HemoCue Hb 201 DM Analyzer & HemoCue DM Docking
HemoCue Hb 201 DM Analyzer& HemoCue DM Docking StationReference Manual
CONTENTSCONTENTSPART IIntroduction . . . . . . . . . . . . . . . . . . . 11 Introduction . . . . . . . . . . . . . . . . . . . . 31.1The HemoCue Hb 201 DM System . . . . . . . . . . 41.1.1Unpacking . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 41.1.2Inspection . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 51.1.3Materials required but not provided . . . . . . . . . . . . . . . 51.2Abbreviations/glossary . . . . . . . . . . . . . . . . . . . 61.3Designated Terminology . . . . . . . . . . . . . . . . . . 91.4Functional description . . . . . . . . . . . . . . . . . . . 111.4.1System Components . . . . . . . . . . . . . . . . . . . . . . . . . 111.4.2Analyzer overview . . . . . . . . . . . . . . . . . . . . . . . . . . . 131.4.3Docking station – General . . . . . . . . . . . . . . . . . . . . . 161.4.4Docking Station overview . . . . . . . . . . . . . . . . . . . . . 181.4.5Functions and features . . . . . . . . . . . . . . . . . . . . . . . 232 Safety . . . . . . . . . . . . . . . . . . . . . . . 252.12.1.12.22.2.12.32.3.1HemoCue Hb 201 DM System . . . . . . . . . . . . 25Usage of the System . . . . . . . . . . . . . . . . . . . . . . . . . 25General . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 26Hazard information . . . . . . . . . . . . . . . . . . . . . . . . . . 26Handling of the System . . . . . . . . . . . . . . . . . . 27System Components . . . . . . . . . . . . . . . . . . . . . . . . . 27i
CONTENTS3 Installation/General operations . . . . . . 13.3.23.3.3Power source. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .Turning on the Analyzer . . . . . . . . . . . . . . . . . . . . . .Power saver mode. . . . . . . . . . . . . . . . . . . . . . . . . . .Turning the Analyzer off . . . . . . . . . . . . . . . . . . . . . .Loading the Analyzer with a Cuvette . . . . . . . . . . . . .2934363637Getting started – Single Docking Station. . . . . 38Connect to a PC or a LAN . . . . . . . . . . . . . . . . . . . . . 38Power source. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 41Getting started – Multiple Docking Stations. . . 42Connecting Docking Stations . . . . . . . . . . . . . . . . . . 42Connect to a PC or a LAN . . . . . . . . . . . . . . . . . . . . . 45Power source. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 463.4Docking Station LED . . . . . . . . . . . . . . . . . . . . 473.5How to operate the Display . . . . . . . . . . . . . . . 7.43.7.53.7.6iiGetting started – Analyzer . . . . . . . . . . . . . . . . 29Display buttons . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 49Using the Barcode Scanner button . . . . . . . . . . . . . . 52Operating the Analyzer . . . . . . . . . . . . . . . . . . 54Start up . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 54Login Image. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 55Main Menu and On-line Help. . . . . . . . . . . . . . . . . . . 56Display buttons and symbols. . . . . . . . . . . . . . 57Navigation buttons. . . . . . . . . . . . . . . . . . . . . . . . . . .Procedure buttons . . . . . . . . . . . . . . . . . . . . . . . . . . .Other display buttons. . . . . . . . . . . . . . . . . . . . . . . . .Display symbols. . . . . . . . . . . . . . . . . . . . . . . . . . . . .Entering information with letters and digits . . . . . . . .Entering information from barcodes . . . . . . . . . . . . .575859626467
