Abbott Tendyne Gebrauchsanweisung Seite 29

c. Rinse each individual component of the
stand and the weight under flowing, warm
(20°C – 25°C) Utility Water for a minimum
of 1 minute, using a low-lint wipe, gloved
hands, or nylon brush to aid in the removal
of visible residual soil. Focus on grooves,
threads, crevices, or engraved areas.
d. Repeat until no soil is visible on the stand
or weight.
e. Prepare a neutral (pH 7.0 – 8.5) enzymatic
cleaning solution (Prolystica‡ 2X
Concentrate or equivalent enzymatic
detergent). Follow the cleaning solution
manufacturers' instructions for
recommended concentration and
temperature.
f. Submerge the stand base, stand posts, and
weight and allow the components to soak
for a minimum of 5 minutes.
Adjust the position of components as
necessary to ensure all component
surfaces contact the enzymatic detergent
solution for a minimum of 5 minutes.
g. Following the minimum 5-minute soak, use
a soft nylon instrument brush to scrub the
entire surface area of the stand base, stand
posts, and weight for at least one minute.
Pay special attention to the post holes and
engraved surfaces. Scrub below the water
line to prevent aerosolizing of
contaminants for a minimum of 3 minutes.
Use a soft nylon brush to clean the internal
threads. Scrub each threaded hole for
a minimum of 30 seconds each.
h. Repeat until no residue is visible on the
stand or weight.
i. Rinse each individual component under
flowing deionized (DI) water for
a minimum of 2 minutes.
j. Dry stand base, stand posts, and weight
using compressed air or a dry lint- free
cloth until the device exterior surfaces are
completely dry.
2. Automatic Washer Cleaning Instructions
a. Disassemble the stand by separating the
two (2) posts from the base (Figure 15).
b. Set the Pre-Wash washer cycle to use cold
utility water for 2 minutes.
TM
IFU, TENDYNE Mitral Valve System
c. Set the following washer cycles:
• Washer Cycle: Pre-Wash – Cold Utility
Water for 2 minutes
• Washer Cycle: Wash – Heated Utility
Water at 55.0°C – 82.2°C for
2-10 minutes
• Use Alkaline detergent (Prolystica‡
Ultra Alkaline or equivalent alkaline
detergent): per detergent
manufacturer's instructions
• Washer Cycle: Neutralizing Rinse –
Heated Utility Water at 25˚C for
5 minutes
Washer Cycle Intermediate Rinse –
•
Cold Utility Water for 4 minutes
• Washer Cycle: Dry – 100°C, for
a minimum of 10 minutes
• Optional manual air dry or wipe dry
with clean, disposable, absorbent,
non-shedding wipe
3. Sterilizing the stand and weight
After cleaning use Prevacuum Steam
Sterilization to sterilize the stand and weight.
The minimum recommended exposure
temperature and time to achieve a Sterility
Assurance Level (SAL) of 10-6 using the
Prevacuum method is indicated in Table 2.
CAUTION: Do not use other sterilization methods
(e.g., ethylene oxide, or hydrogen peroxide gas
plasma). Wrap all components individually.
Table 2: Stand and Weight Steam Sterilization
Parameters
Cycle Parameters
Method Temperature
Option 1:
Prevacuum
134°C (273°F)
Steam
Sterilization
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Drying
Time
Time
3 75
Minutes Minutes