Cal-Chex Hematology Calibrator1_6\VWHP6SHFL¿F9DOXHV2 Open-vial stability LOT 5 days 3 43560195 ,QVWUXPHQW4 %HFNPDQ&RXOWHU®$&Ɣ76HULHV$&Ɣ7GLII$&Ɣ7GLII Parameter 5 :%& RBC HGB [HGB] HCT [HCT] 0&9 PLT 039 10 /L 1012/L g/dL g/L % L/L fL 109/L fL 9 8.9 4.30 11.5 115 35.6 0.356 82.8 204 9.3 Parameter 5 :%& RBC HGB [HGB] HCT [HCT] 0&9 PLT 039 109/L 1012/L g/dL g/L % L/L fL 109/L fL 8.7 4.28 11.4 114 37.3 0.373 87.2 205 9.1 Parameter 5 0.3 0.10 0.2 2 1.0 0.010 2.0 15 :%& RBC HGB [HGB] HCT [HCT] 0&9 PLT 039 NA 10 /L 1012/L g/dL g/L % L/L fL 109/L fL 9 8.7 4.31 11.6 116 34.9 0.349 81 235 9.5 10 /L 1012/L g/dL g/L % L/L fL 109/L fL 9 9.0 4.29 11.5 115 35.9 0.359 83.6 190 9.3 +/- Parameter 5 0.3 0.10 0.2 2 1.0 0.010 2.0 15 :%& RBC HGB [HGB] HCT [HCT] 0&9 PLT 039 NA 109/L 1012/L g/dL g/L % L/L fL 109/L fL 9.4 4.43 12.2 122 37.2 0.372 84 249 9.2 Parameter 5 0.3 0.10 0.2 2 1.0 0.010 2.0 15 NA :%& RBC HGB [HGB] HCT [HCT] 0&9 PLT 039 Parameter 5 0.3 0.10 0.2 2 1.0 0.010 2 15 :%& RBC HGB [HGB] HCT [HCT] 0&9 PLT +/- Parameter 5 0.3 0.10 0.2 2 1.0 0.010 2 15 :%& RBC HGB [HGB] HCT [HCT] 0&9 PLT 039 NA +/109/L 1012/L g/dL g/L % L/L fL 109/L 8.4 4.33 11.7 117 37.2 0.372 85.8 220 +/109/L 1012/L g/dL g/L % L/L fL 109/L fL 8.9 4.30 11.7 117 35.9 0.359 83.4 196 9.5 0.3 0.10 0.2 2 1.0 0.010 2.0 15 NA ,QVWUXPHQW4 Abbott CELL-DYN® 1800 ,QVWUXPHQW4 Mindray BC-3200 +/- ,QVWUXPHQW4 %HFNPDQ&RXOWHU ® LH 750/755 / LH 780/785 +/- ,QVWUXPHQW4 Abbott CELL-DYN® 1400 / 1600 / 1700 ,QVWUXPHQW4 $%;0LFURV6LHPHQV$GYLD Parameter 5 ,QVWUXPHQW4 %HFNPDQ&RXOWHU ®/+67.60$;0+P; +/- ,QVWUXPHQW4 %HFNPDQ&RXOWHU ® UniCel®'[+ :%& RBC HGB [HGB] HCT [HCT] 0&9 PLT 039 350001-47 2014-04 2015-02-04 0.3 0.10 0.2 2 1.0 0.010 2.0 15 NA 7ROHUDQFHOLPLWVDUHJXLGHOLQHVIRUHYDOXDWLQJLQVWUXPHQWGDWDDQGDFFRXQWIRULQVWUXPHQWUHSURGXFLELOLW\DQGRSHUDWRUWHFKQLTXH 0H]HWROHUDQFHMVRXYRGtWNHPNH]KRGQRFHQtLQVWUXPHQWDþQtFK~GDMĤDNY\VYČWOHQtUHSURGXNRYDWHOQRVWLLQVWUXPHQWXDWHFKQLN\RSHUiWRUD /HVOLPLWHVGHWROpUDQFHVRQWGHVJXLGHVG¶pYDOXDWLRQGHVGRQQpHVGHO¶LQVWUXPHQWHWSURXYHQWODUHSURGXFWLELOLWpDYHFO¶LQVWUXPHQWHWODWHFKQLTXHGH l’opérateur. 7ROHUDQ]JUHQ]HQ GLHQHQ DOV 5LFKWOLQLH IU GLH %HZHUWXQJ YRQ ,QVWUXPHQWHQGDWHQ XQG ]LHKHQ GLH ,QVWUXPHQWHQ:LHGHUKROEDUNHLW XQG 7HFKQLN GHV Bedieners in Betracht. I limiti di tolleranza sono linee guida per la valutazione dei dati dello strumento e incidono sulla riproducibilità dello strumento e sulla tecnica dell'operatore. 