CareFusion Snowden-Pencer Diamond-Line 2 Manual De Usuario página 2

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Catalog Numbers
All products covered by these instructions are listed in the appendix.
These instructions for use are intended to be used with the ergonomic ring handle.
(Pictured Below)
Non-electrosurgical devices are defined in Table 1.
Electrosurgical devices are defined in Table 2.
Indications For Use
Endoscopic devices are designed to transmit cutting, grasping and dissecting force
through delicate mechanisms to delicate working tips in minimally invasive cardiac,
general surgical, and plastic surgery.
How Supplied
Snowden-Pencer devices are packaged as non-sterile. Cleaning and sterilization
must occur prior to use.
Limitations on Reprocessing
Repeated reprocessing has minimal effect on these devices. End of life is normally
determined by wear and damage due to use.
Warnings
Devices shall be used in accordance with these instructions for use. Read all
sections of this insert prior to use. Improper use of this device may cause serious
injury. In addition, improper care and maintenance of the device may render the
device 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.
Prior to use of the device in patients who have cardiac pacemakers or other active
implants, a possible hazard exists because interference with the action of the device
or damage to the device may occur. Consult device manufacturer's instructions for
use. In case of doubt, qualified advice should be obtained.
Gas embolism may result from over-insufflation of air, inert gas prior to HF surgery
or laser assist gas.
The Snowden-Pencer instrument is a monopolar device and should only be
connected to a generator that is compatible with monopolar devices.
Do not exceed the 1kVp maximum rating specified for this device. 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 device
and generator to prevent burns/injury to the patient when using the monopolar
device. Ensure the pad is properly sized and properly placed and always recheck the
pad when patient is moved. It is recommended that the device is used with an HF
generator that contains contact quality monitoring (return electrode monitoring) with
a signal to indicate there is contact to the patient.
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.
Do not use Snowden-Pencer devices with energy in the presence of combustible/
explosive gases or other flammable anesthetics, such as nitrous oxide (N O) and
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oxygen. Non-flammable agents used for cleaning and disinfecting, or as solvents
of adhesive should be allowed to evaporate before the application of HF surgery.
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.
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.
To reduce capacitive coupling, the device should only be activated when in position
to deliver energy to the target tissue.
Activating the electrosurgical unit while simultaneously utilizing the suction/irrigation
may alter the path of the electrical energy away from target tissue.
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