FRO-203 CE FCC RR spo2 impiswi zabana bato oximeter murugo ukoreshe pulse oximeter
Narigmed's FRO-204 Fingertip Pulse Oximeter yagenewe kugenzura ubuzima bwizewe kandi bwuzuye mubihe bitandukanye no mubidukikije, bituma habaho ubuvuzi bwuzuye kubakoresha imyaka yose.
Ibiranga:
- Igipimo Cyiza-Cyuzuye:Mugihe cya parufe nkeya hamwe na PI = 0.1%, Narigmed yamaraso ya ogisijeni yo gupima ni SpO2 ± 2%, PR ± 2bpm.
- Imikorere yo kurwanya: Igipimo cyo gupima ibipimo ni ± 4bpm naho SpO2 yo gupima ni ± 3% nubwo haba imyitozo.
-Byuzuye Silicone Yipfundikijwe Urutoki: Iremeza ihumure no gukoreshwa bidafite compression, yemerera kugenzura kwagutse nta kibazo.
- Wongeyeho igipimo cy'ubuhumekero (RR):Emerera kwitegereza igihe kirekire ubuzima bwibihaha. (CE na NMPA birahari).
- Ibipimo Byihuse Ibisohoka:Itanga ibipimo byihuse bisohoka mumasegonda 4, byemeza gusoma neza kandi neza.
- Erekana Mugaragaza Imikorere: Yongera imikoreshereze yemerera kureba byoroshye muburyo butandukanye.
- Ubuzima Asst (Raporo yubuzima):Ibiranga isesengura ryubuzima ryihuse rimenyesha abakoresha niba hypoxia cyangwa umuvuduko ukabije wumutima ukekwa, byemeza kwivuza mugihe.
Narigmed idasanzwe yemewe yo kurwanya algorithm
Oximeter yacu ni nziza mu mikorere irwanya umuvuduko, ikomeza umuvuduko wa pulse hamwe n’amaraso ya ogisijeni yapimye neza muri ± 4bpm cyangwa ± 4% ndetse no mugihe cyo kunyeganyeza 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.
Yagenewe abantu bafite ubwoba bwamaboko
Imisemburo ya pulse igaragaramo tekinoroji yo kurwanya moteri, yagenewe cyane cyane guhinda umushyitsi abarwayi ba Parkinson.
Igishushanyo mbonera
Imiterere yatunganijwe neza, irashobora gukora mubisanzwe mugihe habaye amazi atemba.
Kuburira hakiri kare umuriro na pnewoniya
Urutoki rwa pulse oximeter nigikoresho cyiza cyo kumenya hakiri kare kugabanuka kwa ogisijeni mu maraso mu bana mugihe cy'umuriro. Niba urugero rwa ogisijeni mu maraso rukomeje kugabanuka mu gihe cy'umuriro, ni ikimenyetso cyo kuburira hakiri kare, byerekana ko hakenewe ubuvuzi bwihuse kugira ngo wirinde umusonga uterwa n'umuriro muremure. Uku gutabara hakiri kare birashobora gufasha mugupima no kuvura mugihe, kurinda ubuzima bwumwana wawe.
UMWIHARIKO
| UBWOKO | Gukurikirana urugo \ Igikoresho cyubuvuzi cyinzu |
| Icyiciro | Impanuka ya oximeter |
| Urukurikirane | narigmed® FRO-204 |
| Amapaki | 1pcs / agasanduku, 60box / ikarito |
| Ubwoko bwerekana | UMUKARA |
| Erekana ibipimo | Spo2 / PR / RR / PI / OLED |
| Urwego rwo gupima SpO2 | 35% ~ 100% |
| Ibipimo bya SpO2 | ± 2% （70% ~ 100%） |
| Urwego rwo gupima PR | 25 ~ 250bpm |
| Ibipimo bya PR | Ikirenga cya ± 2bpm na ± 2% |
| Imikorere yo kurwanya | SpO2 ± 3% PR ± 4bpm |
| Imikorere mike yo gukora neza | SPO2 ± 2%, PR ± 2bpm |
| Igihe cyambere cyo gusohora / Igihe cyo gupima | 4s |
| Guhagarika byikora | Zimya nyuma yintoki 8s \ Guhagarika byikora mumasegonda 8 |
| Birahumuriza | Silicone cavity urutoki, irashobora kwambarwa neza mugihe kirekire |
| Ikimenyetso cya batiri nkeya \ Imiterere ya Bateri | Yego |
| Guhindura imishwarara | Ubucyo bwa ecran burashobora guhinduka |
| Gukoresha ingufu zisanzwe | <30mA |
| Ibiro | 54g (hamwe numufuka utagira bateri) |
| Kwirukanwa | 63mm * 35,6mm * 32mm |
| Icyemezo cy'amazi | IPX2 |
| Imiterere y'ibicuruzwa | Ibicuruzwa byateje imbere |
| Umuvuduko - Gutanga | 2 * 1.5V Bateri ya AAA |
| Gukoresha Ubushyuhe | 5 ° C ~ 40 ° C. 15% ~ 95% (ubuhehere) 50kPa ~ 107.4kPa |
| ibidukikije | -20 ° C ~ 55 ° C. 15% ~ 95% (ubuhehere) 50kPa ~ 107.4kPa |
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.
