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EN
READ THIS SECTION BEFORE PLACING PRODUCT INTO SERVICE
INTENDED USE/INDICATIONS FOR USE
InstruSafe® Rounders® Point Guards® are intended to prevent tears in sterilization wrap during storage and transportation.
Rounders® Point Guards® are to be used with wrap on tray corners.
INTENDED USER
InstruSafe® Rounders® Point Guards® are intended to be used by healthcare professionals in the operating room and sterile
processing departments for transportation, sterilization, and storage of medical devices.
STERILIZATION METHODS
The Rounders Point Guards are compatible with the following sterilization methods:
Steam-PreVacuum, 270˚F (132˚C)
Ethylene Oxide (EO)
Low Temperature Hydrogen Peroxide
WARNINGS
Use only neutral (6.0-7.5) pH detergents with the Point Guards to avoid damage. A detergent with a highly acidic or highly
alkaline pH could permanently damage the Point Guard. Do not use if package is damaged or unintentionally opened prior to
use.
CLEANING
1. Manual gross decontamination:
A. Remove all visible soil and contaminates using a soft bristle brush. The entire Point Guard should be immersed while
cleaning to aid in the removal of contaminates and to reduce splashing of detergent on personnel for a minimum of 2
minutes.
B. Rinse thoroughly for a minimum of 1 minute with clean water to remove all detergent. See rinsing instruction of the
detergent label.
2. Ultrasonic clean:
Prepare enzyme wash in an ultrasonic cleaning unit. Place the Point Guard in the detergent and run for a minimum of 10 minutes.
Rinse for a minimum of 2 minutes with cold tap water. Visually inspect Point Guard for contaminates. Repeat the cycle if
necessary to remove visible contamination.
3. Automated washer:
CYCLE WATER TEMPERATURE
PRE-WASH 1 & 2 COLD TAP WATER
ENZYME WASH HOT TAP WATER
WASH 1 HEATED AT 65.5˚C
RINSE 1 & 2 HOT TAP WATER
MAINTENANCE AND INSPECTION
Point Guards were tested for 100 cycles in an automated washer and 100 cycles in an autoclave. Replace Point Guards when
inspection reveals deterioration such as: cracking, peeling, flaking, discoloration, mechanical failure, etc.
PACKAGING
Before wrapping the tray ensure the Point Guard is securely placed on the tray.
DISPOSAL
In the event the Rounders® Point Guards® do not pass inspection prior to use or have otherwise been deemed no longer fit for
purpose, the devices shall be disposed of in line with local protocol. The method of disposal shall depend on the potential risks
of cross-contamination and infection when the need for disposal is identified.
SERIOUS INCIDENT REPORTING
Any serious incident that has occurred in relation to the device should be reported to the manufacturer and the FDA/competent
authority of the Member State in which the user and/or patient is established.
CLEANING PROCESS
RECIRCULATION
TIME: 2 MINUTES
SOAKING TIME:
4 MINUTES
RECIRCULATION TIME:
15 MINUTES
RECIRCULATION TIME:
5 MINUTES
Note: After completion of an
automatic wash cycle, visually inspect
Point Guard for any remaining soil. All
visible soil must be removed by
hand cleaning, brushing, ultrasonic
and additional automatic cycles
prior to sending to sterilization.