πιθανότητα αστοχίας του προϊόντος (όσον αφορά την ακεραιότητά, τη
λειτουργικότητα και την κλινική του αποτελεσματικότητα).
- Η συσκευή περιέχει φθαλικές ενώσεις. Λαμβάνοντας υπόψη τη φύση
της επαφής της συσκευής με το σώμα, την περιορισμένη διάρκεια της
επαφής και τον αριθμό των θεραπειών ανά ασθενή, η ποσότητα
φθαλικών ενώσεων που μπορεί να απελευθερωθεί από τη συσκευή
δεν δημιουργεί ιδιαίτερη ανησυχία για πιθανούς κινδύνους.
Περισσότερες πληροφορίες διατίθενται από τη Sorin Group Italia
κατόπιν αιτήματος.
-
Na xorhgei/ t e kai na diathrei/ t e pa/ n ta mia/ swsth/ do/ s h
antiqrombwtikou/ upo/ e/ l egxo prin, kata/ th dia/ r keia kai meta/ to
bypass.
-
Mh thn upoba/ l lete se a/ l lh pro/ s qeth xrh/ s h.
-
Mhn epanaposteirw/ n ete.
-
Meta/ th xrh/ s h diaqe/ s te th suskeuh/ su/ m fwna me touj
kanonismou/ j pou isxu/ o un sth Xw/ r a xrh/ s hj.
-
H
suskeuh/
pre/ p ei
APOSTEIRWMENH. Se peri/ p twsh pou h sukeuh/ pare/ x etai MH
APOSTEIRWMENH ¨sth peri/ p twsh auth/ fai/ n etai apo/ thn
e/ n deich "mh aposteirwme/ n o" epi/ thj suskeuasi/ a j© sunennohqei/ t e
me th Sorin Group Italia h/ me e/ n an ecousiodothme/ n o antipro/ s wpo/
thj gia thn me/ q odo apostei/ r wshj.
-
Gia perisso/ t erej plhrofori/ e j h/ / kai se peri/ p twsh parapo/ n wn
apeuqunqei/ t e sth SORIN GROUP ITALIA h/ ston ecousiodothme/ n o
antipro/ s wpo thj perioxh/ j .
E. EGKATASTASH
1) TOPOQETHSH TOU SUGKRATHTHRA
Topoqetei/ s te ton sugkrathth/ r a D625 thj LILLIPUT sthn antli/ a
¨eik. B© kai sterew/ s te to me/ s w tou sfixth/ r a pou bri/ s ketai
sto a/ n w a/ k ro tou ekteino/ m enou braxi/ o na.
Gia perisso/ t erej plhrofori/ e j sxetika/ me thn egkata/ s tash
tou sugkrathth/ r a prostre/ c te stij sxetike/ j odhgi/ e j xrh/ s hj.
2) PROETOIMASIA TOU SUGKRATHTHRA
Afaire/ s te to mau/ r o plastiko/ ka/ l umma tou dianome/ a nerou/ .
Stre/ y te to moxlo/ ¨sxet. 19© sth qe/ s h "OPEN".
3) STEREWSH TOU OCUGONWTH STON
SUGKRATHTHRA ¨eik. B©
-
H apostei/ r wsh diasfali/ z etai efo/ s on h aposteirwme/ n h
suskeuasi/ a den ei/ n ai bregme/ n h, anoixth/ , alloiwme/ n h h/
katestramme/ n h.
Mh xrhsimopoiei/ t e th suskeuh/ efo/ s on h apostei/ r wsh
den ei/ n ai diasfalisme/ n h.
-
Ele/ c te thn hmeromhni/ a lh/ c hj sthn anti/ s toixh etike/ t a.
Mh xrhsimopoiei/ t e th suskeuh/ pe/ r an thj hmeromhni/ a j
auth/ j .
-
H suskeuh/ pre/ p ei na xrhsimopoiei/ t ai ame/ s wj meta/ to
a/ n oigma thj aposteirwme/ n hj suskeuasi/ a j.
-
H suskeuh/ pre/ p ei na xrhsimopoiei/ t ai se ashptiko/
periba/ l lon.
Bga/ l te th suskeuh/ apo/ thn aposteirwme/ n h suskeuasi/ a .
