Hitachi EUP-F531, Инструкция по эксплуатации

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-5- Q1E-EP0415
4. Cleaning, Disinfection and Sterilization
The probe and accessory must be reprocessed after each use. Refer
to the reprocessing instruction in this chapter.
WARNINGS
‐
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.
Limitations on
reprocessing
The probe is not completely submersible. The
immersible part is shown in Fig.1. The un-immersible
part should be disinfected by wipe disinfection.
Transportation
before using
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.
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 Processing
uncritical
Application part only
contacts intact and
uninjured skin
Cleaning
Disinfection
semicritical
Application part contacts
mucosa (intracavitary
application)
Cleaning
Disinfection
(Disinfectant with
virucidal effect)
critical
Application part contacts
intracorporeal tissue
directly
(operative application)
Cleaning
Disinfection
(Disinfectant with
virucidal effect -
minimum)
Sterilization
According to the intended use, EUP-F531 probe is classified as critical.