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Walutowy [0] YWynik,Wynik  ZWynik2.Wynik2  [ZBe@ZBe    \ZBy9ZBy  %XTableStyleMedium2PivotStyleLight168fff̙̙3f3fff3f3f33333f333333f3f33333f33333\`#?Pakiet 1 biochemia + immunoFfzaB. nr 1 pakiet 9- serologia' FǭZaB.1 Pakiet 1 biochemia+immuno LPakiet 2-hematologia@ZaB. 1 Pakiet 2 -hematologianPakiet 3 - gazometriaB'ZaB. 1 Pakiet 3 - gazometria FPakiet 4 - koagulologiaBZaB. 1 Pakiet 4- koagulologiaPakiet 5 - barwniki&P.6-odcz. do met. manual.testy!?Pakiet 7 - Paski do moczuF^ ZaB.1 Pakiet 7 - Paski do moczuApakiet 8 - serologia' IFiszaB. nr 1 pakiet 8- serologia' $)Pakiet 9 - serologia grup IIpakiet 10 - alergologiaF2~ zaB. nr 1 pakiet 10 - alergolog00,   ;   ;0  ;A  ;   ;7  ;,  ;C5 PAKIET Nr 1. Dostawa odczynnikw, akcesoriw, materiaBw kontrolnych i kalibratorw wraz z dzier|aw zintegrowanego systemu biochemiczno-immunochemicznego na 36 miesicy4I. Odczynniki, kalibratory, materiaBy eksploatacyjneL.p.Nazwa"Ilo[ zamawianych oznaczeD 36 m-cyMetoda oznaczaniaNr katalogowy wyrobuNazwa handlowaZawarto[ opakowania (testy).Ilo[ opakowaD na 36 m-cy (szt)Cena netto za opakowanie (zB)Warto[ netto (zB) za 36 m-cy Stawka VATWarto[ brutto (zB) za 36 m-cy(kol. H x kol. I)%(kol. J + (kol. J x kol. K %))ABCDEFGHIJKLA.Odczynnik biochemiczne:Albuminy (BCG)Fosfataza zasadowa (ALP)!Aminotransferaza alaninowa (AlAT) alfa- Amylaza(Aminotransferaza asparaginianowa (AspAT)Bilirubina bezpo[redniaBilirubina caBkowitaWapD caBkowity Cholesterol#Cholesterol HDL (met. bezpo[rednia) TriglicerydyKinaza kreatynowa (CK)Kreatynina JaffeMocznik Kwas moczowy"gamma- Glutamylotransferaza (GGTP)Glukoza{elazoMleczanyDehydrogenaza mleczanowa (IFCC)MagnezFosforany nieorganiczneBiaBko caBkowiteBiaBko w moczu i PMR.Albuminy (met. turbidymetr.), mikroalbuminuria(Alfa-1-kwa[na glikoproteina/ orozomukoidAntystreptolizyna OBiaBko C-reaktywne, wysokoczuBeHemoglobina glikowana (HbA1c) TransferynaCzynnik Reumatoidalny Sd (Na+) Potas (K+) Chlorki (Cl-) Sd w moczu Potas w moczuAlkohol etylowyIgGIgEIgAamoniak wankomycynaB.Odczynniki immunochemiczne TroponinaBNPProkalcytonina (Brahms) TSH (3 gen.)Free T4Free T3anty TPOanty TG+przeciwciaBa przeciw receptorowi TSH (TRAb)CA 125HE4AFPCA 19.9Ca 15.3CEAPSAfree PSA ProlaktynaFSH EstradiolLH Progesteron TestosteronDHEASbeta HCGPTHkortyzolSHBGHBsanti-HCVanty Hbsanty HbcToxoplazmoza IgGToxoplazmoza IgMToxoplazmoza IgG Awidno[CMV IgGCMV IgM HIV (Ab+Ag) Rubella IgG Rubella IgM EBV VCA IgMEBV VCA/EA IgG EBV EBNA IgG Witamina D Witamina B12 kwas foliowyInsulinasyphilis Ferrytyna HomocysteinaAnty CCP0Kinaza kreatynowa- izoenzym MB masa (CK-MB masa)C.Kalibratory i kontrole:D.MateriaBy eksploatacyjne:IRazem Pkt I. odczynniki, kalibratory, kontrole i materiaBy eksploatacyjneII. Dzier|awa aparatu Lp.)DZIER{AWA ANALIZATORA (nazwa, typ, model)Ilo[ miesicy'Dzier|awa netto (zB / m-c)'Warto[ netto dzier|awy na 36 m-cy (zB) Stawka % VAT(Warto[ brutto dzier|awy na 36 m-cy (zB)(kol. C x kol. D)(kol. E + (kol.E x kol. F %))0OGAEM: pkt I, II(odczynniki, dzier|awa aparatu)NW przypadku posiadania numerw katalogowych, prosimy o wpisanie ich do tabeli.)WARUNKI DODATKOWE BEZWZGLDNIE WYMAGANE:1.2.Dla ka|dego zaoferowanego wyrobu medycznego bezwzgldny wymg posiadania: aktualnego dokumentu potwierdzajcego dopuszczenia do obrotu, a w przypadku, gdy prawo nie wymaga dopuszczenia do obrotu - dokumentu potwierdzajcego znak zgodno[ci CE dla tego wyrobu.3.Oferowane wyroby musz speBnia wymagania zasadnicze okre[lone w Rozporzdzeniu Ministra Zdrowia z 12 stycznia 2011r. w sprawie wymagaD zasadniczych dla wyrobw medycznych do diagnostyki in vitro (tekst jednolity Dz.U. 2013 poz. 1127) oraz zaBcznikach do wymienionego rozporzdzenia.4.5.$Pakiet stanowi niepodzieln caBo[ .6.#Nazwy odczynnikw w jzyku polskim.7.Dostarczy karty charakterystyki substancji niebezpiecznych (lub o[wiadczenie o braku wymogu ich posiadania) w formie wydruku lub elektronicznej wraz z pierwsz dostaw odczynnikw8.9Instalacja (w tym podBczenie do LIS) na koszt Wykonawcy,9.zMateriaBy kontrolne do immunochemii do dwukrotnej na tydzieD kontroli jako[ci na minimum dwch poziomach warto[ci - N, P.10.lMateriaBy kontrolne do biochemii do codziennej kontroli jako[ci na minimum dwch poziomach warto[ci - N, P.11.]Odczynniki i materiaBy kontrolne dedykowane i zwalidowane do u|ycia z oferowanym analizatorem12.W cz[ci I Wykonawca winien samodzielnie wskaza : C. Kalibratory i kontrole oraz D. MateriaBy eksploatacyjne zwalidowane z analizatorem - ilo[ci dostosowane do wskazanych ilo[ci oznaczeD.13.?Oferent dostarczy instrukcj analizatora obsBugi w j. polskim. qZestawienie wymaganych parametrw granicznych analizatora zostaBo przedstawione w zaBczniku nr 1 do pakietu nr 114.NiespeBnienie ktregokolwiek z powy|szych wymagaD oraz warunkw granicznych lub brak jakiegokolwiek z wymaganych dokumentw spowoduje odrzucenie oferty.& & & & & & & & & & ..& .& & ./data/Z/podpis Wykonawcy lub osb upowa|nionych do skBadania o[wiadczeD woli w imieniu Wykonawcy/ZaBcznik nr 1 do Pakietu nr 9 Dostawa odczynnikw i materiaBw zu|ywalnych do badaD w serologii transfuzjologicznej do systemu DiaMed-ID Micro Typing System bdcego wBasno[ci zamawiajcego wraz z dzier|aw oprogramowania do obsBugi pracowni serologii i banku krwi oraz dzier|aw systemu (< wirwka + inkubator) stanowicego backup dla istniejcego systemu oraz bezpBatnym serwisem sprztu i aparatury na 36 miesicy - (II.)tW poni|szej cz[ci ZaBcznika Zamawiajcy podaB warunki graniczne parametrw i warunkw przez siebie wymaganych dla oferowanego sprztu (systemu). Wykonawca skBadajc ofert jest zobowizany wypeBni kolumny zatytuBowane: "Odpowiedz Oferenta Tak/Nie" (wpisujc Tak lub Nie). Brak odpowiedzi TAK lub odpowiedz NIE (dla parametrw bezwzgldnie wymaganych przez Zamawiajcego) bdzie traktowany jako brak danego parametru, co skutkowa bdzie odrzuceniem oferty jako niezgodnej z tre[ci SIWZ. Wykonawca mo|e wypeBni kolumn  Parametry oferowane (opisa) opisujc we wBa[ciwych pozycjach w wyczerpujcy sposb dany parametr. lGraniczne parametry jako[ciowo-techniczne odczynnikw, aparatury do oznaczeD w serologii transfuzjologicznejLp.Opis wymaganego parametruWarto[ graniczna Tak/Nie Odpowiedz Oferenta Tak/NieParametry oferowane (opisa)I. OdczynnikiBadanie przegldowe przeciwciaB po[rednim testem antyglobulinowym na 3 krwinkach wzorcowych zawierajcych antygen Cw (zgodnie z obowizujcymi przepisami); . Mikrokolumny do testu PTA-LISS wypeBnione surowic poliwalentnTAK2Prba zgodno[ci pomidzy dawc i biorc  PTA LISSMetodyka oznaczeD pozwalajca na eliminowanie pBukania krwinek czerwonych przed wykonaniem badania. St|enie robocze krwinek czerwonych poni|ej 1%Odczynniki - gotowe do u|ycia. Wszystkie oferowane mikrokarty fabrycznie wypeBnione odpowiednimi odczynnikami przez producenta.\Termin wa|no[ci mikrokart po dostawie - min. 6 miesicy, krwinek firmowych - min. 5 tygodni.Dostawa pozycji 7, 8, 10, 13 oraz innych (je[li wymagaj) transportem monitorowanym pod wzgldem temperatury 2-8 st. C potwierdzona wydrukiem. Wydruk z poprzednich dostaw jako zaBcznik do oferty (na wezwanie zamawiajcego).Midzynarodowa zewntrzlaboratoryjna kontrola jako[ci dla metod mikrokolumnowych i probwkowych potwierdzona certyfikatem i mo|liwo[ci wpisywania wynikw onlineWszystkie odczynniki od jednego producenta, tego samego co posiadany sprzt (z wyjtkiem nakBuwaczy do pobierania krwi z drenw, oprogramowania i niezbdnego sprztu komputerowego), Wymagane jest, aby odczynniki byBy gotowe do u|ycia (krwinki wzorcowe zawieszone w odczynniku o niskiej sile jonowej  poni|ej 1%), a karty skBadaBy si z 6 mikrokolumnCPrzechowywanie wszystkich mikrokart w temp. pokojowej (18-25 st. C)"Zamawiajcy wymaga, aby zgodnie z art. 90 ust. 1 ustawy o wyrobach medycznych ( Wyrb powinien by wBa[ciwie dostarczony, prawidBowo zainstalowany i utrzymywany oraz u|ywany zgodnie z przewidzianym zastosowaniem, a u|ytkownik wyrobu jest obowizany do przestrzegania instrukcji u|ywania ) oferowane produkty (odczynniki) byBy zgodne z instrukcjami u|ycia wyrobw medycznych, do ktrych prowadzone jest postpowanie, tj.: ID-Centrifuge 12 SII; ID-Incubator 37 SI; ID-Pipetor FP6, w szczeglno[ci instrukcj wirwki ID-Centrifuge 12SII (Instrukcja obsBugi 11.0-12/2011), ktra stanowi:rozdz. 