, ',:,!
t'
', ,,,1,it0
{*rf" fuffiffiH&m Es,ahtistn,re.v
INTERPRETING.AND TR{NSLATION -\GENCY - 15 "Dragar Tsa:triof ' St.. \imra 9000. Bulgaria: e-urail: lexita@abtbg
Cll * JIEKCI,IJA I(OBATIEB lI C-I4E- - 1u. ",{paru L{amor" 15. Bapm. Ernmpm: rer.: +359 52 631180: rcr.: +359 52 631042
llpeeod om auenu(tcrcu esurc
SIEMENS
EC flEKnAPAqt4fi 3A CbOTBETCTBHE
Cr'rnacxo Anexc ll.3 na flupexrraaa Ha cbBera 93l42lEEC or 14 pnn 1993r.,
n3MeHeHa n AonbnHena c flnpemuaa 2007 147 IEC
l-lponsBorqHren: Siemens AG
Wittelsbacherplatz 2
DE-80333 MpHxeH
l-epnna Hnn
t-lpo13BoRcrBeH a 6asa Siemens AG, Medical Solutions, Business Unit CV
Henkestr. 127, DE-g 1052 EpnaureH, l-epnn a*lz'n
Me,qurqnHcKo ycrpoficrso Multix PRO/TOP ($a vulnnn)
t-lpoRyKroBa ngeHr n*nKaqhfl BHx< cne,qBaqara crpaHnqa
Knacn$nKaLlnrl lffrac llb (curnacHo AHeKc lX
,[npexrvaa 93142/EEC) KbM
lexnaprapaMe c'borBercrBnero Ha ropHoro Me4rqrHcKo ycrpoficrBo c r4sr,lcKBaHnnra
na flnpexrrBa Ha cbBera g3l42lEEC or 14 pnn 1993r.
CuorgercrBnero Ha cucreMara 3a nbnHo rapaHThpaHe Ha Ka.+ecrBoro e
ceprrSuqnpaHa or:
TUV SUD Product Service GmbH
Ridlerstrasse 65
DE-80339 Mtoxxen
l-eprrltannr
!4genrra$raKaLlnoHeH Ne Ha xorrasr,rqrapaHnr opraH 3a nprnaraHe Ha npoqeAypara,
nocolfeHa e AHerc ll Kg[,r ropenocoqenara,[npeKThBa e 0123.
Siemens AG xocra r3KnloqnrenHa orroBopHocr 3a u3.qaBaHero Ha,Hacrof,lqara
4eKJ]apaqnF.
Hacronuqara fleKnapaqnn gaMecrBa Bcut{Kt4 npeAxo.qHn rqeKfiapaqhu, t43AaAeHu 3a
cbr{]4fi nporqyKr.
Mncro m flara: FBnaHreFl , 17 ReKemnprrl 2009r.
Mue: Kuonen (HauanHHK rbproBu<ur orgen) KmF{rep (FlauanHHK,,YnpaaneHr4e Ha KaqecrBoro")
['lognmc {nf - h{e ce L{ere Iml - He Ge \.{eTe
3a ycnonmfiTa Ha rapaHElifiTa il orroeophrocr nfloJln BM}|{Te HAUL4Te 06u4kI yCnOBVn 3A
npo*qaxoa
Honnep Ha rqoKyMeHra: 4781204 QCE 01S 17
crp. 1or
*"Ps
BflPt+**
iil oFnlYt
\*"v-
"*stat*t"
[f pogyrroea rgenrn g utal4rnf,
Cncreunnn ragenrusnraqhoHeH HoMep 3a npoAyKroBara Sanrnnran Multix pRO.TOp
e 4781204 c050c.
