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EN-18
Caution: The Valve Assembly (E) must be fully connected as in Figure 2 before the Needle is inserted to avoid increasing
the risk of capsular perforation.
7. Confirm that the Protective Sheath (J) on the 7 fr Introducer is securely connected to avoid puncture and insert the
7f Introducer over the guidewire. A 9 fr sheath (not included) can provide access for the 7 fr Introducer and may be
placed prior to inserting the 7 fr Introducer.
Caution: The 7 fr Introducer is not intended to be re-formed or manipulated. Doing so may lead to damage of the device,
affect product performance, or cause other complications.
Note: If preferred, the guidewire may be more easily “back loaded” into the 7 fr Introducer while the Valve Assembly
(E) is temporarily disconnected.
Caution: The Valve Assembly (E) must be fully connected as in Figure 2 before the Needle is inserted to avoid the risk of
capsular perforation.
8. Make any appropriate adjustments to avoid capsular perforation using clinical judgment. Contrast material may be
injected through the Side Port (I) in the Valve Assembly (E) of the 7fr Introducer.
9. Remove the guidewire, and 5fr Straight Catheter (Figure 5) if used, when the desired position has been achieved.
10. Confirm that the Needle is charged (Figure 7). If it is not charged, charge the Needle by pulling back on the
Plunger until a firm click is felt and heard (Figure 6).
Caution: Functional tests are performed during manufacture. “Test firing” the device is not necessary and strongly
discouraged as the cutting edge may be damaged if not supported by surrounding tissue.
11. Gently introduce the charged Needle (Figure 7) into the Valve Assembly (E) of the 7 fr Introducer (Figure 2).
Caution: If the Valve Assembly (E) has been disconnected (Figure 9), do not insert the Needle until the Valve Assembly has
been reconnected.
12. Confirm that no critical structures are within the needle stroke length, or “throw”, of the device. Gently advance
the Needle until the Indicator Mark (C) on the Needle meets the Safety Guide (F) on the Valve Assembly (E). In this
position, the tip of the Needle is positioned near the Distal Tip (L) of the 7 fr Introducer.
13. Referencing the Red Directional Arrow (H) on the 7 fr Introducer, direct the 7 fr Introducer and, if desired, apply
gentle forward pressure to “tent” the wall of the hepatic vein adjacent to the biopsy site.