Kodi EU Medical Device Regulation ili ndi chiyani pa ma mobility scooters?
EU ili ndi malamulo okhwima kwambiri pazida zamankhwala, makamaka pakukhazikitsa lamulo latsopano la Medical Device Regulation (MDR), malamulo okhudza zothandizira kuyenda monga.njinga yamoto yovundikiras nawonso amamveka bwino. Zotsatirazi ndi malamulo akuluakulu a ma scooters oyenda pansi pa EU Medical Device Regulation:
1. Gulu ndi Kutsata
Zipando zapamanja, zikuku zamagetsi ndi ma mobility scooters onse amasankhidwa kukhala zida zachipatala za Gulu Loyamba molingana ndi Annex VIII Malamulo 1 ndi 13 a EU Medical Device Regulation (MDR). Izi zikutanthauza kuti zinthuzi zimatengedwa kuti ndi zinthu zomwe zili pachiwopsezo chochepa ndipo opanga amatha kulengeza kuti zinthu zawo zimagwirizana ndi zowongolera paokha.
2. Zolemba zaukadaulo ndi Chizindikiro cha CE
Opanga akuyenera kukonzekera zolemba zaukadaulo, kuphatikiza kusanthula kwachiwopsezo ndi kulengeza kuti zikugwirizana, kuti atsimikizire kuti zinthu zawo zimakwaniritsa zofunikira za MDR. Akamaliza, opanga amatha kulembetsa chizindikiro cha CE, kulola kuti zinthu zawo zizigulitsidwa pamsika wa EU
3. Miyezo ya ku Ulaya
Ma scooters oyenda ayenera kutsata miyezo ya ku Europe, kuphatikiza koma osalekezera ku:
TS EN 12182: Imatchula zofunikira zonse ndi njira zoyesera za zinthu zothandizira ndi zida zothandizira anthu olumala
TS EN 12183: Imatchula zofunikira zonse ndi njira zoyesera zama wheelchair
TS EN 12184: Imatchula zofunikira zonse ndi njira zoyesera zama wheelchair zamagetsi kapena zoyendetsedwa ndi batire, ma scooters oyenda ndi ma charger
TS EN ISO 7176 mndandanda: Imafotokozera njira zosiyanasiyana zoyesera zama wheelchair ndi ma scooters oyenda, kuphatikiza zofunikira ndi njira zoyesera za miyeso, misa ndi malo oyambira oyendetsa, kuthamanga kwambiri, ndi mathamangitsidwe ndi kutsika.
4. Kuyesa ntchito ndi chitetezo
Ma scooters oyenda amayenera kuyesa mayeso angapo okhudzana ndi chitetezo, kuphatikiza kuyesa kwamakina ndi kulimba, chitetezo chamagetsi ndi mayeso a electromagnetic compatibility (EMC), ndi zina zambiri.
5. Kuyang'anira ndi kuyang'anira msika
Lamulo latsopano la MDR likulimbikitsa kuyang'anira msika ndi kuyang'anira zida zamankhwala, kuphatikiza kukulitsa kuwunika kogwirizana kwa kafukufuku wamankhwala odutsa malire, kulimbikitsa zofunikira pakuwongolera msika kwa opanga, komanso kukonza njira zolumikizirana pakati pa mayiko a EU.
6. Chitetezo cha odwala komanso kuwonekera kwa chidziwitso
Lamulo la MDR likugogomezera chitetezo cha odwala komanso kuwonekera kwa chidziwitso, chomwe chimafuna njira yapadera yozindikiritsa zida (UDI) ndi database ya zida zachipatala za EU (EUDAMED) kuti zithandizire kutsata kwazinthu.
7. Umboni wachipatala ndi kuyang'anira msika
Lamulo la MDR limalimbikitsanso malamulo a umboni wachipatala, kuphatikizapo njira yololeza kufufuza zachipatala pakati pa mayiko ambiri a EU, ndikulimbikitsanso kuyang'anira msika.
Mwachidule, malamulo a zida zachipatala ku EU okhudza ma mobility scooters amakhudza kagawidwe kazinthu, zidziwitso zakutsatiridwa, miyezo yaku Europe yomwe iyenera kutsatiridwa, kuyezetsa magwiridwe antchito ndi chitetezo, kuyang'anira ndi kuyang'anira msika, chitetezo cha odwala ndi kuwonekera kwa chidziwitso, umboni wazachipatala ndi kuyang'anira msika. Malamulowa amapangidwa kuti awonetsetse chitetezo ndi magwiridwe antchito a zida zothandizira kuyenda monga ma scooters oyenda ndikuteteza thanzi ndi ufulu wa ogula.