1.1Przeznaczenie i sposb u|ytkowania: Wirwka ID-Centrifuge 6S / 6S Accu, ID-Centrifuge 12SII, i ID-Centrifuge 24S jest urzdzeniem sBu|cym wyBcznie odwirowywaniu ID-Kart rozdz. 3.1.2 U|ycie ID-Karty: W wirwkach zezwala si na u|ywanie wyBcznie ID-Kart. Dostpne s nastpujce typy kart: " ID-Karty z |elem, ktry zawiera specyficzne przeciwciaBa w celu okre[lenia antygenw erytrocytw (antygenw grup krwi i innych rzadkich antygenw); " ID-Karty z |elem, ktre zawieraj globulin anty-ludzk (mono-/polyspecific do wykrywania antyciaB, identyfikacji anty-ciaBa, testu tolerancji i okre[lenie bezpo[redniego testu Coombsa); " ID-Karty z neutralnym |elem w celu ustalenia kontroli w surowicy, NaCl i testu enzymu Wymagane jest zaBczenie do oferty o[wiadczenia producenta posiadanego przez Zamawiajcego systemu o mo|no[ci stosowania oferowanych odczynnikw z tym systemem.6Do oferty zaBczy pozytywn opini o oferowanych testach mikrokolumnowych z IHiT w Warszawie - jednostki stanowicej w Polsce, na podstawie ustawy z dn. 22 sierpnia 1997r. o publicznej sBu|bie krwi (Dz.U. 2017 poz. 1371, < z pzn. zm.), obowizujce przepisy w jednostkach organizacyjnych publicznej sBu|by krwiKarta do bezpo[redniego testu antyglobulinowego (IgG-IgA-IgM-C3c-C3d-ctl) wypeBniona fabrycznie odczynnikami przez producenta. Wszystkie oznaczenia na jednej karcie.15.)Zamawiajcy wymaga, aby wszystkie oferowane produkty zaklasyfikowane do listy A lub B wyrobw medycznych do diagnostyki in vitro, zgodnie z Rozporzdzeniem Ministra Zdrowia z dnia 12 stycznia 2011 r. w sprawie wymagaD oraz procedur oceny zgodno[ci wyrobw medycznych do diagnostyki in vitro (Dz. U. z 2013, poz. 1127) posiadaBy deklaracj zgodno[ci CE z numerem jednostki notyfikowanej oraz aktualnego i wa|nego certyfikatu jednostki notyfikowanej, ktra braBa udziaB w procesie zgodno[ci dla danego produktu. W przypadku produktw, ktre nie zostaBy zakwalifikowane przez producenta jako wyroby medyczne (w szczeglno[ci: zewntrzna kontrola jako[ci, koDcwki do pipety, oprogramowanie do pracowni serologii i banku krwi wraz z niezbdnym oprzyrzdowaniem komputerowym), Zamawiajcy nie wymaga oznaczenia CE.16.Na etapie weryfikacji ofert, potencjalny Wykonawca, po uprzednim wezwaniu telefonicznym bdz pisemnym, obliguje si na bezpBatne dostarczenie prbek oferowanych mikrokart (2 szt. z ka|dego rodzaju) wraz z niezbdnymi certyfikatami po[wiadczajcymi zastosowane w nich odczynniki. II. Aparatura%Oprogramowanie polskojzyczne pozwalajce na prowadzenie pracowni serologii transfuzjologicznej i banku krwi ( wydruki wynikw i ksigi laboratoryjne ) zgodnie z obowizujcymi przepisami , z niezbdnym zestawem komputerowym (z programem operacyjnym) , drukark laserow i skanerem kodw pozwalajcym na bezpo[rednie wprowadzenie danych z etykiet na pojemnikach z krwi do systemu. W przypadku zmiany dotychczasowego oprogramowania konieczne jest przeniesienie dotychczasowej bazy danych do nowego programu w sposb umo|liwiajcy natychmiastowy dostp do danych i wydruk archiwalnych wynikw. Zamawiajcy wymaga, aby oprogramowanie Pracowni Immunologii Transfuzjologicznej dostpne byBo z poziomu przegldarki internetowej (wielowarstwowa aplikacja webowa), co pozwala na Batwy i szybki dostp z urzdzenia ka|dej klasy, niezale|nie od systemu operacyjnego i parametrw komputerw obsBugujcych stanowisko. Oferowane oprogramowanie musi posiada mo|liwo[ rejestracji wynikw testw w formie opisowej, umo|liwiajc wprowadzenie dowolnie dBugiego komentarza bezpo[rednio do badanego testu a dodatkowo musi umo|liwi dodanie pliku w formie PDF lub JPG do badania. Oferowane oprogramowanie musi posiada funkcje rejestracji zamwienia na skBadniki krwi w RCKiK z mo|liwo[ci wydrukowania zamwienia. Podczas rejestracji otrzymanej dostawy oprogramowanie bdzie analizowa ilo[ i rodzaj skBadnika zamwionego z ilo[ci i rodzajem skBadnika otrzymanego. Oferowane oprogramowanie musi posiada mo|liwo[ wydania krwi w trybie pilnej transfuzji (bez wykonania prby krzy|owej)Oprogramowanie przechodzi na stan zamawiajcego po okresie umowy - przekazanie sprztu zostanie potwierdzone protokoBem zdawczo-odbiorczym). Gwarancja techniczna ( naprawy, wymiana podzespoBw, utrzymanie oprogramowania w zgodzie z aktualnymi przepisami prawnymi) i coroczne przegldy techniczne zakoDczone wydaniem [wiadectwa sprawdzenia stanu technicznego urzdzeD i aparatury w czasie trwania umowy bezpBatnedCzas reakcji serwisu (przyjazd in|yniera serwisowego)  maksimum 24 h od zgBoszenia (w dni robocze).KInstrukcja obsBugi aparatury i instrukcje wykonania metod w jzyku polskimBSzkolenie pracownikw w obsBudze aparatu i interpretacji wynikw.u Wpisanie przez Zamawiajcego Tak w kolumnie "Warto[ graniczna" oznacza, |e dany parametr jest bezwzgldnie wymagany. & & & & & & & & & & & & & & & & & .ZaB. nr 1 do Pakietu nr 1. Dostawa odczynnikw, akcesoriw, materiaBw kontrolnych i kalibratorw wraz z dzier|aw zintegrowanego systemu biochemiczno-immunochemicznego na 36 miesicyNazwa oferowanego systemu: Producent:Typ: Model:LpOPIS PARAMETRW WYMAGANYCHWarto[ graniczna: Tak/NieParametry oferowane (opisa) *System zintegrowanyPlatforma zintegrowana biochemiczno-immunochemiczna (nowa)wyposa|< ona w jeden podajnik prbek umo|liwiajcy aspiracj materiaBu do badaD biochemiczno- immunologicznych z tej samej prbki bez konieczno[ci ich rcznego przenoszenia midzy aparatami. Mo|liwo[ wprowadzenia danych prbki oraz danych demograficznych pacjenta przez jednego operatora z jednego stanowiska komputerowego (jeden system operacyjny) do systemu.TakfWszystkie wymienione w formularzu cenowym oznaczenia dostpne do wykonania na oferowanym analizatorze.fIdentyfikacja odczynnikw za pomoc kodw kreskowych z monitorowaniem ilo[ci odczynnikw w opakowaniu.Odczynniki do testw gotowe do u|ycia. Zamawiajcy dopuszcza wymaganie producenta czynno[ci mieszania i otwierania odczynnikw przed wBo|eniem ich na pokBad. tStacja uzdatniania wody jako integralna cz[ systemu wraz z poniesieniem przez wykonawc kosztw jej eksploatacji.AModem serwisowy i mo|liwo[ poBczenia on line na koszt Wykonawcy.Ilo[ miejsc dla prbek badanych - minimum 300iChBodzenie komory odczynnikowej umo|liwiajce cigBe przechowywanie odczynnikw na pokBadzie analizatora.Karuzele odczynnikowe z mo|liwo[ci wymiany i dostawiania odczynnikw w trakcie pracy bez konieczno[ci zatrzymywania czy pauzowania wykonania oznaczeDMo|liwo[ wstawienia do analizatora materiaBu badanego w probwkach pierwotnych z zastosowaniem kodw kreskowych jak i w naczyDkach na mikroprbki:Automatyczne wykonywanie oznaczeD pilnych przed rutynowymiAspiracja prbki przez oferowany analizatory przed aspiracj odczynnika reakcyjnego lub odczynnika wstpnego - bBd aspiracji prbki nie powoduje utraty testu.