entering Patient Data and Selecting the Patient Starting the Measurement Module Installing Batteries in the alpHaONE Preparing the Capsule Pairing the Capsule with the alpHaONE Recorder Placing the Capsule in the Patient Starting a Recording Contents...
  • Page 4 Starting a New Study by Using the alpHaONE Buttons Stop Recording and Transfer Data Editing the Patient Diary Printing an Investigation Report Exiting the Laborie Database Module Patient Instructions Example Diary Chart The Measurement Module Introduction The Menu Bar alpHaONE...
  • Page 5 7 Technical Specifications alpHaONE Software alpHaONE pH Capsule alpHaONE Delivery System alpHaONE Recorder Computer Requirements Appendix A: Safety Information SafetyClassification pH Capsule Data Recorder General Unpacking Installation Computer pH Capsules Investigations Cleaning Appendix B: Handling Procedure for the Delivery System Appendix C: Symbols Glossary Appendix D: Electromagnetic Compatibility (EMC) Appendix E: Patient Diary Appendix F: Software Messages Contents...
  • Page 6 Laborie alpHaONE User & Service Manual LBL-01791 [B]...
  • Page 7 Part I General Information LBL-01791 [B] Laborie alpHaONE User & Service Manual...
  • Page 9 Capsule System’s software for analysis of the pH variation and diagnosis. Figure 1-1: The alpHaONE Data Recorder and Delivery System Intended Use The alpHaONE is intended to record, store, view and analyze pH in the esophagus to assist in the diagnosis and evaluationofrefluxbytrainedandlicensedhealthcareprofessionals.ApHCapsule,whichisinsertedintothe esophagus, measures the pH levels.
  • Page 10 The pH Capsule System comprises the pH capsule, delivery system, data recorder, data analysis software, and relevantaccessories.Allcomponentsaredescribedinthesectionsthatfollow. pH Capsule The pH capsule (Figure 1-2) is made up of a sensor, a gripper, and a signal acquisition module, sealed in a polymer enclosure. pH sensor Gripper Figure 1-2: The pH Capsule Laborie alpHaONE User & Service Manual LBL-01791 [B]...
  • Page 11 During storage and transportation, the capsule is in a non-powered state by means of a breaker. The capsule begins functioninguponremovalofthebreaker.Thecapsuleattachestotheesophagealwall,asillustratedinFigure 1-3, via the gripper and then acquires and transmits data about esophageal pH in real time. pH Capsule 6 cm Figure 1-3: Location of the pH Capsule within the Esophagus Afteranexamination,theesophagealmucosaltissuetowhichthecapsulewasattachedeventuallydies,releasingthe capsule into the digestive tract, from which it is excreted naturally.
  • Page 12 Multifunctional button User-definedeventbutton User-definedeventbuttonsserveasextraeventrecordingmarkersforeventssuchasacough, belch, chest pain, laryngospasm, wheeze, or regurgitate. For example, if the patient coughs during monitoring, press this button tostartacoughevent;therecorderwillautomaticallyreturntothe normal event in 10 seconds. Subtract button UsedastheSubtractkeyduringpairingwiththerecorder. Laborie alpHaONE User & Service Manual LBL-01791 [B]...
  • Page 13 Interface Element Description Multifunctional key • Enter button Used as the Enter button during pairing with the recorder. • Supine event button If the patient is supine during monitoring, press this button to start a Supine event. Press this keyagaintoendtheSupineevent. Indicator light •...
  • Page 14 Software and Computer The alpHaONE system is used in conjunction with a computer and the Laborie alpHaONE application. To run the application, the computer must be running Windows 10 Professional Edition (64 bit). CAUTION For U.S. only: Federal law restricts this device to sale by or on the order of a trained and licensed healthcare professional.
  • Page 15 To avoid serious harm to the patient, MRI examinations must not be performed while the pH capsule is inplaceinthepatient’sbody.PatientsshouldconfirmthatthepHcapsulehasbeenexcretedbeforeMRI examination.PriortoundergoinganMRIexamination,anX-rayshouldbetakentopositivelyconfirmthat the patient has excreted the capsule. Accessories for the alpHaONE Battery ThreeAAAbatteriesarerequiredasthepowersourceforthedatarecorder. NOTE Three new batteries should last for the duration of a 96-hour study.
  • Page 16 The alpHaONE system may be opened for adjustment, replacement, maintenance or repairbyLaborie-qualifiedpersonnelonly.ReturnscanonlybemadeusingLaborie’sreturnprocedures;customers should consult their local Laborie representative for further return procedure information. Before sending equipment for repair, please contact your Laborie representative. Note that all equipment needs to be properly cleaned before packagingandshipment. Warranty AllwarrantyinformationiscontainedwithinLaborie’sGlobalTermsandConditionsofSale,alsoavailableonthe...
