Stryker Harmonic Ace+7, Инструкция по эксплуатации

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Reprocessed HARMONIC ACE
®
+7, 5mm Diameter Shears with
Advanced Hemostasis Page 6 of 19
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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.
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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.
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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.
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Use only the appropriate Foot Switch, Hand Piece, instruments, and power cord to ensure that they are compatible with
the generator.
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After removing the instrument, examine the tissue for hemostasis. If hemostasis is not present, appropriate techniques
should be used to achieve hemostasis.
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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.
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If activation is unintentionally stopped while sealing, maintain jaw closure and reactivate.
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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.
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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.
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Prolonged usage of Advanced Hemostasis Mode may cause tissue pad damage.
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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.
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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.
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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.
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Dispose of all opened instruments whether used or unused.
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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.