Precautions; How Supplied; Directions For Use; Sizer And Gage Sphere Accuracy Statement - Biostable HAART 201 Instrucciones De Uso

 Correct annuloplasty device sizing is an important
element of successful valve repair. Significant under-
sizing can result in valve stenosis or ring dehiscence.
Oversizing can result in valve regurgitation. The size
of the HAART 200 Aortic Annuloplasty Device is se-
lected using Sizers consistent with the design intent of
the Device. Use only the HAART Sizers included in the
HAART 201 Instrument Set to select the proper Device
size.
 Use only the HAART Handle to interface with the
Device Holder, Sizers and Gage Sphere.
 The Sizers, Gage Sphere, and Handle are provided
NONSTERILE and must be cleaned and sterilized prior
to each use.
 Only surgeons having received training in HAART
device implantation and sizing techniques should use
this Device.
 The HAART 201 Instrument Set is not intended for
use with devices other than the HAART 200 Aortic
Annuloplasty Device.
 Ultrasonic cleaning should not be used on the HAART
201 Sizers or Gage Sphere since it may cause crazing
of the polymer material and markings.

5. Precautions

The Sizers and Gage Sphere should be visually inspected
for crazing of polymer materials, cracks and signs of
structural weakness, or unreadable markings before each
use.
The Handle should be inspected for visible cracks or signs
of structural weakness before each use and after bending.
Replace any instrument that exhibits these faults as they
may not function properly and could cause patient injury.

6. How Supplied

The HAART 201 Instrument Set is provided NONSTERILE
in a stainless steel tray. The instruments are provided
clean, but NONSTERILE.
Upon initial receipt of the Instrument Set, remove all
packaging materials and carefully examine all instruments
for signs of shipping damage. The instruments must be
visually inspected, cleaned, and sterilized before each
use.
Discard any instruments that show signs of damage or
unreadable markings.
Store the instrument set in a clean environment.
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7. Directions for Use

The HAART 201 Instrument Set is intended to be used
as an aid in the implantation of the HAART 200 Aortic
Annuloplasty Device. See the Directions for Use for the
HAART 200 Aortic Annuloplasty Device.

8. Sizer and Gage Sphere Accuracy Statement

Sizers serve as a visual gage for choosing an appropriate
Device size based on the leaflet free-edge lengths of the
aortic valve. Size diameters are accurate to ±0.010 inches
(0.254 mm) of the specified size.
The Gage Sphere is intended only as a reference and
visual aid to assess leaflet effective height and leaflet
geometric length following leaflet repair. The scales on
the Gage Sphere are accurate to ±0.008 inches (0.2 mm)
between adjacent marks.

9. Cleaning and Sterilization Prior to Use

Warning: The HAART 201 Instrument Set is provided
NONSTERILE and must be thoroughly cleaned and
sterilized prior to use.

9.1 Cleaning Instructions

The Handle should be removed from the Sizer or the Gage
Sphere prior to cleaning.
Note: If transport of the instruments to the processing
area is likely to be delayed, place the instruments in a
covered container with an appropriate detergent (e.g. Enzol
Enzymatic Detergent or equivalent) to delay drying.
Within a maximum of 2 hours after use, remove gross
soil using a cold (25° to 30°C) water rinse with running
tap water and soak for 1 minute in an enzyme detergent
(e.g. Enzol Enzymatic Detergent) prepared with 2 oz. per
gallon of water. Immerse instruments in a container of an
appropriate cleaner (e.g. Enzol) prepared with 2 ounces to
1 gallon tap water (15° to 30°C) for a minimum of two (2)
minutes. Using a bristle brush, clean the threaded area of
the sizers and gage spheres for 15 to 20 seconds to ensure
removal of any impacted soil.
Rinse in running tap water (20° to 35°C) until all traces of
cleaning solution are visually removed. Visually inspect for
any remaining soil and repeat the process if necessary. Dry
using a soft cloth and transport to the cleaning step.
Clean the instrument in an automated washer using the
following parameters:
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