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Prior to use, inspect device to ensure proper function, insulation
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 (6-8) detergent solutions.
Pre-processing Instructions
Initiate cleaning of device within 2 hours of use.
Transport devices via the institution's established transport
procedure.
Remove excess gross soil as soon as possible after use by
rinsing or wiping the device.
All devices must be processed in the completely open position
(i.e. flushports, jaws, etc.) to allow solution contact of all surfaces.
Manual Cleaning
Manual Cleaning Process - Enzymatic/Neutral pH Detergent
Note: Steps 5, 6, 7, 9, and 11 pertain to only devices with
lumens.
1. Ensure all pre-processing instructions are followed prior to
cleaning.
2. Prepare the enzymatic/neutral pH detergent solution,
utilizing 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
solution and allow it 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
device. 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 changed when it becomes grossly contaminated (bloody
and/or turbid).
5. For lumen devices, use a soft bristled brush with a brush
diameter and length that is equivalent to lumen diameter
and length. Scrub the lumen (i.e. angulated/nonangulated
positions) 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
with 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).
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