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4.
Cleaning, Disinfection and Sterilization
The probe and accessory must be reprocessed after each use. Refer to
the reprocessing instruction in this chapter.
WARNINGS
Limitations on
reprocessing
Transportation
before using
Levels of reprocessing requirements:
Depending on the application of the product and with regard to
risk evaluation, the user has to classify the medical device
according to the current Medical Device Directive for processing
of medical devices as uncritical, semi-critical or critical.
Supporting information concerning this topic is listed in the
table below. The user is responsible for correct classification
of the medical device.
Classification Definition
uncritical
semicritical
critical
According to the intended use, EUP-S50A probe is classified as
uncritical.
‐
The probe is delivered unsterile. Prior to the first
use, reprocess the probe.
‐
Temperature should not exceed 60°C during
reprocessing.
‐
Probe connector is not water resistant.
The probe is not completely submersible. The immersible
part is shown in Fig.1. The un-immersible part should
be disinfected by wipe disinfection.
The probe should be packed in a sterile pouch or
container to transport from Central Sterile Supply
Department (CSSD) to an operating room. Be careful not
to damage the sterile pouch or container during
transportation.
Application part only
contacts intact and
uninjured skin
Application part contacts
mucosa (intracavitary
application)
Application part contacts
intracorporeal tissue
directly
(operative application)
Processing
Cleaning
Disinfection
Cleaning
Disinfection (Disinfectant
with virucidal effect)
Cleaning
Disinfection (Disinfectant
with virucidal effect -
minimum)
Sterilization
-5-
Q1E-EP0659
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