Cautions
Always use the device in field of view of the camera and use caution when using other
devices so as not to damage device insulation.
Smoke-plume extraction may be necessary during electrosurgical cutting or coagulation.
Device (including insulation) and device accessories must be inspected prior to use to
ensure integrity. In particular, electrode cables and endoscopically used accessories
should be checked for possible damage to the insulation.
To prevent the possibility of electrical shocks or burns, do not use devices with breaks in
the insulation.
When used in conjuction with laser equipment, always use caution (i.e. eye protection).
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 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 forceps 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.
Inspect insulation. Any interruptions in the coating may compromise the safety of the
device. To prevent the possibility of electrical shocks or burns, do not use devices with
breaks in the insulation.
Avoid mechanical shock or overstressing the devices. Close distal ends prior to insertion
or removal through cannulas.
Devices 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.
Only the cleaning and sterilization processes which are defined within these instructions
for use have been validated.
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 and/or
insulation. 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.
Use only neutral pH (6-8) detergent solutions.
Rated Voltage
The maximum recurring peak voltage for devices applicable to this IFU is 0.5kVp.
Note: Failure of the electrosurgical generator may result in an unintended increase in
output power.
Electrode Cable Compatibility
All of Snowden-Pencer monopolar electrosurgical devices are compatible with the Unipolar
Bovie Cord with universal plug (88-9199) or equivalent.
Pre-processing instructions
Initiate cleaning of device within 2 hours of use.
Transport devices via the institutions established transport procedure.
Remove excess gross soil as soon as possible after use by rinsing or wiping the device.
All devices must be processed in the completely open position (i.e. jaws, flush-ports etc).
Devices should not be disassembled.
Manual Cleaning
(Steps 5, 6, 7, 9 and 11 are required for lumen devices only.)
1. Ensure all pre-processing instructions are followed prior to cleaning.
2. Prepare the enzymatic/neutral pH detergent solution, utilizing drinking/potable water
with a temperature range of 27°C to 44°C (81°F to 111°F), per manufacturer's
instructions.
3. Place the device in the open/relaxed position, with flush port open. Completely
immerse the device in the detergent solution and allow it to soak for a minimum of
5 minutes. Actuate all movable parts during the initiation of the soak time.
4. Using a soft bristled brush, remove all visible soil from the device. Actuate the device
while brushing, paying particular attention to hinges, crevices and other difficult to
clean areas. Note: It is recommended that the detergent solution be changed when it
becomes grossly contaminated (bloody and/or turbid).
5. For lumen devices, use a soft bristled brush with a brush diameter and length that is
equivalent to lumen diameter and length. Scrub the lumen
(i.e. angulated/nonangulated positions) until no visible soil is detected in the lumen
rinsing step below.
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