\Mo|liwo[ wykonywania automatycznego rozcieDczenia prbek po przekroczeniu liniowo[ci metodyTDetektor skrzepw badanej prbki oraz pcherzykw powietrza dla odczynnikw i prbeknSystem wyposa|ony w UPS podtrzymujcy prac aparatw przez co najmniej 20 min. przy braku energii elektrycznej@Rejestracja w analizatorze wykonywanych procedur konserwacyjnychAnalizator wyposa|ony w drukark dajc mo|liwo[ bezpo[redniego wydruku, wewntrzny skaner kodw kreskowych, komputer i monitorInstrukcja obsBugi w wersji elektronicznej i papierowej w jzyku polskim uwzgldniajaca opis wszystkich kodw systemowych oraz procedur konserwacji dostarczona wraz z analizatorami.uWbudowany program kontroli jako[ci z mo|liwo[ci graficznej prezentacji (analizy Levey Jenningsa , reguBy Westgarda)Wykonawca wybrany w postpowaniu przetargowym zapewni (wBasnym staraniem i kosztem) mo|liwo[ bezobsBugowego przekazywania danych kontroli wewntrzlaboratoryjnej z analizatorw do programu kontroli badaD u|ytkowanego w szpitalnym laboratorium zamawiajcego1Deklaracja zgodno[ci CE dla aparatu i odczynnikw@Gwarancja techniczna ( naprawy, wymiana podzespoBw) i coroczne przegldy techniczne zakoDczone wydaniem [wiadectwa sprawdzenia stanu technicznego urzdzeD i aparatury potwierdzone wpisem do paszportu w czasie trwania umowy bezpBatne (na koszt Wykonawcy)  czas reakcji serwisu do 24h w dni robocze od chwili zgBoszeniajWykonawca wymieni wadliwe urzdzenia na nowe w razie 3-krotnej awarii w cigu roku tego samego podzespoBu.Instalacja, uruchomienie analizatora, uruchomienie dwukierunkowej komunikacji z LIS i szkolenie personelu w laboratorium w zakresie obsBugi na koszt wykonawcy ( obligatoryjne 2 szkolenia ewentualne 1 szkolenie dodatkowe w razie potrzeby)pDostawca dostarczy oprogramowanie online do opracowywania i porwnywania wynikw dla kontroli multiparametrowych,Cz[ immunochemiczna systemu zintegrowanegoqIlo[ chBodzonych miejsc odczynnikowych wystarczajca do jednoczesnego zaBadowania na pokBad min. 45 odczynnikw.SAnalizatory przystosowane do pracy cigBej caBodobowej (wydajno[ min 180 testw /hhCi[nieniowy detektor skrzepw i mikroskrzepw badanej prbki oraz bbelkw powietrza (piany) dla prbek.Zastosowanie w pipetorze wymiennych koDcwek do pobierania prbek lub systemu mycia sond , gwarantujce zapobieganie kontaminacji dla testw wykonywanych w surowicy/osoczu =<0,1ppm.Odczynniki gotowe do pracy, umo|liwiajce wykonanie oznaczeD bezpo[rednio po wyjciu z lodwki zewntrznej, niewymagajce ogrzania do temperatury pokojowej.8Odczynniki oraz kalibratory niewymagajce rekonstytuc< ji.Ilo[ opakowaD odczynnikw, kalibratorw i kontroli zgodna z terminami stabilno[ci po otwarciu zgodnie z zapisami w ulotkach odczynnikowych producenta tych testwOznaczenie kortyzolu zarwno w surowicy i w moczu z prbki pierwotnej. Zamawiajcy nie dopuszcza wstpnego przygotowania prbki moczu do oznaczenia kortyzolu. Potwierdzi w ulotce odczynnikowej.OStabilno[ odczynnikw immunochemicznych na pokBadzie analizatorw min. 21 dni.GCzas wykonywania testw immunochemicznych Troponiny, bHCG do 20 minut;)Cz[ biochemiczna systemu zintegrowanegoMMiejsca na min. 43 zestawy odczynnikowe na pokBadzie analizatora (chBodzone)Analizator pracujcy w technologii tzw.  mokrej chemii o wydajno[ci maksymalnej (Bcznie z ISE) nie mniejszej ni| 1200 testw/h DokBadanie wszystkich odczynnikw na pokBad analizatora w czasie pracy analizatora bez przerywania badaD i pauzowania lub zatrzymywania analizatoraDKuwety wielorazowego u|ytku, myte i sprawdzane na pokBadzie aparatu.sZintegrowany (w jednej obudowie) moduB przystawki jonoselektywnej do oznaczania jonw sodu, potasu i chloru, zawierajcy elektrody do oznaczeD jonw Na, K i Cl Kalibracja elektrod nie cz[ciej ni| co 24h. Analizator posiadajcy mo|liwo[ automatycznej kalibracji moduBu ISE. Mo|liwo[ wymiany odczynnikw do wykokonywania oznaczeD ISE bez potrzeby zatrzymywania analiz.IAnalizator wyposa|ony w czujniki poziomu cieczy w prbkach i odczynnikachUMo|liwo[ automatycznej oceny jako[ci prbki w zakresie lipemii, hemolizy, bilirubinyROPIS PARAMETRW OCENIANYCH W KRYTERIUM: JAKOZ (Parametry techniczno-funkcjonalne) Punktacja:Odpowiedz Wykonawcy: TAK/NIEKTesty anty HCV, HBsAg, HIV nie posiadajcy oznaczeD w tzw. "szarej strefie"cKontrola wewntrzlaboratoryjna firmy zewntrznej (z wyBczeniem parametrw infekcyjnych , PCT TRAb)^MateriaB kalibracyjny i kontrolny dla parametrw immunochemicznych niewymagajcy rekonstytucjiXTesty immunochemiczne oparte o system reakcji wolny od wizania biotyna - streptawidyna.Liniowo[ testw enzymatycznych AMYLAZA, CK, ASPAT, ALAT nie gorsza ni| 3000U/l bez rozcieDczenia prbki. Potwierdzi w ulotce odczynnikowej.|WW. parametry oceniane winny zosta potwierdzone dokumentami (materiaBy informacyjne, karty katalogowe, instrukcje u|ywania)yPAKIET Nr 2 Dzier|awa analizatora hematologicznego 5 DIFF wraz z dostaw odczynnikw na 90000 morfologii na 36 miesicy2Odczynniki, kalibratory i materiaBy eksploatacyjneWielko[ opakowaniaIlo[ opak. Na 36 mies.Cena jedn. netto opak.Warto[ netto (zB)Warto[ brutto (zB)(kol. E x kol. F)(kol. G + (kol. G x kol. H %)) Odczynniki:ADZIER{AWA ANALIZATORA (Nazwa, typ,Producent, rok produkcji-poda)&Dzier|awa netto (zB / m-c)(kol. E + (kol. E x kol. F %))3OGAEM: pkt I, II (odczynniki , dzier|awa aparatu )Dostarczy karty charakterystyki substancji niebezpiecznych (lub o[wiadczenie o braku wymogu ich posiadania) w formie wydruku lub elektronicznej wraz z pierwsz dostaw odczynnikwMateriaBy kontrolne do codziennej kontroli jako[ci na trzech poziomach warto[ci - L, N, H. Jeden rodzaj krwi kontrolnej dla wszystkich oznaczanych parametrw.NiespeBnienie ktregokolwiek z powy|szych wymagaD oraz warunkw granicznych lub brak jakiegokolwiek z wymaganych dokumentw spowoduje odrzucenie oferty.Zestawienie wymaganych parametrw granicznych analizatora oraz wyposa|enia dodatkowego zostaBo przedstawione w zaBczniku nr 1 do pakietu nr 2Wykonawca winien samodzielne wskaza odczynniki, materiaBy kontrolne, kalibratory i mat. eksploatacyjne konieczne do wykonania wymaganej liczby oznaczeD w cigu 12 m-cy_Wymienione w cz. III wyposa|enie dodatkowe przechodzi na wBasno[ Zamawiajcego. (dostawa wyposa|enia w cigu max. 14 dni od podpisania umowy, przekazanie sprztu zostanie potwierdzone protokoBem zdawczo-odbiorczym). Wymagany okres gwarancji na sprzt - min. 24 m-ce lub okres gwarancji producenta (w przypadku gdy gwarancja producenta jest dBu|sza). ZaBcznik nr 1 do Pakietu nr 2 Dzier|awa analizatora hematologicznego 5 DIFF wraz z dostaw odczynnikw na 90 000 morfologii na 36 miesicy"ZESTAWIENIE PARAMETRW ANALIZATORANazwa aparatu: Typ/Model: Rok produkcji:Opis parametrw wymaganychUMo|liwo[ wykonania oznaczeD z peBnym r< ozmazem w trybie mikro (probwki pediatryczne)System aspiracji krwi umo|liwiajcy podanie materiaBu z probwek systemu otwartego jak i zamknitego bez konieczno[ci ich otwieraniaAparat z automatycznym podajnikiem na min 20 probwek dostosowanym do r|nego typu zamknitych systemw pobierania (w celu potwierdzenia wymagane jest zaBczenie do oferty fragmentu instrukcji u|ytkownika)Pomiar retikulocytw (RET w warto[ciach bezwzgldnych i w %) podczas rutynowej pracy bez konieczno[ci specjalnego przygotowania prbkitR|nicowanie WBC na 5 populacji przy u|yciu fluorescencyjnej cytometrii przepBywowej, bez barwienia cytochemicznego,Objto[ aspirowanej prbki krwi max 25 l (w obu trybach: CBC i CBC+5DIFF, dotyczy pobierania materiaBu zarwno w trybie otwartym jak i zamknitym)MWydajno[ min. 50 oznaczeD prbek krwi /godzin w trybie pracy CBC , CBC+DIFF*Automatyczne czyszczenie igBy pobierajcejoAparat wykorzystuje odczynniki bezcyjankowe, nie zawierajce cyjankw nawet w minimalnych ilo[ciach (doBczy do oferty ulotki odczynnikowe i karty substancji niebezpiecznych dla odczynnikw, materiaBu kontrolnego i innych materiaBw zu|ywalnych, ktre w swoim skBadzie zawieraj substancje niebezpieczne) Ulotki odczynnikowe jak i karty charakterystyki w j. polskim.Liniowo[: RBC min do 8 M/l, WBC min do 350 K/l, PLT min do 3000 K/l. HGB min do 22 g/dl (wszystkie liniowo[ci bez wstpnego przygotowania i rozcieDczania prbki pierwotnej)Mo|liwo[ oceny niedojrzaBych granulocytw IG (Metamielocyty + Mielocyty + Promielocyty) jako odrbnej populacji wyra|onej w warto[ciach bezwzgldnych i procentach.Flagowanie wynikw patologicznych wraz z komunikatami opisujcymi typowe patologie oraz informacje o stopniu zaawansowania patologiiNMo|liwo[ oceny anizocytozy erytrocytw wyra|onej zarwno jako RDW-SD i RDW-CVMGraficzna prezentacja wynikw na co najmniej 2 histogramach i 1 scattergramieMo|liwo[ wprowadzania danych demograficznych pacjenta, oraz warto[ci referencyjnych w zale|no[ci od pBci i wieku pacjenta, min 5.Oprogramowanie dajce dowolno[ redagowania wydruku wyniku wraz z podaniem odpowiednich warto[ci referencyjnych dla pBci i wieku.Jeden rodzaj krwi dla wszystkich parametrw, parametry krwi kontrolnej wczytywane za pomoc no[nika magnetycznego lub optycznego.Mo|liwo[ wBczenia aparatu do systemu kontroli zewntrzlaboratoryjej producenta aparatu (kontrola jako[ci wszystkich parametrw, wyniki dostpne w czasie rzeczywistym, informacja w przypadku bBdw.)Oprogramowanie obejmujce system kontroli jako[ci z zastosowaniem reguB Westgarda z graficzn prezentacj i statystyczn ocen wynikw kontroli.:Przystosowanie