FRO-200 Pulse Oximeter tare da Yawan Numfashi
Bidiyon Samfura
Siffofin Samfur
FRO-200 CE FCC RR Spo2 Pediatric Pulse Oximeter
Narigmed's FRO-200 Pulse Oximeter yana ba da ingantaccen ingantaccen kulawar lafiya a cikin yanayi da muhalli daban-daban, yana ba da cikakkiyar kulawa ga masu amfani da kowane zamani.
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- Maɗaukakin Maɗaukaki:
- Daidaitaccen ma'aunin SpO2 tare da ± 2%.
- Daidaitaccen ƙimar bugun bugun jini na ± 2bpm.
- Ayyukan Anti-Motion:
- Dogaran karatu ko da a karkashin motsi.
- Mafi dacewa ga mutanen da ke da rawar jiki ko cutar Parkinson.
- Daidaitaccen ma'aunin SpO2 tare da ± 3% da daidaiton ƙimar bugun jini na ± 4bpm yayin motsi.
- Cikakken Silicone Rufe Finger Pads:
- Yana tabbatar da ta'aziyya da amfani mara matsi.
- Ya dace da tsawaita sa ido.
- Ma'aunin Yawan Numfashi:
- Yana ba da damar duba lafiyar huhu na dogon lokaci.
- Akwai a cikin nau'ikan CE MDR da NMPA.
- Fitowar Ma'auni Mai Sauri:
- Yana ba da fitarwa cikin sauri cikin daƙiƙa 4.
- Nuna Juyawar allo:
- Yana haɓaka amfani ta hanyar kyale sauƙin dubawa daga kusurwoyi daban-daban.
- Mataimakin Lafiya (Rahoton Matsayin Lafiya):
- Yana da aikin gaggawar nazarin lafiya.
- Faɗakar da masu amfani idan ana zargin hypoxia ko hauhawar zuciya.
- Ya dace da Ƙungiyoyi daban-daban:
- An tsara shi don tallafawa mutane masu launin fata masu duhu.
- Ana iya amfani dashi tare da manya, yara, da tsofaffi.
- Kulawa na Tsawon Lokaci:
- Yana goyan bayan sa'o'i 30 na ci gaba da sa ido.
- Maɗaukakin Maɗaukaki:
Amfanin Samfur
Yana Amfani da Narigmed's Dynamic OxySignal Capture Technology
FRO-200 Pulse Oximeter yana ba da aiki na musamman a cikin ƙananan yanayin perfusion, yana tabbatar da ingantacciyar iskar oxygen na jini (SpO2 ± 2%) da ma'aunin bugun jini (PR ± 2bpm) koda lokacin kwararar jini kadan ne. Wannan ya sa ya zama manufa ga marasa lafiya tare da ƙananan wurare dabam dabam, samar da ingantaccen karatu lokacin da ake buƙata mafi yawa. Tare da saurin amsa lokacin amsawa da haɓakar hankali, FRO-200 Pulse Oximeter yana tabbatar da daidaitaccen sa ido a cikin yanayi masu wahala.
Algorithm na Narigmed na Musamman na Anti-Motion
Oximeters ɗinmu suna da kyau a cikin aikin anti-motsi, kiyaye ƙimar bugun jini da daidaiton ƙimar oxygen na jini tsakanin ± 4bpm da ± 3% har ma yayin ci gaba da girgiza yatsa ko girgiza tazara. Ko kuna cikin jama'a masu lafiya ko marasa lafiya na Parkinson, zaku iya tabbatar da ingantaccen ingantaccen karatu. Amintaccen ƙira da fasaha mai ci gaba na na'urar sun sa ya dace sosai don samun ingantaccen kuma ingantaccen sakamakon gwaji na matakan likita a cikin motsi.
Ci gaba, Amintaccen Kulawa, Kyakkyawar Abokin Hulɗa don Oxygenerator da Ventilators
FRO-200 Pulse Oximeter yana fasalta babban azanci don ɗaukar abubuwan da ke lalata iskar oxygen kuma yana goyan bayan sa ido na tsawon lokaci na dare. Ana iya amfani da shi yayin caji, yana mai da shi manufa don ci gaba da bin diddigin lafiya yayin barci da kuma tabbatar da cikakkiyar kulawa ga marasa lafiya.
Ma'auni Mai Sauri A Cikin Daƙiƙa 4 Yafi Sauri fiye da masu fafatawa
Algorithm na jurewar motsi mai haƙƙin haƙƙin haɗe tare da ingantaccen siginar jiki, yana nuna sakamako a cikin daƙiƙa 4.
Yana ba da babban ƙirar nunin rubutu don kallo mai sauƙi
Don kalar fata iri-iri
Mutane da yawa za su iya amfani da shi don duba bayanan ilimin lissafi, kuma ya fi abokantaka ga masu duhu fata.
Ayyukanmu
Dangane da bukatun abokin ciniki, zaku iya siffanta akwatin launi LOGO, zaɓi tushe na caji, tsara nau'in bincike, da tsara daidaitattun daidaita caji.
