Melao ea EU Medical Device Regulation e na le eng bakeng sa li-mobility scooters?

Melao ea EU Medical Device Regulation e na le eng bakeng sa li-mobility scooters?
EU e na le taolo e thata haholo ea lisebelisoa tsa bongaka, haholo-holo ka ho kenya ts'ebetsong ea Melao e ncha ea Melaetsa ea Bongaka (MDR), melaoana ea lithuso tsa ho tsamaea tse kang.mobility scooters le tsona li hlakile haholoanyane. E latelang ke melaoana ea mantlha ea li-scooters tse tsamaeang tlas'a Molao oa EU Medical Device Regulation:

1. Karolelano le Tumellano
Litulo tsa batho ba holofetseng ka letsoho, li-wheelchair tsa motlakase le li-scooters tsa mobility kaofela li khetholloa e le lisebelisoa tsa bongaka tsa Sehlopha sa I ho latela Melao ea Annex VIII 1 le 13 ea EU Medical Device Regulation (MDR). Sena se bolela hore lihlahisoa tsena li nkuoa e le lihlahisoa tsa kotsi e tlase mme bahlahisi ba ka phatlalatsa hore lihlahisoa tsa bona li ipapisa le litlhoko tsa taolo ka bobona.

2. Litokomane tsa Tekheniki le Letšoao la CE
Baetsi ba tlameha ho lokisa litokomane tsa tekheniki, ho kenyeletsoa tlhahlobo ea kotsi le phatlalatso ea tumellano, ho paka hore lihlahisoa tsa bona li fihlela litlhoko tsa bohlokoa tsa MDR. Ha e se e phethiloe, bahlahisi ba ka etsa kopo ea letšoao la CE, ba lumella lihlahisoa tsa bona hore li rekisoe 'marakeng oa EU

3. Litekanyetso tsa Europe
Li-scooters tsa Mobility li tlameha ho latela litekanyetso tse ikhethileng tsa Europe, ho kenyeletsoa empa li sa felle ho:

TS EN 12182: E totobatsa litlhoko tse akaretsang le mekhoa ea liteko bakeng sa lihlahisoa tse thusang le lithuso tsa tekheniki bakeng sa batho ba nang le bokooa.

TS EN 12183: E hlalosa litlhoko tse akaretsang le mekhoa ea liteko bakeng sa litulo tsa batho ba holofetseng

TS EN 12184: E hlalosa litlhoko tse akaretsang le mekhoa ea liteko bakeng sa litulo tsa batho ba holofetseng tsa motlakase kapa tsa libeteri, li-mobility scooters le li-chaja tsa betri.

Letoto la ISO 7176: E hlalosa mekhoa e fapaneng ea liteko bakeng sa litulo tsa batho ba holofetseng le li-scooters tsa motsamao, ho kenyelletsa litlhoko le mekhoa ea liteko bakeng sa boholo, boima le sebaka sa mantlha sa ho tsamaisa, lebelo le phahameng, le ho potlakisa le ho fokotseha.

4. Teko ea ts'ebetso le polokeho
Li-scooters tsa Mobility li tlameha ho feta letoto la liteko tsa ts'ebetso le ts'ireletso, ho kenyeletsoa liteko tsa mochini le ho tšoarella, liteko tsa polokeho ea motlakase le liteko tsa ho lumellana ha motlakase (EMC), jj.

5. Tlhokomelo ea 'maraka le tlhokomelo
Taolo e ncha ea MDR e matlafatsa taolo ea 'maraka le tlhokomelo ea lisebelisoa tsa bongaka, ho kenyelletsa le ho eketsa tlhahlobo e hokahaneng ea lipatlisiso tsa kliniki tse tšelang meeli, ho matlafatsa litlhoko tsa taolo ea kamora 'maraka bakeng sa bahlahisi, le ho ntlafatsa mekhoa ea khokahano lipakeng tsa linaha tsa EU.

6. Polokeho ea mokuli le pepeneneng ea tlhahisoleseling
Molao oa MDR o totobatsa polokeho ea mokuli le pepeneneng ea tlhahisoleseling, e hlokang sistimi e ikhethang ea boitsebahatso (UDI) le database e felletseng ea lisebelisoa tsa bongaka tsa EU (EUDAMED) ho ntlafatsa traceability ea sehlahisoa.

7. Bopaki ba bongaka le tlhokomelo ea 'maraka
Taolo ea MDR e boetse e matlafatsa melao ea bopaki ba kliniki, ho kenyeletsoa le ts'ebetso ea tumello ea lipatlisiso tsa bongaka ea litsi tse ngata e hokahantsoeng ho pholletsa le EU, le ho matlafatsa litlhoko tsa taolo ea mebaraka.

