Thoratec HeartMate II Mode D'emploi page 4

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HeartMate II Surgical Sizer for HeartMate II LVAS
INSTRUCTIONS
Point of Use
Preparing for
Decontamination
Automated
Cleaning
Manual Cleaning
Disinfecting
Drying
Maintenance,
Inspection and
Testing
Packaging
The HeartMate II Sizer is a reusable device. Clean and sterilize using the procedures listed
below
Thorough cleaning and rinsing should begin as soon as possible after use of the device.
Containment devices are cleaned separately from the instruments and therefore have
separate cleaning methods. Follow standard cleaning procedures for containment devices
approved at your facility.
No particular requirements.
It is recommended that devices be sterilized as soon as cleaning is completed.
Not recommended.
Equipment: detergent, water, cleaning brushes
Method:
1. Soak the contaminated device in a warm mixture of water and detergent and allow
sitting for 20 minutes. Use soft bristle brush to remove any blood soil while soaking.
2. Remove the contaminated device from the soaking bath and rinse in hot water at
55-60ºC until there are no visible signs of contaminated soil remains.
3. Place the device in a sonic bath filled with an enzymatic cleaner prepared per the
manufacturer's instructions. Sonicate for 10 minutes.
4. Rinse thoroughly with warm water. If the components of the instrument are
moveable or can be retracted, it is necessary to retract or open the parts for
thorough rinsing at these locations.
5. For a device with internal surfaces, it is necessary to pay particular attention to the
cleanliness of internal surfaces.
6. Check the device for visible soil. Repeat cleaning if soil is visible.
No particular requirements.
No particular requirements.
No particular requirements.
Each HeartMate II Sizer should be carefully inspected upon receipt and prior to each surgical
procedure for damage to surfaces of the device that could affect the performance of the device
or cause harm during implantation. Such damage may include dents, deep scratches, cracks,
and rough edges that could cause tears to tissue during use. If damage is noted upon initial
receipt of the product, return to Thoratec for a replacement.
No particular requirements.
Double wrapping in an autoclave suitable towel for sterilization is acceptable.
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