CONTENTSPART IISettings . . . . . . . . . . . . . . . . . . . . . 694 Settings . . . . . . . . . . . . . . . . . . . . . . 714.1Activating the Settings procedure . . . . . . . . . . 714.2Define Lists . . . . . . . . . . . . . . . . . . . . . . . . . . . 744.2.1Liquid Controls. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 754.2.2Cuvette Batches . . . . . . . . . . . . . . . . . . . . . . . . . . . . 814.2.3Define Operators . . . . . . . . . . . . . . . . . . . . . . . . . . . . 854.2.4Define Comments . . . . . . . . . . . . . . . . . . . . . . . . . . . 904.2.5Define Log Notes. . . . . . . . . . . . . . . . . . . . . . . . . . . . 934.3Basic Settings . . . . . . . . . . . . . . . . . . . . . . . . . 964.3.1Date/Time . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 974.3.2Power Saver . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 994.3.3Audible Signals . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1004.3.4Language. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1014.4Advanced Settings . . . . . . . . . . . . . . . . . . . . 1024.4.1General Settings . . . . . . . . . . . . . . . . . . . . . . . . . . . 1034.4.2Patient Test Settings . . . . . . . . . . . . . . . . . . . . . . . . 1134.4.3QC Test Settings . . . . . . . . . . . . . . . . . . . . . . . . . . . 1224.4.4Linearity Test Settings . . . . . . . . . . . . . . . . . . . . . . . 1344.5Default Settings . . . . . . . . . . . . . . . . . . . . . . . 1364.6Infra Red . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1374.6.1The transmitting Analyzer . . . . . . . . . . . . . . . . . . . . 1374.6.2The Receiving Analyzer. . . . . . . . . . . . . . . . . . . . . . 1404.7Docking Station Settings . . . . . . . . . . . . . . . . 141iii
CONTENTSPART IIIRoutine use . . . . . . . . . . . . . . . . . 1435 Blood specimen collection . . . . . . . . .5.1Capillary blood. . . . . . . . . . . . . . . . . . . . . . . . 1455.2Venous and Arterial Blood. . . . . . . . . . . . . . . 1516 Patient Test procedure . . . . . . . . . . .6.1153Patient Test . . . . . . . . . . . . . . . . . . . . . . . . . . 1536.1.1Patient Test Result . . . . . . . . . . . . . . . . . . . . . . . . . 1596.1.2Verify . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1616.1.3Entering Comments. . . . . . . . . . . . . . . . . . . . . . . . . 1636.1.4Entering Comments – Verified sample . . . . . . . . . . 1687 STAT Test procedure . . . . . . . . . . . .7.17.1.18.1171STAT Test . . . . . . . . . . . . . . . . . . . . . . . . . . . 171STAT Test Result . . . . . . . . . . . . . . . . . . . . . . . . . . 1738 QC Test procedure . . . . . . . . . . . . . .175Events necessitating QC Tests . . . . . . . . . . . 1758.1.1QC Reminder. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1758.1.2QC Lockout . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1778.1.3Supervisory Lockout . . . . . . . . . . . . . . . . . . . . . . . . 1788.2iv145Performing a QC Test . . . . . . . . . . . . . . . . . . 1798.2.1QC Tests at a specific concentration level . . . . . . . 1818.2.2Linearity Test . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1868.2.3Proficiency Test . . . . . . . . . . . . . . . . . . . . . . . . . . . . 197
CONTENTS9 Reviewing stored data . . . . . . . . . . .2019.1Activating the Stored Data procedure . . . . . . 2019.2Review Stored Data. . . . . . . . . . . . . . . . . . . . 2049.2.1Review All Data . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2059.2.2Review PAT/STAT. . . . . . . . . . . . . . . . . . . . . . . . . . 2079.2.3Review QC Tests. . . . . . . . . . . . . . . . . . . . . . . . . . . 2109.2.4Review Analyzer Log. . . . . . . . . . . . . . . . . . . . . . . . 2179.3Delete Stored Data . . . . . . . . . . . . . . . . . . . . 2199.4Review Latest Download . . . . . . . . . . . . . . . . 2229.5Log Input . . . . . . . . . . . . . . . . . . . . . . . . . . . . 22310 Data communications . . . . . . . . . . . .22510.1Interaction Application – Analyzer . . . . . . . . . 22510.2Docking station setup . . . . . . . . . . . . . . . . . . 22610.3Data transfer . . . . . . . . . . . . . . . . . . . . . . . . . 233PART IVOther actions . . . . . . . . . . . . . . . . 23711 Maintenance . . . . . . . . . . . . . . . . . .23911.1Cleaning the Cuvette holder and theoptronic unit . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 23911.2Cleaning the Display . . . . . . . . . . . . . . . . . . . 24111.3Cleaning of the Analyzer Outer case and theDocking Station24111.4Calibrating the Display. . . . . . . . . . . . . . . . . . 242v