7ROHUDQVHJUHQVHUHUUHWQLQJVOLQMHUIRUHYDOXHULQJDYLQVWUXPHQWGDWDRJWDULQVWUXPHQWUHSURGXVHUEDUKHWRJEUXNHUWHNQLNNLEHWUDNWQLQJ /RVOtPLWHVGHWROHUDQFLDVRQSDXWDVSDUDHYDOXDUGDWRVGHLQVWUXPHQWRV\GHSHQGHQGHODUHSURGXFLELOLGDGGHOLQVWUXPHQWR\ODWpFQLFDGHORSHUDGRU 7ROHUDQVJUlQVYlUGHQlUULNWOLQMHUI|UXWYlUGHULQJDYLQVWUXPHQWGDWDRFKWDUKlQV\QWLOOLQVWUXPHQWUHSURGXFHUEDUKHWRFKRSHUDW|UWHNQLN 7KHEUDQGDQGSURGXFWQDPHVRIWKHLQVWUXPHQWVDUHWUDGHPDUNVRIWKHLUUHVSHFWLYHKROGHUV 1i]Y\REFKRGQtFK]QDþHNDYêURENĤSĜtVWURMĤMVRXRFKUDQQêPL]QiPNDPLMHMLFKSĜtVOXãQêFKGUåLWHOĤ/HVQRPVGHPDUTXHVHWGHSURGXLWVGHV LQVWUXPHQWVDSSDUWLHQQHQWjOHXUVGpWHQWHXUVUHVSHFWLIV'LH0DUNHQXQG3URGXNWQDPHQGHU*HUlWHVLQG:DUHQ]HLFKHQGHUMHZHLOLJHQ,QKDEHU Le marche e i nomi degli strumenti sono marchi registrati dei rispettivi titolari. / Merke- og produktnavnene til instrumentene er varemerker tilhørende de respektive eierne. / Los nombres de marcas y productos de los instrumentos son marcas comerciales de sus titulares respectivos. / Instrumentmärken och produktnamn är varumärkta av respektive innehavare. +/109/L 1012/L g/dL g/L % L/L fL 109/L fL 7.8 4.35 12.1 121 37.4 0.374 86 220 9.6 0.3 0.10 0.2 2 1.0 0.010 2 15 NA 1 Hematology Calibrator Hematologický kalibrátor / Etalon d’hématologie / Hämatologiekalibrator / Calibratore ematologico / Hematologikalibrator / Calibrador hematológico / Hematologikalibrator 6\VWHP6SHFL¿F9DOXHV 6\VWpPRYpVSHFL¿FNpKRGQRW\9DOHXUVVSpFL¿TXHVGXV\VWqPH 6\VWHPVSH]L¿VFKH :HUWH 9DORUL VSHFL¿FL GHO VLVWHPD 6\VWHPVSHVL¿NNH YHUGLHU 9DORUHV HVSHFt¿FRV GHO VLVWHPD 6\VWHPVSHFL¿NDYlUGHQ 3 Open-vial stability 5 days 6WDELOLWDRWHYĜHQpOpNRYN\GQt6WDELOLWpHQÀDFRQRXYHUWMRXUV 6WDELOLWlWJH|IIQHWHU)ODVFKHQWDJH6WDELOLWjGHOOD¿DODDSHUWD giorni / Stabiliteten til åpnet ampulle 5 dager / Estabilidad de la FiSVXODDELHUWDGtDV+nOOEDUKHWI|U|SSHQÀDVNDGDJDU ,QVWUXPHQW 1iVWURM,QVWUXPHQW*HUlW6WUXPHQWR,QVWUXPHQW,QVWUXPHQWR Instrument 5 Parameter 3DUDPHWU3DUDPqWUH3DUDPHWHU3DUDPHWUR3DUDPHWHU Parámetro / Parameter Mean 6WĜHGQt0R\HQQH0LWWHOZHUW0HGLD*MHQQRPVQLWW0HGLD Medelvärde +/- Tolerance Limits Limity tolerance / Limites de tolérance / Toleranzgrenzen / /LPLWL GL WROOHUDQ]D 7ROHUDQVHJUHQVHU /tPLWHV GH WROHUDQFLD Toleransgränsvärden [ ] SI Units 0H]LQiURGQtVRXVWDYDMHGQRWHN6,8QLWqV6,6,(LQKHLWHQ8QLWi SI / SI-måleenheter / Unidades SI / SI-enheter Streck 7002 S. 109 Street Omaha, NE 68128 USA EC REP MEDIMARK® Europe 11, rue Emile Zola, BP 2332 38033 Grenoble Cedex 2, France
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