FRO-100 Inzu Yubuvuzi Yerekanwe Yerekana Perfuzione Ntoya SPO2 PR urutoki pulse oximeter
Video y'ibicuruzwa
Ibiranga ibicuruzwa
FRO-100 CE FCC Spo2 Urutoki Pulse Oximeter
Narigmed's FRO-100 Pulse Oximeter itanga igenzura ryizewe kandi ryukuri mubihe bitandukanye nibidukikije, bitanga ubuvuzi bwuzuye kubakoresha imyaka yose.
- Byukuri: Ibipimo bya SpO2 neza hamwe na ± 2% hamwe nigipimo cya pulse ya ± 2bpm.
- Imikorere yo kurwanya: Itanga ibyasomwe byizewe kabone niyo byabangamira kugenda, nibyiza kubantu bafite ubwoba cyangwa indwara ya Parkinson. Ibipimo nyabyo bya SpO2 hamwe na ± 3% hamwe nigipimo cyimpanuka ya ± 4bpm, mugihe hari mukigenda.
- Byuzuye Silicone Yipfundikijwe Urutoki: Iremeza ihumure no gukoreshwa bidafite compression, ikwiranye nogukurikirana kwagutse.
- Ibipimo Byihuse Ibisohoka: Gutanga ibipimo byihuse bisohoka mumasegonda 4.
- Birakwiriye Amatsinda atandukanye: Yashizweho kugirango ifashe abantu bafite uruhu rwijimye, irashobora gukoreshwa nabantu bakuru, abana, nabakuru.
- Gukurikirana igihe kirekire: Shigikira amasaha 30 yo gukurikirana igihe kirekire.
- Ijwi ryibutsa amajwi ：Irashobora gutanga abavuga n'amajwi arenga imipaka.
- Imigaragarire nini yerekana:Imyandikire nini itukura kugirango byoroshye kureba.
FRO-100 Pulse Oximeter nigikoresho cyingenzi mugukurikirana ubuzima bwuzuye, kwemeza ko abakoresha bahabwa amakuru yukuri kandi mugihe cyo gucunga neza imibereho yabo neza.
Ibyiza byibicuruzwa
Koresha uburyo bwa Narigmed's Dynamic OxySignal Capture Technology
Imisemburo ya FRO-100 itanga imikorere idasanzwe mugihe gito cya parufe, ituma ogisijeni yamaraso yukuri (SpO2 ± 2%) hamwe nigipimo cya pulse (PR ± 2bpm) nubwo igipimo cyamaraso ari gito. Ibi bituma biba byiza kubarwayi bafite umuvuduko ukabije, batanga gusoma byizewe mugihe bikenewe cyane. Hamwe nigihe cyo gusubiza byihuse hamwe no kumva neza, FRO-100 Pulse Oximeter itanga igenzura neza mubihe bigoye.
Narigmed's Patent idasanzwe Kurwanya Algorithm
Oximeter yacu ni nziza mubikorwa byo kurwanya umuvuduko, ikomeza umuvuduko wa pulse na ogisijeni yamaraso yapimye neza muri ± 4bpm na ± 3% nubwo mugihe cyo guhora urutoki cyangwa kunyeganyeza intera. Waba uri mubaturage bazima cyangwa abarwayi ba Parkinson, urashobora kwemeza neza gusoma neza. Igishushanyo cyizewe hamwe nubuhanga buhanitse bwibikoresho bituma bikenerwa cyane kubona ibisubizo nyabyo kandi byizewe byibipimo byubuvuzi bigenda.
Gukomeza, Gukurikirana Byizewe, Umufatanyabikorwa mwiza kuri Oxygenerator na Ventilator
FRO-100 Pulse Oximeter irerekana ibyiyumvo byinshi byo gufata ibyuka bya ogisijeni kandi bigashyigikira gukurikirana igihe kirekire nijoro. Irashobora gukoreshwa mugihe cyo kwishyuza, bigatuma biba byiza mugukurikirana ubuzima mugihe cyo gusinzira no kwita kubarwayi byuzuye.
Igishushanyo cya IPX2
Imiterere idakoresha amazi yakozwe muburyo bwihariye ukurikije IPX2 kugirango irinde igikoresho gutose kubera rimwe na rimwe kumeneka amazi.
Byuzuye silikone yuzuye urutoki
Urutoki rwa silicone rwuzuye rutwikiriye urutoki rwemeza ihumure ryinshi no gukoresha nta compression, bituma habaho igenzura ryagutse nta kibazo. Silicone yoroshye ihuza neza urutoki, itanga umutekano kandi woroshye. Igishushanyo cyongera ubunararibonye bwabakoresha kandi cyemeza gusoma neza, bigatuma biba byiza mugukurikirana ubuzima bwigihe kirekire.
Kubwoko butandukanye bwamabara yuruhu
Irashobora gukoreshwa nabantu batandukanye kugirango barebe amakuru yumubiri, kandi irangwa ninshuti kubantu bafite uruhu rwijimye.
Serivisi zacu
Ukurikije ibyo umukiriya akeneye, urashobora guhitamo agasanduku k'amabara LOGO, ugahitamo shingiro yo kwishyuza, ugahitamo ubwoko bwa probe, hanyuma ugahitamo uburyo bwo guhuza n'imihindagurikire y'ikirere.
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.
