This document is valid only on the date printed. If unsure of the print date, please
re-print to ensure use of the latest revision of the IFU (available at www.e-ifu.com).
The onus resides with the user to ensure that the most up-to-date IFU is used.
3 of 12
chlorhexidine-containing products. Flush all lumened devices
with water (or detergent solution) to prevent the drying of soil
and/or debris to the inside.
•
If gross-soil cannot be removed at the point of use, the devices
should be transported to prevent drying (e.g., covered with a
towel dampened with purified water) and cleaned as soon as
possible at a designated processing area.
•
Surgical cement should be removed from devices during
surgical use and prior to setting. When cement hardens it
will typically require physical methods to remove. Chemical
solvents should not be used. Hardened cement may be
removed with an approved stylus or removing tool, but these
may damage devices.
Step 2: Containment and Transportation
•
Surgically used devices may be considered bio-hazardous and
should be safely transported to a designated processing area in
accordance with local policies.
Step 3: Cleaning
Preparation before Cleaning
•
It is recommended that devices should be reprocessed as soon
as is reasonably practical following surgical use.
•
Instruments must be cleaned separately from instrument trays
and cases
•
Non-sterile implants may be cleaned and disinfected in the
provided implant trays.
•
Care should be taken in the handling and cleaning of sharp
devices. These are recommended to be cleaned separately to
reduce risks of injury.
•
Multi-part or complex instruments may require disassembly for
cleaning. Refer to any technique guides or other supplemental
information for specific device disassembly and/or reassembly
instructions.
•
Any devices with moving parts (e.g. ratchets, box locks, hinges
or actuated parts) need to be actuated during cleaning to
ensure access of the cleaning process.
•
All devices with lumens need to be manually cleaned. Lumens
should be flushed to remove debris and brushed thoroughly
using appropriately sized soft-bristled brushes and twisting
action. Brush size should be approximately the same diameter
of the lumen to be cleaned. Using a brush that is too big or
too small for the diameter of the lumen/cannulation may not
effectively clean the lumen. Refer to any technique guides
or other supplemental information for specific device lumen
diameters. After brushing, rinse with water by flushing and blow
clean compressed air through all lumens.
NOTE:
Two cleaning methods are provided, a Manual and an
Automated Method, and at least one shall be performed.
Cleaning: Manual
1. Prepare a neutral or mild alkaline cleaning solution (pH 7 to 9)
in accordance to the detergent manufacturer’s instructions.
The temperature of the solution should be
≤
40°C (104°F) for
manual cleaning.
NOTE:
The cleaning solution may contain enzymes.
Aluminum-safe alkaline cleaners can be used, but can vary
in material compatibility overtime based on their formulation.
Material compatibility should be confirmed with the detergent
manufacturer.
2. Immerse devices and parts in the detergent solution, and
soak for a minimum of 5 minutes.
3. While immersed, use a soft non-metallic bristle brush (plastic
bristles, like nylon) or sponge to thoroughly clean all traces
of blood and debris from all device surfaces for at least
one minute.
4. Ensure all lumens are thoroughly brushed. Push the brush
through the entire length of the lumen using a twisting motion
to remove debris from both ends for at least one minute.
5. During cleaning, actuate joints, handles and other movable
device features to expose all areas to the detergent solution,
if applicable. Ensure all lumens are flushed for at least
one minute.
6. Remove the devices and completely submerge in an ultrasonic
bath prepared with a neutral or mild alkaline pH detergent
(pH 7-9), prepared in accordance with the manufacturer’s
instructions. Use a large syringe (50ml or greater) flush all
lumens with the cleaning solution, articulating areas, and
flexible segments with the detergent solution to minimize the
formation of air pockets or bubbles.
NOTE:
Ultrasonic cleaning is only effective if the surface to be
cleaned is immersed in the cleaning solution. Air pockets will
decrease the efficacy of ultrasonic cleaning.
7. Ultrasonically clean the device components for a minimum of
10 minutes.
8. Rinse all devices by immersion in ambient, < 40°C (104°F),
tap water for a minimum of one minute and until visual
evidence of debris, soil, and cleaning solution are gone. Use a
large syringe (e.g., 50ml or greater) filled to capacity with tap
water to thoroughly flush lumens and channels. Actuate joints,
handles and other moveable device features in order to rinse
thoroughly.
2018-03-09 04:03:33