NOSZ-08 Ibikoresho bidasanzwe Kubitwi
Ibisobanuro Bigufi
1.Ibipimo bisobanutse neza: Emera tekinoroji ya algorithm igezweho kugirango urebe neza ibisubizo by'ibipimo kandi bigabanye amakosa.
2.Ubukangurambaga bukabije: Iperereza ryakozwe kugirango ryumve kandi rishobora guhita ryita ku mpinduka zuzuye mu maraso y’inyamaswa zuzuye, zitanga amakuru nyayo ku baveterineri.
3.Gukomera gukomeye: Igicuruzwa cyakorewe igenzura rikomeye kandi ryipimishije kugirango ryizere ko rishobora gukora neza mubidukikije.
4.Byoroshye gukora: Ibikoresho biroroshye mubishushanyo kandi byoroshye gushiraho. Barashobora guhuzwa na host of veterineri oximeter nta bikorwa bigoye.
5.Umutekano kandi wizewe: Yakozwe mubikoresho byo mubuvuzi, bidafite uburozi kandi bitagira ingaruka, ntibitera uruhu rwinyamaswa, byemeza ko bikoreshwa neza.
Gusaba
Iki gicuruzwa kibereye kugenzura amaraso ya ogisijeni yuzuye yinyamaswa zinyamanswa (nk'injangwe, imbwa, inkwavu, nibindi) n'amatungo (nk'inka, intama, ingurube, nibindi). Ifite agaciro gakomeye mububiko bwinyamaswa, ubuvuzi bukomeye, kuvura reabilité nibindi bihe.
Amabwiriza
1. Huza ibikoresho bya probe kumubiri wingenzi wa oximeter yubuvuzi bwamatungo, urebe neza ko ihuriro rihamye.
2. Sukura uruhu rwahantu hapimwe inyamaswa kugirango urebe ko idafite umwanda, amavuta nibindi byanduye.
3. Witondere witonze iperereza kuruhu rwinyamaswa, urebe ko iperereza rihura cyane nuruhu.
4. Fungura igice cyingenzi cya oximeter yubuvuzi bwamatungo hanyuma utangire ukurikirane ubwinshi bwamaraso ya ogisijeni.
5.Mu gihe cyo gukurikirana, witondere uko inyamaswa yitwaye kandi uhite ubikemura niba hari ibintu bidasanzwe.
1.Uri uruganda?
Turi isoko yinkomoko ya oximeter yintoki. Dufite icyemezo cyo kwandikisha ibicuruzwa byubuvuzi, ibyemezo byubuziranenge bwa sisitemu, ipatanti yivumbuwe, nibindi.
Dufite imyaka irenga icumi yo gukusanya tekiniki na clinique ya monitor ya ICU. Ibicuruzwa byacu bikoreshwa cyane muri ICU, NICU, OR, ER, nibindi.
Turi uruganda rwisoko ruhuza R&D, umusaruro no kugurisha. Ntabwo aribyo gusa, muruganda rwa oximeter, turi isoko yinkomoko nyinshi. Twatanze modules ya ogisijeni yamaraso kubantu benshi bazwi cyane bakora ibicuruzwa bya oximeter.
(Twasabye ibintu byinshi byavumbuwe hamwe nibicuruzwa bigaragara bijyanye na software algorithms.)
Mubyongeyeho, dufite sisitemu yuzuye ya ISO: 13485, kandi dushobora gufasha abakiriya kwandikisha ibicuruzwa bijyanye.
2. Amaraso yawe ya ogisijeni yuzuye?
Nibyo, ubunyangamugayo nicyo kintu cyibanze dusabwa tugomba kuzuza ibyemezo byubuvuzi. Ntabwo twujuje gusa ibyangombwa byibanze, ariko tunatekereza kubyukuri mubintu byinshi bidasanzwe. Kurugero, kwivanga kwimikorere, kuzenguruka kwa periferique, intoki zubunini butandukanye, intoki zamabara yuruhu zitandukanye, nibindi.
Igenzura ryacu rifite amakuru arenga 200 yamakuru agereranya akubiyemo intera iri hagati ya 70% na 100%, ugereranije nisesengura rya gaze yamaraso yavuye mumaraso yabantu.
