User's Manual Part 5

8065751025 3.11
Constellation
®
Vision System
Fragmentation Setup Procedure
1. Scan the bar code on the Constellation
®
Fragmentation Kit with the
Bar Code Scanner in the back of the Constellation
®
console.
Circulator or Non-sterile
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2. Open the pouch and aseptically transfer the sealed plastic tray to
the sterile field. The plastic tray that contains the components is
considered sterile.
Circulator
3. Peel the Tyvek lid from the plastic tray and remove the contents from
the tray. Note: Do not discard the plastic tray as it can be used to
capture the excess fluid during priming and tuning.
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4. Connect the Female/Female luer to the Auxiliary Aspiration line (Light
Blue). There is also an additional Female/Female luer in the small
parts kit that come in the cassette Procedure Pak.
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5. Connect the Auxiliary Aspiration line to the luer port on the proximal
end of the Fragmentation Handpiece.
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6. Connect the Fragmentation Handpiece electrical connector to the
Ultrasound Handpiece port on the console.
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7. Attach the Fragmentation tip to the handpiece with the wrench that
the tip was packaged in. NOTE: Do not discard the wrench as it is
also used for the removal and disposal of the tip.
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8. Thread the tip on clockwise, and when tightened remove the wrench
from the handpiece. Caution: Be cautious when handling without the
tip cover as the tip is sharp.
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9. With the tip wrench removed, attach the Tuning Tip Cover over the
Fragmentation tip and on to the front end of the handpiece. Insure
that the tip is not in contact with the cover and that the tabs are
engaged by means of a positive snap for secure attachment. The
Handpiece and tip is ready for Priming and Tuning
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Push Prime Set Up Procedure
1. Set the Handpiece on the Plastic tray supplied or an absorbent drape
where excess fluid from priming can be captured. If the plastic tray is
used, insure that it is sitting on a stable surface. NOTE: Push Prime
is only available during initial set up together with the Cassette Pak.
Once the console enters Surgery Mode, the Handpiece will need to
be Suck Primed (see below for instructions)
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2. Initiate Prime in the Set Up Screen and the Handpiece will be primed
and tuned as part of the Console Priming/Set Up sequence.
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3. Wait for the confirmation that priming and tuning was successful prior
to use.
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Aspiration Prime Set Up Procedure
1. Prepare a cup or well with sterile fluid (Water/BSS) large enough
such that the entire Priming/Tuning Tip cover is submerged below the
fluid level.
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2. Submerge the front end of the Fragmentation Handpiece slowly in the
fluid container. NOTE: Verify that the entire front end including the
Tuning Tip Cover is submerged in the fluid and the tip cover is filled
with fluid. Verify that the tip is not in contact with the cover or any
other surfaces.
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3. Initiate Prime in the Set Up Screen and the handpiece will be primed
and tuned as part of the console priming set up sequence.
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4. Wait for the confirmation that priming and tuning was successful prior
to use.
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