Hitachi S31 Instruction Manual page 13

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, S31 probe is classified as uncritical.
Definition
Application part only
contacts intact and uninjured
skin
Application part contacts
mucosa (intracavitary
application)
Application part contacts
intracorporeal tissue
directly
(operative application)
Disinfection (Disinfectant
with virucidal effect)
Disinfection (Disinfectant
with virucidal effect -
- 7 -
Processing
Cleaning
Disinfection
Cleaning
Cleaning
minimum)
Sterilization
Q1E-EP1376