11
Manual Cleaning
Cleaning
• Use hospital grade enzymatic detergent. Follow manufacturer instructions for
cleaning detergent concentration.
• Soak device in detergent for 15 minutes.
• Remove soil with cleaning detergent by scrubbing all external surfaces with a soft
bristle brush until all visible soil has been removed.
• Use a small diameter brush or pipe cleaner to clean cannulation holes.
• All exposed surfaces should be free of visible soil.
Rinsing
• Immediately after cleaning, rinse device under warm running water for 3 minutes.
• Pay special attention to rinse all holes and lumens.
• Air dry in clean area. Blow lumens with clean air using filtered air source.
Maintenance and
Inspection
• Inspect to ensure all visible contamination has been removed.
• Check for damage and wear: corrosion, discoloration, cracking.
• Discard damaged or corroded components. If not visibly clean, repeat the process
or dispose of components.
Packaging
• Place product in a single FDA cleared sterilization pouch.
• Ensure pouch is large enough to contain the components without stressing the
seals.
Sterilization
Pre-vacuum Steam Sterilization
USA Full cycle: Wrapped 132°C (270°F) for 4 minutes, with a dry time of 20 minutes
Gravity Steam Displacement Sterilization
Full Cycle: Wrapped 121°C (250°F) for 30 minutes, with a dry time of 15 minutes
EU Full Cycle: Unwrapped 134°C (273°F) for 3 minutes, with a dry time of 10 minutes
Storage
To maintain sterility, instruments should remain wrapped until ready for use.
Additional
Information
When sterilizing multiple instruments in one autoclave cycle, ensure that the
sterilizer’s maximum load is not exceeded.
The instructions provided have been validated by the manufacturer of the medical device as being capable
of preparing a medical device for re-use. It remains the responsibility of the processor to ensure that the
reprocessing is actually performed using equipment, materials and personnel in the reprocessing facility to
fully achieve the desired result. This normally requires validation and routine monitoring of the process.
10. Warranty
SybronEndo warrants certain components of the EndoVac
™
system against defects in material and
workmanship for 12 months from the date of purchase, subject to proper usage. During that twelve-month
period, SybronEndo will replace:
• Master Delivery Tips, if received clogged.
• MacroCannulas, if received in unusable condition.
• MicroCannulas, if received in unusable condition.
Defects caused by misuse, neglect, accident or abuse are not covered by this warranty. SybronEndo assumes
no liability resulting from improper use, damage or breakage due to misuse of these components by the
purchaser. SybronEndo assumes no liability for damage to the EndoVac
™
system components, injuries to
patients or users or other problems resulting from improper use of accessories or other materials not supplied
by SybronEndo.
FRANÇAIS
Conditionnement
Le Kit d’installation complet EndoVac
™
(973-3003) comprend tous les composants principaux* :
A.
Pièce à main (2)
H. Seringues de 3 cc pour EDTA (6)
B.
Pièce à doigt (2)
I.
Tube d’écoulement du dispositif médical
(raccords bleus) (2)
C.
Adaptateur multiport (1)
D.
Macro-canules de 25 mm (20)
J.
Tube d’écoulement pour pièce à main / pièce
à doigt (raccords blancs) (2)
E.
Micro-canules** de 25 mm (20)
F.
Seringues de 20 cc pour NaOCl (6)
K. Mode d’emploi (non illustré)
G.
Pointes d’écoulement principales du
dispositif médical (20)
L.
Guide de réglage rapide (non illustré)
Summary of Contents for EndoVac
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