Cleaning, Disinfection And Sterilization - Hitachi C22K Instruction Manual

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
uncritical
semicritical
critical
According to the intended use, C22K probe is classified as critical.
‐
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.
Definition
Application part only
contacts intact and
uninjured skin
Application part contacts
mucosa (intracavitary
application)
Application part contacts
intracorporeal tissue
directly
(operative application)
-6-
Processing
Cleaning
Disinfection
Cleaning
Disinfection
(Disinfectant with
virucidal effect)
Cleaning
Disinfection
(Disinfectant with
virucidal effect -
minimum)
Sterilization
Q1E-EP1389