Exsurco Medical Amalgatome SD, Руководство пользователя

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A
MALGATOME
®
SD U
SER
G
UIDE
PN#: X101456, Rev. C Page 7 of 56
How Supplied
•
The Amalgatome SD System consists of the following components as shown on previous page:
o Hand Piece (Drive Unit): Consists of the motor and pneumatic hose which powers the system.
o
Interchangeable cutting heads with lock ring and assembly accessories.
o
The single-use disposable surgical excision ring blades are supplied separately.
•
The complete system is shown and is sold with the custom-made sterilization tray, which should be utilized
with this system only.
o
SDSYSTEM024 contains the 2-inch and 4-inch cutting heads.
o
SDSYSTEM04 contains the 4-inch cutting head.
o
SDSYSTEM02 contains the 2-inch cutting head.
•
The system is provided non-sterile and is reusable after cleaning and sterilization prior to use according to the
procedures outlined in this document.
•
Each piece of the system is shipped individually contained in protective suspension or retention boxes and
each must be opened, visually inspected, cleaned and then placed in the sterilization tray for sterilization.
•
The single-use, disposable excision ring excision ring blades are provided sterile and should be considered
sterile unless the sterile packaging has been opened or damaged.
WARNING: Re-sterilization or reuse of the disposable excision ring blades can result in serious physical
harm to the patient. Excision ring blades are for single use and must not be reused.