Stryker Harmonic Ace+7 Instructions For Use Manual

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Reprocessed by

Instructions for Use
Reprocessed HARMONIC ACE® +7, 5mm Diameter Shears with
Advanced Hemostasis

Reprocessed Device for Single Use

Caution: Federal (U.S.A.) law restricts this device to sale by or on the order of a physician.

• STERILE

Explanation of Symbols

Sterilized by Ethylene Oxide Gas

Date of Reprocessing

Use by Date

Product Code

Do Not Reuse

See Instructions For Use

Stryker Sustainability Solutions, Inc. © 2016
1810 W Drake Dr.
Tempe AZ, 85283
sustainability.stryker .com

888.888.3433

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Illustration and Nomenclature (Illustration 1)

1. Coated Blade

7. Grip Housing

2. Clamp Arm and Tissue Pad

8. Trigger

3. Shaft

9. Hand Piece (not included)

4. Rotation Knob

10. Torque Wrench

5. MAX Hand Control Button (both sides of instrument)

11. Advanced Hemostasis Hand Control Button

6. MIN Hand Control Button (both sides of instrument)

Reprocessed HARMONIC ACE®+7, 5mm Diameter Shears with Advanced Hemostasis Description

Reprocessed HARMONIC ACE®+7, 5mm Diameter Shears with Advanced Hemostasis 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 Reprocessed HARMONIC ACE®+7, 5 mm Diameter Shears with Advanced Hemostasis are designed for use exclusively
with the Generator G11 (GEN11) software version 2013_1, 2014_1, or 2016_1. Software revision can be found under "System
lnformation" in the Generator G11 (GEN11) "Settings" menu. Refer to the Generator G11 (GEN11) Operator's Manual for more
information.

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Indications for Use

The Reprocessed HARMONIC ACE®+7, 5 mm Diameter Shears with Advanced Hemostasis are indicated for soft tissue incisions
when bleeding control and minimal thermal injury are desired. The instruments can be used as an adjunct to or substitute for
electrosurgery, lasers and steel scalpels in general, plastic, pediatric, gynecologic, urologic, thoracic, exposure to orthopedic
structures (such as spine and joint space), sealing and transection of lymphatic vessels, and other open and endoscopic
procedures. The instruments allow for the coagulation of vessels up to and including 7 mm in diameter, using the Advanced
Hemostasis hand control button.

Contraindications for Use

Reprocessed HARMONIC ACE®+7, 5 mm Diameter Shears with Advanced Hemostasis are contraindicated for:

• The instruments are not indicated for incising bone.

• The instruments are not intended for contraceptive tubal occlusion.

Warnings and Precautions

• Caution: Federal (USA) law restricts this device to sale by or on the order of a physician.

• Minimally invasive procedures should be performed only by persons having adequate training and familiarity with

minimally invasive techniques. Consult medical literature relative to techniques, complications, and hazards prior to
performance of any minimally invasive procedure.

• Minimally invasive instruments may vary in diameter from manufacturer to manufacturer. When minimally invasive

instruments and accessories from different manufacturers are employed together in a procedure, verify compatibility
prior to initiation of the procedure.

• A thorough understanding of the principles and techniques involved in laser, electrosurgical, and ultrasonic procedures is

essential to avoid shock and burn hazards to both patient and medical personnel and damage to the device or other
medical instruments. Ensure that electrical insulation or grounding is not compromised. Do not immerse instruments in
liquid unless the instruments are designed and labeled to be immersed.

• Verify compatibility with generators. Use device only with Ethicon Endo-Surgery Generator G11 (GEN11) software

version 2013_1, 2014_1, or 2016_1. 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.

• In case of system failure, ensure the availability of the appropriate back up equipment relevant to the specific procedure.

• Audible high-pitched ringing, resonating from the blade or Hand Piece, are an abnormal condition and an indicator that

the blade or Hand Piece is not operating properly. The ringing may be an indicator that the Hand Piece is beyond its useful
life or that the blade has not been attached properly, which may result in abnormally high shaft temperatures and user or
patient injury.

• The instruments allow for the coagulation of vessels up to and including 7 mm in diameter, using the Advanced

Hemostasis hand control button. Do not attempt to seal vessels in excess of 7 mm in diameter.

• Blood and tissue buildup between the blade and shaft may result in abnormally high temperatures at the distal end of the

shaft. To prevent burn injury, remove any visible tissue buildup at the distal end of the shaft.

• As with all energy sources (Electrosurgery, Laser, or Ultrasound), there are concerns about the carcinogenic and infectious

potential of the by-products, such as tissue smoke plume and aerosols. Appropriate measures such as protective eyewear,
filtration masks, and effective smoke evacuation equipment should be used in both open and laparoscopic procedures.

• Do not attempt to bend, sharpen, or otherwise alter the shape of the blade. Doing so may cause blade failure and user or

patient injury.

