Thoratec HeartMate II Mode D'emploi page 3

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HeartMate II Surgical Sizer for Thoratec
INSTRUCTIONS FOR USE
Description
The Thoratec HeartMate II Surgical Sizer (P/N 102772) is a surgical accessory that is intended
to facilitate implantation of the HeartMate II pump (P/N 102139 for Europe and 1355 for
North America) by simulating the size and shape of the actual device. It is not required for the
HeartMate II pump implantation surgical procedure. It is intended to support intra-operative
placement of the pump and sizing of the pocket. Additionally, it can be used to assist in
HeartMate II outflow cannula length optimization.
How Supplied
The HeartMate II Sizer is supplied NON-STERILE and must be cleaned and sterilized prior to
use.
Indication for Use
The HeartMate II Sizer is intended for use with the Thoratec HeartMate II System.
Contraindications
The HeartMate II Sizer is not designed, sold or intended for use except as indicated.
Note:
The Instructions for Use (IFU) for the Thoratec HeartMate
II Surgical Sizer must be used in conjunction with the
IFU for the Thoratec HeartMate II System (Doc. # 103534
for Europe and 103537 for North America).
Caution:
This product is supplied NON-STERILE and must be
STERILIZED prior to use.
Decontamination and Sterilization Processing
Method: The decontamination and sterilization Instructions for the reusable devices provided
by Thoratec below must be used in conjunction with the Instructions for Use for the
device. These recommended procedures are intended as a general guide for cleaning,
decontamination and sterilization of the reusable devices.
Warnings
Limitations on
Reprocessing
It is the responsibility of the user to ensure that the cleaning process as performed achieves
the desired result. All cleaning should be performed in a manner designed to minimize
exposure to bloodborne pathogens.
Devices require a cool down of approximately 20 minutes after sterilization and prior to use.
Automated cleaning is not recommended. Devices should not be subjected to automated
cleaning using washer-disinfectors.
Repeat processing has minimal effect on these instruments. End of life is normally
determined by wear and damage due to use.
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HeartMate II Surgical Sizer for HeartMate II LVAS
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HeartMate II System
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