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"Tarjoajan soveltuvuus ",
"Referenssipaikka ",
"Tarjotulle PET-TT-laitteistolle tulee esitt\u00e4\u00e4 referenssipaikka EU tai ETA alueella, jossa tarjottu laitteisto on ollut k\u00e4yt\u00f6ss\u00e4 potilaskuvauksissa ja jossa on mahdollisuus n\u00e4hd\u00e4 laitteiston k\u00e4ytt\u00f6\u00e4 potilaskuvauksissa. Tarjousvertailuun ottamisen edellytyksen\u00e4 on, ett\u00e4 t\u00e4m\u00e4 ehto t\u00e4yttyy. Referenssipaikaksi hyv\u00e4ksyt\u00e4\u00e4n sairaalat, joihin asennettu laite vastaa teknisesti tarjottua laitetta (sama PET-rengas). TT-laitteen detektorissa voi olla eri detektorin leveys kuin tarjottavassa PET-TT-laitteessa. ",
"Pyydetyt potilaiden PET-TT-tutkimukset tulee toimittaa PET-TT laitteelta, jossa on t\u00e4sm\u00e4lleen sama PET-rengas, kuin tarjottavassa PET-TT-laiteessa. TT-laitteen detektorissa voi olla eri detektorin leveys kuin tarjottavassa PET-TT-laitteessa. Jos kliiniseen kuvanlaadunvertailuun toimitetut TT -kuvat ovat tarjottavaa PET-TT-laitetta vastaavalta TT-laitteelta, joka ei ole PET-TT-laite, tulee t\u00e4m\u00e4 kertoa selv\u00e4sti tarjoustaulukon potilaskuvien tiedot \u2013v\u00e4lilehdell\u00e4, potilaskuvat tulee olla kuvattu t\u00e4sm\u00e4lleen samoilla potilaan asetteluvarusteilla (esim. aivojen tutkimusten p\u00e4\u00e4tuelle), kuvausominaisuuksilla (sama TT) ja kuvaustekniikalla, jotka ovat tarjottavassa PET-TT laitteistossa. Kun tarjottavassa PET-TT-laitteistossa ei ole gantryn kallistusominaisuutta t\u00e4ll\u00f6in ei my\u00f6sk\u00e4\u00e4n toimitetuissa potilaiden aivojen TT-kuvauksissa saa olla gantryn kallistus k\u00e4yt\u00f6ss\u00e4, jotta potilaskuvat hyv\u00e4ksyt\u00e4\u00e4n vertailuun ja niist\u00e4 annetaan vertailupisteit\u00e4.",
"",
"",
"Tarjoustaulukon kohta B10. ",
"Kohdan B10 m\u00e4\u00e4rityksi\u00e4 on tarkennettu ja se on jaettu kahteen eri kohtaan, B10A ja B10B. ",
" ",
"B10A: \u201dKuinka kauan kest\u00e4\u00e4 PET-TT -laitteiston t\u00e4ydellinen k\u00e4ynnistys ja k\u00e4ytt\u00f6kuntoon saat-taminen virtojen kytkemisen j\u00e4lkeen sis\u00e4lt\u00e4en vaadittavat l\u00e4mmitys- ja kalibraatiotoimenpiteet [min]. Selvitys erillisist\u00e4 toimenpiteist\u00e4 ja kestoajoista liiteen\u00e4 pakollinen. T\u00e4ss\u00e4 tarkoitetaan sit\u00e4 aikaa, joka vaaditaan esimerkiksi kesken p\u00e4iv\u00e4n tapahtuvaan k\u00e4ytt\u00e4j\u00e4n suorittaman uudel-leenk\u00e4ynnistyksen tai enint\u00e4\u00e4n 5 minuuttia kest\u00e4neen s\u00e4hk\u00f6katkoksen j\u00e4lkeen. Kysymyksess\u00e4 oletetaan, ett\u00e4 p\u00e4ivitt\u00e4iset PET- ja TT-laadunvalvontamittaukset, -kalibraatiot ja -l\u00e4mmitykset ovat kertaalleen ja onnistuneesti tehty ennen uudelleenk\u00e4ynnistyst\u00e4.\u201d",
"",