1.Are ku factory?
Mu ne tushen masana'anta na bugun bugun jini oximeter. Muna da namu takardar shaidar rajistar samfuran likitanci, takaddun tsarin samar da ingancin, takardar shaidar ƙirƙira, da sauransu.
Muna da fiye da shekaru goma na tarin fasaha da na asibiti na masu sa ido na ICU. Ana amfani da samfuranmu sosai a cikin ICU, NICU, OR, ER, da sauransu.
Mu ne tushen masana'anta hade R & D, samarwa da tallace-tallace. Ba wai kawai ba, a cikin masana'antar oximeter, mu ne tushen tushe da yawa. Mun ba da samfuran oxygen na jini ga sanannun masana'antun alamar oximeter.
(Mun yi amfani da kayan kwalliyar kirkirar da yawa da samfurin bayyanar da suka danganta ga algorithms na software.)
Bugu da kari, muna da cikakken ISO: 13485 tsarin gudanarwa, kuma za mu iya taimaka wa abokan ciniki da alaka da samfurin rajista.
2. Shin matakin iskar oxygen na jinin ku daidai ne?
Tabbas, daidaito shine ainihin abin da ake buƙata wanda dole ne mu cika don takaddun shaida na likita. Ba kawai muna biyan buƙatun asali ba, har ma muna la'akari da daidaito a cikin al'amuran musamman da yawa. Misali, tsangwama na motsi, raunin wurare dabam dabam, yatsu masu kauri daban-daban, yatsun launin fata daban-daban, da sauransu.
Tabbatar da daidaitonmu yana da fiye da saiti 200 na bayanan kwatancen da ke rufe kewayon 70% zuwa 100%, waɗanda aka kwatanta da sakamakon binciken gas na jini na jinin jijiya na ɗan adam.
Tabbatar da daidaito a cikin yanayin motsa jiki shine yin amfani da kayan aikin motsa jiki don motsa jiki tare da takamaiman mita da girman tapping, gogayya, motsi bazuwar, da dai sauransu, da kwatanta sakamakon gwajin oximeter a cikin yanayin motsa jiki tare da sakamakon iskar gas ɗin jini. Analysis for arterial blood Validation, zai zama taimako ga wasu marasa lafiya kamar masu fama da cutar Parkinson don auna amfani. Irin wannan gwajin gwagwarmayar motsa jiki a halin yanzu kamfanoni uku na Amurka ne kawai ke yin su a masana'antar, masimo, nellcor, Philips, kuma danginmu ne kawai suka yi wannan tabbacin tare da oximeters na yatsa.
3. Me yasa iskar oxygen na jini ke jujjuyawa sama da ƙasa?
Muddin iskar oxygen na jini yana canzawa tsakanin 96% zuwa 100%, yana cikin kewayon al'ada. Gabaɗaya, ƙimar iskar oxygen ta jini za ta kasance mai ɗanɗano karko a ƙarƙashin ko da numfashi a cikin yanayin shiru. Canje-canje na ƙima ɗaya ko biyu a cikin ƙaramin kewayon al'ada ne.
Duk da haka, idan hannun ɗan adam yana da motsi ko wasu damuwa da canje-canje a cikin numfashi, zai haifar da babban hawan jini a cikin jini. Don haka, muna ba da shawarar cewa masu amfani su yi shuru lokacin auna iskar oxygen na jini.
4. 4S ƙimar fitarwa mai sauri, ƙimar gaske ce?
Babu saituna kamar "ƙimar ƙirƙira" da "ƙimar ƙayyadaddun ƙima" a cikin algorithm na oxygen na jini. Duk ƙimar da aka nuna sun dogara ne akan tarin samfurin jiki da bincike. 4S saurin fitowar ƙimar yana dogara ne akan saurin ganewa da sarrafa siginar bugun jini da aka kama cikin 4S. Wannan yana buƙatar tarin bayanan asibiti da yawa da bincike na algorithm don cimma daidaitaccen ganewa.
Koyaya, jigo don saurin fitarwa ƙimar 4S shine cewa mai amfani yana nan. Idan akwai motsi lokacin da aka kunna wayar, algorithm ɗin zai ƙayyade amincin bayanan dangane da siffar igiyar igiyar ruwa da aka tattara kuma zaɓin tsawaita lokacin awo.
5. Shin yana goyan bayan OEM da gyare-gyare?
Za mu iya tallafawa OEM da keɓancewa.
Koyaya, tunda buguwar tambarin yana buƙatar allo daban na bugu na allo da keɓantaccen abu da sarrafa bom, wannan zai haifar da haɓaka farashin samfuran mu da farashin gudanarwa, don haka za mu sami mafi ƙarancin buƙatun buƙatu. MOQ: 1K.
Tambura da zamu iya bayarwa na iya bayyana akan marufin samfur, litattafai, da tambarin ruwan tabarau.
