HemoCue® WBC Operating Manual Bedienungsanleitung Manuel d
Contents
1. 1 Vergewissern Sie sich dass der Analyzer ausgeschaltet ist Halten Sie die Taste etwa 10 Sekunden lang gedr ckt 2 Inder Anzeige erscheint ein blinkendes Tonsymbol 3 Dr cken Sie schnell die Taste um die Ausgabe des Tonsignals ein bzw auszuschalten Wenn Sie die Einstellung vorgenom men haben halten Sie die Taste etwa 3 Sekunden gedr ckt bis das Tonsymbol nicht mehr blinkt Der Analyzer wechselt dann wieder in den Bereit Modus 13 Si le signal sonore est active un signal sera mis a l issue de la mesure ou en cas d affichage d un code d erreur Proc der comme suit pour activer ou d sactiver le signal sonore 1 S assurer que l analyseur est hors tension Appuyer sur la touche pendant environ 10 secondes 2 L cran affiche un symbole de cloche clignotant 3 Appuyer rapidement sur la touche pour activer d sactiver le signal sonore A l issue des r glages appuyer sur la touche pendant environ 3 secon des jusqu a ce que la cloche arr te de clignoter L analyseur se remet automatiquement en position de mesure O Als het geluidssignaal is geacti veerd klinkt het signaal wanneer de meting is voltooid of wanneer een foutmelding wordt weergege ven Voer de onderstaande stappen uit om het geluidssignaal te active ren of deactiveren 1 Controleer of de analyser uitgeschakeld is Houd de knop ongeveer 10 seconden ingedrukt 2 In het display verschijnt een knipperend kl2. HemoCue WBC Operating Manual Bedienungsanleitung Manuel d utilisation Gebruiksaanwijzing HemoCue A Quest Diagnostics Company Table of Content HemoCue WBC system 5 COMPONENTS radang ai aa SERE ee 6 SEAE a EE OE EE EE 8 ode EE OE EE AE EN 12 A es EE EE ER OE EE 12 Measuring EE PP E 14 Capillary e ee aane OG ed ee ei 14 ET AE EE IR OR EE EN 22 Control material or VENOUS blood 22 e ee 24 Printer LUNGS ON natalia ala 24 Maintenant ss ERA ESE EES Ee eN RE eN Ese sed 26 Troubleshooting Guide 28 Ao enerverend 44 Inhaltsverzeichnis HemoCue WBC System ss 5 Betania Ee 6 Inbetriebnahme iii 8 Bins te NIG even een 12 FONS OMEN eee sereen N eu 12 MSS SUI Oan ananas ene tenen dennen dn 14 A me einen ee 14 PS SS e sis A A 22 Kontrollmaterial oder ven ses Blut nnen 22 EINSTEIN Ee EE daneen daneen 24 DEWEKE TUK OIA srta ita 24 MEDE se eie Siek EE AE ee ae N Ge Ee T 26 Anleitung zur Fehlersuche sees ee ee Re ee 32 Technische Daten 57 HemoCue WBC system HemoCue WBC System Systeme HemoCue WBC HemoCue WBC systeem Thank you for choosing the HemoCue WBC system The system is indicated for use for quantitative determination of white blood cell WBC count in capillary or venous whole blood The HemoCue WBC system is for n Vitro Diagnostic use only The HemoCue WBC Analyzer is only to be used with HemoCue WBC Microcuvettes The HemoCue WBC system is indicated for use in cl
3. Le support de cuvette doit tre nettoy apres chaque jour d uti lisation Tirer le bras mobile de la cuvette vers sa position de charge Retirer le support de cuvette en le soulevant sans l incliner Nettoyer le support de cuvette avec de l alcool 20 70 ou un d tergent doux REMARQUE Le support de cuvette ne passe pas a l autoclave Si des pi ces optiques se salissent un code d erreur s affiche Pour les nettoyer introduire un tampon HemoCue Cleaner dans l ouverture du support de cuvette R p ter l op ration de 5 a 10 fois Si le tampon est tach recommen cer l op ration avec un nouveau tampon Le tampon doit bien at teindre les pieces comme indiqu dans l image 4a Attendre 15 minutes avant de remettre le support de cuvette en place V rifier que le bras mobile de la cuvette se trouve en position de charge avant de rem placer le support de la cuvette L ext rieur peut tre nettoy avec de l alcool 20 70 ou un d tergent doux Reiniger zu bestellen wenden Sie sich bitte an Ihren Vertriebsh ndler vor Ort 21 fourni avec l analyseur Contacter le distributeur local pour en commander lt gt Controleer voorafgaand aan het on derhoud of de analyser uitgeschakeld is en het display niets weergeeft 1 De cuvettehouder dient dagelijks na gebruik te worden gereinigd Trek de cuvettehouder naar de laadpositie 2 Til de cuvettehouder recht om hoog om deze te verwijderen 3 R
4. The following accessories and spare parts are available e Power adapter e Cuvette holder e HemoCue Cleaners e HemoCue Lancets Patents The product is protected by the following patents or Patent Pending SE 0 500 549 US 5 674 457 EP 0 821 784 SE 0 601 576 US 552 500 RCD 00563838 US 11 102 837 EP 06110903 9 US 11 717 675 PCT SE2007 000654 US 60 906 504 Symbols Used j Attention see instructions for use de CE mark Class Il equipment Only valid within the European Community Indicates seperate collection for waste of electrical and electronic equipment Serial port 5 Relative humidity non condensing 5 Temperature Efficiency Level References 1 2 3 HemoCue WBC Microcuvettes package insert Dacie and Lewis Practical Haematology Tenth edition Evaluation of Precision Performance of Quantitative Measurement Methods Approved Guideline CLSI Document EP05 A2 56 4 Evaluation of the Linearity of Quantitative Measurement Procedures A Statistical Approach Approved Guideline CLSI Document EP06 A 5 Interference Testing in Clinical Chemistry Approved Guideline CLSI Document EP07 A2 6 Method Comparison and Bias Estimation Using Patient Samples Approved Guideline Document CLSI EPO9 A2 7 Protocols for Determination of Limit of Detectionand Limit of Quantification Approved Guideline CLSI Document EP17 A 8 James O Westgard Basic Method Validation Manufacturer Hem
5. hemoglobin 30 250 g L reticylocytes 258 x10 L HbAS immature leukocytes and platelet clumping have not been found to interfere pH values between 6 8 8 0 do not interfere with the system Technical Specifications Dimensions 185 x 133 x 120 mm 7 28 x 5 24 x 4 72 inches Weight 600 g 1 32 pounds with 6 AA batteries installed Power adapter CE marked Only use adapters as listed under Adapters Pollution degree 2 Overvoltage category Atmospheric pressure 700 hPa to 1060 hPa Equipment not suitable for use in the presence of flam mable mixtures 49 The HemoCue WEC system has been tested for electrical safety and EMC according to the following standards e EN 60601 1 1990 A1 1993 A2 1995 A13 1996 Medical electrical equipment Part 1 General requirements for Safety e EN 60601 1 1 2001 Medical electrical equipment Part 1 1 General requirements for Safety Collateral Standard Safety requirements for medical electrical systems e UL 60601 2003 Medical electrical equipment Part 1 1 General requirements for Safety e EN 61010 2 101 2002 Safety requirements for electrical equipment for measurement control and laboratory use Part 2 101 Particular requirements for in vitro diagnostic IVD medical equipment e UL 61010 1 2004 Safety requirements for electrical equipment for measurement control and laboratory use Part 1 General requirements e IEC EN 60601 1 2 A1 Medical electrical equipm
6. Karton entnehmen Sie Analyzer und Zubeh r und stel len Sie sie auf eine stabile Unterlage nicht vibrierend Die Abdeckung des Analyzers nicht ffnen Nicht enthalten Informationen ber HemoCue WBC Microcuvettes erhalten Sie von Ihrem HemoCue Lieferanten HemoCue WBC Analyzer Adaptateur secteur ou 6 piles de type AA HemoCue WBC Microcuvettes Manuel d utilisation HemoCue WBC Guide de r f rence rapide et CD d instructions HemoCue WBC 6 Tampon HemoCue Cleaner n RA ME Placer la boite sur une surface stable sans vibrations pour l ouvrir et sortir l analyseur et ses accessoires Ne pas ouvrir le bo tier de Vana lyseur Non fournis Pour plus d informations sur les HemoCue WBC Microcuvettes veuillez contacter votre distributeur HemoCue lt gt HemoCue WBC Analyzer Wisselstroomadapter of 6 batterijen type AA HemoCue WBC Microcuvettes HemoCue WBC gebruiksaan wijzing verkorte HemoCue WBC gebruiksaanwijzing en instructie cd 6 HemoCue Cleaner S a dn Open de doos neem de analyser en de accessoires uit de doos en plaats ze op een stabiele niet trillende ondergrond Maak het deksel van de analyser niet open Niet meegeleverd Voor informatie over de HemoCue WBC Microcuvettes kunt u contact opnemen met uw HemoCue leve rancier Start up Inbetriebnahme Mise en service Starten d Only use adapters as listed under Specifications in
