Johnson & Johnson Ethicon Endo-Surgery LIGACLIP Instructions page 5

Steam
The following steam sterilization cycle parameters are approved for use.
Sterilizer Type Method
Prevacuum Wrapped
Prevacuum Unwrapped
Gravity Wrapped
Gravity Wrapped
Gravity Unwrapped
Note:
1 The above table includes the minimum temperature and time validated to assure sterility.
2 Based on steam autoclave tolerances, the actual autoclave temperature can exceed the set point
temperature by a maximum of +5 °F (+3 °C).
3 Health Authorities in some regulated regions do not accept unwrapped sterilization methods. Please
review the appropriate guidelines, standards and national Health Authorities' guidelines when
determining acceptable steam sterilization process parameters for use in each respective country.
Warnings and Precautions
• Minimally invasive procedures should be performed only by persons having adequate training and
familiarity with minimally invasive techniques. Consult medical literature relative to techniques,
complications and hazards prior to performance of any minimally invasive procedure.
• Minimally invasive instruments may vary in diameter from manufacturer to manufacturer. When
minimally invasive instruments and accessories from different manufacturers are employed together
in a procedure, verify compatibility prior to initiation of the procedure.
• A thorough understanding of the principles and techniques involved in laser, electrosurgical, and
ultrasonic procedures is essential to avoid shock and burn hazards to both patient and medical
personnel and damage to the device or other medical instruments. Ensure that electrical insulation
or grounding is not compromised. Do not immerse electrosurgical instruments in liquid unless the
instruments are designed and labeled to be immersed.
• Ensure that the clip is the correct size for the vessel or tubular structure being ligated.
• Upon each clip application, fully squeeze the trigger of the instrument until it comes to a stop. Failure
to fully squeeze the trigger can result in improper formation of clips, and therefore, unsatisfactory
ligation of tissue.
• Ensure that each clip has been securely and completely positioned around the tissue being ligated.
• Do not close the jaws of the instrument over other surgical instruments.
• Appliers in disrepair should not be used. The use of such appliers could result in inadequate function
of the clip.
• The condition of the L
of the tissue to be ligated, and the nature of the clip itself are all critical to the performance of any
ligating clip.
• As with any ligating method, inspect each ligation site following placement of the clip to ensure that
the clip has been satisfactorily placed.
• Instruments or devices which come into contact with bodily fluids may require special disposal
handling to prevent biological contamination.
How Supplied
The L Endoscopic Clip Applier is supplied non-sterile.
IGACLIP
Cycle Time
(at temperature)
3–18 minutes
3–5 minutes
15 minutes
50 minutes
3-10 minutes
ligating applier, the closure force exerted by the surgeon, the thickness
IGACLIP
Temperature Preconditioning
Set Points Pulses
270°F / 273°F 3
(132°C / 134°C)
270°F / 273°F 3
(132°C / 134°C)
270°F / 273°F Not applicable
(132°C / 134°C)
250°F (121°C) Not applicable
270°F / 273°F Not applicable
(132°C / 134°C)
5
Drying Time
30 minutes
0 - 30 minutes
30 minutes
30 minutes
0 - 30 minutes