Umthengisi weCatheter yeNelaton Hydrophilic ephezulu yaseTshayina: I-DAXAN Straight-Tip Range yeCatheterization yeXesha eliNgaphakathi

Ukufakwa kwe-catheter rhoqo ngumgangatho omiselweyo wezonyango kwizigulana ezilawula ukwenzakala komqolo, isinyi esibangelwa yi-neurogenic, kunye nokugcinwa komchamo ixesha elide -- amaxesha amaninzi ngemini, ngokungenammiselo. I-catheter esetyenziswa sisigulana yonke imihla ngumgangatho wemveliso okhethwe liqela elifumana uncedo. I-Chengdu Daxan Innovative Medical Tech Co., Ltd. ibhengeza ukufumaneka kwe-catheter yayo ye-Nelaton straight-tip hydrophilic catheter kwihlabathi liphela kubasasazi, abangenisi, kunye namaqabane e-OEM. Njenge- Umthengisi weCatheter yeNelaton Hydrophilic, I-DAXAN yakha umgca ojikeleze izinto ezintathu ezisisiseko zokufumana: ukusebenza kokungqubana kwe-coating okulinganiselweyo ngeqonga layo lokugquma le-Coatapex™ Hydrolyx™, ulungelelwaniso oluthandathu lobukhulu obuqhelekileyo olugubungela abantwana ukuya kubantu abadala, kunye ne-stack yobhaliso elawulayo equka i-CE MDR 2017/745, iimvume ezimbini ze-FDA 510(k), kunye nobhaliso lwe-NMPA lwaseTshayina.

I-Nelaton Catheter kwi-Intermittent Catheterization: Izicelo zeKlinikhi kunye neMigqaliselo yokuFumana iMpahla yoSasazo

Uyilo lweNelaton straight-tip lolona hlobo lwe-catheter oluboniswa ngokubanzi kwi-catheterization eqhubekayo, lufanelekile kwizigulana ezenzakeleyo emgogodleni, ukungasebenzi kakuhle kwemithambo-luvo okubangela i-neurogenic bladder, kunye neemeko ezingezizo ze-neurological kubandakanya i-benign prostatic hyperplasia kunye nokugcinwa komchamo. Ezi zigulana zi-catheter rhoqo nangokuphindaphindiweyo -- zibeka iimfuno eziqhubekayo zokuqina kwengubo, intuthuzelo yokufakwa, kunye nokuzinza kokusebenza kwe-catheter ukuya kwi-catheter.

Iikhrayitheriya zovavanyo lomthengisi we-catheter ye-Nelaton ene-hydrophilic intermittent catheter ziye zavela ngokufanelekileyo. Uthelekiso lwamaxabiso kwinqanaba leyunithi lunike indawo yophicotho lwenqanaba lenkqubo olulinganisa i-coating coefficient yedatha yokungqubana, ukugubungela ikhathalogu kuwo onke amaqela eminyaka yesigulane kunye neentlobo ze-anatomy, kunye nephakheji yamaxwebhu alawulayo ahambelana neemfuno zokucoca kwimarike ekujoliswe kuyo. Umthengisi ohlangabezana nazo zonke iikhrayitheriya ezintathu kubudlelwane bomenzi omnye ususa umaleko obalulekileyo wobunzima bokuthenga kubasasazi abadibanisa kwiimarike ezininzi.

I-Coatapex™ Hydrolyx™ Hydrophilic Coating: I-COF 0.02 kunye nokuLubricity Kugcinwe ngaphaya kweeyure ezingama-24

I-Coatapex™ Hydrolyx™ hydrophilic coating yenziwe kwiqonga le-polyvinylpyrrolidone (PVP) chemistry. I-coefficient yayo ye-friction ilinganiswa iphantsi njenge-0.02, kunye nozinzo lwe-lubricity oluhlala lukho ngaphaya kweeyure ezingama-24. Kwisigulane esifaka i-catheter izihlandlo ezine ukuya kwezintandathu ngemini, umphezulu ohambelanayo we-friction ephantsi ukusuka ekusetyenzisweni kokuqala kosuku ukuya kokugqibela unciphisa ukuvezwa kwe-mucosal friction eqokelelweyo ye-urethral kwaye ixhasa intuthuzelo ye-catheterization yexesha elide. Itekhnoloji ye-coating ixhaswa yi-DAXAN Patent Nos. ZL201610861058.4, ZL201811203221.3, kunye ne-ZL201810063901.3.

Le fomyula yokugquma ayinayo i-latex yendalo, i-DEHP, i-DNIP, okanye i-BPA. Le phrofayili yezinto ezibonakalayo ihlangabezana neemfuno zokuthintela iziyobisi ezisebenza phantsi kweenkqubo zomthetho ze-EU MDR kunye ne-US FDA kwaye ivula ukusasazwa kwiimarike ngemiqathango ethile ye-allergen kunye ne-plasticizer. Ukudibanisa i-quantified friction coefficient, i-sustained-lubricity specification, kunye nokhuseleko lwezinto eziqinisekisiweyo zenza ubungqina obuphambili bokusebenza obuveliswa luluhlu lweNelaton kuphononongo lweziqinisekiso zabasasazi.

