HemoCue Hb 201 DM Analyzer

2 General operations2.3 How to operate theDisplay2.3.1 Display buttonsFIGURE 2-11The Buttons (1) appearing on theDisplay (2) activate the specificfunctions symbolized by the image on thebutton.EnterSettings PasswordThe Buttons (1) should only be pressedusing the fingertip.Important! Sharp-edged objects candamage the Display.1 Buttons2 DisplayActivating a functionFIGURE 2-121EnterSettings Passworda) When a Button (1) is pressed, it willappear highlighted as long as it is keptpressed.b) When the Button is released, thefunction indicated by the button isactivated. An audible signal will soundif the audio function has beenactivated in the Settings.1 Button, highlighted14

2 General operationsChanging a functionFIGURE 2-13a) Keep pressing while moving thefingertip over to another button.EnterSettings PasswordFIGURE 2-14EnterSettings Passwordb) The original button will cease toappear highlighted and the new buttonwill appear highlighted.c) When the new Button is released, thenew function will be activated.15

2 General operationsCancelling a functionFIGURE 2-15EnterSettings Passworda) Keep pressing while moving thefingertip over to an area withoutButtons.FIGURE 2-16b) No Button will appear highlighted.EnterSettings Password16c) When the finger is released from theDisplay, the first Button choice will beignored and no action will beactivated.

2 General operations2.3.2 Using the BarcodeScanner buttonFIGURE 2-1710-30cm4-12inchesWarning! Laser radiation – Do not stareinto the beam or view directly with anoptical instrument.EnterSettings PasswordTo read barcodes, use the built-inBarcode Scanner in the back panel of theAnalyzer.Note! The scanning range (3) of theBarcode Scanner, is approximately10 - 30 cm (4 - 12 inches) from theScanner.a) Press and hold the Barcode Scannerbutton (1). The Barcode Scanner lightsup and scanning can be performed.b) The decoded information from thebarcode (2) appears on the Displaywhen the Analyzer identifies thebarcode. The information is displayedas long as the Barcode Scannerbutton (1) remains pressed. To cancela reading, move the fingertip to an areaoutside the Barcode Scanner Button,before releasing.1 Barcode Scanner button2 Barcode3 Scanning area17

2 General operationsFIGURE 2-1810-30cmc) When information is displayed,remove the fingertip from the BarcodeScanner button (1). The informationwill be stored in the Analyzer, and isno longer displayed.4-12inchesEnterSettings Password181 Barcode Scanner button2 Barcode3 Scanning area

2 General operations2.3.3 Main Menu and On-lineHelp08/09/03 10:55 AMJAMES SMITH1FIGURE 2-19FIGURE 2-19 is referred to as the MainMenu. It is displayed as the Startup Imagefor all Tests, Setting procedures, etc.The Help button (1) may be used todisplay information about other buttons,procedures, etc.1 Help button2 Operator name, Operator ID or blank,depending on the settings19

2 General operations2.4 Display buttons and symbols2.4.1 Navigation buttonsButtonABC12320DesignationFunctionErase buttonErases the last inputPrevious imagebuttonReturns to the previous imageNOTE: Inputs/changes made in thecurrent image will not be savedText mode buttonSwitches to text input modeNumeric modebuttonSwitches to the numeric input modeBarcode ScannerbuttonSwitches to the Barcode ScannermodeScroll bar arrow(Up)Scrolls upwards in a list of differentoptions or in a textScroll bar arrow(Down)Scrolls downwards in a list of differentoptions or in a textNext imagebuttonContinues to the next image in theHelp sequenceABC123

2 General operations2.4.2 Procedure buttonsButtonDesignationFunctionPatient testbuttonActivates the Patient Test procedureSTAT test buttonActivates the STAT (Short TurnAround Time) Test procedureQC test buttonActivates the QC (Quality Control)Test procedureStored databuttonActivates the Stored Data functionSettings buttonActivates the Settings menuVerify buttonAllows for the performance of asecond test, on the same patient,using a new Cuvette, without the needfor re-entering the Patient ID andother informationComment inputbuttonAllows a comment to be added to thecurrent resultComment inputbutton(dotted)Button appearance confirms thatcomments have been added to theresult21