7. batterijdeksel en dit naar achteren te schuiven totdat het is geopend Neem de batterijhouder er voorzich tig uit Plaats de batterijen in de batterijhouder en let daarbij op de juiste richting van de batterijpolen Plaats de batterijhouder terug in het batterijvak en sluit het deksel Neem de geldende milieu voorschriften in acht wanneer u oude batterijen weggooit Trek de cuvettehouder uit naar de laadpositie 4 Press and hold the button until the display is activated all symbols appear on the display The Analyzer performs a self test and after approximately 10 seconds the display will show three flashing dashes and the HemoCue symbol This indicates that the Analyzer is ready for use 5 Ifthe cuvette moving arm is in the measuring position the most recent result will be displayed 6 Toturn the Analyzer off press and hold the button until the display reads OFF and then goes blank If the Analyzer is operat ing on battery power but not being used it will automatically turn off after approximately five minutes and if operating on AC power it will turn off after two hours Halten Sie die Taste gedruckt 4 bis die Anzeige aktiviert wird alle Symbole werden auf dem Display angezeigt Der Analyzer f hrt einen Selbsttest aus und nach ca 10 Sekunden werden auf dem Display drei blinkende Striche sowie das HemoCue Symbol angezeigt Dies zeigt an dass der Analyzer einsatzbereit ist 5 Wenn sich d
8. checks of the HemoCue WBC Microcuvette and the sample itself The operator s ability to handle the microcuvette and apply the sample correctly is also in cluded in these self tests No additional quality controls performed by the operator are required for verification of the system functionality Note that local state or other accreditation agencies may require additional quality control testing If additional quality control checks are required R amp D Systems R amp D HC WBC Control may be used Please refer to the R amp D HC WBC Control as well as the HemoCue WBC Operating Manual regarding handling and procedures Please refer to local guidelines for recommended frequency of use Expected Values Dacie and Lewis Practical Haematology Adults 4 0 10 0 x10 L Children 1 year 6 0 16 0 x10 L Children 2 6 years 5 0 15 0 x10 L Children 6 12 years 5 0 13 0 x10 L Infants 1 month 5 0 19 0 x10 L Infants 2 months 5 0 15 0 x10 L Infants 3 6 months 6 0 18 0 x10 L 45 The values above may vary due to a wide range of fac tors such as sex diurnal variations exercise physical stress or trauma pregnancy indigestion of food and cigarette smoking Measuring Range Displayed range 0 3 30 0 x10 L 300 30000 mm 300 30000 uL Results above the measuring range will be displayed as HHH Results below the measuring range will be displayed as LLL Limit of Detection Functional Sensitivity is estimated as the mean concen
9. directly after the measurement 1 Connect the cable to the ana lyzer and ASCII printer before performing the analysis Perform the analysis 3 When the result is shown on the display it will be printed automatically N Not included The following comport settings are used Baud rate 9600 Databits 8 Parity None Stopbits 1 Flowcontrol None Nur das aktuelle Ergebnis kann un mittelbar nach der Messung an den Drucker bertragen werden 1 Bevor Sie die Analyse durch f hren schlie en Sie das Kabel an Analyzer und ASCII Drucker an 2 F hren Sie die Analyse durch 3 Sobald das Ergebnis auf dem Display angezeigt wird wird es automatisch ausgedruckt Nicht enthalten F r den COM Anschluss werden die folgenden Einstellungen verwen det Baudrate 9600 Datenbits 8 Parit t keine Stoppbits 1 Flusskontrolle keine 25 Seul le r sultat le plus r cent peut tre imprim directement apres la mesure 1 Brancher le c ble entre l ana lyseur et l imprimante ASCII avant d effectuer l analyse 2 Effectuer l analyse 3 Lorsque le r sultat est affich l cran il est automatiquement imprim Non fournis Les param tres de composition suivants sont utilis s D bit en bauds 9600 Bits de donn es 8 Parit Aucune Bits d arr t 1 Contr le de flux Aucune O Alleen het huidige resultaat kan direct na de bepaling worden uitgeprint 1 Sluit de kabel aan
10. schlie en Sie den Deckel Beachten Sie die rtlichen Bestimmungen zur ordnungsgem en Entsorgung von Batterien Ziehen Sie dann den beweg lichen K vettenarm in die Ladeposition heraus d Utiliser uniguement les adaptateurs mentionn s dans la liste des caract risti ques section Adaptateurs Si Valimentation secteur est disponible brancher l adapta teur secteur fourni dans la prise situ e a l arriere de l analyseur S il n y a pas d alimentation secteur ins rer six piles de type AA 1 5 V Pour ouvrir le com partiment des piles situ sur la gauche de l analyseur appuyer sur la marque grav e du capot et le faire glisser vers l arriere Retirer doucement le support des piles Placer les piles dans le support en respectant la polarit Replacer le support dans le compartiment et fermer le capot Consulter les autorit s locales comp tentes en mati re d environnement pour la mise au rebut ad quate des piles Extraire le bras mobile de la cuvette dans sa position de charge O d Gebruik alleen adapters zoals vermeld onder Specificaties in het hoofdstuk Adapters Als er netvoeding beschikbaar is sluit u de netadapter aan op de stroomaansluiting op de achterkant van de analyser Plaats als er geen netvoeding beschikbaar is zes batterijen van het type AA van 1 5 V U opent het batterijdeksel aan de linkerkant van de analyser door te drukken op de geribbelde markering op het
11. wird die ungef hr in einem 45 Grad Winkel zu dem Bluttropfen gehal ten wird siehe Bild auf Seite 22 F hren Sie nun die Analyse entspre chend den Schritten 10 16 auf den Seiten 19 21 durch 23 Pour viter tout risque de contamina tion il est recommand de manipuler les chantillons de sang avec la plus grande pr caution Consulter les autorit s locales comp tentes en mati re d envi ronnement pour connaitre les m thodes d elimination ad quates Toujours mettre des gants de protection avant de manipuler des chantillons de sang La microcuvette est a usage unique 1 Siles chantillons de sang veineux ont t stock s au r frig rateur les laisser atteindre la temp rature ambiante de 15 a 35 C avant de proc der au m lange M langer les tubes d chantillon de sang veineux sur un m langeur m cani que pendant au moins 2 minutes ou retourner les tubes 10 a 20 fois la main Pour les solutions de contr le toujours respecter les instructions d emploi du fabricant 2 Placer une goutte de sang ou de solution de contr le sur une sur face hydrophobe par exemple une plaque en plastique ou en verre en utilisant une pipette ou un autre dispositif de transfert 3 Remplir la microcuvette d un seul trait NE JAMAIS la remplir une se conde fois REMARQUE verifier que l extr mit de la microcuvette est plac e a un angle d environ 45 degr s vers la goutte de sang comme sur l
12. 00i HemoCue WBC Within run and Total Precision was determined according 0 3 1 0 to the CLSI Document EPO5 A2 The results given below come from four batches of HemoCue WBC Microcuvettes 1 1 3 5 Se 36100 209 um 35 available controls at three different levels were used ha AE 12 gt The WBC count was measured in duplicate twice a day 10 1 20 0 morning and afternoon during 20 consecutive days Level 1071 Within run Total Precision Precision CV CV las as aoe sa o las EN 2 as Too vol te o 46 Validation Studies Results of the validation studies based on the intended use of the system are shown in Figure 1 2 3 and 4 Sin gle replicate on the HemoCue WBC system and the mean of duplicate on the comparative method are presented in the plots Coefficients b 0 045 b 1 006 r 0 991 N 280 HemoCue WBC x10 L Sysmex XS 1000i x10 L Figure 1 Point of Care 47 HemoCue WBC x10 L Coefficients b 0 263 b 1 042 r 0 995 N 116 Sysmex XS 1000i x10 L Figure 2 Clinical Laboratory When a capillary skin puncture is performed several defense systems in the body are activated very quickly These defense systems cause an increase in the number of WBCs in the blood closest to the wound leading to greater differences in results from several samples taken from the same finger stick A study was performed on the HemoCue WBC system in which possible in
