Sjm™ Séguin Annuloplasty Ring Sterilization; Sizer Reprocessing Requirements; Reprocessing Option 1 - St.Jude Medical SJM Seguin SARP-24 Mode D'emploi

2. The remaining sutures should be placed around the annulus. Sutures should
be placed through the outer half of the ring sewing cuff, using the green suture
markers around the circumference as a guide, as shown in Figure 8.
3. Once all sutures have been placed on the sewing cuff, the ring may be
parachuted down into the annulus. If desired, the ring holder may be used to
maintain the shape of the ring while the sutures are tied off.
4. To facilitate tying, the handle may be removed from the ring holder by
depressing the release button, as shown in Figure 9. Once all of the sutures
have been tied, the handle may be reattached to the holder to facilitate removal.
5. To remove the ring holder, cut the three retaining sutures as shown in
Figure 10. The holder that is supplied with the ring should be discarded.
CAUTION: To avoid damage to the fabric covering the ring, do not
use cutting edge needles, and avoid manipulation with forceps during
implantation.
CAUTION: Remove any loose suture or thread, which may be a source of
thrombus or thromboembolism.
SJM™ Séguin Annuloplasty Ring Sterilization
The SJM™ Séguin Annuloplasty Ring has been gas (ethylene oxide) sterilized and
inspected prior to packaging, and is ready for use when received.
Do not resterilize the SJM™ Séguin Annuloplasty Ring by any method.

Sizer Reprocessing Requirements

St. Jude Medical has validated these reprocessing instructions. If alternate
methods are used, it is the user's responsibility to ensure that their methods
provide effective cleaning and disinfection. The cleaning method must remove all
visible blood soil and contamination.
Testing indicates that products described herein may undergo 100 cleaning/
disinfection cycles when cleaned using the specified reprocessing methods.
Deviations from the specified methods may result in reduced instrument life or
inadequate cleaning and disinfection.
Reprocess instruments as soon as reasonably possible following use. After
each reprocessing cycle inspect instruments for signs of cracking, crazing, or
degradation that may affect function.

Reprocessing Option 1

Manual Cleaning and Disinfection Method
The following manual cleaning and disinfection method was validated:
1. Wipe the instrument with a wet, disposable sponge to remove gross soil.
2. Rinse the instrument in hot, running tap water for a minimum of 20 seconds to
remove visible blood soil.
3. Soak the instrument in a bath of Terg-A-Zyme™ Enzymatic Cleaner (Alconox)
for five minutes.
4. Items should be mechanically cleaned with appropriately sized non-abrasive
brushes until visibly clean.
5. Rinse instrument with hot de-ionized (DI) water for a minimum of 20 seconds to
remove remaining soil and cleaning agent.
6. Allow to air dry or dry the instrument with a clean, disposable, absorbent, non-
shedding wipe.
Automated Cleaning, Washer-Disinfector Method
The automated washer-disinfector method described below was validated. Testing
was conducted using HAMO™ LS1000 washer-disinfector with Renuzyme™
enzyme detergent.
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