Edwards Lifesciences 4400 Manual

Carpentier-Edwards Classic
• Annuloplasty Ring for Mitral and Tricuspid Valvuloplasty
• Pierścień do annuloplastyki zastawki mitralnej i trójdzielnej
• Anuloplastický krúžok pre mitrálnu a trikuspidálnu valvuloplastiku
English . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1
Polski . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6
Slovensky . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11
References/Piśmiennictwo/Literatúra . . . . . . . . . . . . . . . . . . . . . . 15
Specifications/Specyfikacja/Technické špecifikácie . . . . . . 16–17
Figures/Ryciny/Obrázky . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 17–18
Symbol Legend/Wykaz symboli/Legenda k symbolom . . . . . . . 19
English
For Single Use Only
Rx only
Concept/Description
The Carpentier-Edwards Clas sic Annuloplasty Ring is constructed of titanium
alloy and has a sewing ring margin that consists of a layer of silicone rubber
covered with a polyester knit fabric. Design objectives include: retention of
the natural valve apparatus, remodeling of the annulus, retention of a
normal valve orifice during systole, and prevention of secondary distension
of the annulus (fre quent ly the cause of recurrent incompetence after
con ven tion al valvuloplasties).
Edwards Lifesciences, the stylized E logo, and Carpentier-Edwards Classic are
trademarks of Edwards Lifesciences Corporation and are registered in the U.S.
Patent and Trademark Office.
Klenzyme is a registered trademark of Merck & Co., Inc.
Instru-Klenz is a trademark of STERIS Corporation.
Cidex and Cidezyme are registered trademarks of Advanced Sterilization Products,
a Johnson & Johnson Company and Division of Ethicon, Inc.
DIRECTORY
The mitral ring conforms to the configuration of a normal mitral orifice.
It is kidney-shaped with one long curved segment cor re spond ing to the
posterior leaflet. The ring is open in the rec ti lin ear portion cor re spond ing to
the anterior leaflet (Figure 1) and has transverse colored threads indicating
the anterior and pos te ri or commissures (Figure 2).
The oval tricuspid ring conforms to the configuration of a normal tricuspid
orifice. The ring has one rectilinear segment cor re spond ing to the septal
leaflet and one long curved segment corresponding to the anterior and
posterior leaflets. The ring is open at the anteroseptal com mis sure
(Figure 3). Transverse colored threads indicate the site of the
anteroposterior and posteroseptal commissures (Fig ure 4).
Safety in the Magnetic Resonance (MR) Environment:
MR Conditional
Non-clinical testing has demonstrated that the Carpentier-Edwards Classic
Annuloplasty Ring (models 4400/4500), is MR Conditional. A patient with
the Carpentier-Edwards Classic Annuloplasty Ring, can be scanned safely,
immediately after placement of this implant under the following conditions:
• Static magnetic field of 3 tesla or less
• Maximum spatial magnetic gradient field of 720 gauss/cm or less
• Maximum MR system reported, whole-body-averaged specific
absorption rate (SAR) of 3 W/kg for 15 minutes of scanning
(i.e. per pulse sequence)
In non-clinical testing, Carpentier-Edwards Classic Annuloplasty Ring
(models 4400/4500), produced a temperature rise of less than or equal to
0.6°C at a maximum whole-body-averaged specific absorption rate (SAR)
of 3 W/kg for 15 minutes of MR scanning in a 3 tesla MR system
(Excite, General Electric Healthcare, Software G3.0-052B).
MR image quality may be compromised if the area of interest is in the same
area or relatively close to the position of the device. Optimization of MR
imaging parameters is recommended.
Ring Valvuloplasty Techniques
Established surgical technique can be used in correction of mitral and/or
tricuspid valvular insufficiencies. These tech niques allow for remodeling of
the valvular apparatus with a tailored annuloplasty ring of ap pro pri ate size
and shape. The ring is placed in the atrial po si tion and sutured to the
natural annulus.
1
Model 4400/4500