analizatora do pracy w systemie caBodobowymMo|liwo[ dwukierunkowej komunikacji z systemem informatycznym, Wykonawca zobowizany jest do podBczenia aparatu do laboratoryjnego systemu informatycznego na wBasny koszt..Wewntrzny czytnik kodw paskowych w podajnikuHInstrukcja obsBugi aparatu w jzyku polskim. Dostarczona wraz z aparatemGwarancja techniczna przez caBy okres trwania umowy - uwzgldniajca bezpBatne koszty napraw, wymiany podzespoBw, corocznych przegldw serwisowych (3 przegldy) zakoDczonych wydaniem [wiadectwa sprawdzenia stanu technicznego urzdzeD i aparatury.mOdczynniki i materiaB kontrolny musz pochodzi od producenta aparatu lub by do niego dedykowane (walidacja)CSzkolenie pracownikw w obsBudze aparatu i w interpretacji wynikw.Oprogramowanie umo|liwiajce podgld wyniku bez wykonywania wydruku, umo|liwiajce porwnanie co najmniej 3 wynikw jednego pacjenta w formie skumulowanej (delta check) , oraz umo|liwiajce przesBanie do LIS dopiero wBa[ciwego zaakceptowanego wyniku, bez oznaczeD powtrkowychAparat wyposa|ony w komputer sterujcy, monitor ciekBo krystaliczny o przektnej min. 17 cali, dwustronnie drukujc drukark laserow czarnobiaB, oraz system podtrzymywania napicia pozwalajcy na bezpieczne zakoDczenie pracy aparatu oraz wyBczenie komputera sterujcego aparatem.Wykonawca dostarczy biurko laboratoryjne z blatem zmywalnym na stela|u metalowym z szuflad i szafk (z prawej strony) o wymiarach:dB.112 cm x szer. 60 cm x wys. 85 cm (< wkalkulowane w cen oferty), ktre po zakoDczeniu umowy przechodzi na stan zamawiajcego TAK / NIE Odpowiedz Wykonawcy: TAK / NIE *Oznaczanie parametrw w pBynach z jam ciaBa , pBynie mzgowo- rdzeniowym i pBynie z dializy otrzewnowej (RBC , WBC , MN , PMN) bez stosowania dodatkowych odczynnikw#Aparat wyposa|ony w czujnik [ciekwDowolno[ trybu oznaczenia dla ka|dej prbki CBC lub CBC diff,mo|liwo[ pracy w trybie prbek leukopenicznych z wydBu|onym czasem zliczania leukocytwNMaksymalna liczba punktw jak mo|na uzyska w krytdrium Jako[ wynosi 40 pkt.{WW. parametry oceniane winny zosta potwierdzone dokumentami (materiaBy informacyjne, karty katalogowe, instrukcje uzywania* WypeBnia Wykonawcaq PAKIET Nr 3 Dzier|awa analizatora RKZ wraz z dostaw odczynnikw na 20000 oznaczeD ( ok. 18 oznaczeD dziennie)vI. Odczynniki, kalibratory i materiaBy kontrolne potrzebne do wykonania 20000 oznaczeD w okresie obowizywania umowyNazwa odczynnikaIlo[ opakowaD na 36 mies.Nr katalogowy Nazwa odczynnikaCena 1 op. netto PLNWarto[ netto (zB)(kol. C x kol. E)(kol. F + (kol. F x kol. G %))RAZEM@II. MateriaBy zu|ywalne konieczne do wykonania 20000 oznaczeDIlo[ sztuk/op. Na 36 mies. Nr katalogowyCena 1 szt/ op. netto PLNWarto[ netto (zB)qStrzykawki do gazometrii kompatybilne z oferowanym analizatorem , zawierajce zbalansowan elektrolitowo heparyn"wyBapywacze skrzepu (clot catcher)III.Dzier|awa analizatoraDZIER{AWA ANALIZATORAWarto[ netto dzier|awy (zB)Warto[ brutto dzier|awy (zB)SERWIS APARATU - Gwarancja techniczna ( naprawy, wymiana podzespoBw) i coroczne przegldy techniczne zakoDczone wydaniem [wiadectwa sprawdzenia stanu technicznego urzdzeD i aparatury - uwzgldnione w ramach ceny ofertowejOgBem I - III(WARUNKI DODATKOWE BEZWZGLDNIE WYMAGANEMateriaBy kontrolne do codziennej kontroli jako[ci min. na trzech poziomach warto[ci - L, N, H. (Codzienna kontrola na jednym poziomie)3Gwarancja techniczna ( bezpBatne : naprawy, wymiana podzespoBw, i coroczne przegldy techniczne zakoDczone wydaniem [wiadectwa sprawdzenia stanu technicznego urzdzeD i aparatury). W przypadku niemo|liwej naprawy Wykonawca zobowizuje si do dostarczenia innego aparatu o cechach nie gorszych ni| oferowanye Czas reakcji serwisu (przyjazd in|yniera serwisowego)  maksimum 24 h od zgBoszenia (w dni robocze).Strzykawki do gazometrii kompatybilne z oferowanym analizatorem , zawierajce zbalansowan elektrolitowo heparyn , kapilary do gazometrii zawierajce zbalansowan elektrolitowo heparyn wraz z mieszadeBkiem i zatyczkami i wyBapywacze skrzepw kompatybilne z oferowanym analizatoremWykonawca winien samodzielne okre[li wymagane odczynniki, kalibratory i materiaBy kontrolne, materiaBy zu|ywalne (i ich ilo[ci) potrzebne do wykonania wymaganej liczby oznaczeDZaBcznik nr 1 do Pakietu nr 3 Dzier|awa analizatora RKZ wraz z dostaw odczynnikw na 20000 oznaczeD ( ok. 18 oznaczeD dziennie) w okresie obowizywania umowyOdpowiedz Oferenta Tak/Nie*"Analizator w peBni zautomatyzowanyAnalizator wyposa|ony w UPSWbudowana drukarkaAutomatyczny analizator do oznaczania parametrw krytycznych: pH, pCO2/ pO2, ctHb, O2Hb, MetHb, HbF, COHb, sO2, sd, potas, chlorki, wapD zjonizowany, mleczany, glukoza, bilirubina caBkowita.zAnalizator przeznaczony do pracy caBodobowej w systemie cigBym - natychmiastowe przej[cie z trybu czuwania do trybu pracyvKonstrukcja analizatora musi posiada dwa sposoby podania prbki do wyboru: bezpo[rednio ze strzykawki lub z kapilaryKonstrukcja analizatora musi zapewni, aby wszystkie parametry oznaczane byBy w jednym torze pomiarowym z wykorzystaniem jednej elektrody referencyjnej - dotyczy to zarwno materiaBu badanego od pacjenta jak i materiaBu kontrolnegoAnalizator musi posiada mo|liwo[ wykonania badania we krwi peBnej, osoczu, surowicy oraz pBynach bdcych kontrol jako[ciAnalizator musi posiada mo|liwo[ konfigurowania wybranych parametrw pomiarowych oraz ich wydruku wg potrzeb zamawiajcegoZamawiajcy wymaga, aby czas wymaganych kalibracji, dla oferowanego analizatora, Bcznie w cigu doby nie byB dBu|szy ni| 1 godzina. Analizator musi posiada mo|li< wo[ przerwania kalibracji dla wykonania badania prbki pilnej (uzyskanie peBnego wyniku, bez wzgldu na postp kalibracji)Analizator musi posiada w swoim menu mo|liwo[ oceny wizualnej na ekranie bie|cego stanu wykorzystania odczynnikw i stanu napeBnienia "pojemnika [ciekw"Analizator przystosowany do pracy z odczynnikami konfekcjonowanymi w pojedynczych opakowaniach, co umo|liwi wymian pojedynczych opakowaD, wykorzystanego ju| odczynnika (a nie wymiany kilku odczynnikw w zestawie)zOprogramowanie system kontroli jako[ci, mo|liwo[ peBnych analiz statystycznych krzywych L-J, zastosowanie reguB WestgardaeModuB automatycznej kontroli jako[ci. Mo|liwo[ oznaczania roztworw kontroli jako[ci na 4 poziomach..Aparat wyposa|ony w kolorowy, dotykowy monitorUDostarczenie wraz z analizatorem instrukcji obsBugi w j. polskim w wersji papierowejpWykonawca zobowizany jest do bezpBatnego podBczenia oferowanego analizatora do sieci szpitalnej (LIS Eskulap )^Wykonawca dostarczy protokB komunikacji analizatora oraz dokumentacj w wersji elektronicznejXBezpBatna (w ramach oferty cenowej) obsBuga serwisowa analizatora w czasie trwania umowy\BezpBatna instalacja analizatora oraz szkolenie w zakresie obsBugi w siedzibie zamawiajcegoAPrzy instalacji analizatora wykonawca doBczy paszport technicznyWraz z pierwsz dostaw odczynnikw wykonawca dostarczy ulotki odczynnikowe w jzyku polskim , wykaz odczynnikw zawierajcych substancje niebezpieczne i ich karty charakterystyki w wersji elektronicznej i papierowej Punktacja/Mo|liwo[ rozszerzenia menu badaD o kreatynin RMo|liwo[ rozbudowania aparatu o moduB automatycznego mieszania i podawania prbkisMaksymalna liczba punktw jak mo|na uzyska w krytdrium Jako[ (Parametry techniczno-funkcjonalne) wynosi 40 pkt.PAKIET Nr 4 Dostawa odczynnikw, materiaBw kontrolnych i materiaBw zu|ywalnych wraz z dzier|aw automatycznego analizatora koagulologicznego na 36 miesicyIlo[ oznaczeD na 36 mies. Nr katalogowy / Nazwa odczynnikaCena 1szt/ op. netto (zB)Warto[ netto na 36 mies. (zB) Stawka VAT %Warto[ brutto na 36 m-cy (zB)(kol.E x kol.F)(kol.G + (kol. G x kol. H %))2Zestaw do ozn . czasu protrombinowego + fibrynogen&Zestaw do ozn. Fibrynogenu met. ClausaZestaw do ozn . D-dimerwWarto[ netto na 36 m-cy (zB)Ilo[ sztuk/op.IV. SERWIS APARATU - Gwarancja techniczna ( naprawy, wymiana podzespoBw), i coroczne przegldy techniczne zakoDczone wydaniem [wiadectwa sprawdzenia stanu technicznego urzdzeD i aparatury - uwzgldnione w ramach ceny ofertowej*MateriaBy serwisowe potrzebne do przeglduIlo[ na 36 