Preoperative And Operative Precautions And Warnings; Instrument Reprocessing; Warnings; Reprocessing Limitations - On-X ONXI2 Modo De Empleo

PREOPERATIVE AND OPERATIVE
PRECAUTIONS AND WARNINGS
CAUTION: Use these instruments to facilitate the implantation of the On-X
Prosthetic Heart Valves only.
CAUTION: Test the leaflet mobility only with the On-X
probe on the end of the On-X
CAUTION: Use only the On-X
rotate the valve if any significant resistance to rotation is encountered.
WARNING: Do not contact the carbon components of the valve with any metallic
or abrasive instruments.
WARNING: Under no circumstances should leveraged force be applied to the valve
housing or leaflets, as serious damage may occur.

INSTRUMENT REPROCESSING

This section specifies reprocessing instructions describing the methods to thoroughly clean
and steam sterilize the instruments.
WARNING: Chemical disinfectants that contain phenolics, acetone, ammonium
compounds, iodophors and formalehyde should not be used to disinfect the
instruments.
WARNING: Do not expose instruments with plastic components to temperatures
at or above 350°F (177°C), otherwise damage to plastic component may occur.
WARNING: Do not use or repair a damaged instrument. Contact ON-X LTI
customer service to receive a replacement instrument.
Reprocessing Limitation - Repeated reprocessing has minimal effect on the instruments.
End of life is normally determined by wear and damage during use. The instruments have
been validated for 100 reprocessing cycles. Contact ON-X LTI Customer Service to receive
replacement instruments when 100 reprocessing cycles have been reached.
The plastic valve holder that comes pre-mounted to the valve is a single use device and
should be discarded after valve implantation.
Metallic parts of the instruments are made of titanium and the plastic instruments are made
of polyphenylsulfone (common brand name is RADEL
Polymers).
Point of Use – Within a maximum of two (2) hours after use, remove excess soil on
instrument with a disposable cloth/paper wipe. Soiled instruments should not be allowed to
dry, as dried contaminants are more difficult to remove during cleaning. If transfer is likely to
be delayed, place instruments in covered container with appropriate detergent (e.g. Enzol
Enzymatic Detergent or equivalent) to delay drying.
Cleaning Preparation - It is recommended that the instruments be cleaned as soon as
reasonably practical after use. Before cleaning, remove the valve holder or rotator from the
instrument handle. Discard the valve holder.
Accessories that may be used during the cleaning preparation and cleaning process are
surgical scrub type brushes, chenille pipe cleaners, cotton tipped applicators and cloth
wipes.
Preparation of instruments for cleaning by soaking or ultrasonic cleaning is recommended.
The use of a brush to remove gross contamination is also recommended.
If instruments are heavily soiled, immerse in a container of an appropriate cleaner (e.g. Enzol
ON-X LTI INsTrumeNT IFu - eNGLIsH
®
rotator.
®
rotator to rotate the valve in situ. Do not attempt to
®
leaflet probe or the leaflet
®
R a product of Solvay Advanced
®
®
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