Ishubhu Lokuphakela Isisu Le-PVC Lezokwelapha Elilahlwayo Elinesitifiketi se-CE Isithombe Esivelele

Ishubhu Lokondla Isisu Se-PVC Esilahlwayo Esinesitifiketi se-CE

Incazelo emfushane:

Ithubhu lokuphakela liyithuluzi lezokwelapha elisetshenziselwa ukunikeza ukudla okunomsoco ezigulini ezingakwazi ukuthola ukudla okunomsoco ngomlomo, ezingakwazi ukugwinya ngokuphephile, noma ezidinga ukwengezwa kokudla okunomsoco. Isimo sokuphakelwa yithubhu lokuphakela sibizwa ngokuthi i-gavage, i-enteral feeding noma ithubhu lokuphakela.

Sithumelele i-imeyili

Imininingwane Yomkhiqizo

Amathegi Omkhiqizo

Incazelo

I-feeding tube iyithuluzi lezokwelapha elisetshenziselwa ukunikeza ukudla okunempilo ezigulini ezingakwazi ukuthola ukudla okunempilo ngomlomo, ezingakwazi ukugwinya ngokuphephile, noma ezidinga ukwengezwa kokudla okunempilo. Isimo sokuphakelwa yi-feeding tube sibizwa ngokuthi i-gavage, i-enteral feeding noma i-tube feeding. Ukubekwa kwayo kungaba okwesikhashana ekwelapheni izimo ezibucayi noma impilo yonke uma kwenzeka ukukhubazeka okungapheli. Izinhlobo ezahlukene zama-feeding tubes ziyasetshenziswa kwezokwelapha. Ngokuvamile zenziwe nge-polyurethane noma i-silicone. Ububanzi be-feeding tube bulinganiswa ngamayunithi esiFulentshi (iyunithi ngayinye yesiFulentshi ilingana namamilimitha angu-0.33). Ahlukaniswa ngendawo yokufakwa kanye nokusetshenziswa okuhlosiwe.

Isici

1. Yenziwe nge-PVC engeyona enobuthi yezinga lezokwelapha;
2. Ishubhu elibushelelezi nelibonakalayo (noma elifakwe iqhwa);
3. Usayizi: FR4, Fr6, Fr8, Fr10 Fr12, Fr14, Fr16, Fr18, Fr20, Fr22; Fr24,
4. Iphakheji: Isikhwama se-PE noma isikhwama sephepha-poly
5. I-EO gad ihlanjululwe;
6. Isixhumi sekhodi yombala sokuhlonza osayizi abahlukene;
7. Amehlo aseceleni abushelelezi ngokuphelele kanye nengxenye ekude evaliwe ukuze kungalimazi kakhulu i-anal mucosa ngesikhathi sokufakwa kwepayipi.
8.CE, ISO13485

Imininingwane

Usayizi (Fr-Ch)	Umbala Wokuxhuma	Ubude Obujwayelekile (± 2cm)
FR4	Okubomvu	40cm
FR5	Okumpunga	40cm
FR6	Okumhlophe/Okuluhlaza Okukhanyayo	40cm/120cm
FR8	Okuluhlaza okwesibhakabhaka	120cm
FR10	Okumnyama	120cm
FR12	Okumhlophe	120cm
FR14	Okuluhlaza okotshani	120cm
FR16	iwolintshi	120cm
FR18	Okubomvu	120cm
FR20	Ophuzi	120cm
FR22	I-Violet	120cm
FR24	Okuluhlaza okwesibhakabhaka okukhanyayo	120cm

Isevisi Yethu

1. Amasampula amahhala.
2. Ilogo: noma yiliphi ilogo yangokwezifiso ngendlela othanda ngayo.
Isevisi ye-3.OEM inikezwa.
4. I-DEHP iyatholakala mahhala.
5. Ubuso obuqandisiwe futhi obusobala.
6. Nge-X-ray, kutholakala i-frosted kanye ne-elastic.
7. Isihloko esivaliwe esiyindilinga esinohlangothi oluphambene namehlo amabili asemaceleni kanye nesihloko esivulekile.
8. Kutholakala ngesikhwama se-polybag noma iphakethe le-blister elihlanzekile.

Umbukiso Womkhiqizo

Umthethonqubo:

CE
I-ISO13485

Okujwayelekile:

I-EN ISO 13485: 2016/AC: 2016 Uhlelo lokuphatha ikhwalithi yemishini yezokwelapha lwezidingo zomthetho
I-EN ISO 14971: Amadivayisi ezokwelapha ka-2012 - Ukusetshenziswa kokuphathwa kwezingozi kumadivayisi ezokwelapha
I-ISO 11135:2014 Idivayisi yezokwelapha Ukuhlanza i-ethylene oxide Ukuqinisekiswa nokulawulwa okujwayelekile
I-ISO 6009:2016 Izinaliti zomjovo ezilahlwayo ezingenamagciwane Khomba ikhodi yombala
I-ISO 7864:2016 Izinaliti zomjovo ezilahlwayo ezingenamagciwane
ISO 9626:2016 Amashubhu enaliti yensimbi engagqwali yokwenziwa kwamadivayisi ezokwelapha

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