Uluhlu lweDaxan oluQondileyo: Iindlela ezintandathu eziQondisiweyo zokuCwangcisa ukusuka kwiZifo zabantwana ukuya kwiZifo zabantu abadala

Uluhlu lwe-catheter olusebenzisa amanzi e-Nelaton oluvela eChengdu Daxan Innovative Medical Tech Co., Ltd. lufumaneka ngeendlela ezintandathu ezisemgangathweni: I-Pediatric Female kwi-6 ukuya kwi-14FR kunye ne-20 cm, i-Pediatric Male kwi-6 ukuya kwi-14FR kunye ne-30 cm, i-Adult Female kwi-8 ukuya kwi-24FR kunye ne-20 cm, i-Adult Male Nelaton kwi-8 ukuya kwi-24FR kunye ne-40 cm, i-Adult Male Tiemann kwi-6 ukuya kwi-24FR kunye ne-40 cm, kunye ne-Flexible Tip kwi-6 ukuya kwi-24FR kunye ne-40 cm. Uluhlu lobungakanani baseFransi luqala kwi-6FR ukuya kwi-24FR, ubude be-catheter buqala kwi-20 cm ukuya kwi-40 cm.

Ukubakho kweTiemann kunye nokulungiswa kwe-flexible-tip ecaleni komgca oqhelekileyo weNelaton kuthetha ukuba abasasazi banokujongana nezigulana ezinengxaki yokuvaleka kwe-prostate okanye i-urethral stricture efuna i-engile okanye i-adaptive tip -- ngaphakathi kosapho olufanayo lwemveliso kunye nolwalamano lomthengisi. Oku kugqibelela kwesakhiwo kuvumela umsasazi ukuba akhe ikhathalogu epheleleyo ye-catheterization eqhubekayo, ukusuka kubasetyhini abancinci ukuya kumadoda amadala e-Tiemann, ukusuka kumthombo omnye ofanelekileyo.

Ukhuseleko lwezixhobo kunye nobunjineli boYilo: I-TPU engenaLatex, engenaDEHP eneGripper engachukumisiyo kunye ne-Universal Connector

Ii-catheter bodies ziveliswa kwi-thermoplastic polyurethane ye-medical-grade, eqinisekisiweyo ukuba ayinayo i-latex yendalo, i-DEHP/DNIP, kunye ne-BPA. Ngokusekwe kwesi siseko sezinto, iqonga leCoatapex™ Hydrolyx™ lakhiwe malunga neepropati ezintlanu ezisebenzayo: ukusebenza komphezulu ongaphezulu kwe-hydrophilic, ulawulo lokuxinana okuthambisayo, iipropati zokulwa namagciwane (Patent No. ZL202110292008.X)—umphezulu owenzelwe ukunciphisa ukunamathela kwebhaktheriya, i-anti-encrustation—umphezulu owenzelwe ukumelana ne-encrustation, kunye nomsebenzi we-anti-thrombogenic (Patent No. ZL202310512495.5)—umphezulu owenzelwe ukunciphisa amandla e-thrombogenic. Xa zizonke, ezi misebenzi zijongana nemingcipheko enxulumene ne-catheter edlula kakhulu umcimbi wokufakwa, kubandakanya ukwakheka kwe-encrustation okunokonakalisa ukusebenza kwimijikelo ephindaphindwayo ye-catheterization kunye nokusebenzisana komphezulu we-thrombogenic okufanelekileyo kwiimeko zokusetyenziswa ixesha elide.

Isingxobo segripha esongeziweyo sidityaniswe kwiyunithi nganye yecatheter, nto leyo evumela umsebenzisi ukuba abambe i-catheter ngaphandle kokuthinta umngxuma wokufaka kwaye agcine indlela yokucoca ngaphandle kokufuna isixhobo esahlukileyo sesleeve. Incam yecatheter imilo efana nebhulethi ukuze ingene kakuhle kwi-urethra, kwaye imingxunya yokukhupha amanzi ibekwe ukuze kuncitshiswe ukudibana kodonga lwe-urethra ngexesha lokukhupha amanzi.

Isixhumi se-universal funnel sibonelela ngokuhambelana neengxowa zokuqokelela umchamo eziqhelekileyo kunye neeadaptha zendlu yangasese, ezixhasa zombini usetyenziso lweklinikhi kunye nolwekhaya. Ukupakisha ngakunye kusebenzisa isikhwama se-aluminium foil peel esivuleka lula esinestikha esincamathelayo, esivumela ukugcinwa ngokuthe nkqo kwindawo yasekhaya. I-catheter nganye inikezelwa ingenazintsholongwane kwaye yenzelwe ukusetyenziswa kube kanye.

