Depuy Synthes EXPEDIUM SFX Handbuch Seite 6

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
a minimum of 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 a
minimum of 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 a
minimum of 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 manu-
facturer'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 in accordance with manufacturer's
instructions. An example of a validated cycle used for
cleaning validation included 40kHz at 25°C for 10 mins).
8. Rinse all devices by immersion in ambient, < 40°C
(104°F), tap water for a minimum of one minute and until
evidence of debris, soil, and cleaning solution are visually
removed. 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 to rinse thoroughly.
9. Remove the devices and repeat the rinsing using in
ambient, < 40°C (104°F) critical water (high purity water
generated by processes such as RO, deionization or
distillation) for at least 15 seconds.
10. Remove and dry device using a clean, soft, lint-free cloth
or clean compressed air. Ensure that all lumens and
articulated areas are dried using compressed air.
Cleaning: Automated
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 scrub
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. Load the device components in the washer-disinfector in
accordance with manufacturer's instructions, ensuring that
the devices and lumens can drain freely.
7. Automated washing shall be conducted in a validated
washer-disinfector in compliance to ISO 15883-1 and-2, or
to an equivalent standard. Automated washing can be
included as part of a validated washing, disinfection, and/or
drying cycle in accordance to manufacturer's instructions.
An example of a validated cycle used for cleaning
validation included:
Recircula-
tion Time
Phase (mins)
Pre-wash
Enzyme
wash
Wash
6 of 176
Water Detergent/
Temp Water Type
Cold Tap
2
Water
< 40°C Neutral, Enzymatic
1
(104°F) Cleaner
66°C Neutral pH
5
(151°F) Detergent
N/A