Integra 1523243, Инструкция по эксплуатации

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Introduction
Ultrasonic surgical aspirators facilitate the removal
of cellular and other unwanted soft and hard (e.g.
bone) tissue. These systems provide selective
tissue disintegration with simultaneous irrigation
and aspiration.
Caution
As with the use of all ultrasonic surgical
aspirators, care should be taken to avoid contact
with critical structures or tissue not intended
for removal by ultrasound. The tip cuts and
fragments tissue at the point of contact, and
may also cause unintended localized thermal
effects to surrounding tissue.
This Instructions for Use (IFU) document covers
the installation and use of the Extended Length
Tip, which is compatible with both the CUSA
NXT™ and CUSA Selector® systems. Refer to the
CUSA NXT™ and CUSA Selector® Operator’s
Manuals for additional system information,
including system operation and system
reprocessing instructions.
This IFU should be read in its entirety by surgeons,
nurses, and technicians who will use the Extended
Length Tip before using the instrument in a
surgical procedure.
Indications for Use
The CUSA NXT™ Extended Length Tip for soft
tissue is an accessory to the CUSA NXT™ and
CUSA Selector® Ultrasonic Surgical Aspirator
Systems that are indicated for use in surgical
procedures where fragmentation, emulsification
and aspiration of soft and hard (e.g. bone) tissue is
desirable, including Neurosurgery, Gastrointestinal
and affiliated organ surgery, Urological surgery,
Plastic and Reconstructive surgery, General
surgery, Orthopedic surgery, Gynecological
surgery, Thoracic surgery, Laparoscopic surgery,
and Thoracoscopic surgery.
Warning
• The Extended Length Tip utilizes a silicone flue.
Compressing the flue against the side of the
vibrating surface along the length of the tip can
cause excessive heating and potential burns along
the surgical path.
• Excessive loading of the Extended Length Tip at
the distal end can induce heating due to vibration
and acoustic power transmission into adjacent
tissue that may not be easily visualized due to
anatomical constraints. Discontinue use if tissue is
not easily removed by the Extended Length Tip.
• Thermal management of the surgical site with
the aid of appropriate irrigation and aspiration
setting is essential.
• Avoid excessive lateral loading with the
Extended Length Tip.
• Avoid contacting bone with the Extended
Length Tip.
Warning
For single patient use only. Do
not re-sterilize, reprocess or
re-use.
Device(s) is (are) intended to be used for one
procedure only. It is not re-sterilisable and if
reprocessed or reused may result in the infection
of patient (or patient specimen) through cross-
contamination, as well as would incur the risk of
modifying the properties and performance of the
device, and of increasing the likelihood of the
complications and/or undesirable effects. Once
used, devices must be disposed of in accordance
with hospital policies.
Review the IFU Before Use
It is imperative that the procedures described in
this IFU and the system’s Operator’s Manual are
followed carefully. The use of the instrument in
any other manner may result in personal injury.
While the Operator’s Manual provides information
on the operation of the system, it provides no
instructions for any surgical procedure.
List of Components
The Extended Length Tip kit includes the following
disposable components:
• Tip
• Flue
• Shroud
The components in this kit are nonpyrogenic.
Symbols
Symbol Definition
Consult instructions for use.
Do not use if package is
damaged.
Sterilized using Ethylene
Oxide.
Single use only.
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EN