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.
4 of 12
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.
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
2018-09-06 05:45:44
Summary of Contents for DePuy Synthes VIPER System
Page 15: ...3 14 www e ifu com p 7 9 pH 10 140 C 284 F 1 2018 09 06 05 45 44...
Page 16: ...4 14 www e ifu com 2 3 1 pH 7 9 40 C 104 F 2 5 3 4 5 6 pH 7 9 50 2018 09 06 05 45 44...
Page 131: ...www e ifu com 3 14 pH 7 9 pH 10 140 C 284 F Creutzfeldt Jakob CJD CJD TSE 2018 09 06 05 45 44...
Page 132: ...www e ifu com 4 14 1 2 3 1 pH 7 9 40 C 104 F 2 5 2018 09 06 05 45 44...