13. 50 Guidance and manufacturer s declaration Electromagnetic immunity The HemoCue systems are intended for use in the electromagnetic environment specified below The customer or user of the HemoCue systems should assure that it is used in such an environment Immunity test IEC 60601 test level Compliance level Electromagnetic environment guidance Electrostatic discharge 6 kV contact 6 kV contact Floors should be wood concrete or ESD ceramic tile If floors are covered with IEC 61000 4 2 8 kV air 8 kV air synthetic material the relative humidity should be at least 30 Electrical fast transient 2 kV for power supply 2 kV for power Mains power quality should be that of burst lines supply lines a typical commercial or hospital environ ment IEC 61000 4 4 1 kV for input output 1 kV for input lines output lines Surge 1 kV differential mode 1 kV differen Mains power quality should be that of tialmode a typical commercial or hospital environ IEC 61000 4 5 ment Voltage dips short lt 5 U gt 95 dip in U lt 5 U gt 95 Mains power quality should be that of interruptions and for a 0 5 cycle dip in U fora a typical commercial or hospital environ voltage variations on 0 5 cycle ment power supply lines 40 U 60 dip in U for 5 cycles 40 U 60 dip If the user of the HemoCue systems image IEC 61000 4 11 in U for 5 cycles intensifier requires continued operation 70 U 30 dip in U during po
14. ation distance for the higher frequency range applies NOTE 3 These guidelines may not apply in all situations Electromagnetic propagation is affected by absorption a b and reflection from structures objects and people Field strengths from fixed transmitters such as base stations for radio cellular cordless telephones and land mobile radios amateur radio MA and FM radio broadcast and TV broadcast cannot be predicted theoretically with accuracy To assess the electromagnetic environment due to fixed RF transmitters an electromagnetic site survey should be considered If the measured field strength in the location in which the HemoCue systems are used exceeds the applicable RF compliance level above the HemoCue systems should be observed to verify nor mal operation If abnormal performance is observed additional measures may be necessary such as re orienting or relocating the systems Over the frequency range 150 KHz to 80 Mhz field strength should be less than 3 V m 53 Technical specifications EMC RF Use only cables with the following specification USB shielded maximum 2 m Serial shielded maximun 1 5 m Guidance and manufacturer s declaration electromagnetic emissions The HemoCue systems are intended for use in the electromagnetic environment specified below The customer or the user of the HemoCue systems should assure that it is used in such an environment Emission test Compliance Electromagnetic environment gu
15. berpr fen Sie vor der Durchf hrung von Wartungsarbeiten ob der Analyzer V rifier avant la maintenance que Vanalyseur est teint et que rien ausgeschaltet ist Das Display darf nichts anzeigen 1 5 Der K vettenhalter sollte t glich 1 nach Gebrauch gereinigt werden Ziehen Sie den beweglichen K vet tenarm in seine Ladeposition Entfernen Sie den K vettenhalter 2 indem Sie ihn gerade herausheben Reinigen Sie den K vettenhalter 3 mit Alkohol 20 70 oder einem milden Reinigungsmittel HINWEIS Der K vettenhalter kann nicht autoklaviert werden Wenn die optischen Teile verschmutzt 4 sind wird ein Fehlercode angezeigt Um die optischen Teile zu reinigen schieben Sie einen HemoCue Cleaner in die ffnung des K vettenhalters Bewegen Sie ihn 5 10 Mal heraus und wieder hinein Sollte der Reiniger verschmutzt sein wiederholen Sie das Verfahren mit einem neuen Reiniger Vergewissern Sie sich dass der Reini ger die Teile gem 4a erreicht Warten Sie 15 Minuten bevor Sie 5 den Kuvettenhalter wieder ein setzen Vergewissern Sie sich dass sich der bewegliche K vettenarm in seiner Ladeposition befindet bevor Sie den K vettenhalter wieder einsetzen Die Oberfl che kann mit Alkohol 20 70 oder einem milden Reinigungsmittel gereinigt werden Ein HemoCue Cleaner ist im Lieferum fang des Analyzers enthalten Um weitere Un tampon HemoCue Cleaner est n apparait sur V cran
16. crocuvette is filled with sample Measured value exceeds 30 0 x10 L NOTE Results exceeding the HHH limit should be verified with 30000 mm 30000 uL a suitable laboratory method and be questioned as to the pathological condition of the patient 29 symptom explanation Action No characters on the display 1 Power is not received 1a Check that the power adapter is properly connected to the 2 If on battery power the batteries need to be analyzer and the AC power supply as described in the Start Up replaced section 3 The display is out of order 1b Check that the cable is not damaged 2 Replace the batteries six type AA as described in the Start Up section 3 The analyzer needs service Contact your local distributor The display gives erroneous 1 The display is out of order 1 2 The analyzer needs service Contact your local distributor characters 2 The microprocessor is out of order The display shows FIR General analyzer software error a Remove and replace all cables and or batteries and restart as described in the Start Up section b The analyzer needs service Contact your local distributor The display shows 4 N 1 The batteries need to be replaced 1 Turn off the analyzer and replace the batteries six type AA 2 If on AC power the power adapter or the as described in the Start Up section circuit board is out of order 2a Check that the correct power adapter is used and properly connec
17. d the control material If the problem continues contact the properly and or is not at room temperature manufacturer of the control material 5 The control material is not suitable for use with 4 Make sure that the control material is mixed properly and the HemoCue WBC system at room temperature If the problem continues contact the manufacturer of the control material 5 Contact your local distributor for control material Information 31 Specifications Intended Purpose Intended Use The HemoCue WBC system is indicated for use for quan titative determination of white blood cell WBC count in capillary or venous whole blood The HemoCue WBC system is for In Vitro Diagnostic use only The HemoCue WBC Analyzer is only to be used with HemoCue WBC Microcuvettes The HemoCue WBC system is indicated for use in clinical laboratories and for point of care settings IVD Medical Device Directive The HemoCue WBC system complies with the IVD Medical Device Directive 98 79 EC and carries the CE mark Principles of the Method Procedure Principle of the method A hemolyzing agent lyses the red cells in the microcu vette and a staining agent colors the white cells An image is taken of the stained white cells and the number of cells is counted by image analysis in the analyzer Principle of the procedure The microcuvette serves as a sample container and reac tion chamber The microcuvette is for single use only A blood sample of approx
18. e Eviter les doigts portant des bagues 3 Nettoyer l extr mit du doigt avec un d sinfectant et laisser s cher ou essuyer avec un chif fon sec et non pelucheux 4 Avec le pouce presser douce ment le doigt de l articulation vers l extr mit O Behandel bloedmonsters altijd voor zichtig aangezien deze mogelijk infectieus zijn Neem de geldende milieuvoorschriften in acht bij het afvoeren van afval Draag altijd be schermende handschoenen tijdens het werken met bloedmonsters De microcuvette is bestemd voor eenmalig gebruik 1 Om een test met capillair bloed uit te voeren moet de cuvet tehouder zich in de laadpositie bevinden In het display verschij nen drie knipperende streepjes en het HemoCue symbool Neem een HemoCue WBC Microcuvette uit de verpakking 2 Zorg dat de hand van de pati nt warm en ontspannen is Gebruik alleen de middel of ringvinger voor het nemen van een mon ster Vermijd vingers met een ring 3 Maak de vingertop schoon met een desinfecterend middel en laat de vingertop volledig drogen of veeg deze af met een droge pluisvrije doek 4 Druk met uw duim licht op de vinger vanaf de bovenzijde van de knokkel in de richting van de vingertop 5 Sample at the side of the fingertip 6 While applying light pressure towards the fingertip puncture the finger using a lancet 7 Wipe away the first two or three drops of blood 8 Re apply light pressure towards the finge
