Stryker Harmonic Ace+7, Instructions For Use Manual

Page: 7 / 19

Reprocessed HARMONIC ACE
®
+7, 5mm Diameter Shears with
Advanced Hemostasis Page 7 of 19
9. Note: Take care to avoid injury from the blade tip while sliding the torque wrench onto or off of the shaft.
Operation
1. Connect the assembled Hand Piece and instrument to the generator and turn the generator power on.
Note: MIN is the only mode that can be adjusted.
2. Select the desired minimum power level using the INCREASE and DECREASE "buttons on the generator touchscreen.
Note: The recommended minimum starting power level is Level 3 (Illustration 4). For greater tissue cutting speed use a
higher generator power level, and for greater coagulation use a lower generator power level. The amount of energy
delivered to the tissue and resultant tissue effects are a function of many factors, including the power level selected, blade
characteristics, grip force, tissue tension, tissue type, pathology, and surgical technique.
3. For optimal performance and to avoid tissue sticking, clean the instrument blade, clamp arm, and distal end of the shaft
throughout the procedure by activating the instrument tip in saline (Illustration 5).
Note: Do not touch the instrument to metal while activated (Illustration 6).
Note: Do not clean the blade tip with abrasives. It can be wiped with a moist gauze sponge to remove tissue, if necessary.
If tissue is still visible in the clamp arm, use hemostats to remove residue, taking care not to actuate the Hand Piece. If
desired, the instrument may be unplugged (Illustration 7).
4. The blade is ultrasonically energized when either the foot switch pedal is depressed or one of the hand control buttons is
depressed. Pressing the left foot pedal of the footswitch or the lower hand control button (MIN) on the instrument
activates the selected minimum power level. Pressing the right foot pedal of the footswitch or upper hand control button
(MAX) on the instrument activates the maximum power level. Pressing the Advanced Hemostasis button on the
instrument activates the Advanced Hemostasis. Under default settings, Advanced Hemostasis is hand-activated only. Note:
The "MIN" button can be re-assigned to Advanced Hemostasis by selecting "Convert MIN to Advanced Hemostasis" on the
GEN11 "Settings” screen. Refer to the Generator G11 Operator's Manual "Settings" section (Illustration 8). Once "Convert
MIN to Advanced Hemostasis" is selected, the Advanced Hemostasis button is disabled.
Note: Energy is not delivered in Advanced Hemostasis mode until the jaws are completely closed.
Caution: If activation is unintentionally stopped while sealing, maintain jaw closure and reactivate.
Note: The generator provides an audible tone to indicate when the instrument blade is active. The generator changes to a
second activation tone as Adaptive Tissue Technology regulates the delivery of energy.
•
Thermal influences such as fluids or minimal to no tissue in the jaws may affect the presence or timing of the
tone change.
•
The tone change does not provide confirmation of tissue effect. When the second tone is heard, the situation
should be assessed and the intended surgical action completed, such as gradual application of tension to
facilitate transection.
•
The secondary activation tone change is not a substitute for surgical experience.
Note: Scratches on the blade may lead to premature blade failure.
•
Avoid accidental contact with other instruments during use.
•
Do not use any means other than the torque wrench to attach or detach the instrument from the Hand Piece.
5. Close the clamp arm by closing the trigger, and insert the shaft through a trocar or incision.
6. The instrument can be used for dissection, grasping, coagulation, and cutting between the blade and clamp arm.
Note: To achieve complete sealing, the trigger should be fully closed and the vessel fully contained between clamp arm and
blade of device. An audible and tactile "click" indicates full trigger closure. To achieve full closure of the jaws of the device,
squeeze the plastic trigger until you feel it stop against the plastic handle (plastic to plastic) (Illustration 9). If full trigger
closure is released prior to or during activation on tissue, an audible and tactile "click" is evident. Increase grip force until
full trigger closure is achieved.
Note: Keep clamp arm open when using the inside bottom of the blade for backcutting (Illustration 10).
WARNING: Do not use Advanced Hemostasis mode for procedures where energy application is desired prior to full
closure of the jaws (e.g. solid organs). Energy is not delivered in Advanced Hemostasis mode until the jaws are completely
closed.
WARNING: During benchtop testing of vessels >5 mm, the strongest vessel seals were achieved by allowing the Advanced
Hemostasis mode to completely transect the targeted vessel.
WARNING: Prolonged usage of Advanced Hemostasis Mode may cause tissue pad damage.
7. Close the clamp arm by closing the trigger and remove the shaft from the trocar or incision.
Shaft Rotation
1. The instrument’s shaft can be rotated 360°to facilitate visualization and access to target tissue when dissecting, grasping,
coagulating, and cutting.