7
  !"#   TECHNICAL DOCUMENTATION “CHALLENGER” PTCA Balloon catheter  (Class III invasive medical device, rule 7, Annex IX of Directive 93/42/EEC)   ! " #$#!!  !"# % & ' ( )$*+,*"*%)"-+.%$/$+-$$ 0$*12 324 +( $% 5- + 67 $ # % # ! . 839249++ :;4:;4<;4 ,= ! 5* + +* $" 28(4;;2 :;4:;4<;3 % &##'## = & %$$ ' ! . 839249++.%!2>987?( ((()*+),+-.-+*/01  

Technical Documentation Challenger Vers5 GB

Embed Size (px)

Citation preview

8/8/2019 Technical Documentation Challenger Vers5 GB

http://slidepdf.com/reader/full/technical-documentation-challenger-vers5-gb 1/7

 !"#  

TECHNICAL DOCUMENTATION

“CHALLENGER” PTCA Balloon catheter  (Class III invasive medical device, rule 7, Annex IX of Directive 93/42/EEC)

 

! " #$#!!

  !"#

% &' (

)$*+,*"*%)"-+.%$/$+-$$0$*12324

+(

$%

5-+67

$  #

% # ! . 839249++ :;4:;4<;4,= ! 5* + +* $" 28(4;;2 :;4:;4<;3

%  &##'##

= &%$$ ' ! .839249++.%!2>987?(((()*+),+-.-+*/01

 

8/8/2019 Technical Documentation Challenger Vers5 GB

http://slidepdf.com/reader/full/technical-documentation-challenger-vers5-gb 2/7

 !"#  

4

&'&+'=@7A;43(

2'#2#'!3+)(((453367$$823"!&'(+*B;;C2>D28;C!7$3E.839249+++E.+7<*B;;C2>D28;2!7 $2E.839249++B.!!&'(

 &- ' .( . 839249++ 2 F 883 &'!!$( " F +!(5*+*$"8;;(4;;; +*$"32DC(4;;3 5*+*$"2CC<(4;;C5*+*$"2CC<4(4;;2 +*;883(4;;2 +*CC;(88>+*CC>(4;;4 5*+*;CCC<(4;; 5*+*;CCC<2(88D

5  &####'

G $ ) $ $ !!(•  +* $" 32DC(4;;3 E - E G E

,#*G*;;42>D28;;D•  5* +* $"8;;(4;;;E .

! H =!#*C;;;C><,;

•  .839249++2F883#+*$"32DC(4;;3G$(

2'#2#'!23"

8/8/2019 Technical Documentation Challenger Vers5 GB

http://slidepdf.com/reader/full/technical-documentation-challenger-vers5-gb 3/7

 !"#  

3

4  #

<!

7 ! ! !7! ! ! #= 7 +7 = H =!

0  '#!"

+7

= ! << # = I9<;4 !!

 

Figure 1 Detail of the marker profile in line with the corresponding nylon structure profile. The special mix used for balloon forming is

characterised by a highly transparent and even finish.

8/8/2019 Technical Documentation Challenger Vers5 GB

http://slidepdf.com/reader/full/technical-documentation-challenger-vers5-gb 4/7

 !"#  

2

Figure 2 Greater hypotube flexibility and elasticity

allow the catheter to go through narrow radium bendseasily.

6  !"

 !!!

$J:(3C- 

! ! !(#H

!

@ # 7 ! 7 !@74

$K(4;:

-  !7

! ! 7!

-  -  7

$K($4:- 

-  K

8  !#

-  !!= 3 = !

 -  !"#$

%&!!  

8/8/2019 Technical Documentation Challenger Vers5 GB

http://slidepdf.com/reader/full/technical-documentation-challenger-vers5-gb 5/7

 !"#  

C

 

Figure 3. The neatness of its design and evenness of its profile make the Challenger balloon the best choice for any coronary dilationapplication

-  =  

-  &+*)$ < 

<  '!<  '('($)!22;?2;<   *+(*($,,<  -

'(). !

2

 

Figure 4. Compliance graph of the “Challenger” balloon catheter

<   *+/% 3;?C=

! 9!

8/8/2019 Technical Documentation Challenger Vers5 GB

http://slidepdf.com/reader/full/technical-documentation-challenger-vers5-gb 6/7

 !"#  

>

*:%"*,+$$5,+

4;4C 3; 3C 2;

4 DD 43D 4DD 33D 3DD3 8 42 48 32 38

2 82 422 482 322 382C 8 42 48 32 88> 4;; 4C; 3;; 3C; 2;; 4;3 4C3 3;3 3C3 2;3D 4;> 4C> 3;> 3C> 2;>8 4;8 4C8 3;8 3C8 2;8; 44 4>4 34 3>4 24 4C 4>C 3C 3>C 2C4 4D 4>D 3D 3>D 2D3 44 4 34 3 242 442 42 342 32 242C 44 4 34 3 24> 43; 4D; 33; 3D; 23; 433 4D3 333 3D3 233D 43> 4D> 33> 3D> 23>

,L>,)L>22;?2;)L44

$(M3D;.I9<;;(;N>>)-(O2;3;?C

Table 1. Compliance table and specifications summary.

7 '!#9##

 &'

 L (mm)

D (mm)9 12 15 18 20 30 40

2.0 CC0920 CC1220 CC1520 CC1820 CC2020 CC3020 CC4020

2.5 CC0925 CC1225 CC1525 CC1825 CC2025 CC3025 CC4025

3.0 CC0930 CC1230 CC1530 CC1830 CC2030 CC3030 CC4030

3.5 CC0935 CC1235 CC1535 CC1835 CC2035 CC3035 CC4035

4.0 CC0940 CC1240 CC1540 CC1840 CC2040 CC3040 CC4040

 !!"

)!5*+*$";883<:;4:;4<;> 

8/8/2019 Technical Documentation Challenger Vers5 GB

http://slidepdf.com/reader/full/technical-documentation-challenger-vers5-gb 7/7

 !"#  

 :

==9-7

= ! 7 :;4:;4<;>

$ ###

@ ! 7 !!7( 

  5*+*CC;E$-7

  5*+*CC><E$E,#&$+,%+'E,#

  5*+*$"3<E$ E-E

  5*+*$"3<4E$ E-E

% $( +* CC;(882 :;4:;4<;>4!

%  ###

!

:;4:;4<;8:;4:;4<;8