19. einig de cuvettehouder met alcohol 20 70 of een mild reinigingsmiddel OPMERKING De cuvettehouder kan niet in de autoclaaf worden gesteriliseerd 4 Als het optische gedeelte vuil wordt wordt een foutmelding weergegeven Om het optische gedeelte schoon te maken duwt u een HemoCue Cleaner in de opening van de cuvettehouder Beweeg de cleaner 5 10 keer heen en weer Als de cleaner vuil is deze procedure met een nieuwe cleaner herhalen Zorg ervoor dat de cleaner tot aan het gedeelte komt dat in afbeelding 4a wordt weergegeven 5 Wacht 15 minuten voordat u de cuvettehouder terugplaatst Zorg ervoor dat de cuvettehouder zich in de laadpositie bevindt voordat u de cuvettehouder terugplaatst Het deksel kan worden schoonge maakt met alcohol 20 70 of een mild reinigingsmiddel E n HemoCue Cleaner wordt met de analyser meegeleverd Neem contact op met uw leverancier om nieuwe exemplaren te bestellen Troubleshooting Guide If you are unable to resolve the problem by following this Troubleshooting Guide please contact your local HemoCue distributor or HemoCue AB The Analyzer should be cleaned as described in the Maintenance section prior to service or disposal Consult local environmental authorities for proper disposal The Analyzer has no serviceable parts NOTE Do not open the cover of the Analyzer symptom Explanation AOR OOS Err01 A portion of the image area is unable to be 1 Take a new microcuvette and repeat t
20. ende druppel bloed verschijnt Gebruik voor voldoende bloed stroom bij voorkeur lancetten met een veer die een punctiediepte heb ben van minstens 2 mm 9 When the blood drop is large enough fill the microcuvette in one continuous process Do NOT refill NOTE Make sure that the microcuvette is filled from the tip placed at about a 45 degree angle towards the blood drop according to the picture on page 18 10 Wipe off excess blood from the outside of the microcuvette with a clean lint free wipe Do not touch the open end of the microcuvette 11 Look for air bubbles in the filled microcuvette If present discard the microcuvette and fill a new microcuvette from a new drop of blood Small bubbles around the edge can be ignored NOTE Make sure that the microcuvette is filled accord ing to picture 9 on page 18 since an improper filling angle might cause air bubbles to be introduced NOTE If a second sample is to be taken it is important that this is done after the measurement of the first sample is complete Wipe away the remains of the drop of blood and fill the second microcuvette from a new drop of blood as per steps 7 11 above 9 Wennder Bluttropfen groB genug ist f llen Sie die Mikro k vette ohne abzusetzen Die K vette darf NICHT nachbef llt werden HINWEIS Stellen Sie si cher dass die Mikrok vette von der Spitze aus gef llt wird die ungef hr in einem 45 Grad Win kel zu dem Bluttropfe
21. ent Part 1 General requirements for Safety Part 1 2 Collateral Standard Electromagnetic compability requirements and tests Recommended separation distance between Port able and mobile RF communications equipment and HemoCue WBC Analyzer The HemoCue systems are intended for use in an electro magnetic environment in which radiated RF disturbances are controlled The customer or the user of HemoCue systems can help prevent electromagnetic interference by maintaining a minimum distance between portable and RF communications equipment transmitters and HemoCue systems as recommended below according to the maximum output power of the communications equipment Rated Separation distance according to maximum frequency of transmitter m 150 kHz 80 MHz 800 MHz to 80 MHz to 800 MHz to 2 5 GHz d 1 2VP d 1 2VP d 2 3 P output power of transmitter For transmitters rated at maximum output power not listed above the recommended separation distances d in meters m can be estimated using the equation ap plicable to the frequency of the transmitter where P is the maximum output power rating of the transmitter in watts W according to transmitter manufacturer NOTE 1 At 80 MHz and 800 MHz the separation dis tance for the higher frequencyrange applies NOTE2 These guidelines may not apply in all situ ations Electromagnetic propagation is affected by absorption and reflection from structures objects and people
22. er bewegliche K vettenarm in der Messposi tion befindet wird das letzte 6 Ergebnis angezeigt Zum Ausschalten des Analyzers halten Sie die Taste gedr ckt bis auf der Anzeige zun chst OFF und dann gar nichts mehr angezeigt wird Wenn der Ana lyzer ber Batterien betrieben jedoch nicht verwendet wird schaltet er sich nach etwa 5 Mi nuten automatisch aus Wenn er ber das Netzteil betrieben wird schaltet er sich nach zwei Stunden aus 11 Appuyer sur la touche et la maintenir enfonc e jusqu l activation de l cran tous les symboles s affichent L ana lyseur effectue un autocontr le Au bout de 10 secondes envi ron trois tirets clignotants et le symbole HemoCue apparaissent l cran Cela indique que l analyseur est pr t l emploi Si le bras mobile de la cuvette est en position de mesure le r sultat le plus r cent s affiche Pour teindre l analyseur appuyer sur la touche et main tenir la pression jusqu ce que l cran affiche OFF et s teigne L analyseur s arr te automati quement lorsqu il fonctionne sur piles et qu il n est pas utilis pendant cinq minutes En cas de branchement secteur il s teint au bout de deux heures O 4 Druk op de knop en houd deze ingedrukt totdat het display is geactiveerd alle symbolen verschijnen op het display De analyser voert een zelftest uit Na ongeveer 10 seconden toont het display drie knipperende streepjes en het HemoCue s
23. fluences of capillary sampling technique were included see Figure 3 below 30 Coefficients b 0 066 b 1 033 r 0 972 2 N 119 HemoCue WBC x10 L D 5 10 15 20 25 30 Sysmex XS 1000i x10 L Figure 3 Capillary Sampling Technique An additional study has been performed at a clinical reference laboratory in the U S including a large number of blood samples in order to evaluate the HemoCue WBC system for expected demographic variations age gen der geographics in the population see Figure 4 below 30 Coefficients b 0 451 25 b 0 970 r 0 994 2 N 178 15 10 HemoCue WBC x10 L O 5 10 15 20 30 Beckman Coulter x109 L Figure 4 Demographic Sample Population Interference Studies Interference studies were performed according to CLSI Document EP07 The following substances have not been found to interfere with the HemoCue WBC system The highest concentration or percentages tested is referred to in brackets Acetaminophen 20 mg dL ascorbic acid 6 mg dL ibuprofen 50 mg dL caffeine 308 pmol L creatinine urea 30 mg dL 500 mg dL salicylic acid 60 mg dL tetracycline 30 mg dL unconjugated bilirubin 342 umol L conjugated bilirubin 380 pmol L dex tran 40 30 g L osmolality 167 mmol L HbCO 30 methemoglobin 50 Yo thrombocytes 2000 x10 g L lipemia intralipid 3100 mg L which corresponds to triglycerides approximately 10 5 mmol L
24. he measurement as analyzed described in the Measuring section 1 Due to measurement error 2 NOTE The blood sample should be verified with a suitable 2 Due to abnormal sample laboratory method and be questioned as to the pathological condition of the patient Err02 Uneven spatial distribution of detected cells Take a new microcuvette and repeat the measurement as described in the Measuring section Err03 Image or part of the image area is detected as Take a new microcuvette and repeat the measurement as out of focus described in the Measuring section Err30 1 Optical parts dirty 1a Turn off the analyzer and clean the optical parts as 2 Optical parts wet after cleaning described in the Maintenance section 1b If the problem continues the analyzer needs service Contact your local distributor 2 Wait 15 minutes before turning on the analyzer after cleaning to make sure that the optical parts are dry Err33 Empty microcuvette not filled with sample Take a new microcuvette and repeat the measurement as described in the Measuring section and make sure that the microcuvette is filled with sample Err34 Stray light detected a Turn off the analyzer and make sure the analyzer is not exposed to any bright light sources b If the problem continues the analyzer needs service Contact your local distributor Err35 The battery power is too low Turn off the analyzer a Replace the batteries six type AA as described in the Start U