CONTENTS12 Troubleshooting . . . . . . . . . . . . . . . .12.1245Error messages . . . . . . . . . . . . . . . . . . . . . . . 245PART VMiscellaneous . . . . . . . . . . . . . . . . 25313 Technical specifications. . . . . . . . . . .25713.1General . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 25713.2Intended purpose/ Intended Use . . . . . . . . . . 25713.3Theory . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 25713.4Reagents . . . . . . . . . . . . . . . . . . . . . . . . . . . . 25813.5Sample material. . . . . . . . . . . . . . . . . . . . . . . 25813.6Storage and environmental requirements . . . 25813.7Quality Control. . . . . . . . . . . . . . . . . . . . . . . . 25913.8Measuring range . . . . . . . . . . . . . . . . . . . . . . 25913.8.113.9Whole Blood . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 259Limitations . . . . . . . . . . . . . . . . . . . . . . . . . . . 25913.10 Expected values . . . . . . . . . . . . . . . . . . . . . . 25913.11 Technical Specifications . . . . . . . . . . . . . . . . 26013.12 Signal input and signal output connections . . 26113.13 Electromagnetic Compatibility . . . . . . . . . . . . 262vi
CONTENTS13.14 Warranty . . . . . . . . . . . . . . . . . . . . . . . . . . . . 26413.15 Spare parts and accessories . . . . . . . . . . . . . 26413.16 Symbols on System Components andAccessories26513.17 References . . . . . . . . . . . . . . . . . . . . . . . . . . 266APPENDICESA Default Settings . . . . . . . . . . . . . . . . . . . ivii
CONTENTSviii
PART IIntroductionHb 201 DMVersion 1.0Serial no.0319610019Hb 201 DM
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PART I1 Introduction1 IntroductionThank you for choosing the HemoCue Hb 201 DM system.The HemoCue Hb 201 DM system is a compact, portable, yet versatile,hemoglobin measuring system. It is ideally suited for health care facilities thatrequire central lab quality values within a few minutes, at the point of carelocation.The System consists of the HemoCue Hb 201 DM Analyzer, the HemoCue DMDocking Station, the HemoCue Hb 201 Microcuvettes.This Reference Manual contains instructions for settings, quality assessment,patient testing, and troubleshooting of the HemoCue Hb 201 DM Analyzer, aswell as installation of the HemoCue DM Docking Station. For information on theHemoCue 201 DM - DMS Software, see the separate User’s Guide on the DMSSoftware CD.This chapter gives a brief overview of the functions and features of the Analyzerand the Docking Station.Note! Prior to starting theHemoCue Hb 201 DM Analyzer, readsection 2 Safety, followed by section 3Installation/General operations.3
1 IntroductionPART I1.1 The HemoCueHb 201 DM System1.1.1 UnpackingFIGURE 1-1Instructions forUsea) The Analyzer and the Docking Stationare supplied in two different packages,as described below. Open up thepackage and unpack the contents on adry and stable surface.Analyzer:1 HemoCue Hb 201 DM Analyzer2 HemoCue Hb 201 DM AnalyzerInstructions for Use12Docking Station:3 HemoCue DM Docking Station34
PART I1 Introduction1.1.2 Inspectiona) Check all System Components fordamage.Electrical shock! Use of damagedelectrical equipment poses a risk ofelectrical shock or further damage to theequipment.b) If any visible or suspected damage isdiscovered, contact the localdistributor.1.1.3 Materials required but notprovided1FIGURE 1-2HemoCue Hb 201 Microcuvettes (1),packaged individually or in vialsSystem Components:1 HemoCue Hb 201 Microcuvette5
