2
N
ote that applicable device disassembly should not require any
mechanical tooling (i.e. screwdriver, pliers etc.) unless
o
therwise indicated.
Manual Cleaning
M
anual Cleaning Process - Enzymatic/neutral pH Detergent
N
ote: Steps 5, 6, 7, 9, and 11 pertain to only devices with
l
umens.
1
. Ensure all pre-processing instructions are followed prior to
c
leaning.
2
. Prepare the enzymatic/neutral pH detergent solution,
u
tilizing drinking water with a temperature range of 27°C to
44°C (81°F to 111°F), per manufacturer’s instructions.
3
. Place the device in the open/relaxed position with flush port
open. Completely immerse the device in the detergent
s
olution and allow it to soak for a minimum of 5 minutes.
Actuate all movable parts during the initiation of the soak
t
ime.
4. Using a soft bristled brush, remove all visible soil from the
d
evice. Actuate the device while brushing, paying particular
attention to hinges, crevices and other difficult to clean areas.
Note: It is recommended that the detergent solution be
c
hanged when it becomes grossly contaminated (bloody
and/or turbid).
5
. For lumen devices, use a soft bristled brush with a brush
d
iameter and length that is equivalent to lumen diameter
and length. Scrub the lumen (i.e. angulated/nonangulated
p
ositions) until no visible soil is detected in the lumen
rinsing step below.
6
. For lumen devices, place the device into the open/relaxed
position with the distal tip pointed down. Flush the device
w
ith a minimum of 50 ml of detergent solution utilizing a
temperature range of 27°C to 44°C (81°F to 111°F), by
using the flushing port located on the handle/shaft. Repeat
the flush process a minimum of 2 times (i.e. total of 3
times), ensuring all fluid exiting the lumen is clear of soil.
7. For lumen devices, if visible soil is detected during the final
lumen flush, re-perform brushing and flushing of the lumen.
Note: The final rinse steps (8 and 9) below should be
performed with treated water: deionized, distilled or reverse
osmosis. If drinking water is used as part of the final rinse,
ensure corrosion does not occur.
8. Rinse the device by completely immersing it in treated 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.
9. For lumen devices, following the rinsing step, place the
device into the open/relaxed position with the distal tip
pointed down. Flush the device with a minimum of 50 ml of
treated water utilizing a temperature range of 27°C to 44°C
(81°F to 111°F), by using the flushing port located on the
handle/shaft. Repeat the flush process a minimum of
2 times (i.e. total of 3 times).
10. Dry the device with a clean, lint-free towel.
11. For lumen devices, manipulate the device to allow rinse
water to drain from the lumen.
12. Visually examine each device for cleanliness.
13. If visible soil remains, repeat cleaning procedure until the
device is thoroughly clean.
Proofed by: ____________________________ Date: _____________
Dimensions checked: ______________ Copy checked: _____________
36-3430I
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