6
Cleaning and
disinfection
In accordance with EN ISO 17664, this section provides users with instructions for cleaning,
disinfection and sterilization of SOPRO reusable medical devices. Instructions related to cleaning,
disinfection and sterilization protocols for each medical device and accessory supplied by
SOPRO have been validated. This section is applicable only for devices manufactured by SOPRO.
The user should comply with the national guidelines, laws and regulations of countries where
the requirements for reprocessing are more stringent than those detailed in this leaflet. The
recommendations of the manufacturers of the products and equipment used should also be
observed.
Cleaning is the removal of visible soil (e.g., organic and inorganic material). Cleaning
reduces the initial population of microorganisms, preventing blood proteins and other
contaminants from drying on the devices, facilitating subsequent cleaning and protecting
personnel when handling medical devices and prevents contamination of the environment.
Disinfection reduce the number of pathogenic microorganisms, except bacterial spores.
6.1 Devices and process to apply
Warning: The control unit is a re-usable medical device, supplied non-sterile, and no
sterilizable.
Clean any possible splashes of liquid from the control unit, removing them with a lightly
dampened cloth.
The camera head is a re-usable medical device supplied non-sterile and must be cleaned
prior of the first use and after each use. The camera head is not autoclavable.
The light cable manufactured and provided by SOPRO is a re-usable medical device supplied
non-sterile and must be sterilized prior each use in accordance with its instructions for use.
Products
(camera head)
PLEASE SEE THE
REPROCESSING
SECTIONS FOR
DETAILED
INSTRUCTIONS
S195
✓
Approved method
Always disconnect the device before cleaning it.
Existing alkaline solutions for disinfecting certain medical devices are NOT RECOMMENDED for
70
Pre-cleaning
Cidezyme 0.8%
Cidezyme 0.8%
✓
High-Level
Cleaning
Disinfection (HLD)
CIDEX OPA (0.55%)
✓
Drying
STERILE SHEET
✓
✓