NOMN-03 SPO2 gawo loyezera
Makhalidwe a Zamalonda
| TYPE | SPO2 board for Medical high-performance monitor |
| Gulu | SPO2 board\module ya oxygen oxygen\SPO2 module |
| Mndandanda | narigmed® NOMN-03 |
| Onetsani parameter | SPO2\PR\PI\RR |
| Muyezo wa SpO2 | 35% ~ 100% |
| Kulondola kwa muyeso wa SpO2 | ± 2% (70% ~ 100%) |
| SpO2 resolution ratio | 1% |
| Muyezo wa PR | 25-250bpm |
| Kulondola kwa kuyeza kwa PR | Kuchuluka kwa ± 2bpm ndi ± 2% |
| PR resolution ratio | 1bpm pa |
| Anti-motion performance | SpO2±3% PR ± 4bpm |
| Low perfusion performance | SPO2 ±2%, PR ±2bpm Itha kukhala yotsika ngati PI=0.025% ndi kafukufuku wa Narigmed |
| Perfusion Index Range | 0% ~ 20% |
| PI resolution ratio | 0.01% |
| Mlingo wa kupuma | 4rpm ~ 70rpm |
| RR resolution ratio | 1 rpm |
| Plethyamo Graphy | Chithunzi cha bar \ Pulse wave |
| Kugwiritsa ntchito mphamvu kwanthawi zonse | <15mA |
| Yang'anirani kuzindikiridwa\Penyani kulephera kuzindikira | INDE |
| Magetsi | 5V DC |
| Nthawi yotulutsa mtengo | 4S |
| Njira yolumikizirana | Kulumikizana kwamtundu wa TTL |
| Communication protocol | makonda |
| Kukula | 50mm * 22mm * 3mm |
| Njira zopangira ma waya | Mtundu wa socket |
| Kugwiritsa ntchito | Itha kugwiritsidwa ntchito mu monitor |
| Kutentha kwa Ntchito | 0°C ~ 40°C 15% ~ 95% ( chinyezi) 50kPa ~ 107.4kPa |
| malo osungira | -20°C ~ 60°C 15% ~ 95% ( chinyezi) 50kPa ~ 107.4kPa |
Zotsatirazi
Ukadaulo wa okosijeni wamagazi wa Narigmed utha kugwiritsidwa ntchito pazochitika zosiyanasiyana, anthu kapena nyama, ndipo amagwiritsidwa ntchito ndi madokotala kuyeza mpweya wamagazi, kugunda kwa mtima, kugunda kwamtima, komanso index ya perfusion. Makamaka wokometsedwa ndi bwino kuti anti-kuyenda ndi otsika perfusion ntchito. Mwachitsanzo, poyenda mwachisawawa kapena nthawi zonse pa 0-4Hz, 0-3cm, kulondola kwa pulse oximetry (SpO2) ndi ± 3%, ndipo muyeso wa kugunda kwa mtima ndi ± 4bpm. Pamene chiwerengero chochepa cha perfusion chili chachikulu kuposa kapena chofanana ndi 0.025%, kulondola kwa pulse oximetry (SpO2) ndi ± 2%, ndipo kulondola kwa kuyeza kwa pulse ndi ± 2bpm.
Ili ndi izi zogulitsa:
1. Muyezo wanthawi yeniyeni wa pulse oxygen saturation (SpO2)
2. Yezerani kugunda kwa mtima (PR) munthawi yeniyeni
3. Muyezo wa nthawi yeniyeni wa perfusion index (PI)
4. Yesani kupuma (RR) mu nthawi yeniyeni
5. Kutumiza kwanthawi yeniyeni kwa ma pulse wave wave kutengera mayamwidwe a infrared spectrum.
6. Kutumiza kwanthawi yeniyeni kwa mawonekedwe ogwirira ntchito, mawonekedwe a hardware, mawonekedwe a mapulogalamu ndi mawonekedwe a sensa, ndi makompyuta omwe ali nawo amatha kutulutsa ma alarm pogwiritsa ntchito mfundo zoyenera.
