Thoratec HeartMate II Mode D'emploi page 5

Sterilization Sterilize using a validated steam autoclave with sterilization cycles at or above the minimum
requirements shown in the table below:
Gravity cycle (wrapped)
Flash Cycle (unwrapped)
Pre-Vacuum Cycle
(wrapped)
The HeartMate II Sizer will require a cool-down of approximately 20 minutes after sterilization
and prior to use.
Storage Reusable devices that will be stored between cleaning and sterilization should be dried with a
low-linting, non-abrasive soft cloth to prevent microbial contamination that could result from
wet instruments.
Store the sterilized device protected from direct contact with possible sources of corrosion or
other surface damage consistent with the procedures for sterile instrument storage approved
by your facility.
Additional Recommendations
Information
Detergents: detergents with a pH range between 6.0 and 8.0 should be used. Enzymatic
detergents aid in the removal of organic soil such as blood.
Water: the use of de-ionized water will reduce the mineral deposits on the devices.
Ultrasonic Cleaner: ultrasonic cleaning should be used only after gross oil has been removed
from the devices. Ultrasonic cleaners are used to remove adherent tissue from inner lumen
and other difficult to access locations.
Automatic Washer/Disinfector: Washer-disinfectors are not only used to clean devices, but
also to provide intermediate to high level disinfection with a hot water rinse.
Manual Cleaning Instruments: non-abrasive or soft bristle cleaning brushes, pipe cleaners,
non-abrasive low-linting cloth should be used.
Manufacturer
Contact
It is the responsibility of the user to ensure that the sterilization process as performed achieves the desired result.
Recommended procedures are intended as a general guide for sterilization of reusable medical devices. It is the
responsibility of the users to validate their sterilization equipment to ensure that the recommended minimum
parameters are achieved.
METHOD TEMPERATURE
132ºC (270ºF)
132ºC (270ºF)
132ºC (270ºF)
Thoratec Corporation
6035 Stoneridge Drive
Pleasanton, CA 94588
USA
Tel: 925-847-8600
HeartLine™: 800-456-1477
Fax: 925-847-8574
Internet: www.thoratec.com
Authorized European Representative:
Thoratec Europe Limited
Burnett House
3 Lakeview Court, Ermine Business Park
Huntingdon, Cambridgeshire PE29 6UA
United Kingdom
Tel: +44 (0) 1480 455200
Fax: +44 (0) 1480 454126
Urgent/24-Hr. Tel: +44 (0) 7659 877901
3
®
HeartMate II Surgical Sizer for HeartMate II LVAS
STERILIZATION TIME
15 minutes
10 minutes
3 minutes
DRYING TIME
70 minutes
N/A
50 minutes