25. idance RF emissions Group 1 The HemoCue systems uses RF energy only for its internal function Therefore its RF emis sions are very low and not likely to cause any interference in nearby electronic equipment RF emissions Class B The HemoCue systems are suitable for use in all establishments including domestic es e er tablishments and those directly connected to Harmonie emissions the public low voltage power supply network IEC 61000 3 2 that supplies buildings used for domestic Voltage fluctuations flicker Complies purposes emissions IEC 61000 3 3 54 Adapters Country EU US GB Type FW73335M 12 Input 100V 240 V 50 60 Hz 200 mA Country EU US GB Type HCAO1 Input 100 V 240 V 50 60 Hz lt 500 mA Warning The device is tested according to standard IEC EN 60601 1 2 and is found to comply with the standard Despite this compliance it is impossible to predict any possible effects by other nearby standing instruments stationary portable or mobile units or the possible impact of electromagnetic radiance This is the reason we need to inform users of this Analyzer that disturbance from other equipment might affect the performance of the Analyzer Should you note that this is the fact please contact your local HemoCue distributor The HemoCue WBC is intended for use in the electro magnetic environment specified in Technical specifica tions The customer or user of the HemoCue WBC system should assure that i
26. image de la page 22 Effectuer Vanalyse en suivant les ta pes 10 a 16 d crites pages 19 a 21 O Behandel bloedmonsters altijd voor zichtig aangezien deze mogelijk infectieus zijn Neem de geldende milieuvoorschriften in acht bij het afvoeren van afval Draag altijd be schermende handschoenen tijdens het werken met bloedmonsters De microcuvette is bestemd voor eenmalig gebruik 1 Als het monster veneus bloed in een koelkast is bewaard dient het eerst op kamertemperatuur 15 35 C te komen voordat het wordt gemengd Meng de buizen met het monster van veneus bloed gedurende ten minste twee minuten grondig in een mechanische mixer of keer de buis 10 20 keer verticaal met de hand Volg voor controlema teriaal altijd de instructies die de fabrikant heeft geleverd 2 Breng met een pipet of ander geschikt overbrengingsmiddel een druppel bloed of controle materiaal aan op een hydrofobe ondergrond bijv plastic folie 3 Vul de microcuvette in n keer NOOIT bijvullen OPMERKING Zorg ervoor dat de microcuvet te vanuit de top wordt gevuld en in een hoek van ongeveer 45 graden ten opzichte van de druppel staat zie de afbeelding op pagina 22 Voer de meting uit zoals beschreven in stappen 10 16 op pagina 19 21 Set up Printer function Einstellung Druckerfunktion Configuration Mode impression Set up Printerfunctie O O Om Printer 24 Only the current result can be trans ferred to the printer
27. imately 10 uL is drawn into the cavity by capillary action The microcuvette is placed in the analyzer The result is obtained within 3 minutes The system was designed and developed to establish agree ment with the manual light microscopy method for white blood cell count The system is factory calibrated and needs no further calibration Warning and Precaution The microcuvettes are for n Vitro Diagnostic use only Always handle blood specimens with care as they may be infectious Consult local environment authorities for proper disposal Always wear protective gloves when handling blood specimens The microcuvettes are for single use only 44 Storage and Handling HemoCue WBC Microcuvettes The Microcuvettes are to be stored at 15 35 C 59 95 F lt 90 non condensing humidity Once the seal of the vial is broken the microcuvettes are stable for 3 months An unopened vial of microcuvettes can be stored for a shorter period of time 4 weeks outside the specified storage conditions down to 0 C 32 F and up to 50 C 122 F lt 90 non condensing humidity Allow the microcuvettes to reach 15 35 C 59 95 F before use Use the microcuvettes prior to the expiration date that is printed on the package Keep the vial properly closed All unused microcuvettes should remain in the original package HemoCue WBC Analyzer The analyzer can be stored in temperatures between 0 50 C 32 122 F lt 90 non condensing humidi
28. inical laboratories and for point of care settings All system components are designed and manufactured to provide maximum safety Any other use of the system than indicated may impair the safety Vielen Dank daf r dass Sie sich f r das HemoCue WBC System entschieden haben Das System dient der Bestimmung der Anzahl an wei en Blutk rperchen WBK englische Abk rzung WBC in kapillarem oder ven sem Vollblut Das HemoCue WBC System ist nur f r den n Vitro diagnostischen Gebrauch bestimmt Der HemoCue WBC Analyzer darf nur in Verbindung mit HemoCue WBC Microcuvettes verwendet werden Das HemoCue WBC System ist zur Verwendung in klinischen Laboratorien und im POCT vorgesehen Bei Entwicklung und Herstellung aller Systemkomponenten wird auf maximale Sicherheit geachtet Wenn das System nicht wie angegeben verwendet wird kann dies die Sicherheit beeintr chtigen Merci d avoir choisi le systeme HemoCue WBC Lutilisation du syst me est indiqu e pour d terminer la quantit de globules blancs WBC white blood cell dans le sang capillaire ou le sang veineux total Le syst me HemoCue WBC est destin au diagnostic in vitro uniquement L appareil He moCue WBC Analyzer doit amp tre utilis exclusivement avec les consommables HemoCue WBC Microcuvettes Le systeme HemoCue WBC est utilis e en laboratoire ou directement au lit du patient Tous les composants du systeme sont concus et fabriqu s de mani re a assurer une s curit maximale Tout a
29. la microcuvette 11 V rifier que la microcuvette remplie ne contient pas de bulles d air S il y en a jeter la microcuvette et pr lever un nouvel chantillon avec une nouvelle microcuvette De petites bulles d air en p ri ph rie peuvent tre ignor es REMARQUE bien remplir la microcuvette conform ment a l image 9 de la page 18 Un angle de remplissage inadapt pourrait entrainer l introduc tion de bulles d air REMARQUE si un second chan tillon doit amp tre pr lev il est impor tant de le faire apr s avoir termin la mesure du premier Nettoyer les restes de la goutte de sang et rem plir la seconde microcuvette d une nouvelle goutte de sang en suivant les tapes 7 a 11 qui pr c dent O 9 Als de druppel groot genoeg is de microcuvette in een keer vullen NOOIT bijvullen OPMERKING Zorg ervoor dat de microcuvette vanuit de top wordt gevuld en in een hoek van ongeveer 45 graden ten op zichte van de druppel staat zie de afbeelding op pagina 18 10 Veeg het overtollige bloed van de buitenkant van de micro cuvette weg met een schone pluisvrije doek Raak het open uiteinde van de microcuvette niet aan 11 Controleer de gevulde micro cuvette op luchtbellen Als er luchtbellen zijn dient u de microcuvette weg te gooien en een nieuw exemplaar met een nieuwe druppel bloed te vullen Kleine belletjes tegen de rand kunnen worden genegeerd OPMERKING Zorg ervoor dat de microcuvette word
30. n gehalten wird siehe Bild auf Seite 18 10 Wischen Sie bersch ssiges Blut au en an der Mikrok vette mit einem sauberen fusselfreien Tuch ab ohne dabei die ff nung der K vette zu ber hren 11 berpr fen Sie die gef llte K vette auf Luftblasen Sollten Luftblasen vorhanden sein ent sorgen Sie die Mikrok vette und f llen Sie eine neue Mikrok vette mit einem neuen Tropfen Blut Kleinere Luftbl schen an den R ndern sind ohne Bedeu tung HINWEIS Stellen Sie sicher dass die Mikrok vette gem Bild 9 auf Seite 18 gef llt wird da ein nicht ordnungsgem er F llwinkel zum Einziehen von Luftblasen f hren k nnte HINWEIS Wenn eine zweite Probe entnommen werden soll achten Sie darauf dass dies erst erfolgen darf nachdem die Messung der ersten Probe abgeschlossen ist Wischen Sie Reste des Bluttropfens weg und f l len Sie die zweite Mikrok vette aus einem neuen Bluttropfen wie in den Schritten 7 11 oben beschrieben 19 9 Quand la goutte de sang est assez grande laisser la microcuvette se remplir d un seul trait NE JAMAIS la remplir une seconde fois REMARQUE v rifier que l extr mit de la microcuvette est plac e a un angle d environ 45 degr s vers la goutte de sang comme sur l image de la page 18 10 Nettoyer la surface externe de la microcuvette pour liminer toute trace de sang a l aide d un chiffon propre et non pelu cheux Ne pas toucher l extr mit ouverte de
