Warnings; Precautions - Smith & Nephew DYONICS Handpiece Instructions For Use Manual

Warnings/Precautions

Warnings

• This product is shipped non-sterile . It must be
sterilized before the first use . It must be cleaned
and sterilized before every subsequent use .
• It is the surgeon's responsibility to be familiar
with the appropriate surgical techniques prior
to use of this device .
• Read these instructions completely prior to use .
• Before using DYONICS™ Handpieces for the first
time, review all available product information .
Blades can injure healthy articular soft tissue
and cartilage . Use every available means to
avoid such injury .
• Only Smith & Nephew DYONICS Disposable
Endoscopic Blades can be used with the the
DYONICS POWER Shaver System or
POWER II Control System . The blades are
intended for single use only . Do not resterilize .
Do not lubricate blades . Discard all blades
after use .
• DYONICS Disposable Endoscopic Blades are
packaged as a set . They must be used as
supplied . Do not interchange blade components .
• Periodic irrigation of the blade is recommended
to provide adequate cooling of the blade and
to prevent accumulation of excised materials
in the surgical site . Ensure that suction of
128 mmHg minimum is flowing while the
instrument is running .
• When using a footswitch, ensure that the
footswitch is not accidentally activated while
inserting the blade or plugging the connector
cable into the control unit .
• Inadvertently depressing a footswitch
while plugging in a handpiece will activate
the handpiece .
• To avoid patient burns, do not place the
handpiece on the patient when it is not
in use .
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10600266 Rev. E

Precautions

U.S. Federal law restricts these devices to sale by
or on the order of a physician.
• Prior to each use, inspect the device to ensure it is
functioning properly and not damaged. Do not use
a damaged device.
• In all cases, the judgment of the physician (in the
best interest of the patient) may take precedence
over the procedures described in these Instructions
for Use.
• Irreversible damage will result from any attempt to
disassemble curved blades.
• Irreversible damage to blades or burrs will result if
they are run without the flow of irrigation (dry).
• Do not allow the rotating portion of any blade or
burr to touch any metallic object such as a cannula
DYONICS
the
or arthroscope. Damage to both instruments is
likely. Damage to the blade can range from a slight
distortion or dulling of the blade edge to actual
fracture of the tip in vivo. If such contact does occur,
inspect the tip. If there are cracks, fractures or
dulling, or if there is any other reason to suspect
a blade is damaged, replace it immediately.
• Do not operate the handpiece in the open air for an
extended period. Lack of irrigation may cause the
motor or blade to overheat and seize.
• Excessive side-loading on the blade does not
improve cutting performance and, in extreme
cases, may result in wear and degradation of the
inner assembly.
• Dried blood, saline, and other deposits inside
the handpieces are a major cause of equipment
malfunction.
• Take special care when making curved cuts to avoid
locking the blade. Always keep the blade free to
complete its stroke.
• Do not cool the handpiece by immersing it in
cold water.
DYONICS™ Handpieces Instructions for Use