2 General operations2.4.3 Other display nationFunctionHelp buttonDisplays on-line help regarding otherbuttons, procedures, etc.Confirm buttonSaves text or numbers and/ordisplays the next screen imageNOTE: All inputs/changes will besavedLog Out buttonLogs out the operatorNOTE: The Log Out button is onlydisplayed if the Operator ID isrequired.SpecialCharacter buttonEnters a special character(see explanations below)NOTE: Other special characters canonly be loaded into the Analyzer bymeans of the Barcode Scanner.-123See aboveSpace – press onceSee abovePeriod – press twiceSee aboveHyphen – press three timesView buttonProvides a more detailed descriptionof the highlighted item

2 General operationsButtonDesignationFunctionLetter buttonsAllows input of a textExample:To enter a “G” – press onceTo enter an “H” – press twiceTo enter an “I”– press three timesGHIDEFGHIJKLMNOPQRSTUVWXYZ[ABC123.-123NOTE: Only capital letters will beentered. Lower-case letters can beentered into the Analyzer by means ofthe Barcode Scanner.Digit buttonsAllows input of a digitAdd buttonAllows addition of a comment to aresult, an item to a list, etc.Delete buttonAllows deletion of a comment from aresult, an item from a list, etc.Accept buttonAccepts a measurementReject buttonRejects a resultA rejected result will be saved andflagged as rejected.31234567890123ABCAddDeleteAcceptReject23

2 General operationsButtonDesignationFunctionContinue buttonContinues the current operationStatistics buttonDisplays statistics on the chosensubjectContinue24

2 General operations2.4.4 Display icates the voltage status of theBattery in four levels. The furthest tothe left is fully charged, the one to theright is almost empty.DateIndicates the Date format chosen(from three possibilities) in theSettings MenuBig HourglassThe big hourglass is displayed whenthe Analyzer is in the measuring orselftesting state.(rotating)NOTE: The big hourglass is rotatingwhen displayed.Small hourglassWhen the small hourglass isdisplayed, the instrument is in ameasuring or blanking state.NOTE: When displayed in the MainMenu, only Settings and Stored Datafunctions are available. It is alsopossible to log outWaste binIndicates that a result has beenrejected. The result is stored in theAnalyzer.25

2 General operationsSymbol26DesignationFunctionQC ReminderReminder that a QC Test will berequired within stated time or numberof measurementsQC LockoutQC Lockout, i.e. no more Patient Testmeasurements can be madeThe required QC Test has not beenperformed.LockoutSupervisory LockoutThe Analyzer has been locked by theSupervisor. A text that indicates thiswill be displayed.

2 General operations2.4.5 Entering information withletters and digitsFIGURE 2-2008/09/03 10:55 AMInputs to the Analyzer such as OperatorID, Patient ID, etc. can be made via thedisplay or via the Barcode scanner.EnterOperator ID1ABC1232The display can be set to two differentmodes, text mode for entering letters(including a few special characters) andnumeric mode for entering digits.a) Press the Text mode button (1) or theNumeric mode button (2) dependingon if the first character that is to beentered is a letter or a digit.b) Depending on the mode chosen,follow the description for FIGURE 221 or FIGURE 2-22 .1 Text mode button2 Numeric mode button27

2 General operationsText modeFIGURE 2-21Operator ID1ABCDEFGHIJKLMNOPQRSTUVWXYZa) In the text mode, inputs are madeusing the Letter buttons (1) and theSpecial Character button (2).23[.-4123Note! Only capital letters and a fewspecial characters can be used in the textmode. Lower-case letters can only beentered into the Analyzer by means of theBarcode Scanner.5b) The Erase button (3) erases the lastinput.c) If a digit is to be entered, switch to thenumeric input mode by pressing theNumeric mode button (4). FIGURE 222 will be displayed.d) When all information has beenentered, press the Confirm button (5).1234528Letter buttonSpecial Character buttonErase buttonNumeric mode buttonConfirm button

2 General operationsNumeric modeFIGURE 2-22Operator IDa) In the numeric mode, inputs are madeusing the Digit buttons (1).b) The Erase button (2) erases the lastinput.1234567890ABC1c) If a letter or a special character is to beentered, switch to the text input modeby pressing the Text mode button (3).FIGURE 2-21 will be displayed.2d) When all information has beenentered, press the Confirm button (4).341234Digit buttonErase buttonText mode buttonConfirm button29

