Cardiovascular Systems, Inc. DIAMONDBACK 360 Peripheral Orbital Atherectomy System Exchangeable Series Instructions For Use Manual page 36

12.4.2. Disinfecting the OAS Pump
Disinfect the OAS pump after each use by following the steps below:
1. Verify no debris is present after pump has been cleaned and rinsed with
enzymatic detergent. Repeat the above cleaning procedure if any debris
continues to be visible.
2. Put on a pair of disposable protective gloves. Check the expiration date on
container and remove a fresh moist Super Sani-Cloth
solution from the wipe, ensuring it is saturated, but not dripping. Discard
wipes as they become dry.
3. Disinfect the front pump face, ensuring that all the indicated surfaces are
completely covered with solution during the wiping process for a total of 2 ½
minutes to ensure an adequate "dwell" time. Dwell time means the number
of minutes that a product must be in contact with the surface, and remain
wet, in order to assure proper efficacy, or effectiveness to kill organisms.
Surfaces must not become dry at any point during disinfection. Refer to
the following steps for surfaces to be wiped:
a.
b.
Figure 14. Open pump head cover
4. Thoroughly wipe the seams and crevices of the pump head cover, around
the edges of the lettering, around the button area, and around the power
outlet (see Figure 17). Thoroughly wipe all surfaces of the front face of the
pump (see Figure 18). Continue to keep all surfaces wet for a minimum of
two and a half minutes. Discard the wipes.
Open the pump head cover (see Figure 14).
Thoroughly wipe the edge of the pump head cover all along the closure
seam on both sides (see Figure 15 and Figure 16 below).
Figure 15. Wipe closure seam.
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®
. Wring excess
Figure 16. Wipe Closure Seam