miesicyV. Dzier|awa analizatora(kol.C x kol.D)(kol.E + (kol. E x kol. F %))Analizator: (nazwa, typ) OgBem I - VWykonawca winien samodzielne okre[li wymagane odczynniki, kalibratory i materiaBy kontrolne, materiaBy zuzywalne, serwisowe itp. (i ich ilo[ci) potrzebne do wykonania wymaganej liczby oznaczeDZaBcznik nr 1 do Pakietu nr 4 Dostawa odczynnikw, materiaBw kontrolnych i materiaBw zu|ywalnych wraz z dzier|aw automatycznego analizatora koagulologicznego na 36 miesicyePeBna automatyzacja procesu oznaczenia wraz z rozcieDczaniem prbek badanych, kalibratorw i kontroli7Wydajno[ aparatu co najmniej 100 ozn/h (dla PT i APTT) Mo|liwo[ oznaczeD zarwno metodami wykrzepialnymi (odczyt na zasadzie nefelometrii) jak i chromogennymi/ immunologicznymi (odczyt kolorymetryczny). Brak konieczno[ci przeBczania filtrw odczytu w przypadku prbek z interferencjami (hemoliza, bilirubinemia, lipemia)|Mo|liwo[ oznaczania poziomu fibrynogenu zarwno na podstawie pomiaru czasu protrombinowego jak i klasyczn metod ClaussaAutomatyczny zaBadunek kuwet z magazynku kuwet do bloku reakcyjnego i automatyczny wyBadunek z bloku reakcyjnego do zbiornika na odpadki, bez konieczno[ci przerywania pracy aparatu; mo|liwo[ zaBadunku kuwet tak|e w trakcie pracy analizatoraAparat wyposa|ony w wewntrzny czytnik kodw paskowych do prbek i odczynnikw - odczyt automatyczny wszystkich wkBadanych w statywie materiaBw, brak konieczno[ci indywidualnego skanowania materiaBw przez operatorasOprogramowanie analizatora wyposa|one w system kontroli jako[ci wykonywanych badaD wraz z wykresami Levey-JenningsaOddzielne<  igBy pipetujce do odczynnikw i prbek badanych (zapobieganie kontaminacji); przebijak korkw zamknitego pobrania rwnie| dla prbek CITOOprogramowanie analizatora wyposa|one w wewntrzn baz danych wynikw pacjentw i danych kalibracyjnych (zapamitywanie kalibracji)KMo|liwo[ wykonywania testw  reflex wg zasad ustalonych przez u|ytkownikaAnalizator przystosowany do podBczenia do laboratoryjnego systemu informatycznego (LIS)  komunikacja dwukierunkowa (system Eskulap)cTrwaBo[ odczynnikw do PT, APTT, Fib co najmniej 3 dni na pokBadzie aparatu i tydzieD w temp 2-8C3Tromboplastyna ludzka rekombinowana ISI 1.0 +/- 0,1D-dimery odczynnik w oparciu o przeciwciaBo monoklonalne; trwaBo[ na pokBadzie min 5 dni,w lodwce dla odcz. roboczego min 1 miesic; odczynnik ciekBy wraz z ciekBym materiaBem kontrolnym; liniowo[ w pierwszym badaniu min 6000 ng/ml FEU; UTrwaBo[ kontroli do podstawowych metod krzepniciowych min 24 h na pokBadzie aparatuNCo najmniej 40 pozycji prbkowych, ka|da mo|e by w razie potrzeby prbk CITO[Baza danych min 500 pacjentw wraz z przechowywaniem krzywych wszystkich wykonanych reakcjigMaBa ilo[ czynno[ci konserwujcych, brak konieczno[ci wymiany zrdBa [wiatBa przez okres trwania umowyFWyposa|enie w monitor LCD , klawiatur, mysz, UPS i drukark laserow5Gwarancja techniczna ( naprawy, wymiana podzespoBw), i coroczne przegldy techniczne zakoDczone wydaniem [wiadectwa sprawdzenia stanu technicznego urzdzeD i aparatury w czasie trwania umowy bezpBatne.Wykonawca wymieni wadliwe urzdzenia na nowe w razie 3-krotnej awarii w cigu roku tego samego podzespoBu. 0Instrukcja obsBugi analizatora w jzyku polskimDSzkolenie pracownikw w obsBudze aparatu i w interpretacji wynikw. Wykonawca dostarczy Statyw karuzelowy na 6 pipet Eppendorf Research, Research plus, Reference, Reference 2 do pipet bdcych wBasno[ci zamawiajcego oraz 1 pipet pasujc dow/w statywu o poj. 100-1000l  po okresie umowy w/w przechodz na wBasno[ zamawiajcego Punktacja: EMo|liwo[ wstawienia prbki CITO w ka|dym momencie pracy analizatorakMo|liwo[ wykonywania badaD zarwno z r|nego rodzaju probwek pierwotnych jak i z naczyniek na mikroprbkiNAZWACecha dod. towaru ZamwienieNr katalog. oferentaIlo[ opakowaD na 36 m-cyCena 1 opak. netto (zB)Warto[ netto na 36 m-cy (zB)Warto[ brutto na 36 m-cy. (zB)ilo[j.miary.(kol.G x kol.H)(kol.I + (kol. I x kol.J %))Barwnik May- GrunwaldalBarwnik GiemsyOdczynnik Turka but 100 mlmlOdczynnik SamsonaOdczynnik Pandy'egoOdczynnik Nonne Appelta/Odczynnik do liczenia pBytek krwi met. KomorowDZestaw do szybkiego barwienia rozmazw Quick Panoptic lub rwnowa|ny zestaw a 100 ml ka|dego barwnikazestawOferowane wyroby musz speBnia wymagania zasadnicze okre[lone w Rozporzdzeniu Ministra Zdrowia z 12 stycznia 2011r. w sprawie wymagaD zasadniczych dla wyrobw medycznych do diagnostyki in vitro(tekst jednolity Dz.U. 2013 poz. 1127) oraz zaBcznikach do wymienionego rozporzdzenia.a Wymagania co do wielko[ci opakowaD jednostkowych okre[lone s w rubryce "cecha dodatkowa towaru"Dostarczy karty charakterystki substancji niebezpiecznych (lub o[wiadczenie o braku wymogu ich posiadania) w formie wydruku lub elektronicznej wraz z pierwsz dostaw odczynnikwsWykonawca winien samodzielnie okresli ilo[ opakowaD na 36 m-cy potrzebnych do wykonania wyspecyfikowanej ilo[ci Opakowanie handlowe%Ilo[ opakowaD handlowych na 36 m-cy Cena opak. handlowego netto (zB)Warto[ netto (zB) na 36 m-cyStawka VAT (%)Warto[ brutto (zB) na 36 m-cyile opak. jedn.wielko[ opak. jedn.(kol.I x kol.J)(kol.K + (kol.K x kol.L %))MDTest kasetkowy na krew utajon w kale (czuBo[ analityczna 10 ng/ml)szt:Testy kasetkowe do ozn. narkotykw w moczu (10parametrowe)jTesty kasetowe do ozn. Rotawirusw , norowirusw i adenowirusw w kale (wszystkie testy na jednej kasetce)szt.3Testy paskowe do ozn. biaBka Bence  Jonesa w moczuhTesty kasetkowe do ozn. wirusw grypy A i B , rotawirusw, SARS Cov2 (wszystkie testy na jednej kasetce)&Campylobacter w kale (test kasetkowy )1Kalprotektyna+laktoferyna w kale (test kasetkowy)`Wymagania co do wielko[ci opakowaD jednostkowych okre[lone s w rubryce "cecha dodatkowa towaru"<TrwaBo[ odczynnikw min 6 mies. (w temp. 2-8 st.Celsjusza)<Zaoferowane ilo[ci musz uwzgldnia terminy wa|no[ci testwmZestaw do ozn. krwi utajonej w kale zawiera buteleczki z buforem i aplikatorem (czuBo[ analityczna 10 ng/ml) Testy do narkotykw (zestaw) < powinny dawa mo|liwo[ oznaczania nastpujcych narkotykw: amfetamina (czuBo[ analit.: min. 1000ng/ml), barbiturany (czuBo[ analit.: min. 300ng/ml), benzodiazepiny (czuBo[ analit.: min. 200ng/ml), THC (czuBo[ analit.: min. 50ng/ml) , opiaty (czuBo[ analit.: min. 300ng/ml) , methamfetamina (czuBo[ analit.: min. 1000ng/ml) , cocaina (czuBo[ analit.: min. 300ng/ml), metadon (czuBo[ analit.: min. 300ng/ml), TCA (czuBo[ analit.: min. 1000ng/ml).MDMA (czuBo[ analit.: min. 500ng/ml) NiespeBnienie ktregokolwiek z powy|szych wymagaD oraz warunkw granicznych lub brak jakiegokolwiek z wymaganych dokumentw spowoduje odrzucenie oferty.Nazwa parametruIlo[ oznaczeD na 36 m-cyIlo[ ozn.z 1 op.Ilo[ op. na 36 mies. (szt.)Warto[ netto na 36 mies. PLNWarto[ brutto na 36 mies. PLNPaski do moczu9II. MateriaBy kontrolne do codziennej kontroli jako[ci Ilo[ op. na 36 miesicyCena 1 op. netto (zB)Warto[ netto na 36 mies. (zB)Warto[ brutto na 36 mies.(zB)(kol.D x kol.E)(kol.F + (kol. F x kol.G %))III. SERWIS APARATU - Gwarancja techniczna ( naprawy, wymiana podzespoBw), i coroczne przegldy techniczne zakoDczone wydaniem [wiadectwa sprawdzenia stanu technicznego urzdzeD i aparatury - uwzgldnione w ramach ceny ofertowej WykonawcyCena netto (zB)Warto[ brutto na 36 mies. (zB)#IV. Dzier|awa systemu analizy moczu3Dzier|awa systemu analizy moczu (Nazwa analizatora)+Warto[ netto dzier|awy na 36 miesicy (zB),Warto[ brutto dzier|awy na 36 miesicy (zB)(kol.C x kol. D)(kol.E + (kol. E x kol.F %))OGAEM: pkt I.