1 IntroductionPART I1.2 Abbreviations/glossaryACAlternating CurrentIrDCompact DiscCICConnectivity Industry ConsortiumThe CIC was an open, non-profit, industry-driven consortiumcomprised of device manufacturers, information system vendorsand health care providers. It was chartered to addressimpediments to POC device connectivity with the objective ofenabling seamless information exchange between POC devicesand electronic medical records and laboratory informationsystems.DMData ManagementDMSData Management ServerHCHemoCueHubA physical connecting deviceA hub is a place of convergence where data arrives from one ormore directions and is forwarded in one or more other directions.IPInternet ProtocolIP-addressA number that identifies each sender or receiver of informationthat is sent in packets across the InternetIRInfra Red (light)Electromagnetic radiation with wavelengths longer than those ofvisible light but shorter than those of radio wavesIrDAInfrared Data Association(Continues)6
PART I1 Introduction(Continues)LANLocal Area NetworkA group of computers and associated devices that share acommon communications line and typically share the resourcesof a server within a small geographic area (e.g. an officebuilding). The server usually has applications and data storagethat are shared in common by multiple computer users.LEDLight Emitting DiodeA semiconductor device that emits visible light when an electriccurrent passes through it. In most LEDs the light ismonochromatic, i.e. occurring at a single wavelength.LIDLab Identification (ID) or lab number ID of a test, unique within auser siteNCCLSA globally recognized, voluntary consensus organizationdeveloping standards, guidelines and best practices forhealthcare medical testingORObservation ReviewerThe primary role of an OR is to host one or more services towhich point-of-care diagnostic devices connect. These servicesfacilitate the collection of test results and quality data from, aswell as the management of, these devices. In addition, serviceshosted by an OR may exchange data with already existinginformation systems in the hospital or laboratory, e.g. LaboratoryInformation Systems (LIS).PATPatient TestPCPersonal ComputerPIDPatient Identification (ID)(Continues)7
1 IntroductionPART I(Continues)POCPoint-of-care (The immediate surroundings of a patient)POCTPoint-of-care Testing (Testing procedures performed in theimmediate surroundings of the patient)POCT1-AStandard for communication and messages between diagnosticinstruments, specified by NCCLS, based on specifications fromthe Connectivity Industry Consortium (CIC)QCQuality ControlQC TestA measurement of control material, providing evidence of thestability of the systemSTATShort Turn Around TimeSTAT TestA test mode that allows a patient test to be performed withoutentering information required in the routine patient test mode.Testing is also possible in this mode if the routine patient testingmode of the Analyzer is locked out.USBUniversal Serial BusA "plug and play" interface between a computer and peripheraldevices (e.g. keyboards, scanners, printers)With USB, a new device can be added to the computer withouthaving to add an adapter card or turning the computer off.8
PART I1 Introduction1.3 DesignatedTerminologyThe designations in the table below areused throughout the rest of thisdocument.ItemReferred to as the.GeneralHemoCue Hb 201 DM systemSystemComponents of the HemoCueHb 201 DM systemSystem ComponentsSystem ComponentsHemoCue Hb 201 DM AnalyzerAnalyzerHemoCue DM Docking StationprimaryPrimary (Docking Station)HemoCue DM Docking StationsecondarySecondary (Docking Station)HemoCue DM Docking Station(irrespective of primary or secondary)Docking StationHemoCue 201DM - DMS SoftwareDMS SoftwareHemoCue Hb 201 MicrocuvetteCuvetteDocumentationHemoCue Hb 201 DM Analyzer& HemoCue DM Docking StationReference ManualReference ManualHemoCue 201 DM - DMS SoftwareUser’s Guide (on CD)DMS Software Manual9
1 IntroductionItemPART IReferred to as the.Accessories6 V 2.5 A AC AdapterAC AdapterHemoCue 201 DM BatteryBattery10