  • Page 17 PROVIDEDFORUNDERTHESECONDITIONS.EXCEPTFORTHISLIMITEDLIABILITY,UNDERNOCIRCUMSTANCES WILLLABORIEBELIABLEFORANYDAMAGESWHATSOEVER,INCLUDINGWITHOUTLIMITATIONDIRECT,INDIRECT, SPECIAL,INCIDENTAL,EXEMPLARY,CONSEQUENTIALORPUNITIVEDAMAGES,ORDAMAGESFORLOSSOF PROFITS,DATA,USEOROPPORTUNITY,WHETHERORNOTSUCHDAMAGESWEREFORESEENORUNFORESEEN, ANDWHETHERORNOTLABORIEWASADVISEDOFTHEPOSSIBILITYOFSUCHDAMAGES. The Laborie alpHaONE Application TheLaboriealpHaONEapplicationisprovidedonaUSBmemorystickandmustbeinstalledonthecomputerinorder for the complete system to function. For an overview of the software messages that require an action to resolve, see AppendixF,“SoftwareMessages” on page 89. The application is composed of three modules: •...
  • Page 18 Stop recording and transfer the measured data • Enter the diary During recording, the alpHaONE stores all measured data in its internal memory. When recording is completed, the dataitcontainswillautomaticallytransfertothecomputer.YouthencanusetheAnalysismoduletoanalyzethe results and graphs. If the patient diary is completed, you can print the investigation report.
  • Page 19 When active, the assistant will display helpful messages and suggestions. The message and the assistant will disappear when the OKbuttonisclicked. About This Manual The alpHaONE User & Service Manual is intended for all users of the alpHaONE measurement system. The User’s section provides you with detailed information about the investigation procedure (Chapter...
  • Page 20 To register a complaint or report a serious incident related to this product, please contact the manufacturer and the competent authority of the Member State where the incident occurred. North American Technical Support:  T elephone:1.800.333.1039extension1or1.800.522.6743extension1 Email: service@laborie.com Feedback on the Manual Laboriewelcomesyouropinionandideastoimproveourmanuals.Pleasesendyourquestionsandremarksvia email to: UserDocumentationFeedback@laborie.com Laborie alpHaONE User & Service Manual LBL-01791 [B]...
  • Page 21 Part II User Information LBL-01791 [B] Laborie alpHaONE User & Service Manual...
  • Page 23 7. Stop recording and transfer the captured data 8. Edit the patient’s diary 9. Print the investigation report 10. Exit the Laborie Database module WARNING Investigation procedures as described in this manual do not claim to be comprehensive. How an investigation is performed and how the results are interpreted--the actual diagnosing--remain under all circumstances the responsibility of the healthcare professional performing the investigation.
  • Page 24 To read the indications and contraindications for this system, refer to Chapter1,“Introduction,” on page 3. IMPORTANT BeforegrippingandfixingthepHcapsule,askthepatienttotolieontheirside. Starting the Database Module Onthedesktop,double-clicktheLaborie Loginbutton(   )andthen,intheLoginwindowthatopens,enteryour username and password to start the Database module, shown in Figure 2-1. Figure 2-1: The Database Module Laborie alpHaONE User & Service Manual LBL-01791 [B]...
  • Page 25 In the patient database, by default patient and study information are not shown for privacy reasons. You can either clickNew Patient, to enter a new patient or select a patient via the Search Patient text box. Begin typing any part ofthepatientidentificationinthesearchbox(e.g.,patientname,dateofbirth,orpatientID).Alternatively,youcan entertheasteriskcharacter( * ) to view all patients in the database.
  • Page 26 Figure 2-3: Starting a New Investigation Tostartanewstudy,firstselecttheinvestigationprotocolthatyouwanttouseforthisnewstudybyclickingthe appropriatebuttonandthenClicktheNew investigation button. Tovieworchangetheinvestigationprotocolsettings,clicktheEdit protocol button. For more information about the investigation protocol settings, refer to Chapter3,“TheMeasurementModule,” on page 37. Installing Batteries in the alpHaONE InstallthreeAAAbatteriesinthealpHaONEbatterycompartment.Then,connectthealpHaONEsystemtothe computer cable. IMPORTANT Thedatarecorderalertsandwillstopfunctioningatlowbatterylevel.Besuretocheckthebatterylevel frequently and replace them immediately when running low. IMPORTANT Be sure to dispose of depleted batteries in accordance with all local laws and regulations.
  • Page 27 For the system to function properly, the pH capsules must be paired with the alpHaONE recorder before commencing monitoring. 1. Ensure that all pH data in the alpHaONE recorder has been downloaded to a computer before pairing it with a capsule;otherwise,anewstudyisnotallowedunlessyouperformthefactoryresetprocedure.
  • Page 28 Figure 2-6: Starting the Pairing Process Thecapsule’sLEDindicatorwillbegintoflash,signallingthatitisnowinanactivestate,anditbegins broadcasting a signal that includes an identifying number unique to that capsule. IMPORTANT Don’tremovethecapsulebreakeruntilyouarecompletelypreparedtopairitwiththealpHaONErecorder. 5. The alpHaONE will now begin to search for the capsule, as shown in Figure 2-7. Laborie alpHaONE User & Service Manual LBL-01791 [B]...
