Hitachi EUP B715 Instruction Manual page 30

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, semicritical or critical.
concerning this topic is listed in the table below.
responsible for correct classification of the medical device.
Classification
uncritical
semicritical
critical
Flowchart of reprocessing process of this probe and accessories is as
follows.
Point of use
(Pre-cleaning)
Containment and
transportation
Definition
Application part only contacts
intact and uninjured skin
Application part contacts
mucosa (intracavitary
application)
Application part contacts
intracorporeal tissue
directly (operative
application)
Manual cleaning and
disinfection
Manual Cleaning
Rinsing after manual
Manual Disinfection
Rinsing after manual
disinfection
cleaning
-24-
Supporting information
The user is
Processing
Cleaning
Disinfection
Cleaning
Disinfection
(Disinfectant with
virucidal effect)
Cleaning
Disinfection
(Disinfectant with
virucidal effect -
minimum)
Sterilization
Drying
Packing
Sterilization
Q1E-EP1245