Iimveliso ezingaphantsi kweNelaton ezintathu: Ngaphandle kwengxowa yamanzi, ukulungele ukusetyenziswa, kunye neendidi zengxowa yamanzi zokuguquguquka kwepotifoliyo yoMsasazi

I-DAXAN ibonelela ngeenkqubo ezintathu zemveliso engaphantsi kweNelaton ukuxhasa amanqaku ahlukeneyo exabiso lemarike kunye neemeko zomsebenzisi wokugqibela. I-Hydrophilic Nelaton Straight Catheter engenasipokotho samanzi isebenzisa i-Coatapex™ Hydrolyx™ coating's pre-activation lubricity, isusa icandelo lamanzi elahlukileyo ngelixa igcina iinkcukacha zokusebenza kwe-coating epheleleyo -- ukhetho olungabizi kakhulu kwiimarike apho uvakalelo lwamaxabiso luyinto ephambili ekuqwalaselweni. I-Pre-Lubricated Nelaton Ready-to-Use Catheter ifika i-pre-lubricated kwaye ayifuni manyathelo ongezelelweyo okulungiselela; ifaka ii-eyelets ezishushu ezicoliweyo ukunciphisa umngcipheko wokudibana kwe-mucosal kwaye ifumaneka ngobukhulu ukusuka kwi-8 ukuya kwi-24FR kwizigulane ezibhinqileyo kunye nezingamadoda. I-Disposable Hydrophilic Nelaton Catheter ene-Water Pouch idibanisa i-self-contained water pouch, eyenzelwe ukuhamba okanye iindawo apho amanzi ahambayo angafikeleleki khona.

Zonke ezi zicwangciso zintathu zenziwe phantsi kwenkqubo yolawulo lomgangatho efanayo ye-ISO 13485:2016 kwaye zineqonga elifanayo lokugquma leCoatapex™ Hydrolyx™, elivumela abasasazi ukuba balinganise umnikelo wabo ngokwexabiso kunye nemeko yokusebenzisa ngaphandle kokwazisa umthengisi wesibini.

Iziqinisekiso zoMveliso zeDAXAN ze-ISO 13485:2016, uBhaliso lweMarike, kunye neenkonzo zoLungiso lwe-OEM

KUNENE Isebenza kwindawo yokucoca kunye novavanyo eqinisekisiweyo ye-ISO 13485:2016 engama-6,000 square meter eChengdu, enomthamo wonyaka wokuvelisa i-catheter e-hydrophilic engaphezulu kweeyunithi ezingama-20 ezigidi. Ukusukela oko yasekwa ngo-2016, iChengdu Daxan Innovative Medical Tech Co., Ltd. iqokelele amava angaphezu kweminyaka elithoba ophando oluzinikeleyo kunye nemveliso ye-catheter, kunye neemveliso ezisasazwa kumazwe angaphezu kwama-25. Ukuvelisa kule nqanaba -- kunye neziko lokuvavanya elihlanganisiweyo ngokupheleleyo kumgangatho ofanayo oqinisekisiweyo we-ISO -- kuxhasa ukuhambelana kweqela ukuya kwelinye kunye nokulandeleka kwamaxwebhu okufunwa ngabasasazi bamazwe ngamazwe kuphicotho oluqhubekayo lwababoneleli.

Uluhlu lwe-catheter yeNelaton luphethe i-CE Marking phantsi kwe-EU MDR 2017/745 ngendlela ye-Full Quality Assurance conformity pathway, i-FDA 510(k) clearance K212567 ye-hydrophilic intermittent catheter, kunye ne-FDA 510(k) clearance K243175 yeemveliso ze-catheter ezisekelwe kwi-TPU. Inombolo yoBhaliso lwe-FDA Establishment FEI 3023329815 inokuqinisekiswa ngokuzimeleyo ngedathabheyisi ye-FDA. Ubhaliso lwe-NMPA/CFDA lwaseTshayina lukwabanjwa, kunye neSatifikethi sokuThengisa saMahala esigubungela iimarike ezininzi zokuthumela ngaphandle kunye neSatifikethi seMvelaphi esikhutshwe yi-CCPIT. Xa zizonke, olu bhaliso luvumela abasasazi kwi-EU, e-United States, e-China, nakwiimarike ezongezelelweyo ukuba bacoce amasiko kwaye bangene kwiindlela zokuthenga zasekuhlaleni besebenzisa amaxwebhu anikezelwe ngqo kumenzi.

Iinkonzo zokwenza ngokwezifiso ze-OEM kunye ne-ODM zanda kuluhlu olupheleleyo lwe-FR CH06 ukuya kwi-CH24, ngenkxaso yobude bee-catheter ezininzi, ulungelelwaniso lweentlobo ezine ze-tip-- iNelaton, iTiemann, i-flexible, kunye ne-ball tip-- ukhetho lwezinto ze-PVC okanye ze-TPU, kunye neelebheli zabucala zabasasazi beempawu kunye nabangenisi.

Abasasazi, abangenisi, kunye namaqabane e-OEM afuna iinkcukacha zemveliso, amaxwebhu olawulo, okanye uvavanyo lwesampulu yoluhlu lwe-catheter olusebenzisa amanzi e-DAXAN Nelaton banokungenisa imibuzo ngokuthe ngqo kwiwebhusayithi esemthethweni: https://www.daxanmedical.com/