Umhlahlandlela wokugcina wokubhekana namaski kanye nama-jpcumus we-N95 ekunakekelweni kwezempilo - zhongxing

Emhlabeni wokuthengwa kwezokwelapha, izinto ezimbalwa zibaluleke kakhulu okwamanje ziyinkimbinkimbi njengobuso isivivu. Kusuka kokulula isakaza ku-specis kakhulu I-n95 respirator, ukuqonda ama-nuances akuyona nje ukuhambisana - kumayelana nokuvikela izimpilo. Njengomphathi wokuthengwa kwempahla, ukukwimigqa yangaphambili yokuthola imali, kanye nezinqumo ozenzayo zibe nomthelela oqondile kuzo zombili iziguli futhi ukunakekela impilo Ochwepheshe. Lo mhlahlandlela uwena. Njengoba u-Allen, umenzi onesipiliyoni esingaphezu kwesipiliyoni esikhiqiza ukuchitheka kwezokwelapha okulahlwayo kwezimakethe zomhlaba wonke njenge-USA neYurophu, ngifuna ukusika ukudideka. Sizohlola okuhlukile Izinhlobo zamaski, Nquma imithethonqubo, futhi unikeze ukuqonda okusebenzayo ukukusiza uthole ngokuzethemba. Lokhu akuyona enye nje isihloko; Kubukeka ngemuva kombono wefektri, eklanyelwe ukuphendula imibuzo yakho ecindezela kakhulu.

Uyini umehluko wangempela phakathi kwemaski yokuhlinzwa kanye ne-N95 Respirator?

Ekubukeni kokuqala, a isakaza ne I-n95 respirator kungahle kubonakale kufana, kepha imisebenzi yabo, amacebo, nokusetshenziswa okuhlosiwe kungokwawo emhlabeni. A isakaza Kuyinto efanelekile, ukulahlwa Idivayisi eyakha a Isithiyo esibonakalayo phakathi komlomo nekhala lika umonile kanye nokungcola okungenzeka endaweni esheshayo. Injongo yayo eyinhloko ukuvimba izinhlayiya ezinkulu ibhokisi Ukuhanjiswa, njenge-splashes noma izifutho, ukuvikela abanye ekuphumeni kokuphefumula okugqokile. Imaski yokuhlinza yenziwa yendwangu engalukiwe futhi imvamisa isetshenziswa ezindaweni eziyinyumba ngesikhathi senqubo yezokwelapha ukuze Vikela isiguli zombili kanye nochwepheshe wezokunakekelwa kwempilo kusuka ku Ukudluliselwa kwama-microorganisms, uketshezi lomzimba, futhi I-PENTAINTION ETATION. Kodwa-ke, ngenxa ye-FEED afanele, kuvame ukuba khona insungubezi phakathi kwe imiphetho yemaski nobuso, okusho ukuthi akunikezeli ukuvikelwa okuphelele ekunciphiseni okuncane umoya womoya izinhlayiyana.

A I-n95 respiratorNgakolunye uhlangothi, yi ukuphefumula Idivaysi evikelayo eyenzelwe ukufeza a impela Vala kahle ngobuso futhi isebenza kahle kakhulu ukuzokulungwa iwa- umoya womoya izinhlayiyana. Ukuqokwa kwe- "N95" kusho ukuthi uma kuhlolwe ngokucophelela, umdlaluvuzi Amabhulokhi okungenani amaphesenti angama-95 azinhlanzi ezincanyana kakhulu (0.3 micron). Lokhu kwenza I-n95 respirator ngempumelelo ukulwa nezinhlayiya ezinkulu nezincane. Ngokungafani a isakaza, a I-n95 respirator yakhelwe ukucaca ngokuqinile ebusweni, ukuphoqa umoya ohanjisiwe nomoya ophelile ukuze udlule kuwo vova impahla. Lolu mbono oqinile lubalulekile ekusebenzeni kwayo. Ngenxa yalokhu, kubhekwa njengemishini yokuvikela umuntu (Ikhilongothobele) Kuhloswe bekuvikela ukuvikela le khasi umonile kusuka ekuchayweni kwezinto ezilimazayo ezilimazayo.

Ukubeka kalula, a isakaza Ivikela imvelo ukusuka le khasi umonile, ngenkathi i I-n95 respirator kuvikela umonile ukusuka imvelo. Njengomphathi wokuthengwa kwempahla, ukuqonda lokhu kwehlukaniswa yisinyathelo sokuqala ekuqinisekiseni indawo yakho ihlinzekwa ngohlobo olufanele lwe isivivu ngomsebenzi ofanele. Ubungeke usebenzise inqubo elula isivivu Ngesikhathi senqubo ekhiqiza i-aerosol, futhi ubungeke udinge izindleko I-N95 Ukuze isivakashi sihamba phansi. Ukwenza ukhetho olufanele kukhuthaze ukuphepha nokulawula izindleko ngempumelelo.