PART I1 Introduction1.4 Functionaldescription1.4.1 System ComponentsFIGURE 1-31The System consists of a speciallydesigned Analyzer (1), the HemoCue Hb201 DM Analyzer, specially designedmicrocuvettes (2), HemoCue Hb 201Microcuvettes and a specially designeddocking station (3), the HemoCue DMDocking Station.AnalyzerNote! The HemoCue Hb 201 DMAnalyzer (1) is only to be used togetherwith the HemoCue Hb 201Microcuvettes (2).Note! The system is intended for in vitrodiagnostic use only.231 Analyzer2 Cuvette3 Docking Station(Continues)11
1 IntroductionPART I(Continues)Docking StationFull data management is possible whenthe Analyzer is placed in the DockingStation (3) which is connected via USBor LAN to a PC hosting the DMSSoftware. The Analyzer Battery isrecharged while in the Docking Station.12
PART I1 Introduction1.4.2 Analyzer overviewFront panelFIGURE 1-41Note! Prior to performing ameasurement, read section 2 Safety, andsection 3 Installation/General operationsand perform the settings andconfiguration according to section 4Settings.Note! Do not turn off the Analyzer in themiddle of a procedure. Data may be lost.23The Analyzer (1) is started when theOn/Off button (2) is pressed. The screenimages will be visible on the Display (3).All navigation and information handlingis performed by pressing the appropriatetouch buttons directly on the Display (3).4To perform a measurement, the Cuvetteis filled with sample material and placedin the Cuvette holder (4). The Cuvetteholder is inserted into the Analyzer (seesection 3.1.5 Loading the Analyzer with aCuvette).To turn off the Analyzer (1), press theOn/Off button (2).1234AnalyzerOn/Off buttonDisplayCuvette holder13
1 IntroductionPART IBack panelFIGURE 1-54The following items are found on theback panel of the Analyzer. Power inlet (1) for the AC Adapter Power USB signal inlet (2) forconnection to the Docking Station Built-in Barcode Scanner (3) IR Transmitter/Receiver (4) for datatransfer to/from the Docking Station321Data can be transmitted between theAnalyzer and the Docking Station in twodifferent ways: Via USB using the Power USBsignal inlet (2), if the Docking Stationcommunicates with the DMSSoftware via USB By means of IR-light using the IRTransmitter/Receiver (4), if theDocking Station communicates withthe DMS Software via LAN1 Power inlet (for AC Adapter)2 Power USB signal inlet (for DockingStation)3 Barcode Scanner4 IR Transmitter/Receiver(Continues)14
PART I1 Introduction(Continues)FIGURE 1-643Settings can be transmitted between twoAnalyzers via the IR Transmitter/Receiver (see section 4.6 Infra Red ). TheAnalyzers have to be out of the DockingStations and positioned with the IRTransmitter/Receivers (4) facing eachother.21The Power inlet (1) for the AC Adaptercan only be used when the Analyzer isseparated from the Docking Station.When the Analyzer is placed in aDocking Station, this inlet will beblocked and the Analyzer receives powervia the Power USB signal inlet (2).Note! The combined Power USB signalinlet (2) is not a standard USB port, but aspecial connector which fits thecorresponding connector on the DockingStation.Note! The IR Transmitter/Receiver (4) islocated inside the casing of the Analyzer.Note! Do not cover or block the items onthe back panel; doing so may result inmalfunction.1 Power inlet (for AC Adapter)2 Power USB signal inlet (for DockingStation)3 Barcode Scanner4 IR Transmitter/Receiver15
1 IntroductionPART I1.4.3 Docking station – GeneralSingle Docking StationFIGURE 1-7A Docking Station not connected to otherDocking Stations, is referred to as aSingle Docking Station.Multiple Docking StationsFIGURE 1-8Up to five Docking Stations can beconnected to each other. These arereferred to as Multiple Docking Stations.Only the Analyzer positioned furthest tothe left can be connected to an ACAdapter. Power is supplied to the otherAnalyzers through this connection.Primary and Secondary DockingStationsFIGURE 1-9Note! Primary and Secondary DockingStations are two physically differentproducts.1 Primary or Secondary Docking Station2 Secondary Docking Station(Continues)1162
