Herunterladen Inhalt Inhalt Diese Seite drucken

Werbung

HemoCue
WBC
®
Operating Manual
Bedienungsanleitung
Manuel d'utilisation
Gebruiksaanwijzing

Werbung

Inhaltsverzeichnis
loading

Inhaltszusammenfassung für HemoCue WBC

  • Seite 1 HemoCue ® Operating Manual Bedienungsanleitung Manuel d’utilisation Gebruiksaanwijzing...
  • Seite 3: Inhaltsverzeichnis

    GB/US Table of Content Inhaltsverzeichnis HemoCue WBC system ..........5 HemoCue WBC-System ..........5 ® ® Components ..............6 Bestandteile ..............6 Start Up ................8 Inbetriebnahme .............. 8 Set-up ................12 Einstellung ..............12 Audio signal ................12 Tonsignal .................12 Measuring ..............
  • Seite 4: Hemocue ® Wbc System

    GB/US 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.
  • Seite 5: Components

    Components Bestandteile Éléments Onderdelen...
  • Seite 6 HemoCue WBC Operating HemoCue WBC Bedienungsan- Manuel d’utilisation HemoCue HemoCue WBC gebruiksaan- Manual, HemoCue WBC Quick leitung, HemoCue WBC Kurzan- WBC, Guide de référence rapide wijzing, verkorte HemoCue Reference Guide and Instruc- leitung und Handbuch-CD et CD d’instructions HemoCue WBC gebruiksaanwijzing en...
  • Seite 7: Start Up

    Start up Inbetriebnahme Mise en service Starten...
  • Seite 8 GB/US Only use adapters, as listed Verwenden Sie nur die im Utiliser uniquement les Gebruik alleen adapters under Specifications, in the Abschnitt Netzteile der Tech- adaptateurs mentionnés zoals vermeld onder Adapters section. nischen Daten angegebenen dans la liste des caractéristi- ‘Specificaties’...
  • Seite 10 Striche sowie das streepjes en het HemoCue- and the HemoCue symbol. This symbole HemoCue apparaissent HemoCue-Symbol angezeigt. symbool. Dit geeft aan dat de indicates that the Analyzer is à...
  • Seite 11: Set-Up

    Set-up Audio signal Einstellung Tonsignal Configuration Signal sonore Set-up Geluidssignaal...
  • Seite 12: Messung

    GB/US If the audible signal is activated, Bei aktiviertem Tonsignal wird ein Si le signal sonore est activé, un Als het geluidssignaal is geacti- a signal will be heard when the Tonsignal ausgegeben, wenn eine signal sera émis à l’issue de la veerd, klinkt het signaal wanneer measurement is completed, or if an Messung abgeschlossen ist oder...
  • Seite 13: Measuring

    Measuring Capillary blood Messung Kapillarblut Mesure Sang capillaire Meting Capillair bloed...
  • Seite 14 Om een test met capillair bloed will show three flashing dashes Zur Durchführung eines Tests uit te voeren, moet de cuvet- and the HemoCue symbol. Take sollte sich der bewegliche Kü- Pour effectuer un test, le bras tehouder zich in de laadpositie...
  • Seite 16 GB/US Sample at the side of the Nehmen Sie die Blutprobe seit- Prélever l’échantillon sur la face Neem het monster aan de zij- fingertip. lich an der Fingerspitze. latérale de l’extrémité du doigt. kant van de vingertop af. While applying light pressure Drücken Sie leicht zur Finger- En pressant doucement vers Oefen een lichte druk uit in...
  • Seite 18 GB/US When the blood drop is large Wenn der Bluttropfen groß Quand la goutte de sang Als de druppel groot genoeg enough, fill the microcuvette genug ist, füllen Sie die Mikro- est assez grande, laisser la is, de microcuvette in één in one continuous process.
  • Seite 20: Messung

    After approximately 3 minutes, che und das HemoCue-Symbol. Au bout de 3 minutes environ, symbool. the WBC value is displayed. Nach etwa 3 Minuten wird der le taux de globules blancs s’af- De WBC-waarde verschijnt The result will remain on the WBK-Wert angezeigt.
  • Seite 21: Measuring