7. Mitundu itatu yodziwika bwino ya odwala: wamkulu, ana ndi akhanda, ndipo pambuyo pake Chowona Zanyama.
8. Ili ndi ntchito yoyika nthawi yowerengera kuti ipeze nthawi yoyankhidwa ya magawo osiyanasiyana owerengera.
9. Kukhoza kukana kusokoneza kuyenda ndi kuyeza kofooka kwa perfusion.
10. Ndi muyeso wa kupuma kwa mpweya.
Kufotokozera Kwachidule
PI Perfusion Index (PI) ndi chizindikiro chofunikira cha kuchuluka kwa madzi (mwachitsanzo, kuthekera kwa magazi oyenda) m'thupi la munthu amene akuyezedwa. Nthawi zonse, PI imachokera ku> 1.0 kwa akuluakulu,> 0,7 kwa ana, mpaka kutsekemera kofooka pamene <0.3. PI ikakhala yaying'ono, Zimatanthauza kuti magazi omwe amapita kumalo omwe akuyezedwa ndi otsika ndipo kutuluka kwa magazi kumakhala kochepa. Kuchita kwa mpweya wochepa kwambiri ndi chizindikiro chachikulu cha kuyeza kwa okosijeni muzochitika monga makanda obadwa msanga, odwala omwe ali ndi vuto loyenda bwino, nyama zowonongeka kwambiri, anthu omwe ali ndi khungu lakuda, malo ozizira, malo oyesera apadera, ndi zina zotero, kumene kutuluka kwa magazi nthawi zambiri kumakhala kofooka. zopindika komanso pomwe kuyeza kosakwanira kwa okosijeni kungayambitse kuchepa kwa oxygen panthawi zovuta. Muyezo wa okosijeni wa magazi a Narigmed uli ndi kulondola kwa ± 2% ya SpO2 pakuthira kofooka kwa PI=0.025%.
Narigmed ndi kampani yaukadaulo yaukadaulo ya Class II yomwe imayang'ana kwambiri pa R&D, kupanga, kugulitsa ndi kugwiritsa ntchito mpweya wamagazi ndi zida zowunikira kuthamanga kwa magazi. Bizinesi yayikulu ya kampaniyo ndi R&D, kupanga ndi kugulitsa kwa akatswiri amagazi okosijeni ndi ma module ndi zida za kuthamanga kwa magazi. Ndi yoyenera kwa oyang'anira, zowunikira m'manja magazi okosijeni, kunyumba magazi oyang'anira, pulse oximeters, zachipatala magazi mpweya Chalk ndi zipangizo zina. Kampaniyo imayang'ana kwambiri pakuwongolera kuyeza kulondola komanso kudalirika kwa magawo a okosijeni wamagazi, kuthandizira kuyeza mwatsatanetsatane kwa kununkhira kofooka kotsika mpaka 0.025%, ndikuwongolera magwiridwe antchito oletsa kuchita masewera olimbitsa thupi a kuyeza okosijeni wamagazi. Itha kugwiritsidwa ntchito poyang'anira m'chipatala, ma ventilator, ndi ma jenereta a okosijeni. Kuwunika kwa okosijeni m'magazi kungagwiritsidwe ntchito pazida zachipatala za ICU ndi madipatimenti aakhanda, komanso ukadaulo woyezera kuthamanga kwa magazi, wachangu komanso womasuka. Kampaniyo ikugwiranso ntchito kuti ipange zochitika zambiri zogwiritsira ntchito kunyumba za okosijeni wamagazi ndi magawo a kuthamanga kwa magazi, monga kugona polygraphy.
1.Kodi ndinu fakitale?
Ndife gwero fakitale ya chala pulse oximeter. Tili ndi satifiketi yathu yolembetsa mankhwala azachipatala, chiphaso chaukadaulo wopanga, patent yopanga, ndi zina zambiri.
Tili ndi zaka zopitilira khumi zaukadaulo komanso zachipatala zowunikira ma ICU. Zogulitsa zathu zimagwiritsidwa ntchito kwambiri ku ICU, NICU, OR, ER, etc.
Ndife fakitale yopangira kuphatikiza R&D, kupanga ndi kugulitsa. Osati kokha, mu makampani oximeter, ndife gwero la magwero ambiri. Tapereka ma module a oxygen m'magazi kwa opanga oximeter odziwika bwino.
(Tafunsira ma patent angapo opanga zinthu zambiri komanso mawonekedwe azinthu zokhudzana ndi ma aligorivimu apulogalamu.)
Kuphatikiza apo, tili ndi dongosolo lathunthu la ISO: 13485, ndipo titha kuthandiza makasitomala polembetsa zinthu zogwirizana.
2. Kodi mulingo wa okosijeni m'magazi anu ndi wolondola?
Zowonadi, kulondola ndiko chofunikira kwambiri chomwe tiyenera kukwaniritsa kuti tipeze ziphaso zachipatala. Sitimangokwaniritsa zofunikira zokha, koma timaganiziranso zolondola pazochitika zambiri zapadera. Mwachitsanzo, kusokoneza zoyenda, kufooka kozungulira kuzungulira, zala za makulidwe osiyanasiyana, zala zamitundu yosiyanasiyana yakhungu, etc.
