
Table of Contents
Device Description/Intended Use ............................ 1
Cautions ............................................... 1
Warnings .............................................. 1
Instructions for Use ...................................... 2
INITIAL SETUP ..................................................... 2
ULPA FILTER INSTALLATION ........................................ 2
OPERATING INSTRUCTIONS ........................................ 2
Maintenance ............................................ 3
Cleaning and Disinfection .................................. 3
Specifications ........................................... 4
Reordering Information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5
Liability Statement ....................................... 5
Warranty Information ..................................... 6
To Obtain Warranty Service ................................ 7
EMC Compliance Information .............................. 8
Explanation of Symbols .................................. 12
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Device Description /Intended Use
The CooperSurgical LEEP PRECISION™ Smoke Evacuator is
a stand alone, three-stage air filtration device that is used to capture
airborne particulate from smoke plumes produced during electrosurgical
procedures.
Cautions
•
U.S. Federal law restricts this device to sale by or on the order
of a physician.
• This device produces a strong vacuum force and care should be
exercised to ensure that the suction and the position of the inlet
end of the suction tubing is adjusted properly to prevent injury to
the patient or inadvertent damage to surgical materials.
• The materials in the plume removed by this device are potentially
hazardous. Handle according to 29 CFR 1910.1030 and
OSHA 3127.1992 (Occupational Exposure to Bloodborne
Pathogens) guidelines.
• To prevent a fire or explosion hazard, do not use the system in
the presence of flammable or potentially flammable materials.
• Do not allow fluid to be pulled into the system.
• To prevent premature failure of the ULPA filter cylinder, do not
operate this device without a disposable Pre-Filter in place.
• No modification of this equipment is allowed.
• No Customer serviceable parts.
• Only replacment of power cords or fuses can be done by the user.
Only replace with these items with the exact replacement part(s)
available from CooperSurgical.
Warning
To avoid risk of Electrical Shock, this equipment must only be connected to
a supply mains with protected earth.
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Instructions for Use
INITIAL SYSTEM SETUP
The system arrives in one carton that contains the Vacuum Unit.
The disposable accessories necessary to conduct procedures may
be purchased separately from CooperSurgical.
ULPA FILTER INSTALLATION
Insert the large ULPA Filter cylinder with
the Air Flow arrow pointing downward
(Photo A).
Photo A
OPERATING INSTRUCTIONS
Prepare the unit for use by inserting a
clean, disposable Pre-Filter onto the ULPA
Filter cylinder (Photo B). Be sure this
device is firmly seated.
For procedures requiring close proximity
plume removal (i.e., vaginal speculum)
Assemble the ⅜-inch Reducer (Catalog number
6083) onto the port on the disposable Pre-Filter
top with a slight twisting motion. Attach one end
of an appropriate length of ⅜-inch inner diameter
(ID) Evacuation Tubing (Catalog number 6084)
to the Reducer Connector and direct the other
end to the patient, as well as any appropriate
device being used, such as a vaginal speculum
equipped with a Smoke Evacuation Adapter
(Photo C).
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Photo B
Photo C

For procedures requiring open area plume removal (i.e., external lesions)
1. Assemble the sterile Disposable Evacuation Tubing (Catalog number
6084) directly into the top of the Pre-Filter. Position the opposite end
over the site to be treated.
2. Plug the LEEP PRECISION Smoke Evacuator into an appropriate wall
outlet (see Specifications).
3. Push the POWER switch to the ON position to start the unit.
4. At the completion of each procedure, activate the system to ensure
safe particle containment. Using gloves and a mask, remove the
Pre-Filter, the Reducer, and the used section of Suction Tubing
and discard into an infectious waste receptacle (see Cautions). The
CooperSurgical LEEP PRECISION Smoke Evacuator should be stored
with a new Pre-Filter and Reducer in place on the ULPA filter.
NOTE: The expected life of the ULPA filter is 3–6 months depending on
usage. It must be discarded into an infectious waste receptacle if plume
odor is detected or the suction is diminished.
Maintenance
No maintenance is required during normal operation other than making
sure that ample space is maintained around the unit to allow for free air
flow and adequate cooling.
Cleaning and Disinfection
After each patient use, follow the combined cleaning/disinfection
instructions provided below for the LEEP PRECISION Smoke Evacuator.
CLEANING
1. Prepare an enzymatic, neutral pH cleaner solution according to the
Manufacturer’s instructions.
2. Immerse a clean, lint-free wipe into cleaning solution and thoroughly
wring. Thoroughly wipe the front panel surfaces in a circular motion.
Discard the wipe.
3. Using a soft, nylon brush, scrub difficult-to-access areas such as
crevices or textured surfaces.
4. Immerse a fresh, clean, lint-free wipe under warm flowing, utility water
and thoroughly wring excess water. Thoroughly wipe the front panel
surface and crevices for at least 30 seconds. Discard the wipe.
5. Rinse a fresh, clean, lint-free wipe under warm flowing, utility water and
thoroughly wring excess water. Thoroughly wipe the front panel surface
and crevices for at least 30 seconds. Discard the wipe.
6. Inspect the device for visible soil or debris. If visible soil remains,
repeat cleaning steps 2-5 until device is visually clean.
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