•
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.
•
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, 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 to
transect 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.
•
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.
•
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.
•
Reuse and improper reprocessing or resterilization of single use devices may compromise the structural
integrity of the device and/or lead to device failure that in turn may result in patient injury, illness, or
death.
•
Reuse and improper reprocessing or resterilization of single use devices may create a risk of
contamination and/or cause infection or cross-infection, including, but not limited to, the transmission
of infectious diseases. Contamination may lead to injury, illness, or death.
Disposal
Some internal components of the HARMONIC HD 1000i Shears instrument contain Lead (PZT Lead-
Zirconate-Titanate). Disposal should be performed according to local requirements and regulations.
How Supplied
The HARMONIC HD 1000i Shears instrument is supplied sterile for single patient use. Discard the
instrument after use.
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