Device Description; How Supplied - Medtronic MOSAIC ULTRA SUPRA-X Instrucciones De Uso

UltraSupra_EN_ch.fm 7/29/05 1:15 pm
4.375 x 7.0 inches

1 DEVICE DESCRIPTION

Mosaic/Hancock II Ultra™ Supra-X™ (supra-annular) Sizers model 7305UX (clear) and
Mosaic/Hancock II Ultra™ OD (outside diameter) Sizers model 7305OD (amber) are
manufactured using transparent polysulfone and stainless steel to enable direct observation
of the bioprosthetic valve profile within the patient's native valve annulus.
Each sizer has two ends connected by a malleable, stainless steel wire. These are intended
to aid the surgeon in selecting the optimum size Mosaic or Hancock II Ultra™ aortic porcine
bioprosthesis. These sizers are only intended for use with Mosaic and Hancock II Ultra™
aortic porcine bioprosthetic valves.
2 INDICATIONS
Sizer models 7305UX and 7305OD are intended to size a patient's valve anatomy in order
to select the appropriate Mosaic or Hancock II Ultra™ aortic porcine bioprosthestic valves.
They are not intended for use with any other manufacturer's prosthesis or with any other
Medtronic prosthesis.
3 WARNINGS
Damaged sizers should not be used. Although these sizers are for multiple use, they
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should be replaced if surface deterioration occurs.
4 PRECAUTIONS
Do NOT oversize. Implanting too large a valve may cause folding or deformation of the
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valve that may lead to incompetence or reduced valve life.
It is important to read the valve size located nearest the proper end of the sizer to prevent
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incorrect valve size selection.
When cleaning these plastic accessories, the use of some solvent-based cleaners (such
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as acetone or toluene) may cause early failure of the accessory. To increase sizer
longevity, it is recommended that only water-soluble surfactant-type soaps or mild
detergents be used as cleaning agents. Carefully inspect each sizer prior to use for
cracks or flaws that may result from sterilization, handling, or general use. Do not use
any sizer that shows excessive signs of wear or deterioration.

5 HOW SUPPLIED

5.1 Packaging
The sizers are supplied NONSTERILE in a complete set.
5.2 Available Sizes
The Supra-X™ Sizer set (model 7305UX) includes the following sizes: 19 mm, 21 mm,
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23 mm, 25 mm, 27 mm, and 29 mm. Note that the Hancock II Ultra™ aortic bioprosthetic
valve is not available in size 19 mm.
The OD Sizer set (model 7305OD) includes the following sizes: 19 mm, 21 mm, 23 mm,
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25 mm, 27 mm, and 29 mm. Note that the Hancock II Ultra™ aortic bioprosthetic valve
is not available in size 19 mm.
Instructions for Use (IFU) are included with the sizer sets.
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5.3 Storage
The sizers are intended to be stored indefinitely and may be reused with appropriate
cleaning and sterilization.
A12506001
Medtronic Confidential
CS006
English Instructions for Use 3
Rev 1.0