CareFusion Snowden-Pencer Indications For Use page 2

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Indications For Use
Endoscopic Instruments
Endoscopic instruments are designed to transmit cutting,
grasping and dissecting force through delicate mechanisms to
delicate working tips through a cannula.
General Surgical Instruments
General surgical instruments are designed to grasp, cut,
dissect, elevate and reposition tissue and surgical materials.
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.
Cautions
If there are any variations between these instructions and either
your facility's policies and/or your cleaning/sterilization
equipment manufacturer's instructions, those variations should
be brought to the attention of the appropriate responsible
hospital personnel for resolution before proceeding with
cleaning and sterilizing your devices. Use instruments for their
intended surgical purposes only.
Use of device for a task other than that for which it is intended
will usually result in a damaged or broken device.
Examples
1. Use of a delicate dissector as a grasper.
2. Use of a delicate scissor to cut suture.
3. Use of a dissector to remove clips.
4. Use of a 5mm grasper or dissector instead of a 10mm claw
extractor forcep to remove excised tissue through cannula.
Prior to use, inspect device to ensure proper function and
condition. Do not use devices if they do not satisfactorily
perform their intended function or have physical damage.
Prior to use, all insulated instruments should be inspected to
ensure proper insulation. Any interruptions in the coating may
compromise the safety of the instrument. To prevent the
possibility of electrical shocks or burns, instruments with
cracks in the insulation should be returned to Snowden-Pencer
for repair or replacement.
Do not use Snowden-Pencer instruments if they do not perform
satisfactorily in an operational test. Avoid mechanical shock or
overstressing the devices. Close distal ends prior to insertion or
removal through cannulas.
Always use caution when inserting or removing devices
through cannula. Lateral pressure on the device during removal
can damage the working tip, shaft of the device. Be sure the
tips are closed and the device is pulled straight out until
completely clear of cannula to avoid catching the valve
assemblies in cannulas or dislodging the cannula.
Avoid overstressing mechanism of instruments by properly
gripping and maneuvering during surgery. Instruments are
designed to be held with one finger and thumb in ring handles.
If force is applied in any other fashion (such as holding handles
in a whole hand pistol grip), the mechanism can be easily
overstressed resulting in damage or breakage.
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