Ndi mayeso otani ndi chitetezo chomwe chimafunikira pa ma mobility scooters?
Monga chida chothandizira kuyenda, kuyezetsa magwiridwe antchito ndi chitetezo cha ma scooters oyenda ndikofunikira kuti zitsimikizire chitetezo cha ogwiritsa ntchito komanso kutsata kwazinthu. Malinga ndi zotsatira zakusaka, zotsatirazi ndizoyezetsa zazikulu zamachitidwe ndi chitetezo zomwe ma scooters amafunikira kuchita:
Kuthamanga kwakukulu koyesa:
Kuthamanga kwakukulu kwa scooter yoyendayenda sikuyenera kupitirira 15 km / h. Mayesowa amawonetsetsa kuti scooter yoyenda ikugwira ntchito pa liwiro lotetezeka kuti muchepetse ngozi.
Kuyesa kwa Braking performance:
Imaphatikizanso ma braking misewu yopingasa komanso mayeso otetezeka kwambiri otsetsereka kuti awonetsetse kuti scooter imatha kuyimitsa bwino m'misewu yosiyanasiyana.
Kugwira phiri ndi kuyesa kukhazikika kwa static:
Imayesa kukhazikika kwa scooter pamalo otsetsereka kuti iwonetsetse kuti siyikuyenda itayimitsidwa pamalo otsetsereka.
Mayeso okhazikika amphamvu:
Imawunika kukhazikika kwa scooter pakuyendetsa, makamaka potembenuka kapena kukumana ndi misewu yosagwirizana
Mayeso opinga ndi kuwoloka ngalande:
Imayesa kutalika ndi m'lifupi mwa zopinga zomwe njinga yamoto yovundikira imatha kuwoloka kuti iwone ngati ikudutsa
Mayeso okwera kalasi:
Imawunika kuthekera koyendetsa kwa scooter pamalo otsetsereka
Mayeso ochepera otembenuka:
Imayesa kuthekera kwa scooter kuti itembenuke pamalo aang'ono kwambiri, omwe ndi ofunikira kwambiri pogwira ntchito pamalo opapatiza.
Theoretical driving distance test:
Imawunika mtunda womwe njinga yamoto yovundikira ingayende ikangolipiritsa kamodzi, zomwe ndizofunikira kwambiri pama scooter amagetsi.
Kuyesa kwamphamvu ndi dongosolo:
Zimaphatikizapo kuyesa kwa switch switch, kuyesa kwa charger, kuyesa kuponderezana pakuyendetsa, kuyesa mphamvu pa Control chizindikiro, kuyesa chitetezo chamoto, ndi zina zotere kuti zitsimikizire chitetezo ndi kudalirika kwamagetsi amagetsi.
Mayeso a chitetezo cha dera:
Yesani ngati mawaya onse ndi zolumikizira za scooter zitha kutetezedwa bwino kuti zisapitirire
Kuyesa kugwiritsa ntchito mphamvu:
Onetsetsani kuti kugwiritsa ntchito mphamvu kwa njinga yamoto yovundikira sikudutsa 15% ya zomwe wopanga akuwonetsa.
Kuyeza kulimba kwa mabuleki a Parking:
Yesani mphamvu ndi kukhazikika kwa brake yoyimitsa magalimoto mukamagwiritsa ntchito nthawi yayitali
Kuyesa kwapampando (kumbuyo) kotsalira kwamoto:
Onetsetsani kuti mpando (kumbuyo) wokwera wa scooter sutulutsa utsi pang'onopang'ono komanso kuyaka moto panthawi ya mayeso.
Kuyesa kofunikira mphamvu:
Zimaphatikizapo kuyesa kwamphamvu kwa static, kuyesa mphamvu yamphamvu ndi kuyesa mphamvu ya kutopa kuti zitsimikizire mphamvu zamapangidwe komanso kulimba kwa scooter yoyenda.
Mayeso anyengo:
Pambuyo poyerekezera mvula, kutentha kwambiri komanso kutsika kwa kutentha, onetsetsani kuti njinga yamoto yovundikira imatha kugwira ntchito moyenera ndikukwaniritsa miyezo yoyenera.
Zinthu zoyesererazi zimakhudza magwiridwe antchito, chitetezo ndi kulimba kwa scooter, ndipo ndi njira zofunika kuwonetsetsa kuti scooter yoyenda ikugwirizana ndi malamulo a EU MDR ndi miyezo ina yoyenera. Kupyolera mu mayeserowa, opanga amatha kuonetsetsa kuti katundu wawo akukwaniritsa zofunikira zonse za chitetezo ndi ntchito zisanayambe kugulitsidwa.
Nthawi yotumiza: Jan-03-2025