PART I1 Introduction(Continues)FIGURE 1-10A Primary Docking Station can beconnected to a LAN and both receive/send data itself and pass data from/to aSecondary Docking Station that isconnected to the Primary.12Note! When a Primary Docking Stationis connected via a USB connection, onlythe IP address can be changed. No otherinformation can be sent to/from theAnalyzer.A Secondary Docking Station cannot beconnected to a LAN. In order tocommunicate via a LAN it must beconnected to a Primary Docking Station.A Secondary Docking Station cancommunicate directly to a PC via a USBconnection.Both Primary and Secondary DockingStations can be used singularly.A set of Multiple Docking Stations,(maximum five), consists of either onePrimary and a number of SecondaryDocking Stations or of only SecondaryDocking Stations. If a Primary isincluded, it must be positioned furthest tothe left (1) (when facing the front of theDocking Station).Note! Two Primary Docking Stationsmust not be connected together.1 Primary or Secondary Docking Station2 Secondary Docking Station17
1 IntroductionPART I1.4.4 Docking Station overviewFrontFIGURE 1-113The Docking Station consists of thefollowing items:21 Tracks (1) for the Analyzer Power USB signal outlet (2) for theAnalyzer IR Transmitter/Receiver (3) for datatransmission to/from the Analyzer LED (4)Note! The combined Power USBsignal outlet (2) is not a standard USBport, but a special connector which fitsthe corresponding connector on theAnalyzer.Note! The IR Transmitter/Receiver (3) islocated inside the casing.4Note! Do not cover or block the items onthe back panel; doing so may result inmalfunction.123418TracksPower outletIR Transmitter/ReceiverLED
PART I1 IntroductionBack panel – Primary Docking StationFIGURE 1-12The following items are located on theback panel:32 Power inlet (1) for the AC Adapter USB port (2) for setting up thePrimary Docking StationNote! Different from the USB port inthe Secondary Docking Station1 Network port (3) for datacommunication via a LAN1 Power inlet for the AC Adapter2 USB port3 Network portBack panel – Secondary DockingStationFIGURE 1-13The following items are located on theback panel:21 Power inlet (1) for the AC Adapter USB port (2) for data communicationdirectly with the PCNote! Different from the USB port inthe Primary Docking Station1 Power inlet for the AC Adapter2 USB port19
1 IntroductionPART IData Communication ConnectorsFIGURE 1-1421The male connector (1) for datacommunication between MultipleDocking Stations is positioned under theSide Trim (2).Important! The Side Trim (2) on theDocking Station should always be used toprotect the Connector (1).1 Male Connector2 Side Trim(Continues)20
PART I1 Introduction(Continues)SingleFIGURE 1-1543The female connector (3) is positionedunder the Bottom Trim (4).Note! There is no female connector (3)on a Primary Docking Station .Important! The Bottom Trim (4) on theDocking Station should always be used toprotect the Connector (3).3 Female Connector4 Bottom Trim21
1 IntroductionPART IPlacing the Analyzer in the DockingStationFIGURE 1-16Important! Always slide the Analyzerinto and out of the Docking Station bymeans of the Tracks (1).11 TracksFIGURE 1-17Important! Never try to lift the Analyzerout of the Docking Station or press theAnalyzer downwards into the DockingStation.This may damage the casing and poweroutlets of the Analyzer and/or theDocking Station.22
PART I1 Introduction1.4.5 Functions and featuresThe HemoCue Hb 201 DM system is apowerful data management system fordecentralized testing. It can becustomized by the user allowing theactivation or deactivation of thefollowing functions: Operator ID input, with lockoutfunction if the Operator ID is notrecognized Patient ID input Cuvette batch data input Lab number input Quality Control with input of lotnumbers, range and lockout functions Linearity and proficiency testing STAT testsThe Analyzer stores: Approximately 4000 Patient/STATtest results (including Patient ID,Operator ID, date, time, comments,etc.) Approximately 500 QC test results(including QC level, Operator ID,date, time, comments, etc.) Approximately 500 Analyzer logentries (Error messages, maintenanceetc.)(Continues)23