- IV.;Paski dedykowane i zwalidowane do u|ycia z w/w analizatoremqZestawienie wymaganych parametrw granicznych analizatora zostaBo przedstawione w zaBczniku nr 1 do pakietu nr 7Wykonawca winien samodzielne okre[li wymagane odczynniki, kalibratory i materiaBy kontrolne, materiaBy zuzywalne, serwisowe itp. (i ich ilo[ci) potrzebne do wykonania wymaganej liczby badaDuZaBcznik nr 1 do pakietu nr 7 Dostawa paskw do moczu na 35000 badaD wraz z dzier|aw i serwisem w peBni zautomatyzowanego systemu analizy moczu skBadajcego si z moduBu do analizy parametrw fizykochemicznych moczu oraz moduBu do oceny upostaciowanych elementw w moczu oraz moduBu do automatycznego cyfrowego obrazowania elementw upostaciowanych moczu na 36 miesicyRWymagania graniczne systemu oceny parametrw fizykochemicznych i oceny osadu moczuPeBna moduBowo[ aparatw wchodzcych w skBad systemu  jeden wsplny podajnik (stosowanie tych samych statyww na prbki moczu)Wydajno[ - min. 80 prbek na godzin (bez moduBu obrazowania cyfrowego). Wydajno[ moduBu obrazowania cyfrowego min. 30 prbek na godzinMo|liwo[ wpisania wBasnych reguB zarzdzajcych prac podBczonych analizatorw i decydujcych o konieczno[ci wykonania dodatkowych oznaczeD]Zarzdzanie odczynnikami i procedurami konserwacyjnymi z wszystkich podBczonych analizatorwLIntegracja programw kontroli jako[ci z wszystkich podBczonych analizatorwUmo|liwo[ ostatecznej walidacji wynikw badania oglnego moczu przed wysBaniem do LISGwarancja techniczna ( naprawy, wymiana podzespoBw), i coroczne przegldy techniczne zakoDczone wydaniem [wiadectwa sprawdzenia stanu technicznego urzdzeD i aparatury w czasie trwania umowy na koszt Wykonawcy  czas reakcji serwisu do 24hInstalacja, uruchomienie analizatora i szkolenie personelu w laboratorium w zakresie obsBugi na koszt wykonawcy ( obligatoryjne 2 szkolenia w pierwszym roku i po jednym szkoleniu w drugim i trzecim roku w razie potrzeby)LWymagania graniczne dla moduBu do analizy parametrw fizykochemicznych moczuW peBni automatyczny analizator do pBilo[ciowych badaD fizyko-chemicznych w moczu przy u|yciu testw paskowych (mocz aspirowany bezpo[rednio z probwki)wymagane parametry pomiarowe: pH, glukoza, biaBko, krew,urobilinogen, ketony, bilirubina, azotany, leukocyty, ci|ar wBa[ciwy, kolor moczu, przejrzysto[ moczu(minimalna wymagana objto[ moczu  1 ml)pojemno[ podajnika  min 50 prbek moczu4r|nicowanie krwinek czerwonych i wolnej hemoglobinyUkontrola jako[ci w oparciu o materiaB kontrolny o co najmniej dwch r|nych poziomach1Ci|ar wBa[ciwy mierzony metod refraktometryczn&Wydajno[ -<  min. 80 prbek na godzin.=Dozowanie prbek na pola reakcyjne paskw za pomoc pipetora.0Wymagania graniczne dla moduBu oceny osadu moczuuw peBni zautomatyzowany analizator przeznaczony do dokBadnego ilo[ciowego zliczania elementw upostaciowanych w moczuXmetody pomiaru  cytometria przepBywowa, konduktometria z ogniskowaniem hydrodynamicznymNwyniki podawane w ilo[ciach elementw upostaciowanych w mikrolitrze (l) moczuwymagane parametry raportowane na wyniku: erytrocyty, leukocyty,nabBonki, bakterie, waBeczki, krysztaBy, komrki dro|d|opodobne,pasma [luzu, spermatocyty\dokBadny pomiar bakterii z dodatkowym wskazaniem za pomoc oflagowania Gramm (-) i Gramm (+)qdokBadny pomiar erytrocytw z ocen ich morfologii za pomoc oflagowania (erytrocyty dysmorficzne i izomorficzne)^r|nicowanie nabBonkw (nerkowe, przej[ciowe, epitelialne) z ich dokBadnym ilo[ciowym pomiaremSr|nicowanie waBeczkw (szkliste, patologiczne) z ich dokBadnym ilo[ciowym pomiarem+ilo[ciowy pomiar erytrocytw niezlizowanych%Wydajno[: min. 80 prbek na godzin.;minimalna wymagana objto[ moczu  2 ml (tryb podajnikowy)=praca z podajnikiem o minimalnej pojemno[ci  50 prbek moczu&ilo[ciowy pomiar zlepw leukocytarnych@System wyposa|ony w komputer, drukark i min. 24 calowy monitor.,Oprogramowanie analizatora w jzyku polskim.bDoBczona do oferty peBna instrukcja obsBugi i konserwacji aparatu w jzyku polskim, oraz metodykiGDoBczona do oferty deklaracja zgodno[ci EC (na wezwanie zamawiajacego)SWymagania graniczne dla moduBu do analizy obrazowej elementw upostaciowanych moczuW peBni zautomatyzowany analizator do analizy obrazowej elementw upostaciowanych moczu pozwalajcym na weryfikowanie prbek patologicznychLMetoda pomiaru oparta na analizie obrazowej zdj elementw upostaciowanych GAnalizator pozwalajcy na r|nicowanie elementw na co najmniej 8 klas*Ocena morfologii elementw upostaciowanych6Minimalna wydajno[ analizatora  30 prbek na godzinMMinimalna ilo[ moczu w trybie podajnika: 1,6 ml; w trybie manualnym: 0,6 ml.0Pojemno[ podajnika- co najmniej 80 prbek moczuVKontrola jako[ci w oparciu o materiaB kontrolny o co najmniej dwch r|nych poziomach.TAK/NIEOdpowiedz Wykonawcy:TAK/NIEPoBczenie moduBu fizykochemicznego , moduBw osadu moczu podajnikiem przesuwajcym statyw z probwkami z jednego moduBu do drugiego|WW. parametry oceniane winny zostac potwierdzone dokumentami (materiaBy informacyjne, karty katalogowe, instrukcje u|ywania) Odczynniki i materiaBy zu|ywalneOpis przedmiotu zamwienia%Przewidywana ilo[ oznaczeD / 36 m-cyWielko[ opakowania odczynnika#Cena jednostkowa netto (zB) / 1 op.!Warto[ netto (zB) za 36 miesicy Stawka VAT %"Warto[ brutto (zB) za 36 miesicy+Wpisa nr katalogowy oraz nazw odczynnikw0Wymagany Termin wa|no[ci liczony od daty dostawy(kol.D x kol.F)(kol.G+ (kol.G x kol.H %))qKarta do badania w [rodowisku PTA-LISS. Kolumny wypeBnione surowic antyglobulinow poliwalentn przez producenta 13000 ozn.JKarta do bezpo[redniego testu antyglobulinowego (IgG-IgA-IgM-C3c-C3d-ctl)70 ozn.BKarta do potwierdzenia grupy dawcw (anty A, anty B, anty D VI+ ) 10000 ozn.HKarta do potwierdzenia grupy krwi biorcw (anty A, anty B, anty D VI- ) 9000 ozn.Karta do badania grup krwi (anty A , anty-B, anty DVI-, anty-DVI+, oznaczanie p-ciaB grupowych z krwinkami wzorcowymi A1 , B)  karta wypeBniona odczynnikami przez producenta 9500 ozn.SKarta do badania grup krwi noworodka (anty A, antyB, anty-AB, anty DVI+, ctrl, BTA)144 ozn.FKrwinki wzorcowe gotowe do u|ycia do wykrywania przeciwciaB grupowych 8Krwinki wzorcowe gotowe do u|ycia do wykrywania przeciwciaB w [rodowisku PTA-LISS zawieszone w roztworze o niskiej sile jonowej - opakowania nie wiksze ni| po 200 testwKoDcwki do pipety 50000 szt.Zestaw do zewntrzlaboratoryjnej midzynarodowej kontroli jako[ci w zakresie wykonywanych badaD potwierdzonej certyfikatem 2 x rok dostosowanej do metod mikrokolumnowych i probwkowych 6 zestawwDiluent 19000 ml13~Zestaw krwi kontrolnej do codziennej kontroli jako[ci wymaganej przepisami (st|enie przeciwciaB anty D 0,05 IU/ml i anty Fya)na 36 miesicyII. Dzier|awa urzdzeD i usBuga nadzoru autorskiego nad oprogramowaniem (bdcym wBasno[ci zamawiajcego) pozwalajcych na wykonywanie badaD z prowadzeniem dokumen< tacji oraz intergracja istniejcego oprogramowania eDelphyn z systemem EskulapOpis przedmiotuWpisa nr katalogowy oraz nazw Jedn. miary Czynsz dzier|awny netto za 1 m-cWarto[ brutto na 36 m-cy (zB)(kol.G + (kol.G x kol.H %))UsBuga nadzoru autorskiego nad oprogramowaniem e Delphyn (serwis,dostp do infolinii, przegldy , interwencje , szkolenia, upgradeX Intergracja istniejcego oprogramowania eDelphyn z systemem Eskulap w standardzie HL7 OGAEM (I. + II.) Dostarczy karty charakterystyki substancji niebezpiecznych (lub o[wiadczenie o braku wymogu ich posiadania) w formie wydruku lub elektronicznej wraz z pierwsz dostaw odczynnikwWszystkie produkty od jednego producenta (metody w peBni zwalidowane z posiadanym przez zamawiajcego sprztem), z wyjtkiem oprogramowania, sprztu komputerowego i nakBuwaczy do drenw.Dostawa produktw [rednio raz na miesic, wg dostarczonego harmonogramu dostaw w danym roku. Mo|liwo[ dostaw w trybie pilnym tzw. "Cito" z terminem realizacji 3 dni od zBo|enia zmwienia.MateriaBy i odczynniki umo|liwiajce prac na zawiesinie <1% krwinek czerwonych pozwalajce na eliminacj pBukania krwinek czerwonychvMetoda oznaczeD - mikrokolumnow oparta na aglutynacji krwinek czerwonych na kolumnach wypeBnionych |elem dekstranowymKPo podpisaniu umowy Wykonawca przeka|e Zamawiajcemu nastpujce dokumenty:ea) ze wskazaniem autoryzowanego serwisu technicznego, ktry zapewni peBn obsBug posiadanego sprztuLb) uprawnienia (autoryzacji) producenta dla wskazanego serwisu technicznego.Wszystkie odczynniki od jednego producenta, tego samego co posiadany sprzt (z wyjtkiem oprogramowania, niezbdnego sprztu komputerowego i kontroli zewntrzlaboratoryjnej), Oprogramowanie polskojzyczne pozwalajce na prowadzenie pracowni serologii transfuzjologicznej i banku krwi ( wydruki wynikw i ksigi laboratoryjne ) zgodnie z obowizujcymi przepisami , z niezbdnym zestawem komputerowym (z programem operacyjnym) , urzdzeniem