Electrosurgical instruments can pose a significant shock, burn
or explosion hazard if used improperly, incorrectly or carelessly.
Avoid touching or grounding electrosurgical instruments to
non-insulated instruments, scopes, trocar sleeves, etc. All
persons using such devices should be knowledgeable in the use
and handling of laparoscopic instruments, coagulation
equipment, their accessories and other related equipment.
Do not use in presence of flammable liquids or anesthetics.
Electrosurgical generators used with these devices are designed
to cause destruction of tissue and are inherently dangerous if
operated improperly. Follow all safety precautions and instructions
supplied by the manufacturer of the electrosurgical generator.
The electrode tip must always be in full view before activating
power. Apply power only when electrode tip is in full contact
with the tissue selected for coagulation. Electrode tip must not
come in contact with other metal instruments during use.
Failure to observe these cautions and contraindications may
result in injury, malfunction or other unanticipated occurrences
or events for the operator, staff and/or the patient.
Only the cleaning and sterilization processes which are defined
within these Instructions for Use have been validated.
Use only neutral pH (6-8) detergent solutions.
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. flushports, jaws, etc.) to allow solution contact of all surfaces.
Note: that applicable device disassembly should not require any
mechanical tooling (i.e. screwdriver, pliers etc.) unless
otherwise indicated.
Manual Cleaning
Manual Cleaning Process - Enzymatic/neutral pH Detergent
Note: Steps 5, 6, 7, 9, and 11 pertain to only devices with lumens.
1. Ensure all pre-processing instructions are followed prior to
cleaning.
2. Prepare the enzymatic/neutral pH detergent solution,
utilizing drinking 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.
6. For lumen devices, place the device into the open/relaxed
position with the distal tip pointed down. Flush the device
with a minimum of 50 ml of detergent solution utilizing a
temperature range of 27°C to 44°C (81°F to 111°F), by
using the flushing port located on the handle/shaft. Repeat
the flush process a minimum of 2 times (i.e. total of 3
times), ensuring all fluid exiting the lumen is clear of soil.
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