Directions For Use; Selection Of The Appropriate Sjm™ Séguin Annuloplasty Ring; Pre-Implant Handling; Circulating Nurse (Non-Sterile) - St.Jude Medical SJM Seguin SARP-24 Mode D'emploi

DIRECTIONS FOR USE

Selection of the Appropriate SJM™ Séguin Annuloplasty Ring
Use the SJM™ Séguin Annuloplasty Ring Sizer Set Model SAR-501 to determine
the appropriate SJM™ Séguin Annuloplasty Ring size. This sizer set has been
designed and tested for repeated use. However, if visual signs of deterioration
become apparent, please contact St. Jude Medical customer service.
Sizing and ring selection may be based on a comparison of the intercommissural
distance of the anterior leaflet of the mitral valve with corresponding notches on the
sizer. The two notches on the linear segment of the sizer should be aligned with
the two commissures of the leaflet, as shown in Figure 4. Identify the sizer which
most closely matches the intercommissural distance of the anterior leaflet, and
select the corresponding ring size.
The ring may also be selected by comparing the surface area of the anterior leaflet
of the mitral valve with the surface area of the sizer. To facilitate this comparison,
tension may be placed on the chordae tendineae, thus spreading the leaflets (see
Figure 5). Identify the sizer with the surface area most closely matching that of the
anterior leaflet, and select the corresponding ring size.

Pre-Implant Handling

Circulating Nurse (Non-Sterile)

1. Once the surgeon has determined the required ring size, remove the outer
pouch from the product box.
CAUTION: Do not use the ring if the "USE BY" date on the packaging has
passed.
CAUTION: Examine the device packaging carefully, and ensure the pouch
is unopened and unbroken. If you note any damage, do not use the device,
and contact St. Jude Medical Customer Service.
2. Check the model number and serial number on the outer pouch to make certain
they are identical to those on the box label. If the information is not identical,
do not use the SJM™ Séguin Annuloplasty Ring, and contact St. Jude
Medical Customer Service as soon as possible.
3. Open the outer pouch, and allow the scrub nurse or surgeon in the sterile field
to withdraw the inner pouch containing the SJM™ Séguin Annuloplasty Ring.

Scrub Nurse or Surgeon (Sterile)

1. Check the model number and serial number. Confirm with the circulating nurse
that these are the same as those on the outer box and pouch labels.
2. Remove the ring from the inner pouch. The ring is supplied on a holder. Align
the tip of the ring holder handle with the matching hexagon attachment of the
ring holder. Push the tip of the ring holder handle down into the ring holder until
it securely locks into place (see Figure 6). Ensure that the handle is securely
connected by gently attempting to pull it out of the ring holder.
3. An identification number tag is sutured to the ring. Remove the identification tag
and its suture prior to implantation. Retain the identification number tag for the
patient's records.
CAUTION: Exercise care to avoid cutting or tearing the ring during removal
of the identification tag.
Implanting the SJM™ Séguin Annuloplasty Ring
Insertion of the SJM™ Séguin Annuloplasty Ring in the annulus may be performed
using the suturing method of your choice.
1. Two sutures should be placed in the annulus to mark the commissures. Two
green suture markers on the sewing cuff and the black line in the mid-posterior
guide placement of sutures, as shown in Figure 7.
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