wielofunkcyjnym (drukark laserowa, skaner , kopiarka, fax), drukark kodw kreskowych i skanerem kodw pozwalajcym na bezpo[rednie wprowadzenie danych z etykiet na pojemnikach z krwi do systemu.Zestaw komputerowy o parametrach pozwalajcych na instalacj posiadanego przez laboratorium oprogramowania eDelphyn i systemu LIS Eskulap. W przypadku zmiany dotychczasowego oprogramowania konieczne jest przeniesienie dotychczasowej bazy danych do nowego programu w sposb umo|liwiajcy natychmiastowy dostp do danych i wydruk archiwalnych wynikw. Zamawiajcy wymaga, aby oprogramowanie Pracowni Immunologii Transfuzjologicznej dostpne byBo z poziomu przegldarki internetowej (wielowarstwowa aplikacja webowa), co pozwala na Batwy i szybki dostp z urzdzenia ka|dej klasy, niezale|nie od systemu operacyjnego i parametrw komputerw obsBugujcych stanowisko. Oferowane oprogramowanie musi posiada mo|liwo[ rejestracji wynikw testw w formie opisowej, umo|liwiajc wprowadzenie dowolnie dBugiego komentarza bezpo[rednio do badanego testu a dodatkowo musi umo|liwi dodanie pliku w formie PDF lub JPG do badania. Oferowane oprogramowanie musi posiada funkcje rejestracji zamwienia na skBadniki krwi w RCKiK z mo|liwo[ci wydrukowania zamwienia. Podczas rejestracji otrzymanej dostawy oprogramowanie bdzie analizowa ilo[ i rodzaj skBadnika zamwionego z ilo[ci i rodzajem skBadnika otrzymanego. Oferowane oprogramowanie musi posiada mo|liwo[ wydania krwi w trybie pilnej transfuzji (bez wykonania prby krzy|owej)CDostawa odczynnikw do serologii grup krwi na 36 miesicy - (III.)NAZWA ODCZYNNIKACena opak. netto (zB)!Warto[ netto (zB) na 36 miesicy"Warto[ brutto (zB) na 36 miesicy jedn. miary(kol. I + (kol.I x kol.J %))'PBS (0,15mol/l NaCl buforowany , ph 7 )but. max 1000 mllitrBezwzgldny wymg doBczenia do oferty: aktualnego dokumentu potwierdzajcego dopuszczenia do obrotu, a w przypadku, gdy prawo nie wymaga dopuszczenia do obrotu, - nale|y dostarczy dokument potwierdzajcy znak zgodno[ci CE dla tego wyrobu.Oferowane wyroby musz speBnia wymagania zasadnicze okre[lone w Rozporzdzeniu Ministra Zdrowia z 12 stycznia 2011r. w sprawie wymagaD zasadniczych dla wyrobw medycznych do diagnostyki in < vitro (tekst jednolity Dz.U. 2013 poz. 1127) oraz zaBcznikach do wymienionego rozporzdzenia.~Przyjmujcy zamwienie dostarczy butl 1000 ml z nastawnym dozownikiem 1-10 ml wkalkulowane w ofert wraz z pierwsz dostaw% Pakiet stanowi niepodzieln caBo[ .$ Nazwy odczynnikw w jzyku polskim. Dostarczy karty charakterystki substancji niebezpiecznych (lub o[wiadczenie o braku wymogu ich posiadania) w formie wydruku lub elektronicznej wraz z pierwsz dostaw odczynnikw NiespeBnienie ktregokolwiek z powy|szych wymagaD oraz warunkw granicznych lub brak jakiegokolwiek z wymaganych dokumentw spowoduje odrzucenie oferty.]I. Odczynniki , testy i materiaBy zu|ywalne potrzebne do wykonania 650 oznaczeD na 36 m-cy.Testy do oznaczania obecno[ci surowicy krwi przeciwciaB IgE wytwarzanych dla alergenw pokarmowych ( minimum 20 alergenw pokarmowych: f1, f75, f2, f45, f4, f5, f9, f13, f14, f17, f20,f49, f84, f237, f25, f31, f35, f85, f3, f23, CCD)Testy do oznaczania obecno[ci surowicy krwi przeciwciaB IgE pediatryczny(mieszany), ( minimum 20 alergenw:(gx, t3, w6, d1, d2, e1, e2, e3, m2, m3, m6, f1, f75, f2, f3,f76, f77, f78, e204, f4, f9, f14, f13, f17, f31, f35, f49, CCD )oZestawy testowe do oznaczania przeciwciaB przeciwko Borrelia w klasie IgM (test potwierdzenia)  testy paskowe oZestawy testowe do oznaczania przeciwciaB przeciwko Borrelia w klasie IgG (test potwierdzenia)  testy paskowe II. Dzier|awa sprztuDZIER{AWA SPRZTUSprzt : (nazwa, typ)OgBem I  IIZESTAWIENIE PARAMETRW SPRZTUNWymagania graniczne systemu (sprzt do odczytu, oprogramowanie, paski testowe)Jeden pasek testowy przeznaczony do diagnostyki jednego pacjenta, zawierajcy osobno naniesione alergeny w postaci lnii na oddzielnych, specjalnie dobranych membranach Pasek musi zawiera pole weryfikacji dla reakcji krzy|owych  weryfikacja reakcji krzy|owych za pomoc cross-reactive carbohydrate determinant CCDIMo|liwo[ eliminacji reakcji krzy|owych Anty CCD w przypadku ich wykryciaPNa ka|dym paski testowym linia kontrolna wskazujca prawidBowe wykonanie analizyTOcena paskw pBilo[ciowa, wynik podawany w standardowej skali sze[ciu klas (EAST) 1Odczynniki gotowe do u|ycia, za wyjtkiem buforu.DPaski do potwierdzenia boreliozy w klasie IgM zawieraj antygeny: VlsE Borrelia burgdorferi, wysoko oczyszczona rekombinowana flagelina (p41) i BmpA (p39) oraz wysoko oczyszczone rekombinowane, wysokospecyficzne dimeryczne antygeny OspC (p25) z Borrelia afzelii, Borrelia burgdorferi, Borrelia garinii i Borrelia spielmaniiPaski do potwierdzenia boreliozy w klasie IgG zawieraj antygeny: rekombinowane (VlsE Borrelia burgdorferi, VlsE B. garinii, VlsE B. afzelii), rekombinowane p83, p41, p39, wysokospecyficzne rekombinowane dimeryczne OspC, rekombinowane: p58, p21, p20, p19, p18Ka|dy pasek do potwierdzenia boreliozy dodatkowo zawiera dwie linie kontrolne: dla koniugatu IgG i IgM oraz lini kontroln dla mieszanki klas IgG i IgMGWszystkie odczynniki niezbdne do inkubacji zawarte w zestawie testowymKBrak konieczno[ci zu|ywania paskw testowych na tzw. cut off lub kalibracj&Wszystkie testy od jednego producenta R Odczyt wynikw za pomoc programu komputerowego. Oprogramowanie w jzyku polskim.5Mo|liwo[ archiwizacji obrazu paska, danych pacjenta.]Mo|liwo[ modyfikacji obrazu paska ( wynikw) z automatyczn dokumentacj naniesionych zmian.Komputer( wraz ze specjalistycznym oprogramowaniem) i u|yczonym do tego celu niezbdnym sprztem: monitorem, skanerem, drukark oraz innymi niezbdnymi akcesoriami do prawidBowego wykonania badaniaInstalacja, uruchomienie i szkolenie personelu w laboratorium w zakresie obsBugi na koszt wykonawcy ( obligatoryjne 2 szkolenia w pierwszym roku i po jednym szkoleniu w drugim i trzecim roku w razie potrzeby)#Bufor wspBny dla wszystkich testwTesty potwierdzenia w kierunku boreliozy zawieraj antygeny lipidowe charakterystyczne dla fazy pznej: lipid Borrelia afzelii, lipid Borrelia burgdorferi,  Odpowiedz Oferenta Tak/Nie+Zastosowanie technologii chemiluminescencjiu Wpisanie przez Zamawiajcego Tak w kolumnie "Warto[ graniczna" oznacza, |e dany parame< tr jest bezwzgldnie wymagany. TAK- 5 pkt. / NIE-0pkt. TAK-10 pkt. / NIE-0pkt. TAK-5 pkt. / NIE-0pkt. sW poni|szej cz[ci ZaBcznika Zamawiajcy podaB warunki graniczne parametrw i warunkw przez siebie wymaganych dla oferowanego sprztu (systemu). Wykonawca skBadajc ofert jest zobowizany wypeBni kolumny zatytuBowane: "Odpowiedz Oferenta Tak/Nie" (wpisujc Tak lub Nie). Brak odpowiedzi TAK lub odpowiedz NIE (dla parametrw bezwzgldnie wymaganych przez Zamawiajacego) bdzie traktowany jako brak danego parametru, co skutkowa bdzie odrzuceniem oferty jako niezgodnej z tre[ci SWZ. Wykonawca mo|e wypeBni kolumn  Parametry oferowane (opisa) opisujc we wBa[ciwych pozycjach w wyczerpujcy sposb dany parametr. C Razem odczynniki, kalibratory, kontrole i materiaBy eksploatacyjne:B t W poni|szej cz[ci ZaBcznika Zamawiajcy podaB warunki graniczne parametrw i warunkw przez siebie wymaganych dla oferowanego sprztu (systemu). Wykonawca skBadajc ofert jest zobowizany wypeBni kolumny zatytuBowane: "Odpowiedz Oferenta Tak/Nie" (wpisujc Tak lub Nie). Brak odpowiedzi TAK lub odpowiedz NIE (dla parametrw bezwzgldnie wymaganych przez Zamawiajacego) bdzie traktowany jako brak danego parametru, co skutkowa bdzie odrzuceniem oferty jako niezgodnej z tre[ci SIWZ. Wykonawca mo|e wypeBni kolumn  Parametry oferowane (opisa) opisujc we wBa[ciwych pozycjach w wyczerpujcy sposb dany parametr.  Odpowiedz Oferenta Tak/Nie*u Wpisanie przez Zamawiajcego Tak w kolumnie "Warto[ graniczna" oznacza, |e dany parametr jest bezwzgldnie wymagany. TAK-20 pkt./NIE-0pkt. TAK-5 pkt./NIE-0pkt. TAK-15 pkt./NIE-0pkt. 6 Analizator 5 DIFF - rok produkcji nie starszy ni| 2017- Oprogramowanie aparatu, umo|liwiajce zarzdzanie odczynnikami  szacowanie przez system zu|ycia odczynnikw, wraz z prezentacj takiego zu|ycia w formie graficznej, czytelnej dla operatora, podanej na monitorze informacji o poziomie zu|ycia odczynnikw. (zaBczy(na wezwanie Zamawiajcego zgodnie z art. 107 ust. 2 ustawy Pzp) przykBadowy zrzut ekranu, dopuszcza si zrzut w jzyku angielskim)*GTAK-20 pkt./NIE-0pkt.  