Kutsimikizira kwathu kolondola kuli ndi ma seti opitilira 200 ofananira omwe ali pakati pa 70% mpaka 100%, omwe amafananizidwa ndi zotsatira zakuwunika kwa mpweya wamagazi amagazi amunthu.
Kutsimikizika kolondola muzochita zolimbitsa thupi ndikugwiritsa ntchito zida zolimbitsa thupi kuti muzichita masewera olimbitsa thupi pafupipafupi komanso matalikidwe a kugunda, kukangana, kusuntha mwachisawawa, ndi zina zambiri, ndikuyerekeza zotsatira za mayeso a oximeter muzochita zolimbitsa thupi ndi zotsatira za mpweya wamagazi. kusanthula kwa magazi kutsimikizira magazi, zingakhale zothandiza kwa odwala ena monga odwala matenda a Parkinson kuyeza ntchito. Mayesero oletsa masewera olimbitsa thupi otere amangochitika ndi makampani atatu aku America omwe ali mumsika, masimu, nellcor, Philips, ndi banja lathu lokha lomwe latsimikizira izi ndi ma oximeter a chala.
3. N’chifukwa chiyani okosijeni wa m’magazi amasinthasintha m’mwamba ndi pansi?
Malingana ngati mpweya wa magazi umasinthasintha pakati pa 96% ndi 100%, umakhala mkati mwanthawi zonse. Nthawi zambiri, mtengo wa okosijeni wamagazi umakhala wokhazikika ngakhale pakupuma mutakhala chete. Kusinthasintha kwa mtengo umodzi kapena ziwiri pagulu laling'ono ndizabwinobwino.
Komabe, ngati dzanja la munthu liri ndi kusuntha kapena zosokoneza zina ndi kusintha kwa kupuma, zingayambitse kusinthasintha kwakukulu kwa okosijeni wa magazi. Chifukwa chake, timalimbikitsa kuti ogwiritsa ntchito azikhala chete poyesa mpweya wamagazi.
4. 4S kutulutsa mwachangu mtengo, ndi mtengo weniweni?
Palibe zoikamo monga "mtengo wopangidwa" ndi "mtengo wokhazikika" mu algorithm yathu ya okosijeni wamagazi. Miyezo yonse yowonetsedwa imatengera kusonkhanitsa ndi kusanthula kwazithunzi. Kutulutsa kwachangu kwa 4S kumatengera kuzindikira mwachangu komanso kukonza ma siginecha ogwidwa mkati mwa 4S. Izi zimafuna kusonkhanitsa deta zambiri zachipatala ndi kusanthula kwa algorithm kuti tipeze chizindikiritso cholondola.
Komabe, chifukwa chofulumira kutulutsa kwamtengo wa 4S ndikuti wogwiritsa ntchito akadali. Ngati pali kusuntha foni ikayatsidwa, ma aligorivimu amatsimikizira kudalirika kwa deta kutengera mawonekedwe osonkhanitsidwa ndikuwonjezera nthawi yoyezera.
5. Kodi amathandiza OEM ndi mwamakonda?
Titha kuthandiza OEM ndi makonda.
Komabe, popeza kusindikiza kwazithunzi za logo kumafuna chophimba chosindikizira chosiyana ndi zinthu zosiyana ndi kasamalidwe ka bom, izi zipangitsa kuti mtengo wathu ukhale wokwera mtengo komanso mtengo wa kasamalidwe, kotero tidzakhala ndi dongosolo locheperako lofunikira. MOQ: 1K.
Ma logo omwe titha kupereka amatha kuwoneka pamapaketi azinthu, zolemba, ndi ma lens logo.
6. Kodi ndizotheka kutumiza kunja?
Pakali pano tili ndi mitundu yachingerezi yamapaketi, zolemba zamabuku ndi zolumikizirana ndi zinthu. Ndipo yapeza ziphaso zachipatala kuchokera ku European Union CE (MDR) ndi FDA, zomwe zitha kuthandizira kugulitsa padziko lonse lapansi.
Nthawi yomweyo tili ndi satifiketi yaulere ya FSC (China ndi EU)
Komabe, kumayiko ena apadera, ndikofunikira kumvetsetsa zofunikira zofikira kwanuko, ndipo mayiko ena amafunikiranso chilolezo chosiyana.
Kodi mukutumiza kudziko liti? Ndiroleni nditsimikize ndi kampani ngati dzikolo lili ndi malamulo apadera.
