Storage Conditions; Maintenance Procedures - Integra LifeSciences Jarit Instrucciones De Uso

Step 3: Flush instruments: With a jet pistol, flush instruments via the
flush port with 50ml of distilled water to remove loose debris before
disassembling instruments.
Step 4: Enzymatic Soak: Disassemble instruments per
instructions above. Ensure all inserts are open before immersing
fully disassembled instruments in an enzymatic solution, specific for
use with surgical instruments. Prepare solution and use per enzyme
manufacturer's recommendations/instructions for correct dilution and
temperature.
Step 5: Rinse: Remove from enzymatic soak after ten (10) minutes and
rinse thoroughly for two (2) minutes with distilled water.
Step 6: Cleaning Instruments: Choose a cleaning solution appropriate
for surgical instruments and follow manufacturer's instructions for use.
The use of neutral pH detergents is recommended to avoid corrosion,
pitting and breakage.
• Using a small, clean hand-held brush, remove soil from all surfaces of
instrument while fully immersed in solution.
• Never use steel wool, wire brushes, scalpel blades or highly abrasive
detergent or cleansers to remove soil as these will damage the
instrument's protective surface and lead to corrosion.
• Use a clean, soft bristled brush to clean the working channel of the
shaft components.
• Remove soil from jaws, ends of inserts, and hinge mechanism.
Vigorously flush channels for two (2) minutes with distilled water.
Step 7: Rinse: Thoroughly rinse instruments for two (2) minutes with
distilled water and wipe with a clean, soft cloth.
Step 8: Ultrasonic Cleaning and Rinsing: Follow recommendations
of ultrasonic manufacturer regarding cycle times, detergents, proper
placement of instrument tray, and conditioning ("de-gassing") of
cleaning solution.
• Ensure instruments are completely disassembled and ends of inserts
are in the open position.
• Use an ultrasonic cleaner to remove soil from hard to reach surfaces
such as grooves, crevices and moving parts after gross soil has been
removed.
• Keep different metal types separated (i.e., separate stainless steel
from non-anodized aluminum, brass, copper and chrome-plating to
avoid possible transfer of one metal plating to another).
• Place instruments in a mesh bottom stainless steel instrument tray.
Place tray into ultrasonic cleaner.
Step 9: FINAL RINSE for two (2) minutes with distilled water.
Step 10: Visual Inspection and Instrument Set Assembly: Visually
inspect instrument for cleanliness and ensure all parts are in proper
working order.
Step 11: Lubricate: The use of a water-soluble instrument lubricant
that is compatible with the method of sterilization to be used is
recommended before instruments are sterilized.
• After thoroughly cleaning instruments, proper application of lubricants
to all joints and movable mating surfaces will keep them moving
freely and aid in protecting surface from mineral deposits.
• Proper lubrication is required for all instruments, regardless of surface
coatings.
• Note that ultrasonic cleaners remove all lubrication; therefore, this
maintenance procedure should be done routinely after ultrasonic
cleaning and before sterilization.
Step 12: Drying: Before instruments are wrapped for sterilization or
storage, they must be thoroughly dry. Prepare instrument sets for
sterilization using a wrapper, such as polypropylene wrap or cotton
muslin, which is appropriate for the steam method of sterilization to be
used.
B. MECHANICAL DECONTAMINATION
Follow "Precleaning" and "Cleaning" steps 1-5 under section A. Manual
Decontamination.
Follow manufacturer's specifications when using automatic washer-
sterilizers or washer-disinfectors to process general surgical
instrumentation.
Recommended automatic washer parameters to remove gross amount
of soil:
Treatment Time (mm:ss)
Presoak 02:00
Enzymatic Wash 04:00
Wash (Cleaning) 02:00
Rinse 02:00
Dry 15:00
Remove instruments from automatic washer.
Follow Steps 9-12 of A. Manual Decontamination CLEANING
instructions to perform instrument final rinse, visual inspection,
lubrication and drying before terminal sterilization
C. TERMINAL STERILIZATION
After following decontamination recommendations, reusable
instruments are ready for sterilization.
CAUTION
Integra Jarit Take-Apart Endoscopic Instruments must be sterilized in
® ®
the disassembled and fully open position.
Step 1: Prepare Instruments for Sterilization: Disassemble and
open all instruments parts. Make certain that all external and internal
surfaces will be exposed to the sterilizing agent (e.g., by opening all
hinged inserts and flush ports.)
Step 2: Process Instruments in a pre-vacuum sterilization chamber as
indicated below.
ANSI/AAMI ST79:2006, A1:2008, A2:2009 standards recommend that
sterilizer manufacturer's written instructions for cycle parameters
should also be followed. Medical device manufacturer's exposure times
to sterilization temperature may need to be longer than minimum
indicated by sterilizer manufacturer but must never be shorter. It is the
responsibility of the user to establish whether sterilizer meets these
minimum recommendations.
Recommended steam sterilization parameter to achieve Sterility
Assurance Level (SAL) of 10
Sterilizer Type
Pre-Vacuum
For EU Only
Sterilizer Type
Pre-Vacuum
WARNING
If this device is/was used in a patient with, or suspected of having
Creutzfeldt-Jakob Disease (CJD), the device cannot be reused and must
be destroyed due to the inability to reprocess or sterilize to eliminate
the risk of cross-contamination.
Temperature

STORAGE CONDITIONS

25°C (77°F)
Store suitably packaged and sterilized instruments in a dry, clean, and
60°C (140°F) dust-free environment.
55°C (131°F)

MAINTENANCE PROCEDURES

Improper, ineffective and insufficient maintenance can reduce the life of
70°C (158°F)
an instrument and will invalidate the instrument's warranty.
80°C (176°F)
Protect Instruments: The use of deionized water, careful preliminary
cleaning, use of neutralized pH solutions, adherence to manufacturer's
instructions and visual inspection, will help to keep instruments
performing accurately and free of stains.
Certain compounds are highly corrosive to stainless steel and will cause
serious damage.
Instruments should never be exposed to:
Aqua regia
Ferric chloride
Hydrochloric acid
The following substances should be avoided whenever possible;
rinse with copious amounts of water immediately if instruments are
inadvertently exposed to any of the following substances:
Aluminum chloride
Barium chloride
Bichloride of mercury
Calcium chloride
Carbolic acid
Chlorinated lime
Dakin's solution
-6 :
Configuration Temperature Exposure
Time
Wrapped 132°C (270°F) 4 minutes
Configuration Temperature Exposure
Time
Wrapped 134°C (273°F) 3 minutes
Iodine
Sulfuric acid
Mercury chloride
Potassium permanganate
Potassium thiocyanate
Saline
Sodium hypochlorite
Stannous chloride