Short Overview

The HARMONIC ACE® 5 mm Diameter Shears + Adaptive Tissue Technology 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 and MAX for maximum power level).
An integrated audible and tactile mechanism in the grip housing indicates full trigger closure. The instruments have a clamp arm and 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 instruments allow for the coagulation of vessels up to and including 5 mm in diameter. Adaptive Tissue Technology provides the generator with the ability to identify and monitor the instrument during use, which enables the generator to modulate and decrease 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® 5 mm Diameter Shears + Adaptive Tissue Technology are compatible with Ethicon Endo-Surgery G11 (GEN11), software version X or later, or other compatible Ethicon generators. Refer to the Ethicon Generator 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.
The footnote adjacent to the above symbol on the packaging refers to the relevant Material Present

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