  • Page 29 6. WhenthealpHaONEdetectsthecapsule’ssignal,theVIPwilldisplaythecapsule’suniqueidentifiernumberin the Status area, as depicted in Figure 2-8.Confirmthatthisnumbermatchesthenumberprintedonthebottom of the capsule’s delivery-system handle, and then press Yes to proceed. If the capsule number does not match, press No to cancel the procedure.
  • Page 30 Placing the Capsule in the Patient Upon successful pairing with the capsule, the screen depicted in Figure 2-9 displays, prompting you to begin inserting the capsule in the patient’s esophagus. Figure 2-9: Inserting and positioning the capsule in the Esophagus Laborie alpHaONE User & Service Manual LBL-01791 [B]...
  • Page 31 WARNING Thecapsulewillcauseamicro-traumatotheesophagealwallduringthefixingprocess.Healthcare professionals must carry out operations in strict accordance with this manual to avoid other traumas. CAUTION • Do not use the pH capsule if the sterilization bag in which it is shipped has been opened, damaged, or compromised in any way. Before replacing the compromised capsule with a new one, be sure place the oldcapsulebackinitspackageproperlyandverifythatthebreakerisinplaceandtheLEDindicator is off.
  • Page 32 If 0.08 MPa cannot be achieved, reposition the delivery system until you are able to attain the proper vacuum. 5. Ontheoperationhandle,removetheretainerbehindthefirstthumbslider(theoneclosesttothedelivery system;seeFigure 2-14A)andthendrawbacktheslider(Figure 2-14B), followed by the second slider, and then the third slider, one by one, as illustrated in Figure 2-14C and Figure 2-14D. Laborie alpHaONE User & Service Manual LBL-01791 [B]...
  • Page 33 Figure 2-14: DrawingBacktheThumbSliders CAUTION • The sliders on the operation handle must be moved in the exact order described in Step 5. Failure to do so can result in improper attachment of the capsule or no attachment at all. • Atthediscretionofthehealthcareprofessional,confirmthecapsule’sattachmentviaendoscope. Duringtheconfirmationprocess,avoidcontactingthecapsulewiththeendoscope.Contactbetween the endoscope and the capsule can result in the capsule becoming dislodged.
  • Page 34 When the pH capsule is properly in place, press the Start recording button, as demonstrated in Figure 2-16. Figure 2-16: Starting the Recording Phase The alpHaONE is now recording pH data, as shown in Figure 2-17.ClicktheExit button to return to the Database module and then disconnect the alpHaONE recorder from the computer.
  • Page 35 Figure 2-17: Screen Indicating That a Recording Is in Process Explain to the patient how to use the written diary and the event buttons on the alpHaONE recorder. For more detailed patient instructions, see the section “PatientInstructions” on page 36. NOTE The monitoring phase of the examination is 24, 48, 72, or 96 hours in length, during which time the patient may leave the facility and resume daily activities.
  • Page 36 Please remove the capsule breaker after pressing ENTER. E N TE R E S C b. The screen then displays a progress bar showing the status of the search for the activated capsule. Laborie alpHaONE User & Service Manual LBL-01791 [B]...
  • Page 37 7. Provide the patient with instructions on what to do during the monitoring phase. Explain to the patient how to use the alpHaONE event buttons and the written diary. For more information on providing instuctions to the patient, see the section “PatientInstructions”...
  • Page 38 9. Transfer the data to the computer a. Use the USB cable to connect the alpHaONE recorder to the computer and then, in the Laborie alpHaONE application,double-clicktheLaborieDatabase button. b. Select the patient or enter the patient information if the patient doesn’t yet exist in the database.
  • Page 39 Figure 2-19:  YouthencananalyzethedataimmediatelybyclickingtheReviewbutton.IntheAnalysismodule,thegraphsare displayed layered beneath the Edit diary dialog box (see Figure 2-20). Figure 2-20: The Edit Diary Dialog Box Chapter 2 Performing an Investigation...
  • Page 40 If you accidentally forgot to save the diary and lost the patient’s entries, you can reload the original diary events from the alpHaONE recorder. To do this, open the Edit diary window and then, on the menu bar, choose Edit > Transfer events.
  • Page 41 AfteryouclosetheLaboriealpHaONEapplication,youcanturnoffthecomputerbyclickingtheStart button on the Windows Start menu (located in the lower-left corner of the screen) and then select Shutdown. IMPORTANT To prevent the loss of any data, be sure to exit the Laborie alpHaONE application before shutting down the computer. Chapter 2...
  • Page 42 • DonotundergoMRIexaminationuntiltheexcretionofthecapsuleisconfirmed. Example Diary Chart AppendixE,“PatientDiary” on page providesanexamplediarychart.Thepatientcanusethisformtokeepa writtendiary.Notethateventhoughtheexamplelistsatableforsymptoms,symptomsalwaysneedtobemarked during an examination by pressing the Pain event button on the alpHaONE recorder if automatic symptom analysis needs to be done. Laborie alpHaONE User & Service Manual LBL-01791 [B]...