Ngabe imaski yezokwelapha ilawulwa kanjani ezimweni ezihlukile zokunakekelwa kwempilo?

Umthethonqubo we imaski yezokwelapha isici esibucayi esithinta ngokuqondile ngokuphepha kwesiguli nokuphepha komhlinzeki, futhi kuyehluka kakhulu ngokuya ngohlobo lwe isivivu kanye setha. Ku U.S., Ukuphathwa Kokudla Nezidakamizwa (Uhlobo lwe-fda) kanye ne-National Institute yokuphepha emsebenzini kanye nezempilo (UNiosh), ingxenye ye I-CDC, yimizimba eyinhloko leyo beka umthetho wenqubo le mikhiqizo. Uhlelo olumbaxambili olungadida, kepha luqinisekisa ukuthi yilowo nalowo isivivu Ihlangabezana namazinga athile okusebenza ngokusetshenziswa kwawo okuhlosiwe. Ochwepheshe bokuthengwa kwempahla, lokhu akuyona nje itheyiphu ebomvu; Kuyisiqinisekiso sakho sekhwalithi nokuphepha.

Imaski yokuhlinza, ngokwesibonelo, alawulwa yi- Uhlobo lwe-fda njengamadivaysi e-class II. Kumele bahlangabezane nezidingo ezithile ze Ukuvikelwa okuvimbayo na- ukuzokulungwa Ukusebenza kahle. Le khasi Uhlobo lwe-fdaUmthetho-ndlela ngaphansi 21 CFR 878.4040 ichaza amazinga walokhu I-Medical Coursation Masks. Zihlolelwe izinto ezifana negciwane le-bacterial fieltration (BFE), ukusebenzelana nokuhlunga (i-PFE), ukumelana koketshezi, nokuvutha komzimba. Lokhu kuqinisekisa isivivu ingamelana nama-splashes egazi noma ezinye izinto ezithathelwanayo ngesikhathi senqubo. A isivivu leyo I-FDA-yasulwa ikunikeza ngokuqiniseka ukuthi ibukezelwe ukuphepha nokusebenza kahle kokusetshenziswa ku Ukulungiswa Kwezempilo. Lezi izinhlobo zezinga Imaski yobuso bezokwelashwa engu-3 okubalulekile ekunakekelweni kweziguli okujwayelekile kanye nokulawulwa kokutheleleka.

Ukuhlunga ukuphefumula kwe-Face Phiechee (FFRS), njenge N95s, zilawulwa ngendlela ehlukile. Uma benzelwe ukusetshenziswa kwemboni okujwayelekile (njengokuqamba), bayaqaqa UNiosh ngaphansi kwa- 42 CFR ingxenye 84. UNiosh Ukuhlolwa nokuqinisekisa ukuthi laba bantu bokuphefumula bahlangabezana namazinga okuhlunga kanye nokwakha. Kodwa-ke, lapho I-n95 respirator ihloselwe ukusetshenziswa ku Ukulungiswa Kwezempilo ukuvikela ama-pathogens angenazindiza, kufanele kuhlangabezane nezidingo ze kokubili UNiosh kanye Uhlobo lwe-fda. Lawa madivayisi aqinisekiswe yimibili ayaziwa ngokuthi ukuhlinzwa N95 Rescorators. Bahlinzeka ngokuvikelwa kokuphefumula kwe I-N95 kanye nokuvikelwa kokuvinjwa kwe-fluid a isakaza.

Ungakwazi yini ukuchaza izindima ze-ninoosh ne-FDA ekuvunyelweni maska?

Ukuqonda izindima ezihlukile ze UNiosh kanye Uhlobo lwe-fda kubaluleke kakhulu kunoma yimuphi umphathi wokuthengwa kwempahla evikela ukuphefumula okuphefumula. Cabanga ngabo njengoba ochwepheshe ababili abahlukile beqinisekisa ukuthi umkhiqizo uphephile futhi usebenza ngama-engeli amabili ahlukene. I-National Institute for Ukuphepha emsebenzini kanye nempilo (UNiosh) Ngabe i-ejensi yocwaningo egxile ekuphepheni kwabasebenzi. Indima yayo eyinhloko ephathelene nokuphefumula ukuvivinya nokuqinisekisa ukuthi bahlangana nokwakhiwa okuqinile, ukuzokulungwa, namazinga okusebenza. Lapho ubona a UNiosh ukuvunywa ku I-n95 respirator, kusho ukuthi isivivu Kuhlolwe ngokuqinile ukuze kuqinisekiswe ukuthi kuhluke okungenani okungenani ama-95% ezinhlayiyana ezingezona ezinamafutha asolwandle. Lesi sitifiketi simayelana nokuvikela isisebenzi - kulokhu ukunakekela impilo ochwepheshe.

