On-X CHORD-X Manual De Instrucciones

CHORD-X™ CHORDAL SIZER
INSTRUCTIONS FOR USE
1. DESCRIPTION
The Chord-X™ Chordal Sizer (see Figure
1) is designed to assist the surgeon in
determining the proper length of chordal
replacement prostheses needed to repair
the mitral valve. It may be used to help the
surgeon select a preconfigured prosthesis,
or to easily configure the correct size using
straight suture material, during mitral
valve repair.
2. INDICATIONS
Chord-X™ Chordal Sizer is indicated for
sizing or configuring chordal replacement
prostheses during mitral valve repair.
3. CONTRAINDICATIONS
None known.
4. PRECAUTIONS AND WARNINGS
Successful use of this device requires
appropriate training and experience in
cardiac surgical techniques including
mitral valve repair. The replacement
of chordae tendinae requires accurate
sizing to ensure satisfactory functioning
of the valve mechanism post repair or
replacement. Chordae tendinae replaced
with sutures that are either too long or
too short can result in failure to correct
valvular incompetence.
The device has been sterilized using
gamma irradiation. It is provided sterile
unless the integrity of the package has
been compromised. Do not use the device
if the package has been compromised. Do
not re-sterilize. Do not Reuse. Reuse may
result in infection, serious injury, or patient
death.
STERILE R
On-X Life Technologies, Inc.
1300 East Anderson Lane, Bldg. B, Austin Texas 78752 U.S.A.
TEL: (512) 339-8000 FAX: (512) 339-3636
WEB: www.onxlti.com EMAIL: onx@onxlti.com
CryoLife Europa, Ltd.
Bramley House, The Guildway, Old Portsmouth Road, Guildford
EC REP
Surrey GU3 1LR, United Kingdom
102122 02 G English
(09/2017)
5. RECOMMENDED TECHNIQUES
Note: These instructions only cover the
sizing step of chordae tendineae repair.
Please see the Chord-X ePTFE Suture or
Chord-X Pre-Measured Loops Instructions
for Use for further instruction.
Use the blue leaflet hook to support
•
the edge of the leaflet in the planned
position.
Use the thumb-slide to extend the
•
papillary hook to the planned site of
attachment to the papillary muscle as
shown in Figure 2.
The leaflet hook may be rotated to any
•
desired angle relative to the papillary
hook to improve visibility. Rotate the
leaflet hook by using the grips at the
base of the barrel.
The colors of scale match the label
•
colors for the corresponding Chord-X
Pre-Measured Loops prostheses.
The scale number indicates the size
•
of chordal loops produced by tying
suture around the two hooks. The scale
is accurate to ±1mm. Rotate the barrel
so that the leaflet hook is aligned with
the papillary hook prior to tying loops.
After tying, pull the papillary hook back
to remove tied loops from the hooks.
Once
•
tendineae are in place, a saline test
is recommended to verify that the
chordal loop size is correct and that the
valve is competent.
Gamma CXCS
REF
the artificial chordae
045 9
Papillary Hook
Leaflet Hook
Barrel
Grips for
Barrel Rotation
Thumb-Slide
12
Scale
mm
16
mm
20
Figure 1:
Chordal Sizer
Free Edge of
Mitral Leaflet
Planned Site of
Papillary Muscle
Attachment
Figure 2:
Sizing
English