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4.6.
Packaging
Pack the equipment in a sterile barrier such as Polypropylene fleece
or transparent package made from Polyethylene film and Tyvek®, and then
place it into a tray. The tray should be also covered with a sterile
barrier.
Additionally the equipment can be placed on plastic mesh wires supplied
for plasma sterilization and then packed as mentioned above.
The equipment can be packed in a simple or double packing.
Please note that the size of a sterile barrier should be large enough
to be able to pack the equipment leaving sufficient space to seal it
completely.
A sterile barrier should be sealed by an appropriate sealing machine
and it is important to confirm that the package is sealed completely.
If the sealing is not complete, pack and reseal again.
4.7.
Sterilization
The probe and accessory can be sterilized using either ethylen oxide
gas (EtO) sterilization or plasma sterilization (see table below).
Follow the manufacturer's instructions of the sterilizer regarding
usage, temperature and sterilization-time.
The sterilization method and operating conditions are as follows.
Sterilization Method
Plasma Sterilization:
STERRAD® 50, 100S or 200 (*)
Plasma Sterilization:
Sterrad® NX or 100NX (*)
ETO Sterilization
* STERRAD® systems are manufactured by "Johnson & Johnson"
1) Before performing sterilization, check that the operation data of
sterilizer are in conjunction with min. and max. data applicable for
the probe and the Magnetic sensor attachment.
2) Do not sterilize the probe and the Magnetic sensor attachment by Steam
Autoclaving. If you autoclave them, they suffers serious damage and
will be not functional.
Condition
Short Cycle
Standard cycle
Gas Type: 10% EO/ 90% HCFC
Temperature: 50-55°C
Exposure Time: More than 120 minutes
Pressurization: 162-200kPa
Depressurization: 13-8kPa
Relative humidity: 40-90%
Aeration is minimum 12 hours
WARNING
-9-
Packaging
Sterilization
Q1E-EP0415
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