Reprocessing Option - St. Jude Medical Regent Instrucciones De Uso

Reprocessing Option 1

Manual Cleaning and Disinfection Method
The following manual cleaning and disinfection method was validated:
Wipe the instrument with a wet, disposable sponge to remove gross soil.
1.
Rinse the instrument in hot, running tap water for a minimum of 20 seconds to remove visible blood soil.
2.
Soak the instrument in a bath of Terg-A-Zyme
3.
Items should be mechanically cleaned with appropriately sized non-abrasive brushes until visibly clean.
4.
Rinse instrument with hot de-ionized (DI) water for a minimum of 20 seconds to remove remaining soil and
5.
cleaning agent.
Allow to air dry or dry the instrument with a clean, disposable, absorbent, non-shedding wipe. 6.
Automated Cleaning, Washer-Disinfector Method
The automated washer-disinfector method described below was validated. Testing was conducted using
HAMO 3 LS1000 washer-disinfector with Renuzyme
Prior to placing the instruments in the washer-disinfector, remove visible blood soil using warm DI water and a brush. Secure
instruments in the washer-disinfector and perform the following programmed cleaning cycle:
Table 1. Automated Washer-Disinfector Cycle
Step Cycle Duration
1 Pre-Wash 10 minutes
2 Wash 10 minutes
3 Rinse 10 minutes
4 Cool 5 minutes
5 Dry ---
Sterilization
Sterilize instruments before each use.
CAUTION: Sterilization temperatures must not exceed 138°C/280°F.
NOTE: Higher temperatures or longer sterilization times may be used; however; increasing the sterilization time or
temperature (not to exceed 138°C/280°F) of the stated cycles may reduce instrument life.
Terg-A-Zyme is a trademark of Alconox, Inc.
2
HAMO is a trademark of Steris Group GmbH Corporation.
3
Renuzyme is a trademark of Getinge USA, Inc.
4
2 Enzymatic Cleaner (Alconox) for five minutes.
4 enzyme detergent.
Tap Water Temperature
50°C / 122°F ± 5°C / 9°F
60°C / 140°F ± 5°C / 9°F
90°C / 194°F ± 5°C / 9°F
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3
Comments
Do not use detergents or additives. Drain when
complete.
Follow instructions from manufacturer of washer-
disinfector for optimal mix ratio and concentrations
of enzyme detergent.
Drain when complete.
Drain when complete.
Remove parts from washer-disinfector and cool at
room temperature.
Allow to air dry or dry the instrument with a clean,
disposable, absorbent, non-shedding wipe.