Cleaning And Disinfection - Hitachi EUP-VV531 Instruction Manual

4. Cleaning and Disinfection
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
Application part only contacts intact
uncritical
Application part contacts mucosa
semicritical
critical
According to the intended use, EUP‐VV531 probe is classified as semicritical.
‐
The probe is delivered unsterile. Prior to the first use, reprocess the
probe.
‐
Temperature should not exceed 50°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.
Sterilization is not possible for this probe.
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
and uninjured skin
(intracavitary application)
Application part contacts
intracorporeal tissue directly
(operative application)
Disinfection (Disinfectant with
Disinfection (Disinfectant with
virucidal effect ‐ minimum)
‐4‐
Processing
Cleaning
Disinfection
Cleaning
virucidal effect)
Cleaning
Sterilization
Q1E‐EP1028