8
11.5 Accessory Sterilization
The Model 1111 handle and the Model 1130 sizers are supplied
nonsterile and must be sterilized before using. The handles and
sizers must be cleaned and resterilized prior to each use. Sizers
should be examined for signs of wear, such as dullness,
cracking or crazing and should be replaced if any deterioration
is observed.
Sizers and handles must be removed from their plastic
shipping pouches prior to sterilization. Each institution should
use procedures that include biological indicators to determine
the effectiveness of the sterilization procedure.
The following conditions are recommended:
Autoclave Sterilization:
Gravity Displacement:
Wrapped:
Temperature:
132°-137°C (270°-279°F)
Exposure Time:
10-15 minutes
Unwrapped (“flash”):
Temperature: 132°-137°C
(270°-279°F)
Exposure Time:
3 minutes
Prevacuum:
Wrapped:
Temperature:
132°-137°C (270°-279°F)
Exposure Time:
3-4 minutes
Unwrapped (“flash”):
Temperature:
132°-137°C (270°-279°F)
Exposure Time:
3 minutes
11.6 Return of Explanted Bioprostheses
Edwards is extremely interested in obtaining recovered clinical
specimens of Carpentier-Edwards bioprostheses for analysis.
A written report summarizing our findings will be provided
upon completion of our evaluation. Please contact your local
valve specialist for return of recovered valves. The explanted
valves should be placed into a suitable histological fixative such
as 10% formalin or 2% glutaraldehyde and returned to the
company. Refrigeration is not necessary under these
circumstances.
12. Patient Information
12.1 Registration Information
An Implantation Data Card is included in each device package
for patient registration. After implantation, please complete all
requested information. The valve serial number is listed on the
valve packaging and on the identification tag attached to the
bioprosthesis, and is pre-printed on the Implantation Data
Card. Return the pre-addressed portion of the card to our
Implant Patient Registry. The remaining portions of the card are
provided for hospital and surgeon records. Upon receipt by our
Implant Patient Registry, a wallet-sized identification card will
be produced for the patient. This card allows patients to inform
healthcare providers what type of implant they have when they
seek care. When a valve is discarded or a previous Edwards
Lifesciences device is replaced, report this information to our
Implant Patient Registry.
12.2 Patient Manual
Patient information materials may be obtained from Edwards or
an Edwards clinical sales specialist.
12.3 Magnetic Resonance Imaging (MRI) Compatibility
The device has been shown not to have magnetic interactions at
up to 8 T. It is also safe with respect to RF heating at 1.2 w/kg
for up to 15 minutes. Artifacts have been determined at 1.5 T.
Prices subject to change without notice.
This product is manufactured and sold under at least one or
more of the following U.S. Patent(s); US patent No. 4,885,005;
5,928,281; 5,931,969; 5,961,549; 6,102,944; 6,210,957;
6,214,054; 6,245,105; 6,378,221; 6,413,275; 6,547,827;
6,561,970; and 6,585,766; and corresponding foreign patents.
Likewise, additional patents pending.
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