Ukuphathwa kwezidakamizwa kanye nezidakamizwa (Uhlobo lwe-fda) Ngakolunye uhlangothi, kulawula imaski yezokwelapha kanye namadivayisi okuqinisekisa ukuthi baphephile futhi basebenza ngempumelelo empilweni yomphakathi. Okwe isakaza noma a Kuhlinzwa N95 Respirator, the Uhlobo lwe-fdaIntshisakalo isetshenziswa yithuluzi lezokwelapha. Le khasi Uhlobo lwe-fda Bukeza le mikhiqizo nge Isaziso se-Premarket [510 (k)] Ukulethwa kokuthola ukuthi ngabe kuphephile yini ukusetshenziswa kwezokwelapha Izilungiselelo Zokunakekela. Le khasi Uhlobo lwe-fdaUkuvuselelwa kwezakhiwo ezigxile ezizandleni ezinjenge-fluid yokumelana, ukuqinisekiswa (ukuqinisekisa ukuthi izinto zokwakha ngeke zicasule isikhumba), kanye nokuvutha. Le khasi Uhlobo lwe-fdaIndima ye-S beka umthetho wenqubo le khasi isivivu Njengesithiyo sokuvikela ukumelana nama-splashes, izithombo, kanye namaconsi amaningi wezinhlakahla izinhlayiya, okubalulekile ngesikhathi sokuhlinza izinqubo zokuvikela Kokubili isiguli kanye nomhlinzeki.

Ngakho-ke, ukufingqa:

• UNiosh ticifies the umdlaluvuziAmandla okwenza vova izinhlayiya zomoya ukuvikela umonile.
• Uhlobo lwe-fda isula a isakaza noma Kuhlinzwa N95 Respirator ukusetshenziswa kwayo njengedivaysi yezokwelapha, egxile emandleni ayo okwenza njenge isithiyo se-fluid.

Indawo ejwayelekile yezimboni I-n95 respirator Izidingo kuphela UNiosh ukuvunywa. Kodwa a Kuhlinzwa N95 Respirator isidingo kokubili UNiosh ukuvunywa ngamakhono ayo okuhlunga futhi Uhlobo lwe-fda imvume yokusetshenziswa kwayo njengethuluzi lokuhlinza elimelana noketshezi. Njengomthengi, uma udinga a umdlaluvuzi yegumbi lokusebenza noma ezinye izilungiselelo ngengozi yokuvezwa koketshezi, kufanele ubheke a isivivu Lokho kuneziqinisekiso zombili.

Kungani kufanelekile ukuba kubucayi ku-N95 Respirator?

A I-n95 respirator isebenza ngempumelelo nje njengophawu lwayo. Ngenkathi vova Imidiya yenzelwe ukuvimba okungenani ama-95% ezinhlayiya, leli zinga eliphakeme lokuvikelwa lihlehliswe ngokuphelele uma umoya ungavuza uzungeze imiphetho yemaski. Lo mehluko owodwa obaluleke kakhulu phakathi kwe umdlaluvuzi kanye Nezinga imaski yobuso. A isakaza dres foelly phezu kobuso, kepha a I-n95 respirator i-extenemered for a Vala kahle ngobuso. Ngaphandle kwalolu seseli oluqinile, umoya ongcolile uzolandela indlela yokumelana nobuncane, wedlula vova kanye nokufaka indawo yokuphefumula egqokile ngokusebenzisa insungubezi. Lokhu kukude nenhloso yokugqoka i-filtration ephezulu umdlaluvuzi.

Ukuthola a kufanelekile kufaka izinyathelo eziningana. Okokuqala, umdlaluvuzi kumele kube ngosayizi ofanele nokwakheka kobuso bomsebenzisi. Akubona bonke ubuso obufanayo, yingakho abakhiqizi abaningi banikeza amamodeli nosayizi abehlukene. Okwesibili, umonile kumele uqeqeshelwe ukuthi ungagqoka kanjani kahle futhi ukhiphe isivivu. Lokhu kufaka phakathi ukugoba i-Noseppiece ukuvumelanisa nebhuloho le ekhaleni nomlomo indawo kanye nokuqinisekisa ukuthi imichilo ibekwe kahle. Ekugcineni, ngoba -sesebenzini Sebenzisa ku U.S., I-OSHA idinga abasebenzi ukuthi baphumelele isivivinyo esifanele. Le yinqubo ehlelekile ehlola ukuvuza ezungeze uphawu. Izici ezifana izinwele zobuso kungaphazamisa uphawu, okwenza ukuhlolwa okulungile kungenzeki futhi kunikeze umdlaluvuzi ayisebenzi.