1 IntroductionPART I(Continues)The Analyzer also has the followingfeatures: Easy-to-use Display Built-in Barcode Scanner Powered either by a rechargeablelithium-ion Battery, AC Adapter orvia the Docking Station. The Batteryis recharged when connected to theDocking Station. Communication with DMS Softwareor OR via Docking Station, accordingto POCT1-A standard (also known asthe CIC standard).24
PART I2 Safety2 SafetyTo ensure maximum safety, read this chapter carefully before using the Analyzeror any of the System Components in the HemoCue Hb 201 DM System.2.1 HemoCue Hb 201 DMSystem2.1.1 Usage of the SystemFIGURE 2-1All System Components are designedand manufactured to provide maximumsafety. There are three procedures relatedto the System that may cause personalinjury or damage to equipment. Theseprocedures are found outside the corefunctions of the System:Instructions forUse Handling of electrical components–Always handle electrical componentswith care, otherwise electrical shocksmay occur to the user. Handling of blood specimens –Always handle blood specimens withcare, as they might be infectious. Handling of the Barcode Scanner –Laser radiation. Do not stare into thebeam or view directly with an opticalinstrument.25
2 SafetyPART I2.2 General2.2.1 Hazard informationThe following hazard informationdescribes the level of risk of injury ordamage to the user or equipmentrespectively:Hazard informationWarning!Electrical shock!Risk of serious personal injury!Failure to observe this information canresult in personal injury and/orserious damage to or destruction ofequipment!Risk of electrical shock!Failure to observe this information canresult in personal injury and/orserious damage to or destruction ofequipment!Caution!Risk of minor personal injury!Failure to observe this information canresult in minor personal injury!Important!Risk of damage to equipment!Failure to observe this information canresult in damage to equipment!Important!Note!26SignificanceIs used to emphasize importantinformation. The Note! is not to beregarded as hazard information.
PART I2 Safety2.3 Handling of theSystem2.3.1 System ComponentsCarefully follow the instructions in thisdocument and pay special attention to theHazard information in section 2.2.1Hazard information.BatteryWarning! Lithium-ion battery - Dangerof explosion - Replace the Battery withthe same type recommended byHemoCue.Consult local environmental authoritiesfor proper disposal.CuvetteFIGURE 2-2Warning! Always handle bloodspecimens with care, as they might beinfectious.Always use protective gloves whenhandling Cuvettes that are filled withblood.Although the reagents are present in thecuvettes in extremely low quantities,consult local environmental authoritiesfor proper disposal.27
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PART I3 Installation/General operations3 Installation/GeneraloperationsThis chapter describes the general operations necessary for Analyzer use.3.1 Getting started –Analyzer3.1.1 Power sourceThe Analyzer can be powered either bythe rechargeable Battery or by a standardelectrical outlet via the AC Adapter.Recharging the BatteryFIGURE 3-11The rechargeable Battery (1) is located ina battery compartment on the bottom ofthe Analyzer.a) Recharge the Battery (1) byconnecting the AC Adapter to theAnalyzer or by placing the Analyzer inthe Docking Station. A brand newBattery will take longer to charge thefirst 2 to 3 times.1 Battery(Continues)29
3 Installation/General operationsPART I(Continues)A fully charged Battery will power theAnalyzer for 100 hours when in thestand-by mode or for two days of normaluse. Normal use is defined as 60 samples/day using the Barcode Scanner.The Battery recharges to 70% of itscapacity in less than 2 hours and to nearly100% in less than 10 hours.30
