5-Part Hematology Analyzer Calibrator em i wanpela stebol, multi-paramita refrens materiel we ol i wokim wantaim ol 'preserved biological cellular components' bilong stretim na sekim stretpela bilong skelim bilong ol 'automated differential cell counters'. Em i save givim gutpela 'target value' asainmen long olgeta 'blood count' na 'white blood cell differential parameters', na dispela i mekim na ol i ken bihainim stret ol 'metrological traceability' long ol intanesenel standet refrens rot.
Wanem samting em ol 'hematology controls' / 'calibrators'?
Long klinikel leboretori daignostiks, ol kalibreta na ol kontrol i save mekim ol narapela narapela wok bilong lukluk long en:
Ol kalibretamakim matematikel rilesensip namel long ol instramen sensa signal na ol trupela fisikel sel konsentresen, na kamapim namba wan mesamen beslain.
Ol kontrollukluk long ol wok painimaut we i save kamap long olgeta de na sistem i stap gut longpela taim, na sekim sapos ol skelim i stap insait long mak bilong standet deviesen na noken senisim ol seting bilong sistem.
Rol long Hematology Kwaliti Kontrol
Stretpela kalibresen i givim as mak bilong kaunim ol sel bilong blut:
Sistem Rekalibresen:Re-i kamapim stretpela wok bilong skelim ol samting bihain long ol i mekim bikpela wok bilong lukautim wara, stretim gen ol samting bilong lukluk, o senisim ol samting bilong en.
Reagent Lot Transition:I stretim ol senis long 'baseline' taim yu senisim namel long ol 'production lots' bilong 'diluent', 'lyse', o 'cleaning solutions'.
Metrological Traceability:I linkim ol wok bilong skelim ol samting long laboratori long olgeta de i go stret long ol standet praimeri refrens rot aninit long ISO 17511 gaidens.
Stretim Sif:I stretim ol 'systematic calibration drift' we ol i painim long taim bilong 'statistical quality control monitoring' long olgeta de.
Kontrol Level / Aplikesen
Taim ol 'calibrator' i makim 'central analytical accuracy', ol 'companion quality controls' i save sekim wok bilong ol long ol narapela narapela 'operational ranges':
Low Level
Monita sensitiviti bilong ditekta na low-end linearity, em i bikpela samting long skelim ol klinikel sempel wantaim bikpela sik 'leukopenia', 'thrombocytopenia', o 'anemia'.
Nomal Level
Em i sekim ol wok painimaut insait long ol standet 'physiological ranges' bilong ol helti refrens populesen, na i stap olsem mak bilong wok long olgeta de.
Hai Level
Skelim 'system linearity' na 'optical performance' long ol bikpela sel konsentresen, na mekim stretpela skelim long taim bilong bikpela 'leukocytosis' o 'thrombocytosis' kondisen.
Kontrol na Kalibreta
|
Pasin |
Kalibreta |
Kontrol |
|
Namba wan As tingting |
Stretim ol instramen kalkulesen fakta na ditekta sensitiviti |
Lukautim stretpela wok bilong skelim na wok i go het |
|
Planti taim bilong yusim |
Periodik (instolesen, mentenens, senisim lot, drif) |
Long olgeta de o long olgeta operesenel tes ran |
|
Value Assignment |
Ol i stretim ol mak we ol i makim long rot bilong ol standet refrens rot |
Ol mak we ol i makim pinis wantaim ol mak bilong senis we i orait |
|
Sistem Eksen |
I apdetim ol intanel gain fakta na ol kalibresen koefisen |
Konfemim olsem instramen i redi o makim ol asua long wok |
Ol masin bilong skelim blut we i stret wantaim
Ol i wokim bilong opim na pasim ol 'sampling channels' long ol 'optical scatter', 'electrical impedance', na 'colorimetric' mesamen teknoloji:
- Ol 'differential analyzer' we i yusim 'semiconductor laser scatter' na 'flow cytometry'
- Ol sistem bilong kaunim ol 'impedance cell' we i yusim 'hydrodynamic focusing'
- Cyanide-free hemoglobin colorimetric measurement modules
Ol veliu / parameta we ol i makim
