Resterilization - Medtronic DBS 3387 Gebrauchsanweisung

Resterilization

The lead and accessories of the DBS Lead Kit were sterilized with ethylene
oxide before shipment. Inspect the sterile package for seal integrity and
damage before opening and using the contents. If you are unsure of the
components' sterility for any reason, they should be resterilized at the
hospital site.
Note: If contamination is suspected because of a defective sterile package
seal, leads and accessories can be returned to Medtronic for replacement
or they can be resterilized at the hospital. Medtronic does not accept
returned leads or accessories for resterilization.
Due to variations in hospital sterilizers, precise instructions for sterilization
or aeration cannot be given here. If further information is necessary
regarding procedures to be used, contact the manufacturer of the sterilizer
unit. Use biological indicators or other acceptable method to validate the
effectiveness of the hospital's sterilizer unit.
Medtronic cannot accept the responsibility for the hospital's resterilization
of any components. If, however, the hospital decides to resterilize, usual
and customary sterilization methods should be used.
Cautions:
■ Do not resterilize and use lead or accessories after exposure to body
tissues or fluids.
Do not use radiation to resterilize any component. Do not autoclave
■
lead, percutaneous extension, stylet, burr hole ring/cap, connector
boot, or lead cap.
Subject to the foregoing, the following suggestions may be considered:
Table 2 is a summary of the applicable resterilization options and
restrictions. The paragraphs following the table provide additional
information.
Table 2. Resterilization Options and Restrictions
Component
Ethylene Oxide
o
55
Lead
Percutaneous extension
Stylet
Screening cable
Burr hole ring/cap;
connector boot, lead cap
Other accessories
a
Medtronic cannot accept the responsibility for the hospital's resterilization of any
components.
b
60 minutes
c
30 minutes
18 English Technical Manual
a
Sterilization methods
Autoclave
o
C Maximum 121 C 103 kPa
30 minutes 132
YES NO
YES NO
YES NO
b
YES YES
YES NO
YES YES
"Flash"
Autoclave
o
C 186 kPa
5 minutes
NO
NO
NO
c
YES
NO
YES