l-lpogyxr 1 Multix PRO Hacr Ne 5942973 G050G
I-lpogyw 2 Multix PRO P Hacr Ne 0475558 G050G
l-lpoRyxr 3 Multix TOP u{acr Ng 0475509 G050G
l-lpogyrr 4 Multix TOP ACSS Hacr Nq 0+75517 G050G
f-lpogyxr 5 Muftix TOP P u{acr Ns 5902965 G050G
l-lpogyrr 6 Multix TOP ACSS t'{acr Ne 0475525 G050G
l-lpogyxr 7 Multix PRO Navy t{acr Ns 5902007 G050G
l-lpoRyrr 8 Vertix Solitaire ulacr Ns 5901900 G050G
l-lpogyrcr 9 AXIOM Multix, MP t{acr Ns 8395431 G050G
l-lpoRyxr 10 AXIOM Multix, MT u{acr Ns 8395381 G050G
I-lpogyxr 11 AXIOM Multix, MT, ACSS;N Hacr Ne 8395399 G050G
l-lpoRy w 12 AXIOM Multix, MT, ACSS, P, N r-lacr Ns 8395415 G050G
l-lpoRyxr 1 3.) AXIOM Multix, MU Hacr Nq 86 21520 G050G
l1pogyxr 14 **) AXIOM Vertix MD Trauma Hacr Ns 8908290 G050G
l-lpogyrr 15 AXIOM Vertix Solitaire M Hacr Ns 8627718 G050G
I-eneparoprare Polydoros SX 65/80, Polydoros LX 30/50/80ilite ra polydoros lT 30/55/65/g0
Ca BKJllOqeHh B Cl.tCTeMaTa.
3a scnqM npogyxrra/eneuenrn/qacril Br4xre chcreMHara 6nor-cxeua 4781204 EAB 01S.
*) 3a acnvxn
npoAytfft4/enen/Ienru lqacrn Bnxre 6nox-cxenaa sa o6HoaRs ase 418l,2e4 EAB 02S.
**) 3a
Bcut{Ktl npogyxrra/enenaenru/qacrh Bvrxre bnor-cxenaa sa o6HoeFBaHe 47A12A4 EAB 03S.
Houep Ha rqoKyMeHra: 4TB1Z04 eCE 01S 1T
crp. 2 or 2
{'6ft&P,a Y @ @.9A a 4/d& e@/&/e@ g'&3a/&'&&e/aftxg/&e.O@/&/&/p/t*/2/p,p/&/AA/g/&e&/d/ee
A8.?/A.d/p/r,O/r/t.2/f 4,a,,4.s/&/@,&,p/Ap6g/dJee/*a
"t
tu
donynodnucauuam,SAHKNtr IOIIkIEB l.FffOFfOB, EfH 68 1 0053986, ydocmoeepntear S,
'*reePuocmma Ho npeeoda Ha Hacmont4ua o$uquaneu dorcyueum ([ercnapar4ua to&
$rcuomeemcmeue) om auznwticKu Ha 1unzapcxu eiuK, cbcmoflt4 ce om dee cmpaHuqu, usaipweura6
om uen na 12 der<euepu 20132. I 7t
'fg
Q
'e./4
taKnem npruodou, / .o I,f[[b1
-Vf *- "'i *r
s / ,--:-l' -j &
z
la
z
'/,1/lL///'///ll.//,//1i'/,/////.//,'a1./././,:/,4/1/'i1Vr//,////ia///,////,.a//////.//./@///,1//,////,/,:/7i,//////////'//,,,///1
ffi6=-
rn 1;-
.-r'
.. Tt t -'*
Sto'i'l-i,
*aqt
t
t
is
,,rriii
ffi'ffiffi*,u' ,',ffi:W%
ffiffi ffiffiffi,ffiffi ffiffiru ffiF ffiffiru.ffiffiffi:,Mfiffi
according to Annex ll.3 of Cnuncil Sireetivc S3l4?/lHFe of Juna 14, tg$g
p s a mend ed by CI irectirre 200?l47lEt
hl enufa cturer Siernens AG
:
Vditte sbac herp:lat z 2
t
Muenchan
.nf-gOffib
Germany
'
Facility Siemens AG, Medicaf Solution$, Busiiless Unit CV
[-{enkestr" 127, DE-91{}52 Erlang en, Germany :
l'
Itu'ledlc,al device Muitix Pf; il/TOP tfartrily)
Fr:oduct identification see ngx,t t)fig€
Classif,ication
We d€clare the compliance of the above medical d,evice wiih the requireinents
oi the Council Directive 93l42lEEC of June 14, 1993.