• To avoid user or patient injury in the event that accidental activation occurs, the instrument blade, clamp arm, and distal

end of the shaft should not be in contact with the patient, drapes, or flammable materials while not in use.

• During and following activation in tissue, the instrument blade, clamp arm, and distal 7 cm of the shaft may be hot. Avoid

unintended contact with tissue, drapes, and surgical gowns at all times.

• Avoid contact with any and all other instruments while the instrument is activated. Contact with staples, clips or other

instruments while the instrument is activated may result in cracked or broken blades.

• Do not introduce or withdraw the instrument with the jaws open through a trocar sleeve as this may damage the

instrument.

• Care should be taken not to apply pressure between the instrument blade and tissue pad without having tissue between

them. Clamping the tissue pad against the active blade without tissue on the full length of the blade will result in higher
blade, clamp arm and distal shaft temperatures and can result in possible damage to the instrument. If this occurs, there
may be an instrument failure, and the generator touchscreen displays a troubleshooting message.

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• To avoid user or patient injury, do not activate an electrosurgical device in close proximity to the HARMONIC instruments.

The aerosols created by the activation of the HARMONIC instruments in fatty tissue are potentially flammable.

• Keep the clamp arm open when back cutting or while the blade is active without tissue between the blade and tissue pad

to avoid damage to the tissue pad and increased blade, clamp arm and distal shaft temperatures.

• The entire exposed blade tip and any exposed blade shaft are active and will cut/coagulate tissue when the instrument

blade is activated. Be careful to avoid inadvertent contact between all exposed blade surfaces and surrounding tissue
when using the instrument.

• Use only the appropriate Foot Switch, Hand Piece, instruments, and power cord to ensure that they are compatible with

the generator.

• After removing the instrument, examine the tissue for hemostasis. If hemostasis is not present, appropriate techniques

should be used to achieve hemostasis.

• Successful hemostasis may require adjunct measures when HARMONIC instruments are used on solid organs. Due to the

difficulty of visualizing internal structures, proceed slowly and do not attempt to transect large masses of tissue in one
activation. Avoid the division of large vascular/biliary bundles when using the instrument under these conditions.

• If activation is unintentionally stopped while sealing, maintain jaw closure and reactivate.

• 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.

• 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.

• Prolonged usage of Advanced Hemostasis Mode may cause tissue pad damage.

• Products manufactured or distributed by companies not authorized by Ethicon Endo-Surgery may not be compatible with

the HARMONIC system. Use of such products may lead to unanticipated results and possible injury to the user or patient.

• If during use the generator displays ''Advanced Features Are Not Available In This Device", the following functions of

Adaptive Tissue Technology are no longer available: Regulated Energy Delivery, Enhanced Audible Feedback and
Advanced Hemostasis. As a consequence, the device vessel sealing indication does not exceed 5 mm.

• Instruments or devices which come into contact with bodily fluids may require special disposal handling to prevent

biological contamination.

• Incidental and prolonged activation against solid surfaces, such as bone, may result in blade heating and subsequent blade

failure, and should be avoided.

• Dispose of all opened instruments whether used or unused.

• This device is packaged and sterilized for single use only. Multiple patient use may compromise the device integrity or

create a risk of contamination that, in turn, may result in patient injury or illness.

Directions for Use

1. Verify compatibility of all instruments and accessories prior to using this instrument (refer to Warnings and

Precautions).

2. The Hand Piece is shipped non-sterile. It must be sterilized prior to each use according to the instructions for use supplied

with the Hand Piece.

Assembly

1. Using sterile technique, remove the instrument from the package. To avoid damage, do not flip the instrument into the

sterile field.

2. While holding the Hand Piece in a vertical orientation, attach the Hand Piece to the instrument by rotating the instrument

onto the Hand Piece in a clockwise rotation as viewed from the distal end of the instrument (finger tight only).

3. Use the torque wrench (already mounted to the shaft) to tighten the blade onto the Hand Piece. Turn the torque wrench

clockwise while holding only the gray Hand Piece until it clicks twice indicating that sufficient torque has been applied to
secure the blade.

4. Note: Do not use any other means than the torque wrench to attach or detach the instrument from the Hand Piece.

5. Note: Do not torque the instrument by hand without the torque wrench or damage may occur to the Hand Piece.

6. Note: Hold only the gray Hand Piece and not the instrument handle while applying the torque wrench (Illustration 2).

7. Close the trigger. Remove the torque wrench by sliding it off of the shaft. Do not dispose of the torque wrench until the

procedure is completed. The torque wrench is used to remove the instrument from the Hand Piece following the
procedure (Illustration 3). Dispose of the torque wrench only after completing the procedure.

8. Note: Take care to avoid damage to the blade and clamp arm by closing the trigger while sliding the torque wrench onto or

off of the shaft.