Inani i-EU Medical Device Regulation yama-mobility Scooters?

Inani i-EU Medical Device Regulation yama-mobility Scooters?
I-EU inomthethonqubo oqinile wemishini yezokwelapha, ikakhulukazi ngokusetshenziswa kwe-Medical Device Regulation (MDR), imithethonqubo yezinsiza zokuhamba ezifanaisikuta sokuhambas nazo zicacile. Okulandelayo yimithethonqubo eyinhloko yama-mobility scooters ngaphansi kwe-EU Medical Device Regulation:

1. Ukuhlukaniswa kanye Nokuhambisana
Izihlalo zabakhubazekile ezenziwa mathupha, izihlalo zabakhubazekile zikagesi kanye nezikuta zonke zihlukaniswa njengemishini yezokwelapha Yekilasi I ngokwe-Annex VIII Imithetho 1 kanye no-13 ye-EU Medical Device Regulation (MDR). Lokhu kusho ukuthi le mikhiqizo ithathwa njengemikhiqizo enobungozi obuncane futhi abakhiqizi bangasho ukuthi imikhiqizo yabo ihambisana nezidingo zokulawula ngokwabo.

2. Imibhalo Yezobuchwepheshe kanye Nokumakwa kwe-CE
Abakhiqizi kufanele balungiselele imibhalo yezobuchwepheshe, okuhlanganisa ukuhlaziywa kwengozi kanye nesimemezelo sokuvumelana, ukuze bafakazele ukuthi imikhiqizo yabo ihlangabezana nezidingo ezibalulekile ze-MDR. Uma sekuqediwe, abakhiqizi bangafaka isicelo sophawu lwe-CE, bavumele imikhiqizo yabo ukuthi ithengiswe emakethe ye-EU

3. Izindinganiso zaseYurophu
Ama-Mobility Scooters kufanele ahambisane namazinga athile aseYurophu, okuhlanganisa kodwa angagcini nje:

I-TS EN 12182: Icacisa izidingo ezijwayelekile nezindlela zokuhlola zemikhiqizo eyisizayo nezinsiza zobuchwepheshe zabantu abakhubazekile

I-TS EN 12183: Icacisa izidingo ezijwayelekile kanye nezindlela zokuhlola zezihlalo zabakhubazekile ezenziwa ngesandla

I-TS EN 12184: Icacisa izidingo ezijwayelekile nezindlela zokuhlola zezihlalo ezinamasondo zikagesi noma ezisebenza ngebhethri, izikuta ezihambayo, namashaja ebhethri

Uchungechunge lwe-ISO 7176: Ichaza izindlela ezahlukahlukene zokuhlola izihlalo ezinamasondo nezithuthuthu zokuhamba, okubandakanya izidingo nezindlela zokuhlola zobukhulu, indawo enkulu yokuqondisa, isivinini esikhulu, ukusheshisa nokwehla.

4. Ukuhlolwa kokusebenza nokuphepha
Ama-Mobility Scooters kumele aphumelele uchungechunge lokuhlolwa kokusebenza nokuphepha, okuhlanganisa izivivinyo zemishini nokuqina, ukuphepha kukagesi kanye nezivivinyo zokuhambisana kwe-electromagnetic (EMC), njll.

5. Ukugadwa kanye nokwengamela kwemakethe
Umthetho omusha we-MDR uqinisa ukugadwa kwemakethe kanye nokwengamela kwemishini yezokwelapha, okuhlanganisa nokwenyusa ukuhlolwa okudidiyelwe kophenyo lomtholampilo oluwela umngcele, ukuqinisa izidingo zokulawulwa kwemakethe yangemuva kwabakhiqizi, kanye nokwenza ngcono izindlela zokuxhumanisa phakathi kwamazwe e-EU.

6. Ukuphepha kwesiguli nolwazi obala
Umthetho we-MDR ugcizelela ukuphepha kwesiguli nolwazi olusobala, oludinga isistimu yokuhlonza idivayisi (i-UDI) eyingqayizivele kanye nesizindalwazi sedatha yemishini yezokwelapha ye-EU (EUDAMED) ukuze kuthuthukiswe ukulandeleka komkhiqizo.

7. Ubufakazi bomtholampilo kanye nokuqondisa izimakethe
Umthetho we-MDR uphinde uqinise imithetho yobufakazi bomtholampilo, okuhlanganisa nenqubo yokugunyazwa kophenyo lomtholampilo oluhlanganisa izikhungo eziningi edidiyelwe kuyo yonke i-EU, futhi uqinisa izimfuneko zokuqondisa izimakethe.

Kafushane, imithetho yedivayisi yezokwelapha ye-EU yezithuthuthu ezihambayo ihilela ukuhlukaniswa komkhiqizo, izimemezelo zokuthobela imithetho, izindinganiso zase-Europe okufanele zilandelwe, ukuhlolwa kokusebenza nokuphepha, ukugadwa nokugadwa kwemakethe, ukuphepha kwesiguli nolwazi obala, nobufakazi bomtholampilo nokugadwa kwemakethe. Le mithethonqubo ihloselwe ukuqinisekisa ukuphepha nokusebenza kahle kwezisetshenziswa zokusiza ezihambayo njengezithuthuthu nokuvikela impilo namalungelo abathengi.

