narigmed NOPC-01 silicone ipfunyika spo2 sensor hamwe na lemo umuhuza
Video y'ibicuruzwa
Ibisobanuro Bigufi
NOPC-01 Silicone Gupfunyika SpO2 Sensor hamwe na Moderi y'imbere - Ibisobanuro byibicuruzwa
NOPC-01 Silicone Wrap SpO2 Sensor hamwe na Lemo Connector, ifite module yo gupima ogisijeni mu maraso, itanga igenzura ryuzuye rya SpO2, igipimo cy’imisemburo, umuvuduko w’ubuhumekero, hamwe n’ibipimo bya parufe. Iyi sensor ihuza byihuse hamwe na ogisijeni hamwe na ventilateur, bigatuma biba byiza gukoreshwa mumazu, mubitaro, no gukurikirana ibitotsi. Ikoreshwa rya tekinoroji ya ogisijeni ya Narigmed itezimbere muburyo butandukanye hamwe nimiterere yuruhu, itanga ibisomwa byizewe nubwo bigenda neza kandi bitunganijwe neza. Iremeza neza ibipimo bya SpO2 (± 3%) nigipimo cya pulse (± 4bpm) igenda (0-4Hz, 0-3cm), kandi ikagumana ukuri kwinshi (SpO2 ± 2%, igipimo cya pulse ± 2bpm) mugihe indangagaciro ya hypoperfusion ari ≥ 0.025%.
Ibiranga ibicuruzwa nibyiza
Ibiranga:
- Amaraso ya Oxygene Yuzuye:Itanga igenzura ryukuri rya SpO2, igipimo cya pulse, igipimo cyubuhumekero, hamwe na indangagaciro.
- Umuhuza wa Lemo:Iremeza guhuza umutekano kandi neza hamwe nibikoresho byubuvuzi nka ogisijeni yibanze hamwe na ventilator.
- Gupfunyika Silicone yoroshye:Hypoallergenic kandi nziza, ibereye gukoreshwa mugihe kinini.
- Gusaba kwagutse:Nibyiza gukoreshwa mumazu, mubitaro, no gukurikirana ibitotsi.
- Gukwirakwiza ibintu bitandukanye:Ikora neza muburyo butandukanye bwuruhu hamwe nibibazo bitoroshye.
Ibyiza:
- Icyitonderwa Cyane Cyimuka:Ibipimo bya SpO2 (± 3%) hamwe nigipimo cya pulse (± 4bpm) mugihe cyo kugenda (0-4Hz, 0-3cm).
- Imikorere mike ya Perfusion:Igumana ubunyangamugayo (SpO2 ± 2%, igipimo cya pulse ± 2bpm) kuri hypoperfusion index ≥0.025%.
- Gukoresha byinshi:Nibyiza kubidukikije bitandukanye hamwe nibisabwa, harimo kwita murugo, imiterere yubuvuzi, no gukurikirana ibitotsi.
- Ihumure ry'abarwayi:Igishushanyo cyoroshye cya silicone kigabanya uburakari bwuruhu kandi kongerera ihumure kwambara igihe kirekire.
- Kwishyira hamwe byoroshye:Kwishyira hamwe byihuse hamwe nibikoresho byubuvuzi bihari, kunoza imikorere nta guhinduka kwinshi.
Ibikurikira
1.Gupima neza-neza: Gukoresha tekinoroji ya Narigmed algorithm kugirango tumenye neza ibisubizo byo gupima no kugabanya amakosa.
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3. Gutekana gukomeye: Igicuruzwa cyakorewe igenzura ryiza kandi ryipimishije kugirango ryizere ko rishobora gukora neza mubidukikije.
4. Biroroshye gukora: Ibikoresho biroroshye mubishushanyo kandi byoroshye gushiraho. Barashobora guhuzwa na oximeter host idafite ibikorwa bigoye.
5. Umutekano kandi wizewe: Yakozwe mubikoresho byo mubuvuzi, bidafite uburozi kandi bitagira ingaruka, ntibitera uruhu, byemeza ko bikoreshwa neza.
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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 gukabije kwa periferiya, 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.
