Short Overview

The HARMONIC ACE®+7, 5 mm Diameter Shears with Advanced Hemostasis are intended for soft tissue incisions when bleeding control and minimal thermal injury are desired.
The instruments are sterile, single-patient-use instruments consisting of an ergonomic grip housing assembly with hand control buttons (MIN for minimum power level, MAX for maximum power level, and Advanced Hemostasis for large vessel sealing).
An integrated audible and tactile mechanism in the grip housing indicates full trigger closure. The instruments have a clamp arm and coated curved blade that are designed to work through a 5 mm trocar, through a 5 mm reducer cap in a larger diameter trocar, or through an incision without the use of a trocar. The instrument shafts can be rotated 360° to facilitate visualization and access to targeted tissue. The three dashes on the instrument are intended to represent relative vessel size. The MAX button is typically used for smaller vessels where cutting speed is fastest. The MIN button is typically used in slightly larger vessels and has reduced cutting speed. It is indicated for vessels up to 5 mm in size. The Advanced Hemostasis button is designed for larger vessels and is indicated for vessels up to 7 mm in size. In this mode, cutting speed is further reduced and hemostasis is maximized. The instruments utilize Adaptive Tissue Technology. This provides the generator with the ability to identify and monitor the instrument during use, which enables the generator to modulate and adjust its power output as well as provide audible feedback to the user as appropriate.
Each instrument is shipped with one sterile, single-use, disposable torque wrench. Use only the gray torque wrench provided with the instrument. The torque wrench should not be discarded until the completion of the surgical case. Do not attempt to sterilize the disposable torque wrench.
Note: Use of HARMONIC torque wrenches other than the one provided may result in damage to the device.
The HARMONIC ACE®+7, 5 mm Diameter Shears with Advanced Hemostasis are designed for use exclusively with the Generator G11 (GEN11) software version 2013_1 or later. Software revision can be found under “System Information” in the Generator G11 (GEN11) “Settings” menu. Refer to the Generator G11 (GEN11) Operator’s Manual for more information.

Procedures involving the use of the device should be performed only by healthcare professionals having adequate training and familiarity with open procedures and the use of ultrasonic devices.
One or more components of this device contains the following substance(s) defined as CMR 1B in a concentration above 0.1% weight by weight:
Material Present Residual Risk
Cobalt:
CAS No. 7440-48-4
EC No. 231-158-0
Current scientific evidence supports that medical devices manufactured from cobalt alloys or stainless steel alloys containing cobalt do not cause an increased risk of cancer or adverse reproductive effects.

Ethicon, Intructions For Use, Harmonic. © Ethicon, Inc. 2021