Yiziphi izivivinyo zokusebenza nokuphepha ezidingekayo kuma-mobility Scooters?

Njengensiza yedivayisi yokuhamba, ukuhlolwa kokusebenza nokuphepha kwama-mobility scooters kubalulekile ukuze kuqinisekiswe ukuphepha komsebenzisi nokuthobela umkhiqizo. Ngokwemiphumela yosesho, okulandelayo ukuhlolwa okuyinhloko kokusebenza nokuphepha okudingeka kwenziwe ama-mobility Scooters:

Ukuhlolwa kwesivinini esiphezulu sokushayela:

Isivinini esikhulu sokushayela sesikuta akufanele sidlule ku-15 km/h. Lokhu kuhlola kuqinisekisa ukuthi isikuta sokuhamba sisebenza ngesivinini esiphephile ukwehlisa ubungozi bezingozi.
Ukuhlolwa kokusebenza kwe-Braking:
Kufaka phakathi ukubhuleka emgwaqeni ovundlile kanye nokuhlolwa kwebhuleki kwe-slope okuphephile ukuze kuqinisekiswe ukuthi isikuta singama ngempumelelo ngaphansi kwezimo ezahlukene zomgwaqo.

Ukusebenza kwe-Hill-hold nokuhlolwa kokuzinza okumile:
Ihlola ukuqina kwesikuta ukuze kuqinisekiswe ukuthi asisheleli lapho sipakwe endaweni eyehlelayo.

Ukuhlolwa kokuzinza kwe-Dynamic:
Ihlola ukuqina kwesithuthuthu ngesikhathi sokushayela, ikakhulukazi lapho ujika noma uhlangabezana nemigwaqo engalingani

Ukuhlolwa kwezithiyo nokuwela umsele:
Ihlola ubude nobubanzi bezithiyo isikuta esingawela kuzo ukuze sihlole ukudlula kwaso

Ukuhlolwa kwekhono lokukhuphuka ibanga:
Ihlola ikhono lokushayela lesithuthuthu emthambekeni othile

Ukuhlolwa kwerediyasi encane yokujika:
Ihlola ikhono lesikuta ukujika endaweni encane, okubaluleke kakhulu ekusebenzeni endaweni ewumngcingo.

Ukuhlolwa kwebanga lokushayela okucatshangelwayo:
Ihlola ibanga elingahamba isikuta ngemva kokushajwa okukodwa, okubaluleke kakhulu ezikuta zikagesi

Ukuhlolwa kwesistimu yamandla nokulawula:
Kubandakanya ukuhlolwa kokulawula ukushintsha, ukuhlolwa kweshaja, ukuhlolwa kokucindezela ukushayela ngesikhathi sokushaja, amandla okuhlola isignali yokulawula, ukuhlolwa kokuvikela indawo yokudayisa, njll. ukuze kuqinisekiswe ukuphepha nokwethembeka kwesistimu kagesi

Ukuhlolwa kokuvikela isiyingi:
Hlola ukuthi ingabe zonke izintambo nezixhumi zesikuta zingavikelwa ngokufanelekile ekudluleleni ngokweqile

Ukuhlolwa kokusetshenziswa kwamandla:
Qinisekisa ukuthi ukusetshenziswa kwamandla kwesikuta akudluli u-15% wezinkomba ezishiwo ngumkhiqizi.

Ukuhlolwa kwamandla ebhuleki lokupaka:
Hlola ukusebenza kahle nokusimama kwebhuleki yokupaka ngemva kokusetshenziswa isikhathi eside

Isihlalo (emuva) sokuhlolwa kokubuyiswa komlilo komcamelo:
Qinisekisa ukuthi isihlalo (emuva) umcamelo we-mobility scooter awukhiqizi ukushunqa okuqhubekayo kanye nokuvutha kwelangabi ngesikhathi sokuhlolwa.

Ukuhlolwa kwesidingo samandla:
Kubandakanya ukuhlolwa kwamandla amile, ukuhlolwa kwamandla okuthinta kanye nokuhlolwa kwamandla okukhathala ukuze kuqinisekiswe amandla esakhiwo nokuqina kwesithuthuthu sokuhamba

Ukuhlolwa kwezidingo zesimo sezulu:
Ngemva kokulingisa imvula, izinga lokushisa eliphezulu nokuhlolwa kwezinga lokushisa eliphansi, qinisekisa ukuthi isikuta sokunyakaza singasebenza ngokujwayelekile futhi sihlangabezane nezindinganiso ezifanele.

Lezi zinto zokuhlola zihlanganisa ukusebenza, ukuphepha nokuqina kwesikuta, futhi ziyizinyathelo ezibalulekile zokuqinisekisa ukuthi isikuta sithobela imithetho ye-EU MDR namanye amazinga afanelekile. Ngalokhu kuhlolwa, abakhiqizi bangaqinisekisa ukuthi imikhiqizo yabo ihlangabezana nazo zonke izidingo ezidingekayo zokuphepha nokusebenza ngaphambi kokuba ifakwe emakethe.