PART I3 Installation/General operationsReplacing the Battery2FIGURE 3-2Warning! Only the HemoCue 201 DMBattery can be used in the Analyzer.1The Battery lasts for several years. Itshould be replaced when it fails to retainits charge for an acceptable period.The Battery is available as an accessorythrough HemoCue and HemoCuedistributors.a) To remove the Battery (1), press theFlap (2).1 Battery2 Flap(Continues)31
3 Installation/General operationsPART I(Continues)134FIGURE 3-32Warning! Lithium battery. Never try toopen the battery casing. Risk ofexplosionConsult local environmental authoritiesfor proper disposal.b) Carefully loosen the Battery (1) andlift it upwards.c) To install the new Battery (3), place itin the Analyzer and gently pressdownwards until the Flap (4) snapsinto the locked position.123432Old BatteryFlapNew BatteryFlap
PART I3 Installation/General operationsConnecting the AC AdapterFIGURE 3-4Warning! Only use the AC Adapter thatis recommended by HemoCue. Other ACAdapters, although physically able to beplugged into the Analyzer, may causeserious damage or fire.312a) Insert the AC Adapter’s DC plug (2)into the Power inlet (3) on the backpanel of the Analyzer.b) Plug the AC Adapter (1) into anelectrical outlet.1 AC Adapter2 DC plug3 Power inlet33
3 Installation/General operationsPART I3.1.2 Turning on the AnalyzerFIGURE 3-5a) Turn on the Analyzer by pressing theOn/Off button (1).b) The Start Image, beginning with theHemoCue logo, will be displayed, asseen in FIGURE 3-6.21 On/Off button2 Display1Start ImageFIGURE 3-6Hb 201 DMVersion 1.012The Start Image includes the followinginformation: Analyzer type (1), Softwareversion (2) and the unique Serialnumber (3) of the Analyzer. If the Cuvette holder is in theMeasuring position (see section 3.1.5Loading the Analyzer with a Cuvette),the following text will be displ
The System consists of the HemoCue Hb 201 DM Analyzer, the HemoCue DM Docking Station, the HemoCue Hb 201 Microcuvettes. This Reference Manual contains instructions for settings, quality assessment, patient testing, and troubleshooting of the HemoCue Hb 201 DM Analyzer, as well as installati
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
5. HemoCue Hb 201 Operating Manual, HemoCue Hb 201 Quick Reference Guide and Instruction CD 6. HemoCue Cleaner The HemoCue Hb 201 and its adapter are delivered in a carton. Open the carton on a stable surface and lift out the instrument and accessories. On the bottom of the analyzer there is a lid covering the battery compart-ment.
HemoCue Glucose 201 Operating manual and Quick Reference Guide. 6. HemoCue Cleaner. The HemoCue Glucose 201 Analyzer and power adapter are delivered in a carton. Open the carton on a stable surface and lift out the analyzer and the accessories. Consult local en
82947QW HemoCue, Inc HemcoCue Glucose 201 Microcuvettes and Glucose 201 Analyzer 82947QW HemoCue HemoCue B-Glucose Photometer 82947QW i-Stat Corporation Abbott i-STAT EC 4 Cartridge 82947QW Polymer Technology Systems, Inc Polymer Technology Stems Car
The HemoCue Hb 201 analyzer has an internal electronic “SELFTEST”. Every time the analyzer is turned on, it will automatically verify the performance of the optronic unit of the analyzer. Upon passing the selftest, the display will show the HemoCue symbol and three flashing dashes
HemoCue Corporate Identity Manual Issue 4, May 2019 2 Contents 1 Our Company Profile Working Together for a Strong Brand 4 Communicating Our Brand Through Storytelling 5 Strategic Levels of Communication 6 Our Logotype 7 The HemoCue Shape 8 . HemoCue
HemoCue Hb 201 Method and Sample Collection Method IECBE.1 v1 Issue date: 21.08.14 Review date: 21.08.15 7 Inserting the cuvette Wipe off excess blood on the outside of the microcuvette tip using a tissue. Make sure no bloo
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