exposure times to sterilization temperature may need to be longer than
the minimum indicated by the sterilizer manufacturer but must never
be shorter.
Below are the recommended sterilization parameters:
Sterilizer
Exposure
Exposure
Temperature
Time
Pre-vacuum
121° C (250° F)
20 min
(wrapped)
132° C (270° F)
4 min
134° C (273° F)
3 min
Pre-vacuum
132° C (270° F)
4 min
(unwrapped)
Gravity Steam
132° C (270° F)
18 min
(wrapped)
MAINTENANCE PROCEDURES
Improper, ineffective, and insufficient maintenance can greatly reduce
the life of an instrument and will invalidate the instrument's warranty.
We cannot make any statement about how long an instrument will
last. Designed and crafted to exacting specifications, instruments will
perform for a reasonable number of years when the following steps are
observed:
Protect Instruments: The most effective method of dealing with
instrument problems is to prevent them from occurring. The use of
"treated water," careful preliminary cleaning, the use of neutralized
pH solutions, adherence to manufacturer's instructions, and visual
inspection, will help to keep instruments performing accurately and
cosmetically free of troublesome stains. It is important to act quickly
should a problem arise. Delay will compound the problem and
irreparable harm may result.
• Certain compounds are highly corrosive to stainless steel and will
cause serious damage despite the passivated protective surface.
If instruments are inadvertently exposed to any of the following
substances, they should be rinsed immediately with copious amounts
of water.
Instruments should never be exposed to:
Aqua regia
Iodine
Ferric chloride
Sulfuric acid
Hydrochloric acid
The following substances should be avoided whenever possible:
Aluminum chloride
Mercury chloride
Barium chloride
Potassium permanganate
Bichloride of mercury
Potassium thiocyanate
Calcium chloride
Saline
Carbolic acid
Sodium hypochlorite
Chlorinated lime
Stannous chloride
Dakin's solution
• Any kind of corrosion will lead to rust on steel. Because rust particles
can be transferred from one instrument to another, corroding
instruments should be removed from service to prevent the formation
of rust on other instruments.
• Instruments must be sterilized in the open position or disassembled
as appropriate. Steam will only sterilize the surface it can directly
touch.
• Every effort should be made to protect sharp cutting edges and
fine working tips during all maintenance procedures. Avoid loading
Minimum
retractors and other heavy items on top of delicate and hollow
Dry Time
instruments.
20 min
Diagnosing Spots and Stains: It is common for instruments to become
20 min
15 min
stained or spotted despite the best efforts of the manufacturers and
the hospital staff. In nearly all cases these problems are the result of
minerals deposited upon the surfaces of the instruments, as well as
insufficient cleaning. Adhering to proper technique during cleaning and
sterilizing procedures will prevent most staining occurrences. However,
they will sometimes arise very suddenly and will not disappear on their
own. The following identifies some of the various instrument-related
problems hospitals may encounter.
Brown Stains: Detergents containing polyphosphates may dissolve
copper elements in the sterilizer. This results in copper being deposited
on the instruments by an electrolytic reaction. The hospital may try a
different detergent or check the quantities used. Usually a dull blue
or brown stain is simply a build-up of oxidation on the surface. This
film is harmless and will actually protect the instrument from serious
corrosion.
Blue Stains: Blue stains are usually the result of cold sterilization
techniques. It is important to prepare the solution according to exact
proportions and to change the solution when recommended. Serious
corrosion may occur if the solution is used beyond the manufacturer's
specified time limit. The use of distilled water and a rust inhibitor in the
solution will help retard discoloration.
Black Stains: Black stains may be the result of contact with ammonia.
Many cleaning compounds contain ammonia and it will remain on the
instruments unless they are well rinsed.
Light or Dark Spots: Spots are often the result of condensation pooling
and then drying on flat and concave instrument surfaces. The mineral
content of the water remains on the instrument. Using "treated water"
as the FINAL rinse will help to remove the minerals found in water
that can cause these residual spots. It is also important to follow the
sterilizer manufacturer's instructions for preparing instrument sets for
sterilization. Standing instruments that have flat and concave surfaces
"on edge" will enable the condensate to drain off and more readily
dry, usually without spotting. An additional cause of spotting can be
traced to the instrument wraps. During laundering procedures, it is vital
that detergents are thoroughly rinsed out, and that the final rinse is
prepared so that the wraps have a pH between 6.8 and 7.0. In addition,
healthcare professionals should check the cleanliness of the sterilizer
chamber. Steam can lift soil and poorly rinsed chamber cleaning
detergents from the chamber walls and deposit them onto instruments
and wrappers.
Rust Deposits: It is very unlikely for surgical grade steel to rust.
What appears to be rust is often residual organic matter in box locks
or mineral deposits which have been baked onto the surface of the
instrument. In localities where the water has a high iron content, for
example, an iron deposit will result in a metallic film on the instrument.
This may be prevented with the use of "treated water" for the FINAL
rinse during cleaning procedures.
The most effective method of dealing with instrument problems is
to prevent them from occurring. The use of "treated water," careful
preliminary cleaning, using neutralized pH solutions, following
manufacturer's instructions, and visual inspection, will help to keep
instruments performing accurately and cosmetically free of troublesome
stains. It is important to act quickly should a problem arise. Delay will
compound the problem and irreparable harm may result.
RETURNED GOODS POLICY
Products must be returned in unopened packages with manufacturer's
seals intact to be accepted for replacement or credit unless returned
due to a complaint of product defect. Determination of a product defect
will be made by Integra. Products will not be accepted for replacement
if they have been in the possession of the customer for more than 90
days.
REPAIRS AND MAINTENANCE
Should your instruments require repair or maintenance, contact Integra
for return authorization and address. Instruments returned to Integra for
repair must have a statement testifying that each instrument has been
thoroughly cleaned and sterilized. Failure to supply evidence of cleaning
and disinfection will result in a cleaning charge and delayed processing
of your instrument repair.
PRODUCT INFORMATION DISCLOSURE
INTEGRA AND ITS SUBSIDIARIES ("INTEGRA") AND MANUFACTURER
EXCLUDE ALL WARRANTIES, EXCEPT INTEGRA'S APPLICABLE
STANDARD WARRANTY WHETHER EXPRESSED OR IMPLIED, INCLUDING
BUT NOT LIMITED TO, ANY IMPLIED WARRANTIES OF MERCHANTABILITY
OR FITNESS FOR A PARTICULAR PURPOSE. NEITHER INTEGRA
NOR MANUFACTURER SHALL BE LIABLE FOR ANY INCIDENTAL
OR CONSEQUENTIAL LOSS, DAMAGE, OR EXPENSE, DIRECTLY OR
INDIRECTLY ARISING FROM USE OF THIS PRODUCT. NEITHER INTEGRA
NOR MANUFACTURER ASSUME NOR AUTHORIZE ANY PERSON TO
ASSUME FOR THEM ANY OTHER OR ADDITIONAL LIABILITY OR
RESPONSIBILITY IN CONNECTION WITH THESE PRODUCTS.