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3 Blood specimen collection3 Blood specimencollectionThis chapter describes the procedure for obtaining a blood sample to be used forhemoglobin analysis.3.1 Capillary bloodBefore obtaining a blood sample, theAnalyzer should be in the “Ready” mode.FIGURE 3-1a) Make sure the patient's hand is warmand relaxed. Use only the middle orring finger for sampling. Avoid fingerswith rings on.(Continues)31

3 Blood specimen collection(Continues)FIGURE 3-2b) Clean with disinfectant and allow todry or wipe off with a dry, lint-freetissue.FIGURE 3-3c) Using your thumb, lightly press thefinger from the top of the knuckletowards the tip. This stimulates theblood flow towards the samplingpoint.FIGURE 3-4d) For best blood flow and least pain,sample at the side of the fingertip, notthe center.Warning! Always handle bloodspecimens with care, as they might beinfectious.(Continues)32

3 Blood specimen collection(Continues)FIGURE 3-5e) While applying light pressure towardthe fingertip, puncture the finger usingthe lancet.FIGURE 3-6f) Wipe away the first 2 or 3 drops ofblood with a lint free wipe.Note! Do not use cotton balls.FIGURE 3-7g) Re-apply light pressure towards thefingertip until another drop of bloodappears.(Continues)33

3 Blood specimen collection(Continues)FIGURE 3-8h) When the blood drop is large enough,fill the Cuvette in one continuousprocess.Note! Do not refill!FIGURE 3-9i) Wipe off excess blood from the outersurface of the Cuvette with lint-freetissue, being careful not to touch theopen end of the Cuvette.Note! Make sure that no blood is drawnout of the Cuvette during this procedure.FIGURE 3-10j) Look for air bubbles in the filledCuvette. If any air bubbles are present,fill a new Cuvette. Small bubblesaround the edge can be ignored.Note! If a second sample is to be takenfrom the same finger stick, wipe away theremains of the initial sample and fill asecond Cuvette from a new drop of blood.(Continues)34

3 Blood specimen collection(Continues)FIGURE 3-11k) Place the filled Cuvette in the Cuvetteholder, see FIGURE 3-11.FIGURE 3-12l) Push the Cuvette holder to theMeasuring position.Note! This should be performed within10 minutes after filling the Cuvette!m)Enter the required information.After 15 seconds to 60 seconds, the resultwill be displayed.The result will remain on the display untilthe Confirm button has been pressed.FIGURE 3-13Note! Although the reagents are presentin the Cuvette in extremely lowquantities, consult local environmentalauthorities for proper disposal.35

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3 Blood specimen collection3.2 Venous and ArterialBloodFIGURE 3-14a) The blood should be well mixed priorto performing the measurement.FIGURE 3-15b) Place a drop of blood onto ahydrophobic surface, e.g. a plasticfilm, using a pipette.FIGURE 3-16It is also possible to use a suitable bloodtransfer device.(Continues)37

3 Blood specimen collection(Continues)FIGURE 3-17c) Fill the Cuvette in one continuousprocess.Note! Do not refill!Note! Wipe off excess blood from theouter surface of the Cuvette with lint-freetissue, being careful not to touch the openend of the Cuvette.FIGURE 3-18d) Look for air bubbles in the filledCuvette. If any air bubbles are present,fill a new Cuvette. Small bubblesaround the edge can be ignored.e) Perform the measurement as describedin FIGURE 3-11, and FIGURE 3-13 insection 3.1 Capillary blood.38

4 Routine Use4 Routine UseThis chapter describes the procedure for performing Patient Tests, STAT Testsand QC Tests, as well as describing the process of reviewing stored data.4.1 Patient Test ProcedureThe Patient Test procedure may vary, depending on which information requirementshave been activated in the Settings. The following information may, or may not, berequired: Cuvette Batch No. Patient ID Lab ID1. In the Main Menu, press the Patient Test button.2. Fill and insert a Microcuvette.ABC3. Enter the required information, via the Text mode and Numericmode buttons, or with the Barcode Scanner via the BarcodeScanner button.123The result will be displayed when all required information hasbeen entered and the measurement has been completed.(Continues)39

4 Routine Use(Continues)To add comments to the result, press the Comment input button.The result will remain on the display even if the Cuvette holder ispulled out, allowing for examination of the Cuvette beforecomments are made.Note! A dotted Comment book indicates that comments have beenadded to the resultThe Verify button allows the verification of the result bymeasuring a new sample from the patient.Press the Confirm button to store the information. The MainMenu will be displayed.40

