Publicidad
Idiomas disponibles
Idiomas disponibles
Catalog Numbers
Y-0101, Y-0102, OS1065
Instructions for Use
These instructions provide information on how to set up, use, troubleshoot,
and maintain the V. Mueller Sterilization Racks. For information about the
product that is not covered in this document, contact V. Mueller or your local
distributor.
Intended Use
Sterilization Racks are intended to organize, hold and protect non-lumen
curettes and osteotomes composed of stainless steel and anodized aluminum
for transport, storage, and sterilization by a healthcare provider.
The racks 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 racks 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
Devices 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 rack.
• 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 rack surfaces. Use of these abrasive materials will permanently
damage the protective anodized finish of the sterilization rack.
• Do not clean the anodized sterilization rack in an ultrasonic washer.
Processing
• When sterilizing mixed loads, sterilization racks must be placed below
absorbent, wrapped items on the autoclave cart to avoid excess
condensation dripping onto wrapped goods below the rack.
• Sterilize racks 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.
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.
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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 racks 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 rack. 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 rack in an ultrasonic washer.
Surgical instruments should be reprocessed according to the instrument
manufacturer's instructions prior to organizing in sterilization racks.
Pre-processing Instructions
It is recommended that sterilization racks are reprocessed as soon as is
reasonably practical following use. Racks 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 (racks) 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 rack in open/relaxed position, and completely immerse in the
detergent solution and allow rack 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 rack. Actuate all
movable parts of rack 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 rack 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 rack with a clean, lint-free towel.
7. Visually examine each rack for cleanliness.
8. If visible soil remains, repeat cleaning procedure.
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