Stryker Harmonic Ace+7, Инструкция по эксплуатации

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Reprocessed HARMONIC ACE
®
+7, 5mm Diameter Shears with
Advanced Hemostasis Page 5 of 19
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.