WW. parametry oceniane winny zostac potwierdzone dokumentami (materiaBy informacyjne, karty katalogowe, instrukcje u|ywania - dokumenty te winny zosta zBo|one wraz z ofert ~1 Analizator - rok produkcji nie wcze[niej ni| 2016))Zestaw do ozn . APTT + CaCl 2 0,025 mol/l MateriaBy kontrolne metrykowane na oferowany aparat do codziennej kontroli jako[ci na minimum dwch poziomach warto[ci - N, P8BqZestawienie wymaganych parametrw granicznych analizatora zostaBo przedstawione w zaBczniku nr 1 do pakietu nr 4TAK-20 pkt. / NIE-0pkt. s W poni|szej cz[ci ZaBcznika Zamawiajcy podaB warunki graniczne parametrw i warunkw przez siebie wymaganych dla oferowanego sprztu (systemu). Wykonawca skBadajc ofert jest zobowizany wypeBni kolumny zatytuBowane: "Odpowiedz Oferenta Tak/Nie" (wpisujc Tak lub Nie). Brak odpowiedzi TAK lub odpowiedz NIE (dla parametrw bezwzgldnie wymaganych przez Zamawiajacego) bdzie traktowany jako brak danego parametru, co skutkowa bdzie odrzuceniem oferty jako niezgodnej z tre[ci SWZ. Wykonawca mo|e wypeBni kolumn  Parametry oferowane (opisa) opisujc we wBa[ciwych pozycjach w wyczerpujcy sposb dany parametr. 1 Analizator - rok produkcji nie wcze[niej ni| 2015( W peBni automatyczny, zintegrowany system do oznaczania parametrw fizyko-chemicznych, analizy ilo[ciowej elementw upostaciowanych moczu oraz obrazowania cyfrowego elementw upostaciowanych moczu wraz z oprogramowaniem zarzdzajcym prac systemu, rok produkcji  nie wcze[niej ni| 2017  TAK - 20 pkt. / NIE-0pkt. TAK-20 pkt. / NIE-0pkt.  Odpowiedz Oferenta Tak/Nie*   Bezwzgldny wymg doBczenia do oferty: aktualnego dokumentu potwierdzajcego dopuszczenia do obrotu, a w przypadku, gdy prawo nie wymaga dopuszczenia do obrotu, - nale|y dostarczy dokument potwierdzajcy znak zgodno[ci CE dla tego wyrobu.nZestawienie wymaganych parametrw granicznych urzdzeD zostaBo przedstawione w zaBczniku nr 1 do pakietu nr 8 Odpowiedz Oferenta Tak/Nie F Wirwka serologiczna na minimum 12 miejsc - 1 szt. inkubator - 1 sz< t.sW poni|szej cz[ci ZaBcznika Zamawiajcy podaB warunki graniczne parametrw i warunkw przez siebie wymaganych dla oferowanego sprztu (systemu). Wykonawca skBadajc ofert jest zobowizany wypeBni kolumny zatytuBowane: "Odpowiedz Oferenta Tak/Nie" (wpisujc Tak lub Nie). Brak odpowiedzi TAK lub odpowiedz NIE (dla parametrw bezwzgldnie wymaganych przez Zamawiajcego) bdzie traktowany jako brak danego parametru, co skutkowa bdzie odrzuceniem oferty jako niezgodnej z tre[ci SWZ. Wykonawca mo|e wypeBni kolumn  Parametry oferowane (opisa) opisujc we wBa[ciwych pozycjach w wyczerpujcy sposb dany parametr. ZaBcznik nr 1 do pakietu 10 -Dostawa testw alergicznych do oznaczania sIgE na 36 miesicy wraz z dzier|aw sprztu i oprogramowania do odczytu testw paskowychrNazwa aparatu:+A5:E20A3A5:E15A5:E21A5:E20A5:E21A5:E20A5:E21A5:E20A5:E19A5:E18A5:E17A5:E16A5:E15A5:E14A5:E15+A5:E15PAKIET Nr 8 Dostawa odczynnikw i materiaBw zu|ywalnych do badaD w serologii transfuzjologicznej do systemu DiaMed-ID Micro Typing System bdcego wBasno[ci zamawiajcego wraz z obsBug serwisow oprogramowania do obsBugi pracowni serologii i banku krwi oraz dzier|aw systemu (wirwka + inkubator) stanowicego backup dla istniejcego systemu oraz bezpBatnym serwisem sprztu i aparatury na 36 miesicy - (II.)ZaBcznik nr 1 do Pakietu nr 8 Dostawa odczynnikw i materiaBw zu|ywalnych do badaD w serologii transfuzjologicznej do systemu DiaMed-ID Micro Typing System bdcego wBasno[ci zamawiajcego wraz z dzier|aw oprogramowania do obsBugi pracowni serologii i banku krwi oraz dzier|aw systemu (wirwka + inkubator) stanowicego backup dla istniejcego systemu oraz bezpBatnym serwisem sprztu i aparatury na 36 miesicy - (II.) PAKIET Nr 9SI. Odczynniki , paski i materiaBy zu|ywalne potrzebne do wykonania 35000 oznaczeDhKapilary do gazometrii zawierajce zbalansowan elektrolitowo heparyn wraz z mieszadeBkiem i zatyczkamiNPAKIET Nr 5 Dostawa odczynnikw do metod manualnych na 36 miesicy - barwnikiJPAKIET Nr 6 Dostawa odczynnikw do metod manualnych na 36 miesicy - testyn PAKIET Nr 7 Dostawa paskw do moczu na 35 000 badaD wraz z dzier|aw i serwisem w peBni zautomatyzowanego systemu analizy moczu skBadajcego si z moduBu do analizy parametrw fizykochemicznych moczu oraz moduBu do ilo[ciowej oceny upostaciowanych elementw w moczu oraz moduBu do automatycznego cyfrowego obrazowania elementw upostaciowanych moczu na 36 miesicy  #PAKIET Nr 10 Dostawa testw alergicznych do oznaczania sIgE na 36 miesicy wraz z dzier|aw sprztu i oprogramowania do odczytu testw paskowychTesty do oznaczania obecno[ci surowicy krwi przeciwciaB IgE wytwarzanych dla alergenw wziewnych ( minimum 20 alergenw wziewnych: g1, g3, g6, g12, t2, t3, t4, t7, w1, w6, w9,d1, d2, e1, e2, e3, m1, m2, m3, m6, CCD)vDostawca zapewnia intergracj istniejcego oprogramowania eDelphyn z systemem Eskulap w standardzie HL7 na swj kosztNiezbdny sprzt komputerowy (PC, monitor, klawiatura , mysz, urzdzenie wielofunkcyjne (skaner, drukarka laserowa i fax), drukarka kodw kreskowych i skaner kodw kreskowych, UPS)c) Wykazu dostawcw cz[ci zamiennych, cz[ci zu|ywalnych lub materiaBw eksploatacyjnych okre[lonych przez wytwrc wyrobu - podstawa - art. 90 ust. 3 ustawy z dnia 20.05.2010 r o wyrobach medycznych (Dz. U. 2010.107.679) wykazu podmiotw upowa|nionych przez wytwrc lub autoryzowanego przedstawiciela do wykonywania czynno[ci instalacji, okresowej konserwacji, okresowej lub doraznej obsBugi serwisowej, aktualizacji oprogramowania, okresowych lub doraznych przegldw, regulacji, kalibracji, wzorcowaD, sprawdzeD lub kontroli bezpieczeDstwa - ktre zgodnie z instrukcj u|ywania wyrobu nie mog by wykonane przez u|ytkownika art. 90 ust. 4 ustawy z dnia 20.05.2010 r o wyrobach medycznych (t.j. Dz. U. 2019 poz. 175) ta ustawa nie obowizujeParametry minimalne zestawu komputerowego : Monitor LCD 20", Windows 11 PRO, Komputer\serwer obudowa typu Mini Tower lub Midi Tower, Procesor: intel i7, Dysk SSD 1TB - 4 szt., PByta gBwna z Raid na 4 dyski SSD, Pami Ram: min. 16 GB Zestaw do ozn. DabigatranuIZestaw do Anty -Xa do monitorowania heparyny , Ap<iksabanu i RywaroksabanuAI. Odczynniki potrzebne do wykonania 54610 oznaczeD na 36 m-cy.uWyroby musz bezwzgldnie speBnia wymagania ustawy o wyrobach medycznych z dnia 7 kwietnia 2022 (Dz.U.2022 poz.974)tWyroby musz bezwzgldnie speBnia wymagania ustawy o wyrobach medycznych z dnia 7 kwietnia 2022 (Dz.U.2022 poz.974)NII. Kalibratory i kontrole potrzebne do wykonania 54610 oznaczeD na 36 m-cy.KIII. MateriaBy zu|ywalne konieczne do wykonania 54610 oznaczeD na 36 m-cy.oWyroby musz bezwzgldnie speBnia wymagania ustawy o wyrobach medycznych z 7 kwietnia 2022 (Dz.U.2022 poz.974)uWyroby musz bezwzgldnie speBnia wymagania ustawy o wyrobach medycznych z dnia 7 kwietnia 2022 (Dz.U.2022 poz.974) Wymg doBczenia do oferty ulotek/instrukcji u|ywania speBniajcych wymagania okre[lone w ust. 8.7 Cz[ II zaBcznika nr 1 do ww. rozporzdzenia Wymg doBczenia do oferty ulotek/instrukcji u|ywania speBniajcych wymagania okre[lone w ust. 8.7 Cz[ II zaBcznika nr 1 do ww. rozporzdzenia Wymg doBczenia do oferty ulotek/instrukcji u|ywania speBniajcych wymagania okre[lone w ust. 8.7 Cz[ II zaBcznika nr 1 do ww. rozporzdzenia Wymg doBczenia do oferty ulotek/instrukcji u|ywania speBniajcych wymagania okre[lone w ust. 8.7 Cz[ II zaBcznika nr 1 do ww. rozporzdzenia Wymg doBczenia do oferty ulotek/instrukcji u|ywania w jzyku polskim speBniajcych wymagania okre[lone w ust. 8.7 Cz[ II zaBcznika nr 1 do ww. rozporzdzenia Wymg doBczenia do oferty ulotek/instrukcji u|ywania speBniajcych wymagania okre[lone w ust. 8.7 Cz[ II zaBcznika nr 1 do ww. rozporzdzenia" Wymg doBczenia do oferty ulotek/instrukcji u|ywania speBniajcych wymagania okre[lone w ust. 8.7 Cz[ II nr 16 poz. 75) oraz zaBcznikach do wymienionego rozporzdzenia." 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