    Measuring Control material or venous blood Messung Kontrollmaterial oder venöses Blut Mesure Solution de contrôle ou sang veineux Meting Controlemateriaal of veneus bloed...
  • Seite 22 GB/US Always handle blood specimens Gehen Sie stets sorgsam mit Blut- Pour éviter tout risque de contamina- Behandel bloedmonsters altijd voor- with care, as they might be infec- proben um, da diese infektiös sein tion, il est recommandé de manipuler les zichtig, aangezien deze mogelijk tious.
  • Seite 23: Set-Up

    Set-up Printer function Einstellung Druckerfunktion Configuration Mode impression Set-up Printerfunctie...
  • Seite 24 GB/US Only the current result can be trans- Nur das aktuelle Ergebnis kann un- Seul le résultat le plus récent peut Alleen het huidige resultaat kan ferred to the printer directly after mittelbar nach der Messung an den être imprimé directement après la direct na de bepaling worden the measurement.
  • Seite 25: Maintenance

    Maintenance Wartung Maintenance Onderhoud...
  • Seite 26 Reinigungsmittel gereinigt werden. détergent doux. een mild reinigingsmiddel. with the Analyzer. Contact your local * Ein HemoCue Cleaner ist im Lieferum- * Eén HemoCue Cleaner wordt met de distributor to order more. fang des Analyzers enthalten. Um weitere * Un tampon HemoCue Cleaner est analyser meegeleverd.
  • Seite 27: Troubleshooting Guide

    GB/US 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.
  • Seite 28 Symptom Explanation Action Err60 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.
  • Seite 29 The display does not switch The cuvette holder sensor is out of order. The analyzer needs service.  from “ ”and “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.
  • Seite 30 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.
  • Seite 31: Anleitung Zur Fehlersuche

    Specifications GB/US Intended Purpose/Intended Use Storage and Handling The HemoCue WBC system is indicated for use for quan- HemoCue WBC Microcuvettes titative determination of white blood cell (WBC) count The Microcuvettes are to be stored at 15–35 °C in capillary or venous whole blood. The HemoCue WBC (59–95 °F), <90 % non-condensing humidity.
  • Seite 32 R&D Systems R&D HC WBC Control The measurement should be made as soon as possi- may be used. Please refer to the R&D HC WBC Control, as ble, but within 40 seconds after the blood has been well as the HemoCue WBC Operating Manual regarding drawn into the microcuvette.
  • Seite 33 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 CLSI Document EP06-A been demonstrated duplicate.
  • Seite 34 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.
  • Seite 35 U.S. including a large number These defense systems cause an increase in the number of blood samples in order to evaluate the HemoCue WBC of WBCs in the blood closest to the wound, leading to system for expected demographic variations (age, gen- greater differences in results from several samples taken der, geographics) in the population, see Figure 4 below.
  • Seite 36 Interference Studies The HemoCue WBC system has been tested for electrical Interference studies were performed according to CLSI safety and EMC according to the following standards: Document EP07. The following substances have not been • EN 60601-1:1990, A1:1993, A2:1995, A13:1996 Medical found to interfere with the HemoCue WBC system.
  • Seite 37 Rated Separation distance according to maximum frequency of transmitter (m) output 150 kHz 80 MHz 800 MHz power of to 80 MHz to 800 MHz to 2.5 GHz transmitter √ √ √ d=1.2 d=1.2 d=2.3 0.01 0.12 0.12 0.23 0.38 0.38 0.73 For transmitters rated at maximum output power not...
  • Seite 38 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...
  • Seite 39 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 3 V/m including cables, than the recommended IEC 61000-4-3 80 MHz to 2.5 GHz...
  • Seite 40 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.
  • Seite 41 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.
  • Seite 42 Analyzer. Should you note that this is the fact, please contact your local HemoCue distributor. Spare Parts and Accessories The HemoCue WBC is intended for use in the electro- The following accessories and spare parts are available: magnetic environment specified in Technical specifica- •...
  • Seite 43: Specifications

    E-mail: info@HemoCue.se www.HemoCue.com Temperature 50 °C 122 °F 0 °C 32 °F Efficiency Level References 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.
  • Seite 44 HemoCue AB, Box 1204, SE-262 23 Ängelholm, Sweden. Phone +46 775 70 02 10. Fax +46 775 70 02 12. info@hemocue.se www.hemocue.com...

Inhaltsverzeichnis