  • Page 43 The subsections that follow describe the items available on the Database module menu bar. alpHaONE The alpHaONE menu contains only one command, Transfer data. Use this to initiate the retransfer of data from the alpHaONE recorder to the computer. Settings Thesubsectionsthatfollowdescribethesettingsthatareavailableforyoutoconfigurefromthismenu.
  • Page 44 Figure 3-1: The Edit Protocol Dialog Box Intheinvestigationprotocol,youcandefinethesettingsspecifictoanindividualinvestigation. The application supports up to 10 protocols. Investigation protocols are set once. To change a protocol, the alpHaONE recorder must be connected to the computer. If you need to apply different investigation settings to an examination, you must add a new investigation protocol or edit an existing one.
  • Page 45 Figure 3-2: The Edit Protocol Dialog Box—Events Tab Using the corresponding prepopulated drop-down lists, you can assign a symptom to the button and the button. You can select the analysis type for the Heartburn button, the button, and the button by selecting the Treat as symptomcheckbox.TheeventswillthenbeincludedintheSAPanalysisresults(seethesection“SymptomAnalysis Results”...
  • Page 46 Figure 3-3: TheEditProtocolDialogBox—UserDefinableEventsTab Start/stop time Select the Start/stop timetabtopredefineapartofthecompleterecordedinvestigationforanalysis(starttime,stop time,and/orduration).Afteraninvestigationiscomplete,thesettingdefineswhichpartofthatinvestigationtousefor analysis.Thiscanbeuseful,forexample,forresearchpurposes.Youcanalsosetthestart/stoptimeintheAnalysis module (see the section “Start/Stoptime” on page 64). Laborie alpHaONE User & Service Manual LBL-01791 [B]...
  • Page 47 When the investigation is zoomed in, the scrollbar at the bottom of the graph indicates the part of the pH study that is shown on the screen. To see other parts of the investigation, drag the scrollbar left or right. LBL-01791 [B] Laborie alpHaONE User & Service Manual...
  • Page 48 To move a button on the toolbar, drag the button to the spot on the toolbar where you want it to appear. • To delete a button from the toolbar, drag the button down, off the toolbar, and then release the mouse button when the cursor is clear of the toolbar. Laborie alpHaONE User & Service Manual LBL-01791 [B]...
  • Page 49 Whenyouhavefinishedconfiguringthetoolbartoyourpreference,clicktheClose button. The Menu Bar ThesubsectionsthatfollowdescribeeachofthemenusthatareavailableontheAnalysismodulemenubar. Results On the menu bar, choose Results (Figure 4-4) to display and set results for pH analysis and symptom analysis. Figure 4-4: The Results Menu Configuring the Results In the pH analysis and Symptom results dialog boxes, choose Results > Select results (Figure 4-5)orclicktheSelect resultsbuttontoopenadialogboxinwhichyoucanselectspecificresultstoanalyze,asshowninFigure 4-6.
  • Page 50 Manuals menu in the Database module. Exporting Results In the pH analysis and Symptom results dialog boxes, choose Results > ExporttoexporttheresultstoafileinASCII, RTF,XLS,orWKS(Lotus123compatible)format,asdepictedinFigure 4-7. Figure 4-7: Export Results pH Analysis Results On the menu bar, choose Results > pH analysis resultstodisplayparameterssuchasthenumberofrefluxperiods, refluxtime,andtheDeMeesterscore,asillustratedinFigure 4-8. Laborie alpHaONE User & Service Manual LBL-01791 [B]...
  • Page 51 Figure 4-8: DisplayingpHAnalysisResults ThepHanalysisisdoneontheselectedpHanalysischannel(basedonpH≤4;seethesection“pHAnalysisSettings” on page 60). Most results depend on the position of the patient, so it is important that information about the patient’s position is entered in the diary. SomeofthepHanalysisresults(e.g.,theDeMeesterscore,theAdultscore)canbebasedonpHrefluxmarkers. Therefore, in the pH analysis settings (see the section “pHAnalysisSettings” on page 60), you must select the Enable pH reflux markersoption.After(automatic)insertionofpHrefluxmarkersonthepHchannel(s),the parametersorresultsindicatedbyanasterisk(*)arecalculatedbasedonpHrefluxmarkers.
  • Page 52 Symptom Analysis Results On the menu bar, choose Results > Symptom analysis results to display the symptom analysis results, as presented in Figure 4-9. Figure 4-9: SymptomAnalysisResults * Johnson,DeMeester:Twenty-four-hourpHmonitoringofthedistalesophagus.Aquantitativemeasureofgastro-intestinalreflux. Am. J. Gastroenterology. 1974. † KayeMD:Postprandialgastro-esophagealrefluxinhealthypeople.Gut. 1977. Laborie alpHaONE User & Service Manual LBL-01791 [B]...
  • Page 53 The symptom analysis is done on the selected pH analysis channel (see the section “pHAnalysisSettings” page  60), combined with the symptom events in the diary. ThefirstpartoftheanalysisshowsthepHsymptomanalysisresults. The calculated parameters include the number of symptoms analysed, the number of symptoms that are related to acidreflux,thesymptomindexforreflux(SI),andthesymptomsensitivityindex(SSI).ThepHdataandthesymptom periods from the diary are analyzed to see whether there is a possible relation, indicated by the plus (+) sign.