Njengomphathi wokuthengwa kwempahla, umthwalo wakho wenani udlulela ngale kokuthenga nje N95s. Kumayelana nokuqinisekisa inhlangano yakho inohlelo oluphelele lokuvikela ukuphefumula. Lokhu kusho ukuhlinzeka ngokuhlukile umdlaluvuzi Amamodeli wokuhlalisa izakhiwo ezahlukahlukene zobuso nokusekela ukuqeqeshwa okudingekayo kanye nezinqubomgomo ezifanele zokuhlola. Okushibhile I-n95 respirator lokho akufanele noma ngubani akuyona into yokuxoxisana; Kuyisikweletu. Ukuxhumana nomphakeli wakho ngezinhlobonhlobo zobukhulu nobukhulu abakunikezayo kuyingxenye ebalulekile yokwenza ukuthenga okunolwazi. Umenzi onokwethenjelwa kufanele akwazi ukuhlinzeka ngemininingwane enemininingwane futhi asekele uhlelo lwakho lokuhlola olufanelekile.

Yini ama-respirators okuhlinza uN95 futhi adingeka nini?

A Kuhlinzwa N95 Respirator ingqungquthela ye-hybrid ye imaski yezokwelapha, enikeza izinga eliphakeme kakhulu lokuvikelwa ekufuneni Izilungiselelo Zokunakekelwa Kwezempilo. Kuhlanganisa izici zejwayelekile I-n95 respirator nalabo be isakaza. Lokhu kusho ukuthi akugcini ngokuhlinzeka ngokuvikelwa kokuphefumula okuvunyiwe kwe-ninoosh kumazinyo angenazindiza kodwa futhi I-FDA-yasulwa njenge- Iklasi II idivaysi yezokwelapha ngokumelana kwayo ekungenisweni kwamanzi. Cabanga ngakho njenge- I-N95 egqoke i-raincoat. Yakhelwe Vikela isiguli zombili kanye nochwepheshe wezokunakekelwa kwezempilo (I-HCP) Ngezinqubo lapho kunengozi enkulu yazo zombili izindiza zezindiza kanye nama-splashes noma izithombo zegazi kanye uketshezi lomzimba.

Lawa ma-real-inhloso anezinhloso aqondile ihlose ukusetshenziswa Ezindaweni lapho inzalo kanye nokuvikelwa komoya noketshezi kubaluleke kakhulu. Lokhu kufaka amakamelo okusebenza, iminyango yezimo eziphuthumayo ngesikhathi sokunakekelwa kwe-TRAUMA, kanye nezinqubo ezikhiqiza i-aerosol ezigulini ezinezifo ezaziwayo noma ezisolwayo ezithathelwanayo, njenge-Intubation noma i-Bronchoscopy. Le khasi ukusakazeka kwe-Covid-19 waletha ukubaluleka kwe Kuhlinzwa N95 Ukugxila okubukhali, njengoba kwanikeza isivikelo esiphelele ku-virus edluliselwa ngamaconsi kanye nama-aerosols. Le khasi Isithiyo se-Fluid noma ukusebenza kahle kwe-filtration Kule maski kuhlolwe ngokuqinile ukuze kuqinisekiswe ukuthi zinikeza isihlangu esithembekile.

Lapho sithola khona, kubalulekile ukuqinisekisa ukuthi a isivivu Ithengiswa njenge- "Kuhlinzwa N95"Kuqinisekiswe ngokweqiniso bobabili UNiosh kanye Uhlobo lwe-fda. Kufanele ukwazi ukuthola a UNiosh Inombolo yokuvunywa ku- umdlaluvuzi ngokwayo (e.g., TC-84A-XXXX) futhi iqinisekise ukuthi icacisiwe yi Uhlobo lwe-fda ngaphansi kwa- ikhodi yomkhiqizo msh. Ukusebenza nomhlinzeki obonakalayo ongahlinzeka ngale mibhalo ngaphandle kokungabaza akunakuxoxwa. Ngenkathi laba bantu bokuphefumula bebiza kakhulu, bayingxenye ebalulekile Ikhilongothobele engcupheni ephezulu Izilungiselelo Zokunakekela, kanye nokuyekethisa ngekhwalithi yabo akuyona inketho.

Ingabe ama-valves okuphefumula e-respirator ukuyekethisa ukuphepha esimweni somtholampilo?