Kugenzura neza muburyo bw'imyitozo ngororamubiri ni ugukoresha ibikoresho by'imyitozo ngororamubiri kugira ngo ukore imyitozo hamwe na radiyo runaka hamwe na amplitude yo gukubita, guterana amagambo, kugenda ku bushake, n'ibindi, no kugereranya ibisubizo by'ibizamini bya oximeter mu myitozo ngororamubiri n'ibisubizo bya gaze y'amaraso. isesengura ryamaraso ya arterial Validation, byafasha abarwayi bamwe nkabarwayi barwaye indwara ya Parkinson gupima imikoreshereze. Ibizamini nkibi byo kurwanya imyitozo kuri ubu bikorwa gusa n’amasosiyete atatu yo muri Amerika mu nganda, masimo, nellcor, Philips, kandi umuryango wacu wonyine niwo wakoze iri genzura ukoresheje oximeter yerekana urutoki.
3. Kuki ogisijeni yamaraso ihindagurika hejuru no hepfo?
Igihe cyose ogisijeni yamaraso ihindagurika hagati ya 96% na 100%, iba iri mubisanzwe. Mubisanzwe, agaciro ka ogisijeni mu maraso kazaba gahagaze neza nubwo uhumeka utuje. Imihindagurikire yindangagaciro imwe cyangwa ebyiri murwego ruto nibisanzwe.
Ariko, niba ikiganza cyumuntu gifite kugenda cyangwa izindi mvururu nimpinduka zo guhumeka, bizatera ihindagurika ryinshi muri ogisijeni yamaraso. Kubwibyo, turasaba ko abakoresha baceceka mugihe bapima ogisijeni yamaraso.
4. 4S yihuta gusohora agaciro, nigiciro nyacyo?
Hano ntamiterere nka "yaremye agaciro" n "" agaciro gahamye "mumaraso yacu ya ogisijeni algorithm. Indangagaciro zose zerekanwe zishingiye kumubiri wikitegererezo no gusesengura. 4S yihuta y agaciro gashingiye kubimenyekanisha byihuse no gutunganya ibimenyetso bya pulse byafashwe muri 4S. Ibi bisaba gukusanya amakuru menshi yubuvuzi no gusesengura algorithm kugirango ugere ku kumenyekana neza.
Ariko, icyambere cyo kwihuta 4S agaciro ni uko uyikoresha akiriho. Niba hari kugenda iyo terefone ifunguye, algorithm izagaragaza ubwizerwe bwamakuru ashingiye kumiterere yakusanyirijwe hamwe hanyuma ahitemo yongerera igihe cyo gupima.
5. Ese ishyigikira OEM no kuyitunganya?
Turashobora gushyigikira OEM no kwihindura.
Ariko, kubera ko ikirangantego cyerekana ikirango gisaba ecran ya ecran itandukanye hamwe nibikoresho bitandukanye hamwe nubuyobozi bwa bom, ibi bizatuma kwiyongera kubiciro byibicuruzwa hamwe nigiciro cyo gucunga, bityo tuzaba dufite umubare muto wibisabwa. MOQ: 1K.
Ibirango dushobora gutanga birashobora kugaragara kubipfunyika ibicuruzwa, imfashanyigisho, n'ibirango bya lens.
6. Birashoboka kohereza hanze?
Kugeza ubu dufite icyongereza verisiyo yo gupakira, imfashanyigisho hamwe nibicuruzwa. Kandi yabonye ibyemezo byubuvuzi bivuye mu muryango w’ubumwe bw’ibihugu by’Uburayi CE (MDR) na FDA, bishobora gushyigikira kugurisha ku isi.
Muri icyo gihe kandi dufite icyemezo cyo kugurisha FSC kubuntu (Ubushinwa na EU)
Nyamara, kubihugu bimwe byihariye, birakenewe kumva ibyifuzo byaho byinjira, kandi ibihugu bimwe na bimwe bikenera uruhushya rwihariye.
Ni ikihe gihugu wohereza mu mahanga? Reka nemeze hamwe nisosiyete niba kiriya gihugu gifite ibisabwa byihariye byo kugenzura.