-
Epiqewrei/ s te optika/ kai ele/ g cte me prosoxh/ to proi+ o / n
prin
apo/
th
apoqh/ k eushj
mh/
mporou/ n na prokale/ s oun zhmie/ j sto proi+ o / n .
-
Mh
xrhsimopoiei/ t e
aketo/ n h, klp.: se epafh/ me to proi+ o / n mporou/ n na
prokale/ s oun zhmie/ j sto i/ d io.
-
Alogonou/ x a ugra/ o/ p wj Aloqa/ n io kai Fqorioqa/ n io den
pre/ p ei na e/ r xontai se epafh/ me thn poluanqrakikh/ domh/
34
thj suskeuh/ j .
Auto/ qa prokalou/ s e zhmie/ j te/ t oiej pou qa mporou/ s an na
prodika/ s oun thn akeraio/ t hta kai leitourgiko/ t hta thj
suskeuh/ j .
Eisa/ g ete to LILLIPUT 1 OPEN SYSTEM prose/ x ontaj na pera/ s ete
ton leuko/ dianome/ a nerou/ tou sugkrathth/ r a ¨ eik.
ston enalla/ k th qermo/ t htaj. O ocugonwth/ j pre/ p ei na ei/ n ai
mplokarisme/ n oj me/ s w twn stop pou odhgou/ n tai apo/ du/ o
ko/ k kinej diata/ c eij parempo/ d ishj anastrofh/ j .
Stre/ y te to moxlo/ ¨eik. B
To LILLIPUT 1 OPEN SYSTEM ei/ n ai tw/ r a swsta/ sterewme/ n o.
na
xrhsimopoiei/ t ai
mo/ n o
an
xrh/ s h.
Sunqh/ k ej
metafora/ j
sumbate/ j
me
ta
prokaqorisqe/ n ta
dialu/ t ej
o/ p wj
alkoo/ l ,
aiqe/ r a,
C
© me/ s a
-
sxet. 19 © sth qe/ s h "CLOSE".
4) PROETOIMASIA TOU
QERMOKUKLOFORHTH
Sunde/ s te touj swlh/ n ej nerou/ ston sugkrathth/ r a me/ s w twn
sunde/ s mwn Hansen qhluko/ SORIN GROUP ITALIA kwdiko/ j 9028.
-
Su/ n desmoi diaforetikoi/ apo/ ekei/ n ouj pou upodeiknu/ o ntai
qa
mporou/ s an
eswteriko/ tou kuklw/ m atoj te/ t oiej pou na meiw/ s oun thn
apotelesmatiko/ t hta tou enalla/ k th qermo/ t htaj.
-
H qermokrasi/ a tou nerou/ sthn ei/ s odo tou enalla/ k th
qermo/ t htaj den pre/ p ei na uperbai/ n ei touj 42°C (108°F).
-
H pi/ e sh tou nerou/ ston enalla/ k th qermo/ t htaj den
pre/ p ei na ceperna/ e i ta 300 kPa (3 bar / 44 psi).
5) ELEGXOS
QERMOTHTAS
ei/ n ai
O e/ l egxoj pragmatopoiei/ t ai me thn epanakuklofori/ a nerou/
sto eswteriko/ tou enalla/ k th gia orisme/ n a lepta/ . H
akeraio/ t hta thj domh/ j diasfali/ z etai apo/ thn pantelh/
apousi/ a diarroh/ j nerou/ apo/ to diame/ r isma/ tou.
6) SUNDESH TOU KUKLWMATOS
Olej oi sunde/ s eij kata/ mh/ k oj thj antli/ a j pre/ p ei na ei/ n ai
asfalisme/ n ej me desi/ m ata.
FLEBIKH GRAMMH
grammh/ twn 3/16" h/ twn 1/4" ston su/ n desmo pou anafe/ r etai sth
Flebikh/ Decamenh/ san "VENOUS RETURN" (sxet. 4).
GRAMMES
ANARROFHSHS:
prostateutika/ kalu/ m mata apo/ ta filtrarisme/ n a eiso/ d ou
sto pa/ n w me/ r oj thj Decamenh/ j Kardiotomi/ a j ¨4 ei/ s odoi twn
3/16" - 1/4" (4,76 - 6,35 mm), sunde/ s te ta a/ k ra twn swlh/ n wn
anarro/ f hshj
kai
prosanatoli/ z ontaj tij eiso/ d ouj filtrari/ s matoj proj tij
antli/ e j anarro/ f hshj.