4 Routine Use4.2 STAT Test ProcedureThe STAT Test fulfils the same function as a Patient Test but can be performed byoverriding the requirement of performing any type of QC Test. When performing aSTAT Test, it is optional whether or not to enter Cuvette Batch, Patient ID or LabNumber in order to make the measuring procedure quicker.1. In the Main Menu, press the STAT Test button.2. Fill and insert a microcuvette.ABC3. Enter the required information, via the Text mode and Numericmode buttons, or with the Barcode Scanner via the BarcodeScanner button, or just press the Confirm button if no data is to beadded.123The result will be displayed when all required information hasbeen entered and the measurement has been completed.To add comments to the result, press the Comment input button.The result will remain on the display even if the Cuvette holder ispulled out, allowing for examination of the Cuvette beforecomments are made.Note! A dotted Comment book indicates that comments havebeen added to the result.The Verify button allows the verification of the result bymeasuring a new sample from the patient.Press the Confirm button to store the information. The MainMenu will be displayed.41

4 Routine Use4.3 QC Test ProcedureBased on the settings made for the QC Test Reminder, the QCReminder icon will be displayed in the Main menu to warn of animpending QC lockout.If the impending QC is not performend within the pre-definedreminder time, the Anlayzer will perform a lockout. To unlock theAnalyzer, the required QC measurements must be performed andapproved. Patient Tests cannot be performed during a lockout.1. In the Main Menu, press the QC Test button. In the nextdisplay, choose the required QC level.2. Fill a Cuvette with the appropriate level of Liquid Control.Place the Cuvette in the Cuvette holder and gently insert it into themeasuring position.ABC3. Enter the required information, via the Text mode and Numericmode buttons, or with the Barcode Scanner via the BarcodeScanner button.123Note! If a Liquid Control Lot Number has not previously beenstored in the Analyzer and/or has expired, the following text willbe displayed: Invalid Control Lot.(Continues)42

4 Routine Use(Continues)The result will be displayed when all required information has been entered and themeasurement has been completed.For a result within the Approved area (the blank area), the Qualitative Test Resultwill indicate “Pass”.For a result within the Warning area (the dotted area), the Qualitative Test Result willindicate “Pass, Warning”.For a result within the Fail area (the solid area), or for two consecutive results withinthe Warning area, the Qualitative Test Result will indicate “Fail”.To avoid or unlock a QC lockout, the Qualitative Test Result must indicate “Pass”.To view a graphic presentation of the most recent QC Tests, pressthe Statistics button.To add comments to the result, press the Comment input button.The result will remain on the display even if the Cuvette holder ispulled out, allowing for examination of the Cuvette beforecomments are made.Note! A dotted Comment book indicates that comments havebeen added to the result.Press the Confirm button to store the information. The MainMenu will be displayed.43

4 Routine Use4.4 Stored data4.4.1 Reviewing Stored DataNote! Access to the Stored Data functions is dependent on the operator’s user leveland on the predefined setting of Operator ID use. Only a Supervisor can delete data,change an accepted or rejected result, or add comments.In the Main Menu, press the Stored Data button.If the entry requirement for an Operator ID is set to “Not Used” in the Setup, apassword has to be entered to be able to perform changes in the Stored Data.Otherwise the Analyzer can respond in two different ways:If the operator’s user level does not permit access to the Stored Data or the incorrectpassword was entered, the text: Incorrect Password or User Level, No changes tothe Stored Data will be Saved will be displayed.Press the Confirm Button to view the Stored Data.The following options are displayed: Review Delete Latest Download Log InputWhen the Review button is pressed in the Stored Data menu, the following optionsare displayed: All DataPAT/STATQC TestAnalyzer Log(Continues)44

4 Routine Use(Continues)Select an option by pressing it.If required, change the From date via the Digit buttons. Press Confirm. Repeat theinstruction to change the To date.The stored data within the date interval will be available for review. The latest recordis displayed first. If no data within the date interval is found, the following messagewill be displayed:No Records FoundPress the Previous image button to return to the All Data image.4.4.2 Deleting Stored DataOnly a Supervisor can delete Store

The System consists of the HemoCue Hb 201 DM Analyzer, the HemoCue DM Docking Station and the HemoCue Hb 201 Microcuvettes. This Manual contains step-by-step instructions for the routine use of the HemoCue Hb 201 DM Analyzer. For installation, set-up and other vital information, consult the HemoCue Hb