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Product Specific:
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STORAGE GUIDELINES
All products should be stored in cool, dark conditions in the containers in which they are supplied. Rubber and latex are particularly sensitive to sunlight and artificial light with ultraviolet content and to ozone which is generated by fluorescent lighting, electric motors and similar machinery. Products must not come into contact with metals, strong cleaning solutions, phenols, cresols, hydrocarbons, alcohol or oxidizing agents. Articles should be issued from storage in strict rotation to ensure only the latest remains. All products, particularly rubber and latex products deteriorate with age. Any products showing signs of deterioration should be destroyed and discarded. Any product with a "use by" date should be discarded if it is older than the date shown. Do not confuse this date with any date of sterilization which only shows the final processing and is not an indication of expiration.
STERILIZATION GUIDELINES
General Information
Re-use and re-sterilization will cause deterioration. To avoid failure in use, products should be checked and any product showing signs of deterioration must be discarded. As storage, use and exposure to many factors varies, a pre-set life (time) or number of re-sterilization cycles cannot be advised by RUSCH. All products indicated for re-sterilization should be thoroughly cleaned immediately after use.
Single Use Products
Products indicating that they are single use (disposable) should
not be sterilized or re-sterilized as the product may be damaged
functionally. Single use products are normally supplied sterile
and are labeled on the pack "single use only" or similar.
ET0 Gas (Ethylene Oxide) Method
Black Rubber Products
Red Rubber Products
Silicone Products
Latex Products
Face Masks
On Face Masks, plugs must be removed and luer caps on red rubber
E.T. Tubes left open: Even so if the vacuum cycle is too rapid,
damage may result so care must be taken during the evacuation
cycle. In other respects all reusable products are suitable for
ET0 gas sterilization. Sterilization cycles with temperatures
up to a maximum 52°C (125°F) are recommended. Equipment
manufacturer's recommendations must be followed.
Laryngoscope Blades
Sterilization cycles with temperatures up to 65°C (150°F)
are recommended. Follow accepted hospital protocol for aeration.
CAUTION: Use of inert gases in the sterilization process such as chlorinated
hydrocarbons (e.g. Freon) may damage rubber and latex products.
Check all products for signs of deterioration, particularly a
sticky surface.
Aeration
Residual ethylene oxide must be eliminated so follow the sterilizer
manufacturer's guidelines and accepted hospital protocol for aeration.
Steam (Autoclaving) Method
Black Rubber Products
(e.g., Anesthesia Masks, Tubes and Breathing Bags):
Remove plugs from inflatable face mask cushions to avoid damage.
Sterilization cycles with temperatures up to a maximum 121°C
(250°F) are recommended. Avoid contact with instruments or
any metal object. Conductivity will be affected by repeated sterilization
and should be checked periodically. Allow to dry and recover for
48 hours.
Latex and Red Rubber Products
(E.g. Endotracheal Tubes, Urology Catheters):
Sterilization cycles with temperatures up to a maximum 121°C
(250°F) are recommended. Avoid contact with instruments or
any metal object. Allow to dry and recover for 48 hours.
Laryngoscope Blades
Sterilization cycles up to a maximum of 131°C (270°F)
and pressure of 28 p.s.i. are recommended. Use standard autoclave wrap and avoid contact with other instruments.
Securely tighten bulb in standard blades prior to use. CAUTION: Flash sterilization above 131°C (270°F) and hot air sterilization
may damage the instrument. Repeated autoclaving may reduce the
light transmission and life expectancy of the blade.
CAUTION: Sudden immersion of fiber optic blades in cold water may lead to
cracking of the fiber optic bundles and potentially damage the light
transmission.
Cold Method
All products: (except Laryngoscopes)
Cidex has been tested and has been found to be compatible with the
materials we use. Sterilants based on phenol compounds, bleach or
Betadine solutions are not suitable. Follow the sterilant manufacturer's
guidelines carefully.
1 Immerse product fully in the solution ensuring displacement of
trapped air.
2 Soak items according to manufacturer's instructions for disinfection
or sterilization.
3 Remove products and allow to drain.
4 Rinse in sterile water for at least 5 minutes.
5 Blot dry on a sterile field.
6 Allow rubber and latex at least 48 hours to dry and recover elasticity.
Laryngoscope Blades
Soaking in Cidex solution for 10 to 15 minutes is acceptable; however,
soaking for longer than 15 minutes may result in damage to the blade.
Dry Heat Method
Dry heat will cause rapid deterioration of materials and must not
be used.
Washer Sterilizer Pasteurizer
Laryngoscope Blades
If a machine washer/sterilizer or pasteurization methods are used
adhere strictly to manufacturer's instructions regarding concentration
and duration.
Disinfect at temperatures up to 65°C (150°F).
CAUTION: Do not dry heat. Air cool for 5 minutes or blot dry.
Steris® Process
The Steris® Process as developed by Steris ® Corporation,
Mentor, Ohio, consists of a peroxyacetic acid active compound for
the sterilization of many medical devices. RUSCH laryngoscope blades
have been successfully sterilized using this process. The process
also proves to be anticorrosive.
Please note that Steris® processing should comply with a// directions
and warnings which Steris® Corporation recommends with their
units.
Product Resterilization
RUSCH Inc. and its associated product suppliers have manufactured
sterile devices according to unique validated sterilization cycle
parameters. The validated sterilization cycle is only effective
with the sterilizer used in the products' initial manufacturing.
RUSCH Inc. cannot make sterilization recommendations in instances
where users want to resterilize product utilizing other sterilization
equipment. Qualification of product sterility and integrity will
remain the responsibility of the facility operating the sterilizing
equipment. Note: Expiration dates on current packaging refer to concern
for product integrity. Re-sterilizing expired product will not extend
the shelf life.
WARNING: The above listed Sterilization Guidelines, provided
by RUSCH Inc., are intended as suggestions only. They are based
on procedures compatible with specific materials. Sterilization
must be performed to approved hospital protocol. Because each sterilization
chamber is unique, RUSCH Inc. cannot provide a guaranteed cycle
for processing devices.
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