Ka bokhuts'oane, melaoana ea lisebelisoa tsa bongaka tsa EU mabapi le mobility scooters e kenyelletsa ho hlophisoa ha lihlahisoa, liphatlalatso tsa tumellano, litekanyetso tsa Europe tse tlamehang ho lateloa, tlhahlobo ea ts'ebetso le polokeho, tlhokomelo le tlhokomelo ea 'maraka, polokeho ea bakuli le pepeneneng ea tlhahisoleseling, bopaki ba tleliniki le taolo ea mebaraka. Melawana ena e reretswe ho netefatsa polokeho le katleho ya disebediswa tse thusang motsamao tse kang mobility scooters le ho sireletsa bophelo bo botle le ditokelo tsa bareki.

Ke liteko life tsa ts'ebetso le polokeho tse hlokahalang bakeng sa li-mobility scooters?

Joalo ka sesebelisoa se thusang sa motsamao, tlhahlobo ea ts'ebetso le polokeho ea li-mobility scooters ke senotlolo ho netefatsa polokeho ea basebelisi le ho latela lihlahisoa. Ho latela liphetho tsa lipatlisiso, tse latelang ke liteko tsa mantlha tsa ts'ebetso le polokeho tseo li-scooters tsa motsamao li hlokang ho feta ho tsona:

Teko e phahameng ea lebelo la ho khanna:

Lebelo le phahameng la ho khanna la mobility scooter ha lea lokela ho feta 15 km/h. Teko ena e netefatsa hore mobility scooter e sebetsa ka lebelo le sireletsehileng ho fokotsa kotsi ea likotsi.
Teko ea ts'ebetso ea Braking:
E kenyelletsa liteko tsa braking tse otlolohileng tsa 'mila le liteko tse sireletsehileng tsa matsoapo ho netefatsa hore scooter e khona ho ema hantle tlasa maemo a fapaneng a tsela.

Ts'ebetso ea ho ts'oara thaba le teko ea botsitso e tsitsitseng:
E lekola botsitso ba scooter letsoapong ho netefatsa hore ha e thellehe ha e emisitsoe letsoapong.

Teko e matla ea botsitso:
E lekola botsitso ba scooter nakong ea ho khanna, haholo ha u thinya kapa u kopana le litsela tse sa lekaneng

Teko ea ho tšela litšitiso le foro:
E lekola bolelele le bophara ba litšitiso tseo scooter e ka li tšelang ho lekola ho feta ha sona

Teko ea bokhoni ba ho hloa mephato:
E lekola bokhoni ba ho khanna ba scooter letsoapong le itseng

Teko e fokolang ea radius:
E lekola bokhoni ba scooter ho potoloha sebakeng se senyenyane, se bohlokoa haholo bakeng sa ho sebetsa sebakeng se moqotetsane.

Teko ea boithuto ba sebaka sa ho khanna:
E lekola sebaka seo scooter e ka se tsamayang kamora tefiso e le 'ngoe, e leng bohlokoa haholo bakeng sa lithuthuthu tsa motlakase.

Teko ea sistimi ea matla le taolo:
E kenyelletsa tlhahlobo ea switch switch, tlhahlobo ea tjhaja, tlhahlobo ea khatello ea ho khanna nakong ea ho tjhaja, tlhahlobo ea lets'oao la matla ho Control, tlhahlobo ea ts'ireletso ea motor stall, joalo-joalo ho netefatsa polokeho le ts'epo ea sistimi ea motlakase

Teko ea tšireletso ea potoloho:
Lekola hore na lithapo tsohle le likhokahano tsa mobility scooter li ka sireletsoa ka nepo ho tsoa ho overcurrent

Teko ea tšebeliso ea matla:
Netefatsa hore tšebeliso ea matla ea mobility scooter ha e fete 15% ea matšoao a boletsoeng ke moetsi.

Teko ea matla a ho khathala ha mariki a ho paka:
Lekola katleho le botsitso ba brake ea ho paka ka mor'a tšebeliso ea nako e telele

Teko ea ho thibela mollo oa setulo (ka morao):
Netefatsa hore mosamo oa setulo (ka morao) oa mobility scooter ha o hlahise mosi o tsoelang pele le lelakabe le tukang nakong ea tlhahlobo.

Teko ea tlhoko ea matla:
E kenyelletsa teko ea matla a sa fetoheng, teko ea matla le teko ea matla a mokhathala ho netefatsa matla a sebopeho le ho tšoarella ha mobility scooter.

Teko ea tlhoko ea boemo ba leholimo:
Kamora ho etsisa pula, mocheso o phahameng le liteko tsa mocheso o tlase, etsa bonnete ba hore mobility scooter e ka sebetsa ka mokhoa o tloaelehileng le ho fihlela maemo a nepahetseng.

Lintho tsena tsa tlhahlobo li akaretsa ts'ebetso, polokeho le nako e telele ea scooter, 'me ke mehato ea bohlokoa ho netefatsa hore mobility scooter e lumellana le melaoana ea EU MDR le litekanyetso tse ling tse amehang. Ka liteko tsena, bahlahisi ba ka netefatsa hore lihlahisoa tsa bona li fihlela litlhoko tsohle tse hlokahalang tsa polokeho le ts'ebetso pele li ka kenngoa 'marakeng.