The conforrnity of the f ull quality assurance system is cenlfied by:
ftlV Stin Produc '$ervire,Gmbf-J
Ridlerstrasse 65 .
Df;-8CI339 Muencheh
Germany
lFhe ide-nt{fieatio.n numbel' oi the notified bodtT for,,implsr,yrsntailon of tl*e prdce'
dure set out in Ann-ex il fo the above Dire*tive is.0.i,23.
Tlrls dec-larati,on of conforrnity is is*ued under the sole r,esponsibility of Siemens
.AG.
Tn'is declaration supersedes eny declaration issued previously for the sarhe
pr0duct.
Ptacn and elate Hr[*r]##ft, ilecem,ber 17, ?il#,S
:Fixryle ffiuing*r
t H*ir'.J nf *;;i+l;,1 lt.tllnngrmrnt ;
Signatur#
F*;'e*nditi*ns *i guarrant*e and liabiiity please rsfer to,our Ge,n*rfii Ccr"rci
il**uri*u*nl,r,rlrrurbsr ,{78i ?Sd. ilf,f;. S15 17
SfiPH
& opvtrkt
,r
''tl'
,:llil
,lii
FrsC ust rf ds n,tff$sati arr
The systern identiiiication number for th* l'+t*itix FH'*fftrP fnr*il'i-r is 47S1 ?S.4
GSS0G"
Frodu,cl tvluttix F'ffi0
1
'?,art fVfi" SS 2 7*, fi'fiS**
i
Prsdu#t 2 l',,,4ultix PRf; P Par,t No. 047S5SB G0E0G
,Produ$t 3 tuiultix TOP Fart f\jc, 047SS0g GOSfiS
Prod uct 4 Muftix TOP ACSS Part rtJr*. 0r-tTS fr1l S,firg,Q,S
Fr*d,u{:t 5 I'+1ultix TOp F Part N#, SSSISSS ,G'O'Ffi,
Prroduct 6 ful,UItIX TOP ACSS P Part F,ltr. il.125,5?5 G$,S{JG.
Frn:duct 7 ir4ultix FRC' NavrT Pa,n lrjn. gs.frZ'nfi; .fi*inr}l$,
Proriuct I Verti-x 'Sof itai,re Fan fu,n. 5.$S1 ,g S,G,fissfi
Product g AXIOM Mult:ix, Mt? Part N#, ,#n*S43 T fi.fr,ff#S,
:
:'l'-r+
Product 10 AXliC,M [V?uhix, MT
,,Iii.ii:i
. ii:i::tii;uurrittitllii*,trii+;mi;l
Fart Nn. 83$FSB I G0F0G
Fi,gdlrcl i AXI,C.F.4 i'vnultix, il,,IT, Ail,Sg"
i
. iuili'i*'i+*ffi,u,
1 t'.j Fa,rt Fj#. S39'5,89.9,','G0F0G
i:,i:r
*i,i''
i:ii.': ilriri rii+
i11t,,l,ffil#n+'
Froduot i 2 AJ'{f nm Multix, f147, ACSS , F, it Par"t l'{-* *3,g$4i 5 Ci{j15fiG
FrndHct 13 ") AXIfiM hdulrix, Mu :
Part N#. rrffi,831 ' 2il. .,G,ftF#,ffi
Frsduc't 14 **) AXlOfu4 Ver,tix h4D Traur-nfr Part Nb. *,$ s?'s0 Gs5
Fraduci T 5 AXfCfu{ !'erti;< Sol,ireire f# Far,t N,$, ffi,*,t??t# Gi*:To* i,
The generators Polydoros SX 65180, Folydcr,os l*X gol5ol&0tlite
and pe}Yd,ercs lT
30/55/65i80 are included in the $ysrems.
FOr ell: prod,uctsirunitslparts see sy$terfl flmw,s.h,€tt
4?g;t?04 frA.fl CIl-$,
') For all products/ unitsl parts ses upgracje flo*.,chaft 47gj2*a
fiAE Ozs
* *) For sl{,prodlretsl unirsl parts *eeupgredg'{itow-rhart a,igiei}+ EAg Ogs
D*surnsnt nrrmtrer.4i'8'i il*J ililfi fflS l T
tto;'2
