`
`Edwards Lifesciences v. Boston Scientific Scimed
` IPR2017-00060 U.S. Patent 8,992,608
` Exhibit 2034 - Part 5
` PROTECTIVE ORDER MATERIAL
`
`
`
`Page 57 of 172
`
`Edwards Lifesciences v. Boston Scientific Scimed
` IPR2017-00060 U.S. Patent 8,992,608
` Exhibit 2034 - Part 5
` PROTECTIVE ORDER MATERIAL
`
`
`
`Page 58 of 172
`
`Edwards Lifesciences v. Boston Scientific Scimed
` IPR2017-00060 U.S. Patent 8,992,608
` Exhibit 2034 - Part 5
` PROTECTIVE ORDER MATERIAL
`
`
`
`Page 59 of 172
`
`Edwards Lifesciences v. Boston Scientific Scimed
` IPR2017-00060 U.S. Patent 8,992,608
` Exhibit 2034 - Part 5
` PROTECTIVE ORDER MATERIAL
`
`
`
`Page 60 of 172
`
`Edwards Lifesciences v. Boston Scientific Scimed
` IPR2017-00060 U.S. Patent 8,992,608
` Exhibit 2034 - Part 5
` PROTECTIVE ORDER MATERIAL
`
`
`
`Page 61 of 172
`
`Edwards Lifesciences v. Boston Scientific Scimed
` IPR2017-00060 U.S. Patent 8,992,608
` Exhibit 2034 - Part 5
` PROTECTIVE ORDER MATERIAL
`
`
`
`Page 62 of 172
`
`Edwards Lifesciences v. Boston Scientific Scimed
` IPR2017-00060 U.S. Patent 8,992,608
` Exhibit 2034 - Part 5
` PROTECTIVE ORDER MATERIAL
`
`
`
`l J
`
`
`
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`
`If necessary, appropriately
`dilate the vessel by
`inserting the dilator past
`the aortic bifurcation
`
`A second dilator may or
`may not be included with
`the system for vessel
`dilation
`
`If the same dilator is used
`
`for vessel dilation and
`
`sheath insertion, check to
`ensure dilator has not
`
`been damaged before
`inserting into sheath
`
`
`
`With Audio
`
`Click Above to Play Video‘
`
`
`
`Sheath Insertion
`
`- Hydrate sheath but do not wipe off hydrophilic coating
`
`Insert the sheath with the Edwards logo facing upward so the seam remains
`down to ensure proper sheath performance
`
`Insert slowly with continuous motion to minimize friction
`
`- Ensure fully expandable portion remains completely within the vessel for proper
`hemostasis
`
`- Ensure the sheath tip is inserted beyond the aortic bifurcation
`
`’—
`
`NOTE:
`Do not use if the sheath is damaged (i.e. kinked or stretched)
`
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`Fully Expandable
`
`Partially Expandable
`
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`Additional Considerations
`
`
`
`Apply tension to wire to provide firm rail for placement
`
`Always observe fluoroscopy during insertion
`
`Proper screening is critical to reducing vascular complications
`
`SAPIEN 3 Valve and Edwards
`
`Commander System
`
`Sheath ID (unexpanded)
`
`14F
`
`14F
`
`16F
`
`Minimum Access Vessel Diameter*
`
`5.5 mm
`
`5.5 mm
`
`6.0 mm
`
`*The Edwards eSheath introducer set is contraindicated for tortuous or
`
`calcified vessels that would prevent safe entry ofthe introducer and sheath
`
`
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