  • Page 54 (zoom out), and F6 (zoom in). Other Fixed-Zoom Intervals Youcanchooseazoomintervalof30seconds,1minute,2minutes,4minutes,10minutes,15 minutes,30minutes, 1 hour,or4hours. Undo Zoom To undo a zoom action, choose Graph > Undo zoomor,onthetoolbar,clickthe(   )button.Themousepointerwill return to its previous position. NOTE Only one zoom action is saved for undo. Laborie alpHaONE User & Service Manual LBL-01791 [B]...
  • Page 55 Displaying a Specific Study Day UsingtheDayselectorbuttonsonthetoolbar,youcanchooseaspecificdaywithinthestudytodisplayonthegraph (depending on the length of the study) or you can choose to view all days. The button highlighted in blue indicates the current selection. Displaying Contour Plots The contour plots, shown in Figure 4-10,presentagraphicrepresentationofthemovementofthefluidsinthe esophagus and the pH value through color tones to help you better visualize both. To display the contour plots of the pHvalues,onthetoolbar,clicktheContour plot (C) button and then choose Graph >...
  • Page 56 Changing the Marker Colors Tochangethecolorofthemarkersquaresandcorrespondingpoles(atthetopofthescreen),right-clickthetopofthe markerandthenselectColor.Tochangethebackgroundcoloroftherefluxes,seethesection“SystemSettings” page 57. Inserting pH Reflux Markers YoucaneasilyaddpHrefluxmarkerstotheinvestigationbyCtrl-clickingonapHgraph.Notethatthisispossibleonly when the Enable pH reflux markers option has been selected in the pH analysis settings (see the section “pHAnalysis Settings” on page 60). ToaddapHrefluxmarker,holddowntheCtrlkeyonthekeyboardandthenclicktwotimesinthepHgraphsarea, oncetomarkthebeginningofthepHreflux,andthesecondtimetomarktheendofthepHreflux. Laborie alpHaONE User & Service Manual LBL-01791 [B]...
  • Page 57 Inserting General Artifact Markers Theinsertionofthegeneralartifactmarkerinfluencesthesymptomanalysisresults. On the menu bar, choose Marker > Insert marker,or,onthetoolbar,clicktheInsert marker button to open the Marker selection dialog box, as shown in Figure 4-12. Figure 4-12: InsertingaMarker SelecttheArtifactmarkerthatyouwanttoinsertandthenclickOK. Move the cursor to the location on the graph wherethemarkertoappearandthenclicktoinsertthemarkeratthedesiredbeginandendtimes. Symptom Analysis Results: Symptom Related or Not to pH Reflux Asymptomisnotseenasrefluxrelatedwhenthestartvalueand/orlowvalueofthepHdropiswithinartifact markers.Figure 4-13showsanexample,inwhichthestartvalueofthepHdropiswithinartifactmarkers.
  • Page 58 For the symptom results the symptoms between pH artifacts are omitted at the symptom results for pH only. In the pHanalyzecolumnofthesymptomresults,thesesymptomsaremarkedwithpH Artifact. ThesamplesmarkedaspHartifactareexcludedinthepHtable,thetext(Artifact time excluded) displays in the pH tablewhentherearepHartifactmarkersavailable. Inserting Other Markers YoucaninsertothermarkersviathemenubychoosingMarker > Insert marker, as described earlier in this section. youcanalsoinsertamarkerbydoingeitherofthefollowing: • Onthekeyboard,presstheInsertkey • Right-clickinthegraphandthen,onthecontextmenuthatopens,chooseInsert marker, as illustrated in Figure 4-15. Laborie alpHaONE User & Service Manual LBL-01791 [B]...
  • Page 59 Todisplayalistofallmarkersinsertedduringtheinvestigation,chooseMarker > Marker overview. Diary Whenthedataisreviewedforthefirsttime,thesoftwareautomaticallyshowsallthediaryeventsthepatientindicated via the buttons on the alpHaONE recorder. If you want to edit it again, on the menu bar, choose Diary > Edit diary to open the Edit diary dialog box. for more detailed information, see the section “EditingthePatientDiary”...
  • Page 60 Themousepointerchangestoapen(   ). 2. WhilekeepingtheCtrlkeypressed,clickatthepositioninthediarybarwhereyouwanttoaddtheevent(see Figure 4-17, Click 1).Amenuopensonwhichyoucanselecttheeventtypethatyouwanttoadd(Figure4-19, Click 2). Releasing Ctrlbeforeclickingthesecondtimewillcanceltheoperation;likewiseifyouclickCancel or clickoutsidethepop-upmenu. Mealandsupineperiodsareaddedwithafixedtime.Afterinsertingthemarkeryoucanchangethebeginandend times, as described in the next subsection. Figure 4-17: ThePop-UpMenutoAddaDiaryEvent Deleting, Repositioning, or Changing a Diary Event Selectthediarygraphandthenselectthediaryeventthatyouwanttoeditbyclickingontheevent.Theselectedevent ismarkedbyaredrectangle,asdepictedinFigure 4-18. Laborie alpHaONE User & Service Manual LBL-01791 [B]...