Ama-valves okuphefumula ku umdlaluvuzi ziyisici esenzelwe induduzo, kepha zinemiphumela ebalulekile yokusebenzisa a Ukulungiswa Kwezempilo. A isivalwana kuyindlela eyodwa yendlela evula lapho umonile uphefumula ngaphandle, uvumele umoya ofudumele, omanzi uphunyuke kalula. Lokhu kwenza umdlaluvuzi ukhululekile kakhudlwana ukugqoka isikhathi eside futhi wehlise ukwakha okwakhiwa ngaphakathi kwe isivivu. Kwabasebenzi bezimboni, njengalabo abazokwakha noma bezokukhiqiza, lesi yisici esihle kakhulu. Kodwa-ke, esimweni sezokwelapha, ikakhulukazi ukulawula komthombo, okufanayo isivalwana iba yinkinga enkulu.

Impikiswano ukuthi I-valve yokuphefumula Ivumela amaconsi okuphefumula agqokile angasebenzi kahle ukuthi axoshwe ngqo emvelweni. Ngenkathi isivalwana ayiyekeli ukuvikelwa komuntu ogqoke umdlaluvuzi, ingena ngokuphelele inhloso yamaskandi ekuvimbeleni umonile ekusakazeni amagciwane kwabanye. Ensimini eyinyumba noma lapho unakekela iziguli ezivikelwe, lokhu kuyingozi engamukeleki. Ngesikhathi I-COVID 19 ubhubhane, the I-CDC Kunconywe ngokucacile ekusebenziseni ama-respirators nge ama-valves okuphefumula Ukulawulwa komthombo, njengoba benza okuncane Ukuthola ukunciphisa ukusakazeka kwaleli gciwane kumuntu onegciwane.

Ngakho-ke, cishe bonke Izilungiselelo Zokunakekelwa Kwezempilo, ama-respirators nge ama-valves okuphefumula azifanele. Uma u gqoka ubuso isivivu Esibhedlela noma emtholampilo, inhloso ibili: Zivikele futhi uvikele labo abaseduze kwakho. I-Valeved umdlaluvuzi kufeza kuphela umgomo wokuqala. Njengomphathi wokuthengwa kwempahla, le yimininingwane eqondakalayo okufanele uyibukele. Ngaphandle kokuthi uthenga ngokukhethekile -sesebenzini umsebenzi lapho ukulawulwa khona komthombo akuyona ukukhathazeka (okuvela kuyo ukunakekela impilo), kufanele ukhethe njalo N95s noma abanye abaphefumuleli phandle kwa- a isivalwana. Lokhu kuqinisekisa ukuthi uyahlinzeka Ukuvikelwa okungcono kuyo yonke imvelo yokunakekelwa.

Yini okufanele ngiyifune lapho ngithola imaski yezokwelapha evela phesheya kwezilwandle?

Ukugoqa imaski yezokwelapha Kusuka kumenzi ezweni elifana neChina kungaba yinzuzo enkulu ngokuya ngezindleko nevolumu, kepha kudinga ukukhuthala kanye necebo elicacile. Njengomnikazi wefektri, ngikhuluma ngabaphathi bokuthengwa kwempahla njengawe nsuku zonke, futhi ngiyazazi ukukhathazeka kwakho. Ukhiye ukuhambisa ngaphezu kwentengo futhi ugxile ekubambisaneni nasekuqinisekisweni. Okokuqala nokubaluleke kakhulu, kudinga ukucaca ekubonakalweni. Umkhiqizi odumile uzokunikeza kalula isitifiketi sawo se-ISO 13485 (sohlelo lokuphathwa kwekhwalithi yezokwelapha), amadokhumenti okumaka kwe-CE (ezimakethe zaseYurophu), nanoma yikuphi okufanele Uhlobo lwe-fda izincwadi zokubhalisa noma zokuvulwa. Musa nje ukuthatha izwi labo ngakho; Cela amadokhumenti futhi wazi ukuthi ungaziqinisekisa kanjani.

Okwesibili, ukuxhumana kuyikho konke. Elinye lamaphuzu amakhulu obuhlungu engimuzwayo ngokuxhumana okungasebenzi kahle. Udinga umphakeli ngokuthengisa okuphendulayo, okukhuluma isiNgisi kanye nethimba lokusekela eliqonda izidingo zakho zobuchwepheshe nezomlawuli. Babuze imibuzo enemininingwane mayelana nenqubo yabo yokukhiqiza, amasheke wokulawula ikhwalithi, kanye nezinhlelo zokulandela ama-batch. Bangakutshela kahle ukuthi iyiphi into eluhlaza evuthiwe ungene ku isivivu uyathenga? Umlingani omuhle angakwazi. Leli zinga lemininingwane libuye libe lubalulekile ekuhleleni kokudla. Xoxa ngezikhathi zokuhola, izinketho zokuthumela, kanye nemigomo yokukhokha ngaphambili ukugwema ukubambezeleka okungashiya indawo yakho emfushane ezintweni ezimbalwa.