7. Birashoboka gushyigikira kwiyandikisha mugihugu cya XX?
Ibihugu bimwe bisaba kwiyandikisha kubakozi. Niba umukozi ashaka kwandikisha ibicuruzwa byacu muri kiriya gihugu, urashobora gusaba umukozi kwemeza amakuru bakeneye kuri twe. Turashobora gushigikira gutanga amakuru akurikira:
Icyemezo cyo gutanga uruhushya 510K
Icyemezo cya CE (MDR)
Icyemezo cya ISO13485
Amakuru y'ibicuruzwa
Ukurikije uko ibintu bimeze, ibikoresho bikurikira birashobora gutangwa kubushake (bigomba kwemezwa numuyobozi ushinzwe kugurisha):
Raporo rusange yubugenzuzi bwumutekano kubikoresho byubuvuzi
Raporo yikizamini cya electromagnetic
Raporo y'ibizamini bya biocompatibilité
Raporo yubuvuzi
8. Ufite icyemezo cyubuvuzi?
Twakoze ibikoresho byo kwa muganga kwiyandikisha no gutanga ibyemezo, icyemezo cya FDA 510K, icyemezo cya CE (MDR), na ISO13485.
Muri bo, twabonye icyemezo cya CE (CE0123) muri TUV Süd (SUD), kandi cyemejwe hakurikijwe amabwiriza mashya ya MDR. Kugeza ubu, turi abambere murugo bakora uruganda rwa oximeter.
Kubyerekeranye na sisitemu yubuziranenge bwumusaruro, dufite icyemezo cya ISO13485 nimpushya zo gukora murugo.
Mubyongeyeho, dufite icyemezo cyo kugurisha kubuntu (FSC)
9. Birashoboka kuba umukozi wihariye mukarere?
Ikigo cyihariye kirashobora gushyigikirwa, ariko dukeneye kuguha uburenganzira bwikigo cyihariye nyuma yo gusaba isosiyete kwemererwa hashingiwe kumikorere yikigo cyawe nubunini buteganijwe kugurishwa.
Mubisanzwe ni igihugu runaka aho bamwe mubakozi bakomeye bafite uruhare runini mugace no kugabana ku isoko, kandi bafite ubushake bwo kumenyekanisha ibicuruzwa byacu, kugirango bashobore gufatanya.
10. Ibicuruzwa byawe ni bishya? Yagurishijwe kugeza ryari?
Ibicuruzwa byacu ni bishya kandi bimaze amezi make ku isoko. Byarateguwe gusa kandi bihagaze nkibicuruzwa byohejuru. Kugeza ubu dufite umubare muto wabakiriya kugurisha OEM. Kubera icyemezo cyo kwiyandikisha, ntabwo yinjiye kumugaragaro ku masoko ya FDA na CE. Bizagurishwa muri Amerika ya ruguru no mu muryango w’ubumwe bw’ibihugu by’Uburayi nyuma yo kubona icyemezo cyo kwiyandikisha mu Gushyingo.
11. Ibicuruzwa byawe byagurishijwe mbere? Isubiramo ni iki?
Nubwo ibicuruzwa byacu ari ibicuruzwa bishya, ibihumbi icumi byoherejwe kugeza ubu, kandi ubwiza bwibicuruzwa burahagaze. Tumaze imyaka irenga icumi dukora oximeter, kandi tuzi ibibazo byose byabakiriya. Twakoze isesengura ryuburyo bwo kunanirwa (DFMEA / PFMEA) kuri buri nenge, uhereye kubishushanyo mbonera niterambere, umusaruro, kugenzura ubuziranenge bwibikoresho fatizo, kugenzura ibicuruzwa, gupakira Kugenzura ubuziranenge bwibikorwa byose, nko gutanga, kugirango twirinde ingaruka zishobora kubaho.
Mubyongeyeho, ibicuruzwa byacu bishushanya bifite ibiyiranga, birumvikana cyane, kandi isuzuma ryabakiriya ni ryinshi.
12. Ibicuruzwa byawe ni icyitegererezo cyihariye? Hoba hariho ingorane zo kuvutswa?
Nuburyo bwacu bwite, kandi twasabye ibicuruzwa byerekana ibicuruzwa hamwe nibintu byavumbuwe bijyanye na software algorithms.
Isosiyete yacu ifite umuntu witanze ashinzwe kurinda ibicuruzwa byubwenge. Twakoze isesengura ryuzuye ry'uburenganzira ku mutungo bwite mu by'ubwenge ku bicuruzwa byacu, kandi icyarimwe twashizeho uburyo bwo kurinda umutungo bwite mu by'ubwenge kurinda ibicuruzwa n'ikoranabuhanga.
