• Avoid mechanical shock or overstressing the insert
assemblies; this will cause damage.
• The jaws must be completely closed prior to insertion or
removal through cannulas.
• Be sure the jaws are closed and the instrument is pulled
straight out until completely clear of the cannula to avoid
catching the valve assemblies in cannulas or dislodging the
cannula.
• Lateral pressure on the instrument during removal can
damage the working jaw, shaft of the insert assembly and/or
insulation.
• When used in conjunction with laser equipment, always use
caution (i.e. eye protection).
• Only the cleaning and sterilization processes, which
are defined within these instructions for use, have been
validated.
• Use only neutral pH (6-8) solutions for cleaning. Use of
acidic or alkaline detergents can remove chromium oxide
from the surface of stainless steel causing pitting or
breakage of insert assemblies.
• Insufflation should be done on a larger diameter port
(>3 mm diameter) or before a 3 mm insert assembly is
placed.
The following cautions are applicable to the electrosurgical
insert assemblies listed in the Appendix:
• To avoid eschar formation during use, clean the jaws as
needed utilizing a wet towel or sponge.
• Keep the active electrodes clean. Build-up of eschar may
reduce the instrument's effectiveness. Do not activate
the instrument while cleaning; Injury to operating room
personnel may result.
Rated Voltage
The maximum recurring peak voltage for these insert
assemblies is 1.5kVp.
Activation Duration
The recommended activation duration is maximum three (3)
seconds on/with minimum 30 seconds off.
Instructions for Use
Note: Figures referenced are located on the first page of this
IFU.
Component Familiarization
Refer to (Figure 1) for all components of the modular insert
assembly:
(A) Jaws
(B) Insert assembly
(C) Flush port
Cleaning
Note: Insert assembly must be cleaned and sterilized prior to
use.
Point of Use Processing
• Remove excess gross soil as soon as possible after use by
wiping device while rinsing or immersing.
• Transport devices via the institution's established transport
procedure.
• Initiate cleaning of the device within two (2) hours of use.
Cleaning – General Instructions
• All insert assemblies must be cleaned in the disassembled
(i.e. insert assembly separated from handle) configuration.
Note that disassembly should not involve the use of any
mechanical tooling (i.e. screwdriver, pliers, etc.).
• All flush ports shall remain in the fully open position.
• Insert assemblies may be cleaned by following either the
Manual or Automatic Cleaning Instructions.
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