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EN-29

Containment and Transportation

• Reprocess the device as soon as reasonably practical following use

• Transport the device in a tray to avoid damage.

A 30 minute wait time was used during cleaning validation.

Preparation for Cleaning

1. Disassemble the coupler from the scope and camera head.

2. Prepare an enzymatic detergent according to the manufacturer’s

recommendations (one ounce per gallon of tap water at 35–40 °C)

3. Wipe the entire device with the detergent, using a clean cloth.

4. Immerse the device in the detergent. Using a syringe, inject any inside

regions of the device with 50 mL of the detergent to ensure all parts of

the device are reached.

5. Soak the device in the detergent for a minimum of 15 minutes.

ENZOL® Enzymatic Detergent is validated for cleaning ecacy.

Cleaning: Manual

1. Brush

• Prepare a fresh solution of enzymatic detergent according to the

manufacturer’s recommendations (one ounce per gallon of tap

water at35–40 °C).

• Thoroughly brush the exterior of the device with a soft-bristled

brush, focusing on any mated or rough surfaces.

• Using a syringe, inject any lumen or mated surface a minimum

ofvetimes with 50 mL of the detergent.

• Brush any lumens a minimum of ve times from each end, using

anappropriate bottle brush.

• Brush any movable parts in all extreme positions.

2. Rinse

• Rinse the device with reverse osmosis/de-ionized (RO/DI) water at

ambient temperature until all detergent residue is removed. Flush

any lumens or mated surfaces a minimum of ve times. Once all

detergent residue is removed, continue to rinse for a minimum of

30seconds.

• Drain excess water from the device and dry it using a clean cloth

orpressurized air.

• Visually inspect the device for cleanliness, paying close attention

tohard-to-reach areas. If visible soil remains, repeat steps 1 and 2.

Stryker 1488 User Manual

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