Tri-Level Hematology Analyzer Control kɔnɔ, hadamaden ni baganw ka selilɛriw yɔrɔ sabatilenw bɛ sɔrɔ minnu sirilen bɛ jimatiri tampon kɔnɔ. A dabɔra hakɛ saba danfaralenw na-Dɔgɔman, Nɔrɔlen ani sanfɛ-nin jilama ɲɛfɔlifɛn in bɛ sumanikɛcogo tigitigi sɛgɛsɛgɛ, ka jateminɛ sabatili nɔfɛtaama, ani ka baarakɛcogo filiw jira farikolo la joli kuruw jatebɔlanw kɔnɔ minnu bɛ kɛ otomatiki la.
Jolilabanaw kɔlɔsili / kalibratɛriw ye mun ye?
Jogoɲumanya ɲɛnabɔli kɛnɛyaso jolilabanaw la, o bɛ tali kɛ fɛn fila la minnu tɛ kelen ye:
Kɔlɔsili minnu bɛ kɛ:Don o don sɛgɛsɛgɛli kɛcogo misaliw ni u cɛmancɛ hakɛ dɔnna ani u hakɛ dancɛw. U bɛ kɔnɔna sitɛmu tiɲɛni n’a baarakɛcogo ɲɔgɔndan kɔlɔsi waati kɔnɔ k’a sɔrɔ u ma minɛnw sigicogo caman sɛmɛntiya.
Kalibratɛriw:Reference standards kɛrɛnkɛrɛnnenw ye nafa fɔlɔ kɛrɛnkɛrɛnnenw di. U bɛ farikolo sumanifɛnw ni fɛn caman tigɛli cogoyaw ladilan walasa ka bɔli kɛcogo ɲuman sabati ka kɛɲɛ ni jateminɛ kɛcogo ye.
Jɔrɔ min bɛ jolilabanaw ka jogoɲini na
Baarakɛcogo kɔrɔ min bɛ kɛ ni kɔrɔsili matirili saba-dafalen ye, o bɛ baarakɛcogo wajibiyalenw ɲɛfɔ:
Sɛgɛsɛgɛli Desizɔn Dancɛw:A bɛ sistɛmu baarakɛcogo jateminɛ bana jugumanba la-i n’a fɔ sitopeni jugumanba ani jolisegindumuni taamasiɲɛ-kɛrɛfɛ kɛnɛyaso hakɛ bɛnnenw na.
Misaliw dɔnni:A bɛ jilama mikro-blockages, reagent oxidation, optical laser degradation, ani baseline electronic mankan dɔn ka sɔrɔ ka kɛnɛyaso ka kunnafoni di.
Taabolo labatoli:A bɛ kɔnɔna jogoɲini taabolo dafa minnu b’a ɲini tuma bɛɛ kɔlɔsili caman-dafalen na baarakɛcogo jiginni kelen-kelen bɛɛ kɔnɔ.
Kontrɔli Nivow / Aplikasiyɔn
Nivo 1 (Dɔgɔya) .
Laɲini kɛra selilɛriw hakɛ dɔgɔyali la. A bɛ sumani jaabi sɛgɛsɛgɛ jolidɛsɛ, jolidɛsɛ ani joli segin furakisɛw la minnu bɛ sɔrɔ a dɔnni dan dɔgɔmanw kɛrɛfɛ.
Nivo 2 (Normal) .
A ɲɛsinnen bɛ farikolo-ɲɛnajɛ-yɔrɔw ma. A bɛ baarakɛcogo jɔnjɔn kɔlɔsi don o don sɛgɛsɛgɛli kɛcogo kɔrɔlenw senfɛ.
Nivo 3 (Kɔrɔlen) .
A ɲɛsinnen bɛ selilu hakɛ cayalenba ma. A bɛ sinsinni ni ɲɛnayeli jaabi sabati-hakilila caman waatiw la i n’a fɔ jolisegindumuni walima jolilabanaw.
Kontrɔli ni kalibratɛri
|
Karamɔgɔya |
Jolilabanaw kɔlɔsili |
Jolilabanaw ka jateminɛkɛlan |
|
Kun |
A bɛ don o don sistɛmu tiɲɛni n’a sabatili kɔlɔsi |
A bɛ minɛnw tiɲɛni paramɛtiriw ladilan |
|
Fiɲɛturukala |
Sɛgɛsɛgɛli bɛ kɛ don o don walima baarakɛwaati kelen-kelen bɛɛ la |
A bɛ baara kɛ calibration maintenance walima shift drift kɔfɛ |
|
Donanw cogoya |
Laɲini kɔrɔ ye min bɛ fara ɲɔgɔn kan ni sanfɛla/jukɔrɔla danfara ye |
Laɲini nafa jɔnjɔn kelen |
|
Waleya min bɛ kɛ bɔli kan |
Flagw bɛ sɛgɛsɛgɛli caman kɛ minnu ma labɛn |
Re-a bɛ jatebɔ kɛ ani ka sitɛmu tɔnɔ sɔrɔcogo sɛbɛn u kan |
Jolilabanaw sɛgɛsɛgɛlikɛlan minnu bɛ bɛn ɲɔgɔn ma
A dabɔra farikolo-ɲɛnajɛ-ɲɔgɔndan kama selilu jatebɔyɔrɔw bɛɛ la ni:
- Kuranko gɛlɛya sumanikɛlan
- Laser ka jɛnsɛnni ɲɛnama
- Fɔtomɛtiri Hɛmoglobine (Hémoglobine) dɔnni
Nafaw / Paramɛtiriw minnu dira
|
Paramɛtiri |
Inite |
Dɔgɔya (Nivo 1) . |
Normal (Nivo 2) . |
Sanfɛ (Nivo 3nan) . |
|
WBC ye |
10⁹/L |
2.10 ± 0.40 |
7.20 ± 1.00 |
18.50 ± 2.50 |
|
RBC (RBC) ye |
10¹²/L |
2.30 ± 0.20 |
4.40 ± 0.30 |
5.30 ± 0.40 |
|
HGB |
g/dL (g/dL) ye |
6.2 ± 0.5 |
13.5 ± 0.6 |
18.0 ± 0.8 |
|
HCT (HCT) ye |
% |
18.5 ± 2.0 |
39.0 ± 3.0 |
51.0 ± 4.0 |
|
PLT ye |
10⁹/L |
65 ± 20 |
210 ± 40 |
480 ± 60 |
Fɛn dilannenw ka ɲɛfɔli
|
Ta |
Fɛnɲɛnɛmako ɲɛfɔli |
|
Farikolo cogoya |
Labɛn-ka-baara kɛ ni seli suspension suspension ye |
|
Matirisi (Matrix) ye |
Adamadenw ni baganw joli kɔnɔfɛnw |
|
Foroko minnu bɛ kɛ |
12 × 3,0 mL fiyɛli kɛsu kelen kɔnɔ (4 × Dɔgɔman, 4 × Nɔrɔlen, 4 × Kɔrɔta) . |
|
Sariyabaju sigicogo kura |
U si ma wajibiya |
|
Jogoɲumanya sariya |
ISO 13485 ka fɛn dilanni sigida |
Storage & Stability (Sɔrɔli & sabatili).
