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CareFusion V.Mueller SCS30011 Instrucciones De Uso página 2

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  • ESPAÑOL, página 6
Catalog Numbers
SCS30011, SCS30109, SCS30812, SCS31010, SCS31015-0, SCS31015-L,
SCS31015-S, SCS31020-L, SCS31020-S, SCS3142010, SCS51523, SCS30418
Explanation of Symbols
Refer to the BD Symbols Glossary for symbol definitions at www.bd.com/
symbols-glossary.
Instructions for Use
These instructions provide information on how to set up, use, troubleshoot, and
maintain the V. Mueller Sterilization Containment Systems. For information about
the product that is not covered in this document, contact V. Mueller or your local
distributor.
Intended Use
V. Mueller Sterilization Containment Systems are intended to organize and secure
medical devices during sterilization, transport and storage. Multiple versions of
these systems are available to accommodate a range of instrument sets.
The containment systems are not intended to maintain sterility; they are intended
to be used in conjunction with a validated FDA cleared sterilization wrap in order
to maintain sterility of the enclosed devices.
How Supplied
V. Mueller devices are packaged as non-sterile. Cleaning and sterilization must
occur prior to use.
Initial Receiving
Inspect, thoroughly clean, and rinse all reusable components before placing into
service. Not properly preparing your V. Mueller Sterilization Containment Systems
may adversely affect the protective anodized finish.
Limitations on Reprocessing
Repeated reprocessing has minimal effect on these devices. End of life is normally
determined by wear and damage due to use.
Warnings
Containment systems shall be used in accordance with these instructions for use.
Read all sections of this insert prior to use. Improper use of this device may cause
serious injury. In addition, improper care and maintenance of the device may
render the device non-sterile prior to patient use and cause a serious injury to the
patient or health care provider.
General Precautions Cleaning
• Use only properly diluted, enzymatic / neutral pH detergent solution
recommended for safe use on anodized aluminum. Use of highly acidic or
highly alkaline detergents could permanently damage the protective finish of
the containment system.
• Alcohol is not recommended for manual cleaning or wiping down. All cleaning
agents should be thoroughly rinsed off prior to any sterilization process to
remove all residual chemicals which could damage the protective anodized
finish.
• Do not use abrasive cleaners, abrasive cleaning pads, or metal brushes on
sterilization containment system surfaces. Use of these abrasive materials
will permanently damage the protective anodized finish of the sterilization
containment system.
• Do not clean the anodized sterilization containment system in an ultrasonic
washer.
Processing
• When sterilizing mixed loads, sterilization containment systems must be
placed below absorbent, wrapped items on the autoclave cart to avoid excess
condensation dripping onto wrapped goods below the containment system.
• Sterilize containment systems using hospital protocol. Since sterilizers vary
in design and performance characteristics, it is strongly recommended that
the user verify the cycle parameters for the specific sterilizer and types of
instruments being sterilized prior to use.
• Always practice safe lifting and handling of heavy objects.
• It is important that each facility verify the manufacturer's written sterilization
instructions (Instructions for Use) to verify that the conditions in their
particular facility (i.e. steam quality, equipment, protocols) achieve the same
results as the manufacturer. If not, the sterilization rack manufacturer, as
well as the equipment manufacturer, should be consulted to identify potential
causes and remedies.
en
Cautions
If there are any variations between these instructions and either your facility's
policies and/or your cleaning/sterilization equipment manufacturer's instructions,
those variations should be brought to the attention of the appropriate responsible
hospital personnel for resolution before proceeding with cleaning and sterilizing
your devices.
Use of device for a task other than that for which it is intended will usually result in
a damaged or broken device.
Prior to use, inspect device to ensure proper function and condition. Do not use
devices if they do not satisfactorily perform their intended function or have physical
damage.
Only the cleaning and sterilization processes which are defined within these
instructions for use have been validated.
Use only neutral pH (5.5-8.5) detergent solutions.
Recommended Sterilization Cycle Parameters
The following recommendations may include sterilization temperature/exposure
parameters and maximum loads different than those which your institution
commonly uses. Since individual sterilizers may perform differently, it is important
to conduct individual sterilizer testing of containerized instrument sets using
biological and chemical indicators to verify exposure times and to determine
adequate sterilizing parameters in your particular facility.
Sterilizers vary in design and performance characteristics. It is strongly
recommended that the user verify the cycle parameters for the specific sterilizer
prior to use. In some instances the recommended cycle parameters may present
extended cycle times when compared to typical sterilizer cycles used in health care
facilities. It is important to verify the parameters in conjunction with the sterilizer.
Adjusted cycle times or dry times may be required to properly sterilize and dry
desired loads.
Cleaning and Processing
After each use, sterilization containment systems should be washed with a properly
diluted, enzymatic / neutral pH detergent solution recommended for use on
anodized aluminum. A neutral pH is defined as 7. The post-dilution pH level should
not be below 5.5 or exceed 8.5.
Caution: A detergent with a highly acidic or highly alkaline pH could permanently
damage the anodized finish of the containment system. Alcohol is not
recommended for manual cleaning or wiping down. All cleaning agents should
be thoroughly rinsed off prior to any sterilization process to remove all residual
chemicals which could damage the protective anodized finish. Do not clean the
anodized sterilization containment system in an ultrasonic washer. Surgical
instruments should be reprocessed according to the instrument manufacturer's
instructions prior to organizing in sterilization containment systems.
Pre-processing Instructions
It is recommended that sterilization containment systems are reprocessed as
soon as is reasonably practical following use. Containment systems should be
transported via the institutions established transport procedure.
Initiate cleaning of device within 2 hours of use.
Remove excess gross soil as soon as possible after use by rinsing or wiping the
device.
All devices (containment systems) must be processed in the completely open
position (i.e. flushports, jaws, etc.) to allow solution contact of all surfaces.
Manual Cleaning
1. Ensure all pre-processing instructions are followed prior to cleaning.
2. Prepare the enzymatic / neutral pH detergent solution, utilizing tap water with
a temperature range of 27°C to 44°C (81°F to 111°F), per manufacturer's
instructions.
3. Place containment system in open/relaxed position, and completely immerse in
the detergent solution and allow containment system to soak for a minimum of
5 minutes. Actuate all movable parts during the initiation of the soak time.
4. Using a soft bristled brush, remove all visible soil from the containment system.
Actuate all movable parts of containment system while brushing, paying
particular attention to hinges, crevices and other difficult to clean areas.
Note: It is recommended that the detergent solution is changed when it becomes
grossly contaminated (bloody and/or turbid).
5. Rinse the containment system by completely immersing in tap water with a
temperature range of 27°C to 44°C (81°F to 111°F), for a minimum of
30 seconds to remove any residual detergent or debris.
6. Dry the containment system with a clean, lint-free towel.
7. Visually examine each containment system for cleanliness.
8. If visible soil remains, repeat cleaning procedure.
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