31. oCue AB Box 1204 SE 262 23 Angelholm Sweden Phone Fax E mail info HemoCue se www HemoCue com 46 775 70 02 10 46 775 70 02 12 9 HEMOCUE A Quest Diagnostics Company HemoCue AB Box 1204 SE 262 23 ngelholm Sweden Phone 46 775 70 02 10 Fax 46 775 70 02 12 info hemocue se www hemocue com 903007 081023 GB DE FR NL
32. oksymbool 3 Druk snel op de knop om het signaal in of uit te schakelen Als de instelling is voltooid drukt u ongeveer 3 seconden op de knop totdat het symbool niet meer knip pert De analyser keert nu terug naar de Gereed modus Measuring Capillary blood Messung Kapillarblut Mesure Sang capillaire Meting Capillair bloed 14 Always handle blood specimens with care as they might be infec tious Consult local environmental authorities for proper disposal Always wear protective gloves when handling blood specimens The mi crocuvette is for single use only 1 To perform a test the cuvette moving arm should be in its loading position The display will show three flashing dashes and the HemoCue symbol Take a HemoCue WBC Microcuvette from the vial 2 Make sure the patient s hand is warm and relaxed Use only the middle or ring finger for sampling Avoid fingers with rings on 3 Clean fingertip with disinfec tant and allow to dry com pletely or wipe off with a dry lint free wipe 4 Using your thumb lightly press the finger from the top of the knuckle towards the tip Gehen Sie stets sorgsam mit Blut proben um da diese infekti s sein k nnten Zur ordnungsgem en Entsorgung beachten Sie die Be stimmungen der rtlichen Umwelt beh rde Tragen Sie beim Umgang mit Blutproben stets Schutzhand schuhe Die Mikrok vetten sind nur zur einmaligen Verwendung vorgesehen 1 Zur Durchf hrung eine
33. op de analyser en de ASCII printer voordat u de test uitvoert 2 Voer de meting uit 3 Wanneer het resultaat op het display wordt getoond drukt de printer het resultaat auto matisch af Niet inbegrepen De volgende instellingen van de COM poort worden gebruikt Baud rate 9600 Databits 8 Pariteit Geen Stopbits 1 Flowcontrol Geen Maintenance Wartung Maintenance Onderhoud Before performing maintenance make sure that the analyzer is turned off and that the display is blank 1 The cuvette holder should be cleaned after each day of use Pull the cuvette moving arm to its loading position 2 Remove the cuvette holder by lifting it straight up 3 Clean the cuvette holder with alcohol 20 70 or mild deter gent NOTE The cuvette holder cannot be autoclaved 4 Ifthe optical parts becomes dirty an error code will be displayed To clean the optical parts push a HemoCue Cleaner into the opening of the cuvette holder Move from side to side 5 10 times If the cleaner is stained repeat with a new cleaner Make sure that the cleaner reaches the parts accord ing to 4a 5 Wait 15 minutes before replac ing the cuvette holder Make sure that the cuvette moving arm is in its loading position before replacing the cuvette holder The cover may be cleaned with alcohol 20 70 or a mild detergent One HemoCue Cleaner is included with the Analyzer Contact your local distributor to order more
34. p section b Use the power adapter as described in the Start Up section 28 Symptom Explanation Acten General hardware error a Turn off the analyzer and turn it on again after 30 seconds Take a new microcuvette and repeat the measurement as described in the Measuring section b If the problem continues the analyzer needs service Contact your local distributor Self test error during start up of analyzer a Turn off the analyzer and turn it on again after 30 seconds Take a microcuvette and perform the measurement as described in the Measuring section b If the problem continues the analyzer needs service Contact your local distributor Blanking test failed for other reasons than Err30 a Turn off the analyzer and turn it on again after 30 seconds Err34 Take a new microcuvette and repeat the measurement as described in the Measuring section b If the problem continues the analyzer needs service Contact your local distributor Empty cuvette holder Take a microcuvette and perform the measurement as described in the Measuring section 1 Measured value is below 0 3 x10 L 1 NOTE Results exceeding the LLL limit should be verified 300 mm 300 uL with a suitable laboratory method and be questioned as to the 2 Empty microcuvette not filled with sample pathological condition of the patient 2 Take a new microcuvette and repeat the measurement as described in the Measuring section and make sure that the mi
35. rtip until another drop of blood appears Spring loaded lancets with a puncture depth of at least 2 mm are prefered to produce a sufficient blood flow 5 Nehmen Sie die Blutprobe seit lich an der Fingerspitze 6 Drucken Sie leicht zur Finger spitze hin und punktieren Sie den Finger mit einer Lanzette 7 Wischen Sie die ersten zwei oder drei Bluttropfen ab 8 Dr cken Sie wieder leicht zur Fingerspitze hin bis ein wei terer Bluttropfen austritt Lanzetten die durch eine Feder vorgespannt sind und eine Einstich tiefe von mindestens 2 mm haben werden bevorzugt um eine ausrei chenden Blutfluss zu erzielen 17 5 Pr lever l chantillon sur la face laterale de l extr mit du doigt 6 En pressant doucement vers l extr mit du doigt piquer le point de pr l vement avec une lancette 7 Essuyer les deux ou trois premi res gouttes de sang 8 Exercer de nouveau une l g re pression sur l extr mit du doigt pour faire appara tre une nou velle goutte de sang Des lancettes ressort d une pro fondeur de pr l vement d au moins 2 mm sont pr f rables pour obtenir un flux sanguin suffisant Cu 5 Neem het monster aan de zij kant van de vingertop af 6 Oefen een lichte druk uit in de richting van de vingertop en prik in de vinger met een lancet 7 De eerste 2 of 3 druppels bloed wegvegen 8 Handhaaf de lichte druk in de richting van de vingertop tot er een volg
36. s Tests sollte sich der bewegliche K vettenarm in seiner Ladepositi on befinden Auf der Anzeige erscheinen drei blinkende Stri che und das HemoCue Symbol Nehmen Sie eine HemoCue WBC Microcuvette aus der Dose 2 Stellen Sie sicher dass die Hand des Patienten warm und ent spannt ist Verwenden Sie f r die Probenentnahme nur den Mittel oder Ringfinger Achten Sie darauf dass sich am Finger kein Ring befindet 3 Reinigen Sie die Fingerkuppe mit einem Desinfektionsmittel Warten Sie bis sie wieder ganz trocken ist oder wischen Sie sie mit einem trockenen fussel freien Tuch ab 4 Dr cken Sie den Finger mit Ihrem Daumen mit leichtem Druck vom Kn chel zur Spitze hin 15 Pour viter tout risque de contami nation il est recommand de mani puler les chantillons de sang avec la plus grande pr caution Consulter les autorit s locales comp tentes en mati re d environnement pour conna tre les m thodes d limina tion ad quates Toujours mettre des gants de protection avant de manipuler des chantillons de sang La microcuvette est usage unique 1 Pour effectuer un test le bras mobile de la cuvette doit se trouver en position de charge Trois tirets clignotants et le sym bole HemoCue apparaissent a V cran Retirer le consommable HemoCue WBC Microcuvette du flacon 2 S assurer que la main du patient est chaude et d tendue Le pr levement devra tre effec tu sur le majeur ou Vannulair
