CareFusion Snowden-Pencer Instructions D'utilisation page 6

Limitations on Reprocessing
Repeated reprocessing has minimal effect on reusable insert
assemblies. End of life is determined by wear and damage due
to use. For additional guidance, see the Inspection section of
these instructions.
Warnings
• Insert assemblies shall be used in accordance with these
instructions for use. Read all sections of these instructions
prior to use. Improper use of this insert assembly may
cause serious injury. In addition, improper care and
maintenance of the insert assembly may render the insert
assembly non-sterile prior to patient use and cause a
serious injury to the patient or health care provider.
• When not in use, store in a location that is isolated from the
patient.
The following warnings are applicable to the electrosurgical
insert assemblies listed in the Appendix:
• Prior to use of the instruments in patients who have cardiac
pacemakers or other active implants, consult the implanted
device manufacturer's instructions for use. A possible
hazard exists due to interference with the intended action of
the implanted device or damage to the implanted device. In
case of doubt, qualified advice should be obtained.
• To prevent the possibility of electrical shocks or burns, do
not use insert assemblies with breaks in the insulation.
• Gas embolism may result from over-insufflation of air, inert
gas prior to high-frequency (HF) surgery or laser assist gas.
• The Snowden-Pencer insert assemblies are monopolar
devices and should only be connected to an electrosurgical
generator that is compatible with monopolar devices.
• Do not exceed the maximum rated voltage specified. Adjust
the electrosurgical generator to a setting appropriate for the
maximum peak output voltage.
• A dispersive electrode, such as a grounding pad, should be
used with the insert assembly and electrosurgical generator to
prevent burns/injury to the patient when using the monopolar
insert assembly. Ensure the pad is properly sized and properly
placed and always recheck the pad when patient is moved.
It is recommended that the insert assembly is used with
an electrosurgical generator that contains contact quality
monitoring (return electrode monitoring) with a signal to
indicate there is contact to the patient.
• When HF surgical equipment and physiological monitoring
equipment are used simultaneously on the same patient, any
monitoring electrodes should be placed as far as possible
from the surgical electrodes. Needle monitoring electrodes
are not recommended. In all cases, monitoring systems
incorporating HF current limiting devices are recommended.
• Conductive fluids (e.g., blood or saline) in direct contact
with an active electrode may carry electrical current or heat,
which may cause unintended burns to the patient.
• Non-flammable agents should be used for cleaning and
disinfection wherever possible. Flammable agents used for
cleaning or disinfecting, or as solvents of adhesives should
be allowed to evaporate before the application of HF surgery.
• There is a risk of pooling of flammable solutions under the
patient or in body depressions such as the umbilicus, and in
body cavities such as the vagina. Any fluid pooled in these
areas should be mopped up before HF surgical equipment
is used. Attention should be called to the danger of ignition
of endogenous gases. Some materials, for example cotton,
wool, and gauze, when saturated with oxygen may be
ignited by sparks produced in normal use of the HF surgical
equipment.
• The use of flammable anesthetics or oxidizing gases, such
as nitrous oxide (N
surgical procedure is carried out in the region of the thorax
or the head unless these agents are removed.
O) and oxygen, should be avoided if a
2
2