DrillSaw Mini 300™ System
User’s Guide
DFU-0223-2 Rev. 0
Page 27
6.
Remove the devices from the solution and proceed to Section 5.3.
5.3 Automated Cleaning and Thermal Disinfection
1.
After preliminary cleaning is complete, load the devices in the washer-disinfector
such that all design features of the device are accessible to cleaning and such that
cannulated and recessed parts will drain accordingly during the wash cycle (upright
position). Ensure that items such as the battery housing are open and point
downward so that they do not retain water.
2.
If using alkaline cleaning agents, a neutralization step should be utilized as
appropriate.
3.
Run an automated wash cycle with fundamentally approved efficiency of the
washer-disinfector (for example, CE marking according to EN ISO 15883 or FDA
approval/clearance/registration). The following minimum recommended wash cycle
parameters were utilized by Arthrex during the validation of these instructions.
If your washer-disinfector has an ULTRASONIC cleaning stage, you must
deactivate it prior to cleaning the DrillSaw Mini 300 System handpieces.
Ultrasonic cleaning of the handpiece is NOT approved, and can cause damage to the
handpiece.
RECOMMENDED WASHING CYCLE PARAMETERS
Phase
Recirculation Time
Temperature
Detergent
Pre-Wash
3 Minutes
Cold Water
N/A
Cleaning
Wash
10 Minutes
Follow detergent
manufacturer’s
recommendation
Enzymatic or
alkaline detergent
Rinse 1
3 Minutes
Follow detergent
manufacturer’s
recommendation
Neutralizing agent
(as needed)
Rinse 2
3 Minutes
Cold Water
N/A
Thermal
Disinfection
Rinse
5 Minutes
194°F
(90°C)
N/A
Drying
Minimum 6 Minutes
or until visibly dry
Minimum 212°F
(100°C)
N/A
Remove the devices from the washer-disinfector following the completion of the
program and check devices for visible soil. Repeat cleaning if soil is visible and re-
inspect; otherwise, proceed to Sterilization section.