37. schei nen Kai drei feststehende Stri che und das HemoCue Symbol Nach etwa 3 Minuten wird der WBK Wert angezeigt Das Er gebnis bleibt im Display stehen so lange sich der bewegliche K vettenarm in der Messpositi on befindet Die gef llte Mikro k vette kann nicht ein zweites Mal gemessen werden Gehen Sie stets sorgsam mit Blutproben um da diese infekti s sein k nnten Zur ordnungsgem en Entsorgung beachten Sie die Bestimmungen der rtlichen Umweltbeh rde 21 12 13 14 15 16 Placer la microcuvette remplie dans le support de cuvette dans les 40 secondes qui suivent le remplissage Pousser doucement le bras mo bile de la cuvette en position de mesure glissera automatique ment en position de mesure La mesure d marre Au cours de la mesure x trois tirets et le symbole HemoCue apparaissent a l cran Au bout de 3 minutes environ le taux de globules blancs s af fiche Le r sultat reste affich tant que le bras mobile de la cu vette est maintenu en position de mesure Ne pas effectuer de nouvelle mesure avec la micro cuvette remplie Pour viter tout risque de contamination il est recom mand de manipuler les chan tillons de sang avec la plus grande pr caution Consulter les autorit s locales comp ten tes en mati re d environnement pour connaitre les m thodes d elimination ad quates Cu 12 13 14 1 16 Plaats de gevulde microc
38. t gevuld zoals in afbeelding 9 op pagina 18 is te zien omdat door het vullen in een onjuiste hoek luchtbellen in de microcuvette kunnen komen OPMERKING Als u een tweede monster moet nemen dient u altijd eerst de meting van het eerste mon ster te voltooien Veeg de restanten van de druppel bloed weg en vul een tweede microcuvette met een nieuwe druppel bloed zoals hierbo ven beschreven in de stappen 7 11 12 13 14 15 16 Place the filled microcuvette in the cuvette holder within 40 seconds after filling Gently push the cuvette moving arm towards the measuring po sition It will automatically slide to the measuring position and the measurement starts During the measurement Sal three fixed dashes and the HemoCue symbol will be shown After approximately 3 minutes the WBC value is displayed The result will remain on the display as long as the cuvette moving arm is in the measuring position Do not remeasure the filled microcuvette Always handle blood speci mens with care as they might be infectious Consult local environmental authorities for proper disposal 12 13 14 15 16 Setzen Sie die gef llte Mikrok vette innerhalb von 40 Sekun den nach dem F llen in den K vettenhalter ein Schieben Sie den beweglichen K vettenarm vorsichtig in Richtung der Messposition Er gleitet automatisch in die Messposition und die Messung beginnt W hrend der Messung er
39. t is used in such an environment The HemoCue WBC Analyzer uses RF energy only for its inter nal function Therefore its RF emissions are very low and not likely to cause any interference in nearby electronic equipment The HemoCue WBC system is suitable for use in all establishments including domestic establishments and those directly connected to the public low voltage power supply network that supplies buildings used for domestic purposes Accessory equipment connected to the analog and dig ital interfaces must be certified according to the respec tive IEC standards i e IEC 60950 1 for data processing equipment and IEC 60601 1 for medical equipment 55 Furthermore all configurations must comply with the system standard IEC 60601 1 1 Connections of additional equipment to the signal input or signal output connec tions is deemed to be configuring a medical system and therefore assumes responsiblity for the systems compliance within the requirements of IEC 60601 1 1 For further information please contact your local distributor Warranty The Analyzer carries a 24 month warranty from the day of receipt After the expiration date of the warranty service such as maintenance and repairs are offered ata fixed price Service and Disposal The Analyzer should be cleaned as recommended under Maintenance prior to service or disposal Consult local environmental authorities for proper disposal Spare Parts and Accessories
40. ted and working as described in the Start Up section 2b The analyzer needs service Contact your local distributor The display does not switch The cuvette holder sensor is out of order The analyzer needs service from Band WbC to three Contact your local distributor flashing dashes and ready for measuring The cuvette holder is not The magnet in the cuvette holder is missing The analyzer needs service moving into the correct Contact your local distributor position Measurement on patient 1 Improper sampling technique 1 Take a new microcuvette and repeat the measurement as samples are higher or lower 2 The microcuvettes are beyond their expiration described in the Measuring section than antipicipated date damaged or have been improperly stored 2 Check the expiration date and the storage conditions of the microcuvettes 30 Symptom Explanation Acton S Measurement on control 1 Improper sampling technique 1 Take a new microcuvette and repeat the measurement as materials are out of range 2 The microcuvettes are beyond their expiration described in the Measuring section either too high or too low date damaged or have been improperly stored 2 Check the expiration date and the storage conditions of the 3 The control material is beyond its expiration microcuvettes date or has been improperly stored 3 Check the expiration date and the storage conditions of 4 The control material has not been mixe
41. the Adapters section If AC power is available plug the supplied power adapter into the power inlet at the back of the Analyzer If no power is available insert sixtype AA batteries 1 5 V To open the battery lid on the left side of the Analyzer press on the ribbed marking engraved on the battery lid and slide it backwards until it opens Gently take out the battery holder Place the batteries in the battery holder observing the indication of polarity Put the battery holder back in the bat tery compartment and close the lid Consult local environmental authorities for proper disposal of batteries Pull the cuvette moving arm out to the loading position d Verwenden Sie nur die im Abschnitt Netzteile der Tech nischen Daten angegebenen Netzteile Wenn eine Wechselstromver sorgung verf gbar ist schlie Ben Sie das mitgelieferte Netzteil an den Stromversor gungseingang an der R ckseite des Analyzers an Wenn keine Stromversorgung verf gbar ist legen Sie die sechs AA Batterien mit 1 5 V ein Um den Deckel des Batte riefachs auf der linken Seite des Analyzers zu ffnen dr cken Sie auf die gerippte Markierung auf dem Batteriefachdeckel und schieben Sie ihn zur ck bis er sich ffnet Nehmen Sie den Batteriehalter vorsichtig heraus Legen Sie die Batte rien in den Batteriehalter und beachten Sie dabei die Hinweise zur Polarit t Legen Sie den Batteriehalter wieder zur ck ins Batteriefach und
42. the manufacturer 2 Place adrop of blood or control material onto a hydrophobic plastic or glass slide using a pi pette or other suitable transfer device 3 Fill the microcuvette in one continuous process Do NOT refill NOTE Make sure that the microcuvette is filled from the tip placed at about a 45 degree angle towards the blood drop according to the picture on page 22 Perform the analysis as per steps 10 16 on page 19 21 Gehen Sie stets sorgsam mit Blut proben um da diese infekti s sein k nnten Zur ordnungsgem en Entsorgung beachten Sie die Bestim mungen der rtlichen Umweltbe h rde Tragen Sie beim Umgang mit Blutproben stets Schutzhandschuhe Die Mikrok vetten sind nur zur ein maligen Verwendung vorgesehen 1 Falls die ven sen Blutproben im K hlschrank aufbewahrt wurden m ssen sie vor dem Mischen Raum temperatur erreichen 15 35 C Mischen Sie die Probe mit einem mechanischen Mixer mindestens 2 Minuten oder wenden Sie das R hrchen 10 20 Mal hin und her Befolgen Sie bei Kontrollmateri alien immer die Bedienungsanlei tung des Herstellers 2 Bringen Sie mit einer Pipette oder einem anderen geeigneten Hilfsmittel einen Tropfen Blut oder Kontrollmaterial auf einen hydrophoben Objekttr ger aus Kunststoff oder Glas auf 3 Bef llen Sie die K vette in einem Zug Die K vette darf NICHT nach bef llt werden HINWEIS Stellen Sie sicher dass die Mikrok vette von der Spitze aus gef llt