ARTHRIAKH GRAMMH: afaire/ s te to ko/ k kino ka/ l umma apo/
thn arthriakh/ e/ c odo tou ocugonwth/ pou upodeiknu/ e tai san
"ARTERIAL OUTLET" (sxet. 6) kai sunde/ s te mia/ grammh/ twn 3/16" —
1/4".
GRAMMH
ANTLIAS:
topoqethqei/ metacu/ tou sunde/ s mou eco/ d ou thj Flebikh/ j
Decamenh/ j ¨sxet. 7© kai tou sunde/ s mou flebikh/ j eiso/ d ou tou
ocugonwth/ ¨sxet. 8© lamba/ n ontaj upo/ y h th fora/ peristrofh/ j
thj antli/ a j.
Afaire/ s te to ki/ t rino ka/ l umma apo/ to su/ n desmo aerismou/
¨sxet. 9© thj Decamenh/ j Kardiotomi/ a j.
An xreiastei/ na xrhsimopoih/ s ete ocugonwme/ n o ai/ m a gia
aimatikh/ kardioplhgi/ a , sunde/ s te e/ n a krouno/ 3 odw/ n sth
su/ n desh luer pou upa/ r xei sth grammh/ epanakuklofori/ a j. H
tri/ t h odo/ j tou krounou/ qa pare/ x ei to ocugonwme/ n o ai/ m a.
An qelh/ s ete na proxwrh/ s ete se aimatikh/ epana/ k thsh sto
te/ l oj tou bypass, sunde/ s te e/ n a krouno/ "ON-OFF" ¨me sunde/ s eij
luer lock arsenikh/ kai qhlukh/ © metacu/ tou arsenikou/ luer lock
thj grammh/ j epanakuklofori/ a j thj mona/ d aj ocugo/ n wshj
kai thj xrhsimopoiou/ m enhj flebikh/ j decamenh/ j . Anoi/ c te ton
krouno/ "ON-OFF" ¨Qe/ s h "ON").
7) KROUNOS DEIGMATOLHYIAS ¨
h/ / kai
Mporei/ t e na afaire/ s ete ton krouno/ tou LILLIPUT apo/ th qe/ s h
tou kai na ton sunde/ s ete ston anti/ s toixo sugkrathth/ r a (D
712). Ta spira/ l tou swlh/ n a pou saj pare/ x ontai me ton
krouno/ epitre/ p oun thn epanatopoqe/ t hsh se akti/ n a 1 peri/ p ou
me/ t rou.
Ele/ g cte an o epiloge/ a j ¨sxet. 10© bri/ s ketai sth qe/ s h "OFF".
8) SUNDESH
QERMOKRASIAS
H su/ n desh gia ton aisqhth/ r a arthriakh/ j qermokrasi/ a j
¨ko/ k kinh - sxet. 11© bri/ s ketai plhsi/ o n thj arthriakh/ j
eco/ d ou, enw/ sto flebiko/ su/ s thma o aisqhth/ r aj ¨mple - sxet.
12© ei/ n ai ape/ n anti apo/ thn flebikh/ ei/ s odo.
Oi aisqhth/ r ej qermokrasi/ a j SORIN GROUP ITALIA e/ x oun kwdiko/
9026.
9) GRAMMES EPANAKUKLOFORIAS KAI
EKKENWSHS
Ele/ g cte an to leuko/ clamp ¨sxet. 13© pou bri/ s ketai sth
grammh/ epanakuklofori/ a j metacu/ arthriakh/ j eco/ d ou thj
mona/ d aj ocugo/ n wshj kai thj sklhrh/ j decamenh/ j ei/ n ai
anoixto/ .
na
dhmiourgh/ s oun
antista/ s eij
TOU
ENALLAKTH
:
mporei/ na sundeqei/ mia/ flebikh/
afou/
afaireqou/ n
stre/ y te
th
kefalh/
¨sxet.
to
tmh/ m a
thj
antli/ a j
pre/ p ei
elk. A
ME
AISQHTHRES
sto
ta
5©
©