• "Drinking/potable water" refers to water which meets the
specifications for Utility Water listed in AAMI TIR34.
• "Treated water" refers to water which meets the
specifications for Critical Water listed in AAMI TIR34, and is
extensively treated (for example by deionization, distillation,
or reverse osmosis) to ensure that microorganisms and the
inorganic and organic material are removed from the water.
Disassembly
Note: Figures referenced are located on the first page of this IFU.
1. Press and hold both assembly/release buttons on the distal
end of the handle. (Figure 4)
2. Remove the insert assembly from the handle by pulling it
away from the handle while keeping the buttons pressed.
(Figure 4)
Cleaning Instructions – Manual
1. Ensure all pre-processing instructions are followed prior to
cleaning.
2. Immerse the insert assembly in drinking/potable water with
a temperature range of 27°C to 44°C (81°F to 111°F). Wipe
insert assembly with a lint-free cloth to remove gross soil
for at least 45 seconds.
3. Prepare an enzymatic/neutral pH detergent solution in a
clean container, utilizing drinking/potable water with a
temperature range of 27°C to 44°C (81°F to 111°F), per the
detergent manufacturer's instructions.
4. Place insert assembly in the open/relaxed position. Open the
flush port. Place jaws in the open position. Immerse insert
assembly in the detergent solution and actuate all moveable
parts. Soak insert assembly for a minimum of five (5) minutes.
5. Using a soft bristled brush, remove all visible soil from the
entire insert assembly. Actuate the jaws 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).
6. Position the insert assembly with the distal tip pointed
down. Connect a syringe with a Luer lock to the flush port
and flush with a minimum of 50 ml of detergent solution
with a temperature range of 27°C to 44°C (81°F to 111°F)
(Figure 5). Repeat the detergent flush process a minimum
of three (3) times (i.e. total of 4 times), ensuring all fluid
exiting the insert assembly is clear of soil. If visible soil is
detected during the final detergent flush, repeat steps 5 and
6 until no visible soil is detected.
Note: Rinse steps (7 through 9) should be performed with
treated water with a temperature range of 27°C to 44°C
(81°F to 111°F).
7. Rinse the insert assembly by completely immersing it in
treated water for a minimum of 60 seconds. Actuate all
moveable parts during immersion.
8. Position the insert assembly with distal tip pointed down.
Connect a syringe with a Luer lock to the flush port and
flush with a minimum of 50 ml of treated water. (Figure 5)
Repeat the flush process a minimum of three (3) times
(i.e. total of 4 times).
9. Perform a final rinse by completely immersing the insert
assembly in treated water for a minimum of 30 seconds.
Actuate all moveable parts during immersion.
10. Position the insert assembly with the distal end pointed
down to allow rinse water to drain.
11. Dry the insert assembly with a clean, lint-free towel.
12. Visually examine each insert assembly for cleanliness.
13. If visible soil remains, repeat the cleaning procedure until
the insert assembly is thoroughly clean.
Cleaning Instructions – Automatic
1. Ensure all pre-processing instructions are followed prior to
cleaning.
6