7. Kodi ndizotheka kuthandizira kulembetsa m'dziko la XX?
Mayiko ena amafunikira kulembetsa kowonjezera kwa othandizira. Ngati wothandizira akufuna kulembetsa malonda athu mdzikolo, mutha kufunsa wothandizira kuti atsimikizire zomwe akufuna kuchokera kwa ife. Titha kuthandizira kupereka zidziwitso zotsatirazi:
510K chilolezo chovomerezeka
CE (MDR) chilolezo chovomerezeka
Chitsimikizo cha ISO 13485
Zambiri zamalonda
Malinga ndi momwe zinthu zilili, zinthu zotsatirazi zitha kuperekedwa mwachisawawa (ziyenera kuvomerezedwa ndi woyang'anira malonda):
Lipoti la General Safety Inspection for Medical Devices
Lipoti la mayeso ofananira a Electromagnetic
Lipoti la mayeso a Biocompatibility
Lipoti lachipatala la mankhwala
8. Kodi muli ndi chiphaso choyenerera kuchipatala?
Tachita kulembetsa ndi kutsimikizira zida zachipatala zapakhomo, satifiketi ya FDA ya 510K, satifiketi ya CE (MDR), ndi chiphaso cha ISO13485.
Pakati pawo, tidalandira satifiketi ya CE (CE0123) kuchokera ku TUV Süd (SUD), ndipo idatsimikiziridwa motsatira malamulo atsopano a MDR. Panopa, ndife woyamba zoweta Mlengi chala kopanira oximeter.
Ponena za dongosolo la kupanga, tili ndi satifiketi ya ISO13485 ndi chilolezo chopanga zapakhomo.
Kuphatikiza apo tili ndi Satifiketi Yogulitsa Kwaulere (FSC)
9. Kodi ndizotheka kukhala wothandizira yekha m'derali?
Mabungwe apadera atha kuthandizidwa, koma tikuyenera kukupatsirani ufulu wokhawokha mutapempha chivomerezo ku kampaniyo potengera momwe kampani yanu ikugwirira ntchito komanso kuchuluka kwa malonda omwe mukuyembekezeka.
Kawirikawiri ndi dziko linalake kumene akuluakulu ena ali ndi chikoka chachikulu m'deralo ndi kugawana nawo msika, ndipo ali okonzeka kulimbikitsa malonda athu, kuti athe kugwirizana.
10. Kodi mankhwala anu atsopano? Yagulitsidwa nthawi yayitali bwanji?
Zogulitsa zathu ndi zatsopano ndipo zakhala zikugulitsidwa kwa miyezi ingapo. Amapangidwa mwapadera ndikuyikidwa ngati zinthu zapamwamba kwambiri. Pakali pano tili ndi makasitomala ochepa ogulitsa OEM. Chifukwa cha satifiketi yolembetsa, sinalowe m'misika ya FDA ndi CE. Igulitsidwa ku North America ndi European Union mutalandira satifiketi yolembetsa mu Novembala.
11. Kodi zinthu zanu zagulitsidwa kale? Ndemanga yake ndi chiyani?
Ngakhale kuti zinthu zathu ndi zatsopano, makumi masauzande a iwo atumizidwa mpaka pano, ndipo khalidwe la mankhwala ndi lokhazikika. Takhala tikupanga oximeter kwa zaka zopitilira khumi, ndipo tikudziwa zovuta zilizonse zamakasitomala. Tapanga kulephera kwamayendedwe (DFMEA/PFMEA) pachilema chilichonse, kuyambira kapangidwe kazinthu ndi chitukuko, kupanga, kuwongolera zamtundu wazinthu zopangira, kuyang'anira zinthu, kuyika Kuwongolera mtundu wanjira yonse, monga kutumiza, kupewa zoopsa zomwe zingachitike.
Kuphatikiza apo, kapangidwe kathu kazinthu kamakhala ndi mawonekedwe ake, ndizovuta kwambiri, ndipo kuwunika kwamakasitomala ndikokwera kwambiri.
12. Kodi mankhwala anu ndi chitsanzo chachinsinsi? Kodi pali chiopsezo cholakwira?
Uwu ndi mtundu wathu wachinsinsi, ndipo tafunsira ma patent amawonekedwe azinthu zathu ndi ma patent opanga okhudzana ndi ma aligorivimu apulogalamu.
Kampani yathu ili ndi munthu wodzipereka yemwe ali ndi udindo woteteza zinthu zanzeru. Tasanthula mokwanira za ufulu waukadaulo wazogulitsa zathu, ndipo nthawi yomweyo tinapanga masanjidwe achitetezo chofananira chamimisiri yazinthu zathu ndi matekinoloje.