  • Page 61 Figure 4-18: Selecting a Diary Event • Todeletethediaryevent,onthekeyboard,pressD or the Deletekey. • To reposition the diary event, drag the event to the left or right, as demonstrated in Figure 4-19. Figure 4-19: Repositioning a Diary Event • To change the beginning or end time of a period event, drag the begining edge or ending edge of the red rectangle to the desired point, as shown in Figure 4-20.
  • Page 62 On the menu bar, choose Utilities > Diagnostics to print or save diagnostic information concerning the selected study. Normally,youwilldothiswhenaskedbyLaborieoroneofitsrepresentatives. Settings Channel Settings On the menu bar, choose Settings > Channel settings to display the channel settings, as shown in Figure 4-22. Laborie alpHaONE User & Service Manual LBL-01791 [B]...
  • Page 63 Figure 4-22: Channel settings Youcaneditthechannelsettingsoftheselectedinvestigation;forexample,thechannelnameandcolor. System Settings On the menu bar, choose Settings > System settings to display the System settings dialog box, as shown in Figure 4-23. Figure 4-23: SystemSettingsfortheAnalysisModule Chapter 4 TheAnalysisModule...
  • Page 64 Example: When the artifact period and meal period overlap, the color for artifacts is displayed in the overlapping area. Colors Tab Tochangethebackgroundcolorsofthemeals,symptoms,acidpH,orrefluxes,selecttheColors tab (see Figure 4-25). For instance, choose Refluxfromthedrop-downlistontheleft.Youcanchoosethebackgroundcolorforrefluxinthe drop-down list on the right. Laborie alpHaONE User & Service Manual LBL-01791 [B]...
  • Page 65 Or, you can change the color of scales, the grid, or the mouse pointer. You can save color schemes for use in other investigations. Report Tab On the Report tab (Figure 4-26),youcanconfigurethefollowing: • SelectRefluxgraphs.Bythisoptionitispossibletoprinttherefluxes,whichhavebeenmarkedinthe investigation.BeforetheLaboriereporterisstarted,adialogisdisplayedtoselecttherefluxgraphs. • Selectthickgraphs. • Select settings for graphs on multiple pages: set the number of pages, time per page and select portrait/ landscape.
  • Page 66 6 and 1 (default setting) will have a color tone between backgroundcolorandpHcolor.PixelswithapHvalueof6willhavebackgroundcolor.PixelswithapHvalue of 1willhavepHcolor. pH Analysis Settings TochangethepHanalysissettingsfortherefluxandalkalinerefluxdetection,onthemenubar,chooseSettings > Analysis settings and then select the pH tab, as illustrated in Figure 4-28. Laborie alpHaONE User & Service Manual LBL-01791 [B]...
  • Page 67 Figure 4-28: TheAnalysisSettingsDialogBox—pHTab pH analysis channel ThischannelanalyzespH.Also,refluxmarkersareinserted,refluxareascolored,andrefluxperiodssearched(to change these options, choose Settings > System settings). Exclude post-prandial periods Selectthischeckbox(forinfants)toexcludetheperiodsafteramealfromthecalculationsofthepHresults.The periodsaretreatedasiftheyweremarkedasanartifact.Thetotalinvestigationtimewillalsobereduced.Selecting thischeckboxactivatestheexclusiontimelistboxinwhichyoucanselectthetime(inminutes)toexclude. If you select this option, the Exclude post-prandial periods setting on the Symptom tab automatically will be selected, as well. Exclude meal periods SelectthisoptiontoexcludemealanddrinkperiodsfromcalculationsofthepHresults.Theperiodsaretreatedas iftheyweremarkedasanartifact.Ifyouselectthisoption,theExclude meal periods setting on the Symptom tab automatically will be selected, as well.
  • Page 68 Reflux counts for period at start Ifselected,arefluxthatstartsinperiod“A”(e.g.,upright)andendsinperiod“B”(e.g.,supine)iscountedasareflux duringperiod“A.”Ifitisnotselected,itiscountedasrefluxduringperiod“B.” Symptom Analysis Settings On the menu bar, choose Settings > Analysis settings and select the Symptom tab (Figure 4-29) to change the symptom analysis settings. Laborie alpHaONE User & Service Manual LBL-01791 [B]...
  • Page 69 Figure 4-29: TheAnalysisSettingsDialogBox—SymptomTab Youcansetthesymptompreandpostonsettime,excludepost-prandialormealperiods,andtreatpHdropsasreflux. If you selected the Exclude post-prandial periods or Exclude meal periods, the settings on the pH tab automatically will also be selected, as well. The Treat pH drops as refluxoptioninfluencesthepHanalysisresultsinthesymptomtable(Figure 4-30). This option establishesadifferencebetweenacidpHReflux(basedonpH<4orbasedonpHrefluxmarkerswhenenabledinthe pHanalysissettings;seethesection“pHAnalysisResults” on page 44) and a pH drop. When a symptom is related toapHDrop,a”D”isshowninthesymptomtable.WhenasymptomisrelatedtoacidReflux(pH<4orpHreflux markers),aplussign(+)isshown.