Storage min ma dabɔ: degere 2 ka se degere 8 ma . Aw bɛ aw tanga yeelen tilennen ma. Aw kana a bila nɛnɛ na.
A datugulen-Fiyɛli ka ɲɛnamaya: tile 105 ka bɔ a dilanni don na ni a maralen don ka to degere 2 la ka se degere 8 ma .
Da wuli-Viyali sabatili: tile 14 walima 14 sɛgɛsɛgɛli kɛlenw ni u maralen don degere 2 fo degere 8 la sɛgɛsɛgɛli kɛlen kɔfɛ dɔrɔn.
Tɛmɛsira cogoyaw: Sumaya foroko ni fasa-change nɛnɛ pakew bɛ kɔnɔna nɛnɛ-cakɛda funteni mara.
Jogoɲumanya Lakanali
Traceability (Sɔrɔcogo):Nafa minnu kalifara ka kɛɲɛ ni dantigɛli fɛɛrɛw ye.
Lotiw ka ɲɔgɔndɛmɛ:Coefficient de variation inter-vial min maralen bɛ CV kɔnɔ < 1,5%.
Batch bɔli:Sɛgɛsɛgɛli sɛgɛsɛgɛli sɛgɛsɛgɛli kɛcogo caman kan sani lot bɔli ka kɛ.
Donanw sɛbɛnni:Lot-kɛrɛnkɛrɛnnenya la baara tabali minnu bɛ di ni fɛn dilannenw ka minɛn kelen-kelen bɛɛ ye.
Ɲininkaliw
J: Fiɲɛw ka kan ka ɲagami cogo di sani u ka u ta?
A: Aw bɛ a to fiyɛlilan ka se so funteni ma ($15^\\circ\\text{C}$–$30^\\circ\\text{C}$) miniti 15 kɔnɔ. Aw bɛ fiyɛlilan kuru ka ɲɛ bolokɔniw ni ɲɔgɔn cɛ siɲɛ 8–10, o kɔ aw bɛ a laban-kɔrɔta dɔɔni dɔɔni-dakun kan siɲɛ 8–10. Aw bɛ aw yɛrɛ tanga yɛrɛyɛrɛli ma walasa fiɲɛ kana don a kɔnɔ.
J: Lot-kɛrɛnkɛrɛnnenya la sɛgɛsɛgɛli nafaw bɛ sɔrɔ min?
A: Sɛgɛsɛgɛli sɛbɛnw minnu bɛ paramɛtiriw laɲiniw ni kɔrɔsili yɔrɔw jira, olu bɛ pake pake kelen-kelen bɛɛ kɔnɔ. Nizɛri dosiyew bɛ se ka sɔrɔ lot nimɔrɔ sɛgɛsɛgɛli fɛ.
J: Fɛɛrɛ jumɛnw ka kan ka kɛ ni kɛnɛyako binna laɲiniw kɔkan?
A: Aw bɛ ɲagami kɛcogo, so funteni, ani furakisɛ fiyɛli sɛgɛsɛgɛ. Re-sample kɛ furakisɛ la. Ni nafaw tora -laɲini na, aw bɛ ji tubabukan lajɛ ni bugunw tɛ, ka reagent hakɛw lajɛ, ka sɔrɔ ka kɔrɔsili fiyɛli kura dabɔbali kɔrɔbɔ.
J: Fiyɛlilan kɔrɔlenw filicogo wajibiyalenw ye mun ye?
A: Aw bɛ furakisɛ da wulilenw minɛ i n’a fɔ fɛnɲɛnamaw. Aw bɛ ji tolenw ni u pakew fili ka kɛɲɛ ni laboratuwari ka biyohazard filili sariyaw ye minnu bɛ kɛ ka kɛɲɛ ni sariya ye.
J: Nɛnɛ-cakɛda dafalen bɛ mara cogo di diɲɛ kɔnɔ bolifɛnw ta waati?
A: Cikanw bɛ baara kɛ ni minɛnw cogoyaw ye minnu bɛ ni nɛnɛ-maralanw ye, ka degere 2 –8 degere hakɛ wajibiyalen mara fiɲɛ ni kɔgɔji doni siraw bɛɛ la
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