Ekugcineni, cabanga ngomkhiqizo uqobo. Cela amasampula ngaphambi kokubeka i-oda elikhulu. Lapho ubamukela, bahloli ikhwalithi. Bheka ama-welds ku- izindlebe izindlebe, umuzwa we Indwangu ephefumulelwe, nobuqotho be-NosePhisi. Qhathanisa ne isivivu Uyazi futhi uyamethemba. Ngabe kuyazizwa i-flimsy? Ngabe kukhona amaphunga angajwayelekile? Le mininingwane emincane ingaba izinkomba zezinkinga ezinkulu zokulawula ezisezingeni eliphakeme. Ukuhlanza okuvela phesheya kwamayelana nokwakha ukwethenjwa. Kungubambiswano lapho izinhlangothi zombili zizuza ngokucaca, ikhwalithi, kanye nokuxhumana okuvulekile. Ukuthi ufuna Izingubo zokuhlukaniswa ezisezingeni eliphakeme noma elula imaski yobuso, lezi zimiso zokukhuthala okufanele zisebenza njalo.

UFundefu ka-Covid-19 washintsha kanjani ukubukeka kwemaski yobuso?

Le khasi I-COVID 19 Ubhubhane kwakuwumcimbi wokuzamazama komhlaba okubonisa kabusha ukuqonda okuqondakalayo nokusetshenziswa kwe- imaski yobuso. Ngaphambi kuka-2020, emazweni amaningi asentshonalanga, isivivu-Izicathulwe kwakuvalelwe kakhulu Izilungiselelo Zokunakekelwa Kwezempilo. Ubhubhane luguqule isivivu Uphawu olubi lwempilo yomphakathi kanye nomthwalo wemfanelo emphakathini, ogqokwa yi- umphakathi jikelele nsuku zonke. Lesi sidingo esingakaze sibe khona sidale inkinga enkulu yokuhlinzekwa komhlaba jikelele, ekuvezeni ubungozi futhi siholele ekuhlaselweni kokukhiqizwa okusha, okusemthethweni nokukhohlisa. Ochwepheshe bokuthengwa kwempahla, imakethe yaba yi-chaotic vamscape yama-akhronimi amasha (KN95, FFP2), abahlinzeki abangaqinisekisiwe, kanye nemikhiqizo yenkomba.

Enye yamashifu abaluleke kakhulu kwakungukugxila ekulawulweni komthombo. Umlayezo wezempilo wezempilo oyinhloko waba ogqoke a isivivu wayengekho nje ngokuvikelwa komuntu, kepha ngokuvikela umphakathi. Lokhu kuphakamisa ukubaluleka kokulula imaski yendwangu noma inqubo isivivu ekunciphiseni ukusakazeka kwe-Covid-19. Le khasi I-CDC nezinye izinhlaka zezempilo zikhishwe imihlahlandlela enemininingwane yokuthi gqoka ubuso ukumboza ngempumelelo, kufaka phakathi izincomo ku- thuthukisa ukufanele kokuhlinzwa kanye Imaski yendwangu ngokubopha izindlebe zendlebe noma usebenzisa i-mask fitter. Ubhubhane lwentando yeningi isivivu, kodwa futhi kudale ulwazi insungubezi lokho kwashiya abathengi abaningi futhi nabanye ochwepheshe abadidekile nge Izinhlobo ezahlukahlukene zamaski.

Ngokombono wokukhiqiza nokuthengwa kwempahla, ubhubhane lwaphoqa ukuvela okusheshayo. Sibone ukugunyazwa okuphuthumayo (i-EUAS) kusuka ku Uhlobo lwe-fda ukuvumela ukusetshenziswa kwabaphikisi bendabuko, njenge KN95 kusuka China, in ukunakekela impilo Izilungiselelo lapho N95s kwakuyindlala. Lokhu kuqokomise ukubaluleka kokuqonda amazinga aphesheya. Iphinde yagcizelela nesidingo esibucayi sokuqinisekiswa kokuthengwa kwamathempeli okuqinile. Le nkinga yasifundisa ukuthi ukuncika emthonjeni noma esifundeni esisodwa kuyingozi futhi lapho usungule ubudlelwano nabathembekile, abakhiqizi abaqinisekisiwe babalulekile. Ifa le I-COVID 19 yimakethe eyazi ngokwengeziwe, iqonda ngokwengeziwe, nokufuna okuthe xaxa kwekhwalithi nokusobala kuyo Ikhilongothobele.