  • Page 70 For the Laborie and Symptom events, you can change the settings for Full name, Analysis type, and Show seconds. You cannot change the Full name setting for Supine and Meal periods. This can be changed only in the Measurement module (see the section “TheEditProtocolDialogBox”...
  • Page 71 ExportdetailedinformationofallrefluxandsymptomeventstoanXLSfile. symptoms to XLS Report Laborie Reporter Ifyouwanttoviewthereportormakechangestoitbeforeprintingorexportingit,onthemenubar,chooseReport > Laborie reporteror,onthetoolbar,clicktheReporter button, as illustrated in Figure 4-32. Figure 4-32: The Laborie Reporter Dialog Box YoucanfindmoreinformationintheseparateReportermanual,inPDFformat,whichyoucanaccessviatheManuals menu in the Database module. Printing or Exporting a Report or Graph Immediately You can print or export the report or graph immediately by choosing Report > Print/PDF/JPG Report or Print/PDF/JPG graph.ThereportorgraphisprintedorexportedaccordingtothePrint/PDF/JPGsettings.Ifyouwanttoadjustthe...
  • Page 72 Figure 4-33: AvailableShortcutKeys Ifyouwouldlikeahardcopyoftheshortcutkeysoverview,clickthePrint button. Laborie alpHaONE User & Service Manual LBL-01791 [B]...
  • Page 73 Part III Service and Installation LBL-01791 [B] Laborie alpHaONE User & Service Manual...
  • Page 75 5 Installation Introduction This chapter explains how to install the Laborie application and set up the alpHaONE measurement system. The end of this chapter provides information to test whether the installation has been completed successfully. Figure 5-1: The alpHaONE Recorder—Front View The alpHaONE system is supplied with a USB interface cable for communication with the computer.
  • Page 76 CommunicationviathecomputerispossibleonlywhenbatteriesareinsertedinthealpHaONErecorder.Alwaysuse a fresh set of batteries in the alpHaONE before starting a new study. This will prevent the investigation from being interrupted before completion due to depleted batteries. Connecting the alpHaONE Recorder to the Computer Connect the alpHaONE recorder to the computer using the USB cable that shipped with the alpHaONE system.
  • Page 77 Clean the system as described in the following section The expected service life and the period of support and service of the product by Laborie is six years after delivery. For information about all accessories and disposables, refer to their respective user manual or Instructions for Use.
  • Page 78 WARNING Aftereachinvestigation,cleanthealpHaONE. Cleantheexternalsurfaceregularlywith75%alcoholatroomtemperature. NOTE The colors and transparency of the alpHaONE device may change over time. Monthly On a monthly basis, clean the following parts with a slightly moisturized cloth: • Exterior of the computer • Monitor • Printer •...
  • Page 79 ■ W: 6.0 mm ± 0.4 mm ■ H: 5.5 mm ± 0.4 mm • Weight:≤2g • Effectiveworkingtime:≥96hours • Dataacquisitionfrequency:0.33Hz • Effectivecommunicationdistance:≥12m(withoutinterferenceorobstructionintheair) • pH measurement range: 1 to 9 • pH measurement accuracy: a. Acidity:±0.5 b. Alkalinity:±1 LBL-01791 [B] Laborie alpHaONE User & Service Manual...
  • Page 80 Computer interface: Mini USB connection Computer Requirements The computer and its peripherals connected to the alpHaONE system must comply with the latest version of one of the following standards: IEC 60950, EN 60950, or UL 60950. The minimum computer requirements for the Laborie/Windows software for the alpHaONE system are as follows: •...
  • Page 81 Part IV Appendixes LBL-01791 [B] Laborie alpHaONE User & Service Manual...
  • Page 83 BeforeworkingwiththealpHaONEmeasurementsystemandthismanual,pleasetakenoticeofthesafetyinformation as described in this appendix. The alpHaONE measurement system is a prescription device to be used only by licensed and trained healthcare professionals or individuals who have been trained and authorized by a healthcare professional or by a medical institution, under the supervision of a healthcare professional.
  • Page 84 • Classifiedbyoperatingmode:continuousoperation. The alpHaONE complies with part 15 of the FCC Rules. Operation is subject to the following two conditions: (1) this device may not cause harmful interference, and (2) this device must accept any interference received, including interference that may cause undesired operation.
  • Page 85 CAUTION ExercisecarewhenunpackingthealpHaONErecorder. Installation WARNING Safety can be compromised if the alpHaONE system or one of its modules shows visible damage. WARNING Do not attempt to open the alpHaONE system. WARNING ThepatientconnectionsofthealpHaONEsystemarecardialfloating(CF).Whenthesystemisconnected toacomputer,ensurethattherequirementsoftheIEC60601-1aresatisfied:(1)thecomputermust conformtoIEC60950,UL1950,orIEC60601,and(2)theenclosureleakagecurrentofthecomputer(and USB connector) must be limited in single-fault condition.
