![background image](http://html1.mh-extra.com/html/abbott/tendyne-tendv-lp-29l/tendyne-tendv-lp-29l_instructions-for-use-manual_451022023.webp)
IFU, TENDYNE
TM
Mitral Valve System
Page 23 of 284
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.
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
Time
Drying
Time
Option 1:
Prevacuum
Steam
Sterilization
134°C (273°F)
3
Minutes
75
Minutes
Содержание Tendyne TENDV-LP-29L
Страница 27: ...IFU TENDYNETM Mitral Valve System Page 27 of 284 APPENDIX A...
Страница 50: ...Brugsanvisning TENDYNETM mitralklapsystem Side 50 af 284 BILAG A...
Страница 129: ...TENDYNETM 129 284 EL MR Conformit Europ enne 93 42 2011 65 E Abbott Medical...
Страница 135: ...TENDYNETM 135 284 8 0 10 5 4 2 CT Tendyne Tendyne SDS Abbott 10 3...
Страница 137: ...TENDYNETM 137 284 MR 8 8 1 TendyneTM Tendyne Tendyne Tendyne Tendyne...
Страница 147: ...TENDYNETM 147 284 1 cm 4 5 0 035 5 6 7 1 8 1 9 10 2 11 12 3 1 10 11 1 A2 2 CT A1 3 3 4 1 5 3 6 3 5...
Страница 149: ...TENDYNETM 149 284 5 6 7 a b D D c 8 9 tuohy 10 11 12 13 14 15 16 10 14 1 a 2 15...
Страница 155: ...TENDYNETM 155 284 A...
Страница 205: ...Bruksanvisning TENDYNETM mitralklaffsystem Side 205 av 284 VEDLEGG A...
Страница 232: ...Instru es de utiliza o sistema de v lvula mitral TENDYNETM P gina 232 de 284 ANEXO A...
Страница 282: ...Bruksanvisning TENDYNETM mitralisklaffsystem Page 282 of 284 BILAGA A...
Страница 283: ...IFU TENDYNETM Mitral Valve System Page 283 of 284...