6. Shin zai yiwu a fitar dashi?
A halin yanzu muna da nau'ikan marufi, litattafai da mu'amalar samfur na Ingilishi. Kuma ta sami takardar shaidar likita daga Tarayyar Turai CE (MDR) da FDA, waɗanda ke tallafawa tallace-tallace na duniya.
A lokaci guda kuma muna da takardar shaidar siyarwa ta FSC (China da EU)
Koyaya, ga wasu takamaiman ƙasashe, ya zama dole a fahimci buƙatun shiga gida, kuma wasu ƙasashe kuma suna buƙatar izini daban.
Wace kasa kuke fitarwa zuwa? Bari in tabbatar da kamfani ko ƙasar tana da buƙatun ƙa'ida na musamman.
7. Shin yana yiwuwa a goyi bayan rajista a cikin ƙasar XX?
Wasu ƙasashe suna buƙatar ƙarin rajista don wakilai. Idan wakili yana son yin rijistar samfuranmu a wannan ƙasa, zaku iya tambayar wakilin don tabbatar da irin bayanin da suke buƙata daga gare mu. Za mu iya tallafawa samar da bayanai masu zuwa:
510K takardar shaidar izini
CE (MDR) takardar izini
ISO 13485 takardar shaidar cancanta
Bayanin samfur
Dangane da halin da ake ciki, ana iya ba da waɗannan kayan na zaɓi na zaɓi (buƙatar mai sarrafa tallace-tallace ya amince da shi):
Gabaɗaya Rahoton Binciken Tsaro don Na'urorin Lafiya
Rahoton gwajin dacewa da lantarki
Rahoton gwaji na biocompatibility
Rahoton asibiti na samfur
8. Kuna da takardar shaidar cancantar likita?
Mun yi rajistar na'urar likitancin gida da takaddun shaida, takaddun shaida na 510K na FDA, takaddun shaida na CE (MDR), da takaddun shaida na ISO13485.
Daga cikin su, mun sami takardar shedar CE (CE0123) daga TUV Süd (SUD), kuma an tabbatar da ita daidai da sabbin ka'idojin MDR. A halin yanzu, mu ne farkon masana'anta na gida na oximeter clip yatsa.
Game da samar da ingancin tsarin, muna da ISO13485 takardar shaidar da cikin gida samar lasisi.
Bugu da kari muna da Takaddun Siyarwa na Kyauta (FSC)
9. Shin zai yiwu a zama wakili na musamman a yankin?
Ana iya tallafawa keɓantaccen hukuma, amma muna buƙatar samar muku keɓancewar haƙƙin hukuma bayan neman izini ga kamfani dangane da matsayin aikin kamfanin ku da girman tallace-tallacen da ake tsammanin.
Yawancin lokaci wata ƙasa ce inda wasu manyan wakilai ke da babban tasiri na gida da kuma rabon kasuwa, kuma suna shirye su haɓaka samfuranmu, don su iya haɗin gwiwa.
10. Shin samfuranku sababbi ne? Har yaushe aka sayar?
Kayayyakin mu sababbi ne kuma sun kasance a kasuwa na 'yan watanni. An ƙera su na musamman kuma an sanya su azaman samfura masu daraja. A halin yanzu muna da ƙananan abokan ciniki don tallace-tallace na OEM. Saboda takardar shaidar rajista, ba a hukumance ta shiga kasuwannin FDA da CE ba. Za a sayar da shi a Arewacin Amurka da Tarayyar Turai bayan samun takardar shaidar rajista a watan Nuwamba.
11. An sayar da kayayyakin ku a baya? Menene bita?
Ko da yake samfuranmu sabbin kayayyaki ne, an aika dubun-dubatar su zuwa yanzu, kuma ingancin samfurin ya tabbata. Mun kasance muna yin oximeter fiye da shekaru goma, kuma muna sane da duk wata matsala ta abokin ciniki. Mun yi nazarin yanayin gazawa (DFMEA/PFMEA) ga kowane lahani, daga ƙirar samfuri da haɓakawa, samarwa, sarrafa ingancin kayan albarkatun ƙasa, duba samfuran, marufi Sarrafa ingancin gabaɗayan tsari, kamar bayarwa, don guje wa haɗarin haɗari.
Bugu da ƙari, ƙirar samfurin mu yana da halaye na kansa, yana da matukar damuwa, kuma ƙimar abokin ciniki yana da girma sosai.
12. Shin samfurin ku samfurin sirri ne? Akwai wani hadarin ƙeta?
Wannan samfurin mu na sirri ne, kuma mun nemi samfuran bayyanar samfuran mu da haƙƙin ƙirƙira masu alaƙa da algorithms na software.
Kamfaninmu yana da mutum mai sadaukarwa wanda ke da alhakin kare samfuran kayan fasaha. Mun yi cikakken bincike game da haƙƙin mallakar fasaha don samfuranmu, kuma a lokaci guda mun yi shimfidar wuri don daidaitaccen kariyar kayan fasaha na samfuranmu da fasaharmu.