Ingabe imaski yendwangu noma imaski yenqubo evamile efanelekile ekuhlelweni kokunakekelwa kwempilo?

Ukufaneleka kwe imaski yendwangu noma inqubo evamile isivivu kuncike ngokuphelele kumsebenzi othize kanye nezinga lengozi ngaphakathi kwe Ukuhlelwa Kwezempilo. A imaski yendwangu ngokuyinhloko idivaysi yokulawula yomthombo ye umphakathi jikelele. Ngenkathi a Ukufaneleka Kahle imaski yendwangu -ithini Ukuthola ukunciphisa ukuphuma kwamaconsi okuphefumula kusuka ku umonile, inikeza ukuvikela okuncane ku umonile kusuka ezinhlwini ezinhle ezi-inhaling noma ama-aerosols. Ngalesi sizathu, imaski yendwangu ngokuvamile ithathwa njengento engafanele yokusetshenziswa kwemitholampilo ngabasebenzi bezempilo abahlinzeka ukunakekelwa kweziguli. Baswele i-stracting ukuzokulungwa namazinga wokumelana noketshezi odingekayo imaski yezokwelapha.

Inqubo Ejwayelekile imaski yezokwelapha, uhlobo lwe isakaza, iyindaba ehlukile. Ziyi-speple in ukunakekela impilo. Lezi ukulahlwa imaski I-FDA-ilawulwe futhi yakhelwe ukuhlinzeka ngesithiyo kumaconsi kanye nama-splashes. Zilungele ngokuphelele imisebenzi ehlukahlukene yemisebenzi, efana nezivivinyo ezijwayelekile, ukuthwala iziguli, kanye nokusetshenziswa ezindaweni ezijwayelekile zesibhedlela ukukhuthaza ukulawulwa komthombo. Banikeza ukulinganisela okuhle kokuvikelwa nokuphefumula kwezimo ezinobungozi obuphansi. Kodwa-ke, bakhona -I a umdlaluvuzi. Azibunzi uphawu oluqinile futhi azinikezi ukuvikelwa okuthembekile ekuhlolweni kwama-hathogens amancane asolwandle.

Ngakho-ke, umthetho wesithupha ukufa isivivu engozini.

• Imaski yendwangu: Hhayi ukusetshenziswa kwemitholampilo nge-HCPS.
• Inqubo / Imaski yokuhlinza: Ilungele ukulawulwa komthombo nokuvikelwa kumaconsi ezimweni zemitholampilo ephansi. Kubalulekile ekuvikeleni iziguli ekuphumeni komhlinzeki ngesikhathi sezinqubo eziyinyumba.
• I-n95 respirator: Kudingeka ukuvikela izinhlayiya zomoya, ikakhulukazi ngesikhathi sezinqubo ezikhiqiza i-aerosol.

Ukuze uthole Umphathi Wezokuthengwa Kwempahla, lokhu kusho ukulondolozwa kokusungula okuhlotshisiwe. Udinga ukulethwa okuthembekile kwekhwalithi ephezulu Imaski yobuso bezokwelapha Ukusetshenziswa kwansuku zonke, eceleni kwesitoko se UNiosh-okuthandwa Ama-respirators we-N95 ngezimo ezinobungozi obukhulu. Imayelana nethuluzi elilungile lomsebenzi ukuze aqinisekise ukuthobela nokuphepha.

Izitifiketi zokuzulazula: Yini i-ISO, ye-CE, futhi i-FDA iqonde ngempela ekuthengeni kwakho maska?

Ngomphathi wokuthengwa kwempahla, izitifiketi ziwukuthemba kwakho. Bangubufakazi obunamandla bokuthi umkhiqizo uhlangabezana nezindinganiso ezisunguliwe. Ake sihlukanise okujwayelekile kakhulu uzohlangana nakho lapho kukhona imaski yezokwelapha.

I-ISO 13485 Ingabe indinganiso yamazwe omhlaba yohlelo lokuphathwa kwekhwalithi lokukhiqiza amadivayisi wezokwelapha. Lapho ifektri efana neyami yi-ISO 13485 eqinisekisiwe, kusho ukuthi sikhombisile ikhono lethu lokuhlinzeka ngamadivayisi wezokwelapha ahlangabezana nezimfuneko zokulawula ezisebenzayo. Akusona isitifiketi somkhiqizo; Kuyisitifiketi senqubo. Kukutshela ukuthi umenzi unezinhlelo eziqinile ezikhona ekwakhiweni, ukukhiqizwa, ukulandelela kanye nokulawulwa kwengozi. Lesi yisiqinisekiso sakho sesisekelo sokwenza kanye nokwethenjwa komhlinzeki kuyo yonke imikhiqizo, kusuka ku imaski yobuso ezintweni eziyinkimbinkimbi kakhulu Amashubhu wokuvumelanisa wezokwelapha.

