Integra Jarit Indicaciones De Uso

Integra Jarit Fan Retractor
®
INDICATIONS FOR USE
For use by, or as directed by, a surgeon in endoscopic surgery. For use
when a rigid endoscopic instrument for grasping, dissecting and/or
other manipulation of soft tissue is determined to be appropriate by the
surgeon.
The liver elevator is used for cholecystectomies (gall bladder
operations) in order to elevate the liver (Latin: elevare). Hereby, the
elevator is positioned below the liver, and by means of twisting the
knurled wheel "spread" positioned at the end, the fan is spread. By
turning the knurled wheel "lift" positioned at the front, the required
inclination can be determined.
CONTRAINDICATION
Instruments should not be used for anything other than their intended
use.
WARNING
Consult individual national infection control/prevention protocols for
specific guidance regarding processing medical devices with suspected
exposure to Creutzfeldt-Jakob Disease (CJD).
CAUTION
After cleaning, especially ultrasonic cleaning, check screws on
instruments because the vibration from the ultrasonic cleaning may
cause them to loosen or fall out.
Integra Jarit surgical instruments are supplied non-sterile and must be
cleaned, lubricated and sterilized prior to use according to hospital
protocol and the procedures outlined in this document. Failure to follow
these procedures will invalidate the instrument's warranty and can
cause the instrument to fail.
Inappropriate use of instruments will lead to damage that is usually not
repairable.
04
03
Operating this instrument, it is necessary to ensure that the handling
force is not too high. As it is possible to feel an increasing resistant, the
final position or function/operation is reached. In both cases, no more
power must be carried out on the handling, as there is a high risk of
breakage.
DISASSEMBLY OF FAN RETRACTOR
Please, disassemble only pre-washed instruments.
Bring the Fan Retractor into the initial position, i.e. with closed fan and
non-angled end. Twist the clamping nut 03 off the handle 01.
Twist the front knurled screw "lift" of handle 01 to the left (down) until
the outer tube 02 can be removed. Unscrew the tilt-spreading unit 04
from the outer tube 02.
Please keep in mind, not to hold on to the fan elements, as there is a
high risk of breakage.
The Fan Retractor is now completely disassembled.
ASSEMBLY OF FAN RETRACTOR
Screw the outer tube 02 and the tilt-spreading-unit 04 together.
Please keep in mind, not to hold on to the fan elements, as there is a
high risk of breakage.
By means of twisting movement, insert the outer tube 02 into the
handle 01 until the outer tube 02 snaps in. Twist the front knurled
screw "lift" to the right (up) until the outer tube is level with the handle
01.
Slide the clamping nut 03 onto the outer tube 02 and screw it onto the
handle 01.
The pin of outer tube 02 must be positioned correctly into the provided
notch of handle 01.
Slide the clamping nut 03 onto the outer tube 02 and screw it onto
handle 01
Check the instrument for proper function.
The Fan Retractor is now completely assembled.
01 HANDLE
02 OUTER TUBE
03 CLAMPING NUT
04 TILT-SPREADING-UNIT
02
INSPECTION OF ALL INSTRUMENTS
All instruments are carefully inspected before shipment. Because
damage may occur during transit, the instruments should be thoroughly
inspected upon receipt. All instruments must be inspected prior to
use.
Handling and Operating Instruments: Instruments should be handled
and operated by personnel completely familiar with their use, assembly
and disassembly. Before a new instrument is used and prior to each
surgical procedure, the instrument must be decontaminated, lubricated
and sterilized as described below. Handle the instrument with care. The
instrument must be inspected to assure proper functioning prior to each
use with particular attention paid to the condition of all moving parts.
Each instrument with a screw must be inspected before and after use
to ensure that the screws do not move when operating the instrument.
Screws can loosen and back out of an instrument as a result of normal
operation and/or the vibration during ultrasonic cleaning. Failure to
make a complete inspection to assure the proper operation and function
of the instrument may result in unsatisfactory performance, perhaps
because a part is missing. Do not use if the instrument does not appear
to be functioning properly. Use of an instrument for a task other than
that for which it is intended could result in a damaged or broken
instrument, or one which provides an unsatisfactory performance. In
order to insure warranties and guarantees, instruments in need of repair
should be sent to Integra.
DECONTAMINATION AND STERILIZATION PROCEDURES
As with any decontamination procedure, personnel should follow
accepted guidelines for hand washing, the use of protective attire, etc.
as recommended by A.A.M.I. Standards and Recommended Practice,
"Safe Handling and Biological Decontamination of Medical Devices
in Health Care Facilities and in Non-Clinical Settings," ANSI/AAMI
ST35:2003.
Decontamination is a two step process:
1) Thorough cleaning and rinsing.
2) Sterilization or disinfection.
It must be possible to operate the instruments smoothly, without any
screwing and grinding noise.
A. MANUAL DECONTAMINATION
PRECLEANING: Remove gross debris from surgical instruments
with a lap sponge and sterile water routinely during the procedure to
prevent drying on of blood and body fluids, etc. It is important to rinse
instruments that have been exposed to blood and saline solution before
these substances dry. Blood and body fluids as well as saline solutions
are highly corrosive. In addition, blood can produce a stain that is
difficult to remove.
01
CLEANING: To prevent the formation of biofilm, cleaning should
occur as soon as possible after instrumentation is used. Biofilm is
an accumulation of a biomass of bacteria and extracellular material