|
Paramita |
Sotpela nem |
Tipikel Assigned Taget Value |
Yunit |
|
Kaun bilong ol retpela sel bilong blut |
RBC |
4.50 ± 0.15 |
10¹²/L |
|
Hemoglobin Konsentresen |
HGB |
135 ± 3 |
g/L |
|
Hematocrit |
HCT |
40.0 ± 1.5 |
% |
|
Min Korpuskula Volium |
MCV |
88.0 ± 2.0 |
fL |
|
Namba bilong ol waitpela sel bilong blut |
WBC |
7.50 ± 0.30 |
10⁹/L |
|
Pesen bilong ol 'neutrophil' |
NEUT% |
60.0 ± 3.0 |
% |
|
Limfosait Pesen |
LYMPH% |
28.0 ± 2.5 |
% |
|
Monocyte Percentage |
MONO% |
6.0 ± 1.5 |
% |
|
Pesen bilong Eosinofil |
EO% |
4.0 ± 1.0 |
% |
|
Basophil Percentage |
BASO% |
2.0 ± 0.8 |
% |
|
Namba bilong ol pletlet |
PLT |
240 ± 15 |
10⁹/L |
Ol spesifikasen bilong prodak
|
Samting |
Teknikel Spesifikesen |
|
Stet bilong bodi |
Redi-long-yusim wara i hangamap |
|
Matriks Komponen |
Ol 'biological cell suspensions' we ol i bin lukautim gut |
|
Pulimapim volium |
3.0 mL long wan wan botel |
|
Traceability Standard |
ISO 17511 bihainim ol refrens rot |
|
Ol Konfigurasen bilong Pakejing |
2 x 3.0 mL / 4 x 3.0 mL / Ol OEM bikpela paket we ol i wokim long laik bilong ol yet |
Stoa na Stebiliti
Tempereja bilong putim:Putim stret namel long 2 digri na 8 digri. Lukautim long ais na lait stret.
Laip bilong Shelf we i no op yet:105 de stat long de bilong wokim taim ol i putim long 2 digri i go inap 8 digri.
Open-Vial Stability:7 de aninit long strongpela aseptik hanling na kwiktaim go bek long 2 digri i go long 8 digri stoa bihain long kisim sempel.
Thermal Logistics:Ol i salim wantaim ol kol kontena we i gat tempereja-monitoring na i stap namel long 2 digri na 8 digri.
Kwaliti Asurens
Reference Method Alignment:Ol veliu we ol i makim long yusim ol 'standardized microscopic reference methods' na ol 'verified master reference instruments'.
Homogeneity Control:Olgeta lot i save go insait long 'vial-to-vial consistency testing na 'coefficient of variation verification' pastaim long ol i rilisim.
Manufakturing Kompliens:Ol i wokim aninit long ISO 13485 kwaliti menesmen sistem bilong ol 'diagnostic medical devices'.
Sefti bilong ol samting i stap laip:Ol samting we ol i bin testim i no -reactive long HBsAg, anti-HCV, na anti-HIV antibodi.
FAQ
Q: Wanem taim ol i mas mekim 'calibration'?
A: Kalibresen i mas kamap taim ol i putim instramen pastaim, bihain long bikpela optikal o fluid mentenens, taim ol i senisim ol 'reagent lots' we i soim 'systematic drift', o taim ol 'deili quality control' risal i save pundaun ausait long ol mak bilong kontrol.
Q: Dispela kalibreta i ken wok wantaim 'open' na 'closed vial aspiration'?
A: Yes, ol i wokim 'fluid suspension' bilong holim wankain 'viscosity' na 'cellular distribution' long tupela 'manual open-vial modes' na 'automated closed-vial sampling systems.
Q: Olsem wanem ol i save kamapim ol 'target values' bilong wanwan 'parameter'?
A: Ol i makim ol veliu bihainim ISO 17511 'metrological traceability guidelines', na yusim ol 'reference measurement procedures' na ol 'standardized master analyzers'.
Q: Wanem ol samting yu mas redim pastaim long kisim ol sempel?
A: Tanim botol isi isi long han planti taim long mekim gutpela 'suspension'. Noken seksekim hariap long stopim fom o 'micro-bubble entrapment we inap long bagarapim ol 'optical scatter readings'.
Q: Olsem wanem ol i save lukautim gut ol samting long taim bilong salim ol samting i go long ol narapela kantri?
A: Ol sipmen i save yusim ol kontena we i gat insulet na i gat ol 'cold pack' na ol 'internal temperature monitors' bilong holim 2 digri i go inap 8 digri envairomen long olgeta taim bilong trensit.
Hot Tag: 5-pat hematoloji analisa kalibreta, Saina 5-pat hematoloji analisa kalibreta manifakta, saplaia