Ukumaka Ingabe uphawu lwesitifiketi olukhombisa ukuvumelana nezempilo, ukuphepha, kanye namazinga okuvikela ezemvelo emikhiqizo ethengiswayo endaweni yezomnotho yaseYurophu (EEA). Okwe isakaza noma umdlaluvuzi, UMark we-CE uyasho ukuthi umkhiqizo uhlolwe ukuze uhlangabezane nezinkombandlela noma iziqondiso ze-EU ezifanele (njengokulawulwa kwensiza yezokwelapha noma ukulawulwa kwemishini yokuvikela). Iphasiphothi ephoqelekile yemikhiqizo efaka imakethe ye-EU. Okomthengi osuselwa e-US, kuyilapho kungeyona imfuneko eqondile, isebenza njengenkomba eqinile yokuthi umenzi wanamathela kumazinga aphezulu aphesheya.

Ekugcineni, Uhlobo lwe-fda (Ukudla kanye nezidakamizwa) kulawula imaski yezokwelapha e-United States. Njengoba sesixoxile, Imaski yokuhlinza ziyabhekwa Iklasi II amadivaysi ezokwelapha futhi adinga Uhlobo lwe-fda imvume, ngokuvamile nge-510 (k) Isaziso se-Premarket. Le nqubo ikhombisa ukuthi idivaysi okungenani iphephile futhi isebenza ngempumelelo njengedivayisi ethengiswa ngokusemthethweni engaphansi kwemvume ye-Premarket. Ingomane Ukuhlinzwa N95 Rescorators, badinga bobabili UNiosh ukuvunywa futhi Uhlobo lwe-fda imvume. Ukuqinisekisa umphakeli Uhlobo lwe-fda Ukubhalisa nokuvunyelwa komkhiqizo kuyisinyathelo esingesona esixoxiswanayo kwinqubo yakho yokukhuthala efanele. Umhlinzeki othembekile uzohlinzeka ngezinombolo zabo zokubhalisa kanye nezinhlamvu ezingama-510 (k) ngemuva kwesicelo. Lezi zitifiketi ziyisihlangu sakho esimweni esingesihle futhi zilawulwa.

Ukubekezelela okusemqoka ukukhumbula

Njengoba uzulazula emhlabeni oyinkimbinkimbi wezokwelapha isivivu na- umdlaluvuzi Ukuthengwa, gcina la maphuzu abalulekile engqondweni:

• Umsebenzi uyala ifomu: A isakaza kuvikela abanye ukusuka le khasi umonile ngokuvimba amaconsi. A I-n95 respirator kuvikela umonile ukusuka imvelo ngokuhlunga izinhlayiya zomoya.
• I-Fit iyikho konke ku-respirator: A I-n95 respirator ayisebenzi ngaphandle kophawu oluqinile. A kufanelekile, kuqinisekiswe ngovivinyo olufanele, kubalulekile ukufeza izinga elithenjisiwe lokuvikelwa.
• Yazi abalawuli bakho: E-US, The Uhlobo lwe-fda -muhle Imaski yokuhlinza Njengamadivaysi ezokwelapha, ngenkathi UNiosh iqinisekisa ukusebenza kwe-filtration of respirators. Kuhlinzwa n95s kumele ahlangabezane namazinga wazo zombili.
• Ama-valves anenduduzo, hhayi imitholampilo: Ama-respirators ne- ama-valves okuphefumula Vikela umonile kepha hhayi labo abaseduze nabo. Ngokuvamile azifanele Izilungiselelo Zokunakekelwa Kwezempilo lapho ukulawulwa khona komthombo kubalulekile.
• Qinisekisa, ungathembi: Lapho sithola khona emazweni aphesheya, funa futhi uqinisekise izitifiketi ezinjenge-ISO 13485, umaki ka-CE, futhi Uhlobo lwe-fda imvume. Uzakwethu nabahlinzeki ababonakalayo ababeka phambili ikhwalithi nokuxhumana.
• Qondanisa imaskhi engcupheni: Sebenzisa indlela evuthayo. I-Stock Standard imaski yezokwelapha Ukusetshenziswa okujwayelekile nokugcina Ama-respirators we-N95 Okwengozi enkulu, izinqubo ezikhiqiza i-aerosol ukuqinisekisa ukuphepha kanye nokuphatha izindleko ngempumelelo.