"B10B: \u201dKuinka kauan kest\u00e4\u00e4 PET-TT -laitteiston t\u00e4ydellinen k\u00e4ynnistys ja k\u00e4ytt\u00f6kuntoon saat-taminen yhden tunnin t\u00e4ydellisen s\u00e4hk\u00f6katkon j\u00e4lkeen sis\u00e4lt\u00e4en vaadittavat l\u00e4mmitys- ja ka-libraatiotoimenpiteet [min]. Selvitys erillisist\u00e4 toimenpiteist\u00e4 ja kestoajoista liiteen\u00e4 pakollinen. Kysymyksess\u00e4 oletetaan, ett\u00e4 p\u00e4ivitt\u00e4iset PET- ja TT-laadunvalvontamittaukset, -kalibraatiot ja -l\u00e4mmitykset ovat kertaalleen ja onnistuneesti tehty ennen uudelleenk\u00e4ynnistyst\u00e4.\u201d",
"",
"",
"Tarjoustaulukon kohta C3. ",
"Jos PET-kuvauksen hengitystahdistusinformaatio voidaan laskea kuvadatan perusteella ohjelmallisesti j\u00e4lkik\u00e4teen ja on annettu selvitys toiminnosta saa maksimipisteet kohdasta. Jos t\u00e4t\u00e4 ominaisuutta ei ole, saa nolla pistett\u00e4.",
"",
"Muutetaan pisteytysperiaatteeksi: Kyll\u00e4 = max, ei = 0, Selvitys.",
"",
"",
"Tarjoustaulukon kohdat B5 ja B6. ",
"Kohdat B5 ja B6 on poistettu. ",
"",
"",
"Tarjoustaulukon kohta G15. ",
"T\u00e4t\u00e4 kohtaa tarjoustaulukossa on korjattu. Kohdassa G15 viitataan kohtiin G15a -G15c",
"",
"G15: SELVITYS: Muut annoss\u00e4\u00e4st\u00f6ominaisuudet TT-kuvauksissa. Selvityksess\u00e4 tulee tarkas-tella erityisesti kohtia G15a-G15c. ",
"",
"",
"Tarjoustaulukon kohta G14. ",
"T\u00e4t\u00e4 kohtaa tarjoustaulukossa on korjattu. Kohdassa G14 viitataan kohtiin G14a -G14d",
"",
"G14: SELVITYS: Annosmodulaatio TT-kuvauksissa. Selvityksess\u00e4 tulee tarkastella erityisesti kohtia G14a-G14d. ",
"",
"",
"Tarjoustaulukon kohta B9. ",
"T\u00e4ss\u00e4 kohdassa on tarjoustaulukossa virhe. Kohdassa B9 tulee ilmoittaa valmista-jan virallisissa dokumenteissa suositeltuihin viikoittaisiin, kohdan B8 mukaisten p\u00e4ivitt\u00e4isten kalibrointi- ja laadunvalvontamittauksien lis\u00e4ksi teht\u00e4viin kalibrointi- ja laadunvalvontamittauksiin kuluva aika minuutteina. Vastauksessa tulee ilmoittaa valmistajan dokumentti, johon viitataan.\t",
"",
"B9: Mik\u00e4 on TT-laitteen viikottaisiin kalibrointi- ja laadunvalvontamittauksiin kuluva aika? [min] T\u00e4ll\u00e4 tarkoitetaan niit\u00e4 suoritteita, jotka vaaditaan teht\u00e4v\u00e4ksi kohdan B8 mittausten lis\u00e4ksi v\u00e4-hint\u00e4\u00e4n kerran viikossa. Jos kohdassa B8 ilmoitettu aika vaatii viikottaisten mittausten suorittamisen, t\u00e4h\u00e4n kohtaan on annettava viikottaisen kalibrointi- ja laadunvalvontamittauksiin kuluva aika siten, ett\u00e4 kohdassa B8 ilmoitettu aika oletetaan toteutuvan kaikkina muina viikon p\u00e4ivin\u00e4. T\u00e4ss\u00e4 ei tarvitse huomioida mahdollisesti vaadittavan testikohteen noutamista tai asettamista paikoilleen. ",
"",
"",
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