Indications For Use; How Supplied - CareFusion Snowden-Pencer Guia De Inicio Rapido

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Catalog Numbers
Table 1 (Reusable handles - non-sterile) SP90-1050, SP90-1150, SP90-1250
Table 2 (Single use scissor tips - sterile) E89-5100B, E89-5300B, 89-5100B, 89-5105B,
89-5200B, 89-5300B
Table 3 (Accessories) 88-9860, 88-9861

Indications For Use

Endoscopic devices are designed to transmit cutting and dissecting force through delicate
mechanisms to delicate working tips through a cannula.
Electrosurgical devices are intended to be connected to Electrosurgical Units via cables to
allow monopolar cutting and coagulation.

How Supplied

The switch blade handles are supplied as non sterile. Cleaning and sterilization must occur
prior to use. (See table 1)
The switch blade scissor tips are supplied as sterile. (See table 2)
Do not use if single use sterile package is damaged.
Limitations on Reprocessing
Repeated processing on the reusable devices has minimal effect. End of life is normally
determined by wear and damage due to use.
The switch blade scissor tips are for single use only. Reuse may result in a non-functional
product or contribute to cross contamination.
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 0.5kVp 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 oxygen. Non-
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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.
Improper connections of accessories may result in inadvertent accessory activation or
other potentially hazardous conditions.
Connect adaptors and accessories to the electrosurgical unit only when the unit is off.
Failure to do so may result in an injury or electrical shock to the patient or operating room
personnel.
Start with the lowest possible power setting on the electrosurgical generator. To achieve
the desired cutting and coagulation, check the patient circuit and then gradually increase
the power setting. Note: the output power selected should be as low as possible for the
intended purpose.
Do not activate the electrosurgical unit until the device has made contact with the patient.
Interference produced by the operation of the HF surgical equipment may adversely
influence the operation of other electronic equipment.
Use of low frequency power could result in neuromuscular stimulation.
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