  • Page 86 • hasbeenhandledbyunqualifiedpersonnel. CAUTION To prevent the loss of any data, be sure to exit the Laborie alpHaONE application before shutting down the computer. CAUTION Automaticsafeguardsbuiltintothesoftwareshouldbeseenasanaid.Theyarenotasubstitutefor careful personal monitoring and an alert investigator.
  • Page 87 Mains disturbances • Extreme temperatures, pressures, humidity, dust, and so on. Abnormalhandlingincludes,butisnotlimitedtothefollowing: • Anyhandlingotherthanthatspecifiedinthemanual • Rough handling • Handlingbyunqualifiedstaff Provided such or similar conditions do not occur, this apparatus will prove to be durable and reliable. NOTE CheckthefunctionalityofthealpHaONEsystemwiththehardwaretest(diagnosticprogram)regularly. AppendixA Safety Information...
  • Page 88 2. Pull apart the two halves of the operation handle casing, as shown in the following illustration: 3. Slidebackthesecondandthirdbuckletowardtheendoftheoperationhandlewithaminimumof1cm,as shown here: 1 cm This will release the capsule and allow the removal of the delivery system. Laborie alpHaONE User & Service Manual LBL-01791 [B]...
  • Page 89 NOTE: Sterility symbols are applicable to consumable devices only. Please refer to consumable device Instructions for Use for complete symbol and instructional overview. * Note that some of the symbols on the measurement system can be originally in color LBL-01791 [B] Laborie alpHaONE User & Service Manual...
  • Page 90 ±1kVforACandDC IEC 61000-4-4 powerlines Surge ±1kVlinetoline Not applicable Mains power quality should be that of a typical commercial or hospital environment. IEC 61000-4-5 ±2kVlinetoearth Continued on next page Laborie alpHaONE User & Service Manual LBL-01791 [B]...
  • Page 91 Immunity Test IEC 60601 Test Level Compliance Level Electromagnetic Environment Guidance Voltage <5%U (>95%dipinU .) for Not applicable Mains power quality should be that of a typical dips, short 0.5cycle40%U (60%dip commercial or hospital environment. If the interruptions, and in U )for5cycles70%U userofthemodelJSPH-3requirescontinued voltage variations (30%dipinU ) for 25 cycles operation during power mains interruptions, it is...
  • Page 92 P is the maximum output power rating of the transmitter in watts (W) accordable to the transmitter manufacturer. Note1:At80MHzand800MHz,theseparationdistanceforthehigherfrequencyrangeapplies. Note2:Theseguidelinesmaynotapplyinallsituations.Electromagneticpropagationisaffectedbyabsorptionandreflectionfrom structures, objects, and people. Laborie alpHaONE User & Service Manual LBL-01791 [B]...
  • Page 93 Appendix E: Patient Diary Patient name Investigation date MEALS BEGIN TIME END TIME REMARKS Breakfast Coffee Lunch Dinner Coffee Snack SUPINE PERIOD BEGIN TIME END TIME REMARKS Supine Supine PAIN EPISODES BEGIN TIME END TIME DESCRIPTION OF PAIN LBL-01791 [B] Laborie alpHaONE User & Service Manual...
  • Page 94 IMPORTANT • Usetheeventkeys(buttons)onthealpHaONEasyourhealthcareprofessionalsinstructed. • Do not open the battery compartment except to install new batteries. • Do not use excessive amounts of water for cleaning the alpHaONE system or any other component. • NeverallowwatertoinfiltratethealpHaONEsystemoranyotherpart. • DonotshowerorbatheinatubwiththealpHaONErecorder;itisnot waterproof. • If you are uncertain about proper operation of the system, contact your healthcare professional.
  • Page 95 Appendix F: Software Messages Inthisappendix,youcanfindanoverviewofthesoftwaremessagesaswellasmessagesthatcandisplayonthe alpHaONE recorder, along with possible action(s) to resolve. Table F-1: Troubleshooting the alpHaONE pH Capsule Fault Cause Possible Actions to Resolve Capsuleisnotblinkingafter Expired capsule Replace the capsule. breakerremoval ActivationFailed Expired capsule Replace the capsule. Low signal Move the capsule closer to the recorder.
  • Page 96 This color scheme is read-only Operator tries to change a system color Modify a different color scheme. scheme Verify: Programming failed! Programming investigation protocol failed Contact your Laborie representative. Laborie alpHaONE User & Service Manual LBL-01791 [B]...
  • Page 97 Try again later or contact your Laborie could not be repaired! Try again later or representative. call your dealer. Closing program. Demographics database is busy! Demographics database is not responding Try again later or contact your Laborie Probablyanetworkrelatedproblem. representative. Errorduringcopyingoffile Diskisfullorfilesizeistoolarge Freeupdiskspace.
  • Page 98 Message Cause Posible Actions to Resolve Investigation database could not be Investigation database is corrupted Try again later or contact your Laborie opened!Probablyduetofilecorruption. representative. Try again later or call your dealer. Closing program. Investigation database is busy and could Repairing investigation database failed...