43. tration for a spiked sample whose CV is 20 The Func tional Sensitivity has been determined to be 0 3 x10 L James O Westgaard Basic Method Validation Limit of Blank is defined as the highest measurement result that indicates that the analyte is not present in the sample Limit of Blank has been determined to be 0 06 x10 L CLSI Document EP17 A Limitations of the Method Procedure a The measurement should be made as soon as possi ble but within 40 seconds after the blood has been drawn into the microcuvette b Do not remeasure the filled microcuvette c Mixing samples for an extended period may affect the result d Results above the measuring range will be displayed as HHH Results below the measuring range will be displayed as LLL e Studies have shown that patient samples with gt 2 nucleated red blood cells NRBCs may give falsely elevated white blood cell count Specific Performance Characteristics Additionally a study has been performed to determine Linearity the precision using fresh blood samples The study was The method used in the HemoCue WBC system has ac performed on venous whole blood samples tested in cording to the CLS Document EP06 A been demonstrated duplicate to be linear between 0 3 30 0 x10 L 300 30000 mm 300 30000 uL within 0 2 x10 L difference in 0 3 3 5 F A x10 L and within 6 difference in 3 6 30 0 x10 L Amar Magia Magia Within run and Total Precision Sysmex XS 10
44. ty Operating temperature is 15 35 C 59 95 F lt 90 non condensing humidity Allow the analyzer to reach ambient temperature before use Specimen Collection and Preparation Capillary or venous whole blood may be used EDTA anticoagulant may be used preferably in solid form to avoid dilutional effects Mix all specimen tubes thoroughly on a mechanical mixer for at least 2 minutes or invert the tube 10 20 times by hand The specimen can be stored at room temperature 15 35 C 59 95 F or in a refrigera tor 2 8 C 35 46 F for 48 hours If the specimen has been stored in a refrigerator it will be viscous and the blood should be allowed to warm up to room temperature before mixing Materials Required e HemoCue WBC Analyzer e HemoCue WBC Microcuvettes e Lancet capillary samples e Pipette or other transfer device venous samples e Lint free tissue non fraying Quality Control The HemoCue WBC Analyzer has an internal qual ity control the self test Every time the analyzer is turned on it will automatically verify the measurement performance When passing the self test the display will show the HemoCue symbol and three flashing dashes indicating that the analyzer is ready to perform a measurement An error code will be displayed if the self test fails Another part of the built in self test QC is performed for each measurement including both checks of the HemoCue WBC Analyzer but also several condition
45. utre usage du systeme peut entrainer un risque pour la s curit Hartelijk dank dat u gekozen hebt voor het HemoCue WBC systeem Het systeem is bedoeld voor de kwantitatieve bepaling van de leukocytentel ling WBC telling in capillair of veneus volbloed Het HemoCue WBC systeem is alleen bestemd voor in vitro diagnostisch gebruik De HemoCue WBC Analyzer mag alleen worden gebruikt met HemoCue WBC Microcuvettes Het HemoCue WBC systeem is bedoeld voor gebruik in klinische laboratoria en point of care situaties Alle systeemcomponenten zijn ontworpen en vervaardigd om maximale veiligheid te bieden Als het systeem voor andere doeleinden wordt gebruikt dan is aangegeven kan de veiligheid in gevaar komen Components Bestandteile El ments Onderdelen O HemoCue WBC Analyzer AC adapter or Six type AA batteries HemoCue WBC Microcuvettes HemoCue WBC Operating Manual HemoCue WBC Quick Reference Guide and Instruc tion CD 6 HemoCue Cleaner WIRUN Open the carton and lift out the analyzer and accessories and place them on a stable surface non vi brating Do not open the cover of the analyzer Not included For infomation about HemoCue WBC Microcuvettes please contact your HemoCue distributor HemoCue WBC Analyzer Netzteil oder Sechs AA Batterien HemoCue WBC Microcuvettes HemoCue WBC Bedienungsan leitung HemoCue WBC Kurzan leitung und Handbuch CD 6 HemoCue Cleaner eN ffnen Sie den
46. uvette in de cuvettehouder Dit dient binnen 40 seconden na het vul len van de cuvette te gebeuren Duw de cuvettehouder voor zichtig naar de laadpositie De houder schuift automatisch door naar de laadpositie waarna de meting begint Tijdens de meting ziet u in het display drie niet knipperen de streepjes en het HemoCue symbool De WBC waarde verschijnt na ongeveer 3 minuten Het resultaat blijft zichtbaar zolang de cuvettehouder zich in de meetpositie bevindt Meet de gevulde microcuvette niet opnieuw Behandel bloedmonsters altijd voorzichtig aangezien deze mogelijk infectieus zijn Neem de geldende milieuvoorschrif ten in acht bij het afvoeren van afval Measuring Control material or venous blood Messung Kontrollmaterial oder ven ses Blut Mesure Solution de contr le ou sang veineux Meting Controlemateriaal of veneus bloed 22 Always handle blood specimens with care as they might be infec tious Consult local environmental authorities for proper disposal Always wear protective gloves when handling blood specimens The mi crocuvette is for single use only 1 Ifthe venous blood samples has been stored in a refrigerator al low itto warm up to room tem perature 15 35 C 59 95 F before mixing Mix the venous sample tubes thoroughly on a mechanical mixer for at least 2 minutes or invert the tube 10 20 times by hand For control materials always follow instructions for use pro vided by
47. wer mains interruptions it is for 25 cycles 70 U 30 recommended that the HemoCue systems dip in U for image intensifier be powered from an lt 5 U gt 95 dip in U 25 cycles uninterruptible power supply or a battery for 5 seconds lt 5 U gt 95 For explanation of U dip in U for see NOTE 1 5 seconds 51 Immunity test IEC 60601 test level Compliance level Electromagnetic environment guidance Conducted RF 3 Vrms Portable and mobile RF communications IEC 61000 4 6 150 kHz to 80 MHz equipment should be used no closer to any part of the HemoCue systems Radiated RF 3 V m including cables than the recommended IEC 61000 4 3 80 MHZ to 2 5 GHz separation distance calculated from the equation applicable to the frequency of See NOTE 2 and NOTE 3 the transmitter Recommended separation distance d 1 2 P d 1 2NP 80 MHz to 800 MHz d 2 3 P 800 MHz to 2 5 GHz Where P is the maximum output power rating of the transmitter in watts W ac cording to the transmitter manufacturer and d is the recommended separation distance in meters m Field strengths from fixed RF transmitters as determined by an electromagnetic site survey a should be less than the compli ance level in each frequency range b Interference may occur in the vicinity of equipment marked with the following symbol a 52 NOTE 1 Uisthea c mains voltage prior to application of the test level NOTE2 At80 MHz and 800 MHz the separ
48. ymbool Dit geeft aan dat de analyser gereed is voor gebruik 5 Als de cuvettehouder zich in de meetpositie bevindt wordt het meest recente resultaat getoond 6 Om de analyser uit te zetten drukt u op de knop en houdt u deze ingedrukt totdat in het display OFF verschijnt en het display vervolgens wordt uitgeschakeld Als de analyser op batterijen werkt maar niet wordt gebruikt zal deze na ongeveer vijf minuten automa tisch worden uitgeschakeld Als de analyser op de netvoeding werkt zal de analyser na twee uur worden uitgeschakeld Set up Audio signal Einstellung Tonsignal Configuration Signal sonore Set up Geluidssignaal lt 12 If the audible signal is activated a signal will be heard when the measurement is completed or if an error code is displayed To activate or deactivate the audible signal fol low the steps below 1 Make sure that the analyzer is turned off Press the button for approximately 10 seconds 2 The display now shows a flash ing bell symbol 3 Press the button rapidly to change between signal on and off When the setting is completed press the button for approximately 3 seconds until the bell stops flash ing The analyzer will return to the ready mode Bei aktiviertem Tonsignal wird ein Tonsignal ausgegeben wenn eine Messung abgeschlossen ist oder wenn ein Fehlercode angezeigt wird Um das Signal zu aktivieren oder zu deaktivieren folgen Sie den folgenden Schritten
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