Procedure:
- Fill a container of a suitable size to hold all the individual components to be disinfected with a solution of drinking water and disin-
fectant, observing the proportions indicated on the packaging of the disinfectant.
- Completely immerse each individual component in the solution, taking care to avoid the formation of air bubbles in contact with
the components. Leave the components immersed for the period of time indicated on the disinfectant packaging, and associated
with the concentration chosen for the preparation of the solution.
- Recover the disinfected components and rinse them thoroughly with lukewarm drinking water.
- After disinfecting the accessories, shake them vigorously and place them on a paper towel, or alternatively dry them with a hot air
jet (e.g. hair dryer).
- Dispose of the solution according to the disinfectant manufacturer's instructions.
Sterilisation
The sterilisation procedure described in this section is only effective on treated components if it is adhered to in all points and only if
the components to be treated are sanitised beforehand, and is validated in accordance with ISO 17665-1.
Equipment: Steam steriliser with fractionated vacuum and overpressure compliant with EN 13060.
Procedure: Package each individual component to be treated in sterile barrier system or packaging in accordance with EN 11607.
Insert the packed components into the steam steriliser, making sure to keep the vessel (9) upright.
Perform the sterilisation cycle in accordance with the instructions for use of the equipment by selecting a temperature of:
(method A): 134°C and a time of 10 minutes first.
(method B): 121°C and a time of 20 minutes first.
Storage:
After sanitising, disinfection or sterilisation, reassemble the vessel and connecting pipes according to the instructions given in the
'CONNECTION DIAGRAM' .
At the end of each use, store the medical device complete with accessories in a dry and dust-free place.
• The manual aspirated flow control (15) is a sterile disposable product and must be replaced each time it is used.
• The ANTIBACTERIAL HYDROPHOBIC FILTER (7) is a single-use product and must be replaced each time it is used.
6a
HYGIENIC PREPARATION IN THE HOME
✓
method A
✓
method B
✓
method C
✓
MAX 300
TIMES
HYGIENIC PREPARATION IN A CLINIC OR HOSPITAL
✓
method A
MAX 50
TIMES
method B
\
✓: planned \: not planned
Table of planned methods / patient accessories
6b
6c
Sanitisation
✓
✓
✓
✓
✓
✓
Disinfection
✓
✓
MAX 300
MAX 300
TIMES
TIMES
Sterilisation
✓
✓
MAX 50
MAX 50
TIMES
TIMES
\
\
8
9
10
✓
✓
✓
✓
✓
✓
✓
✓
✓
✓
✓
\
MAX 300
MAX 300
TIMES
TIMES
\
\
\
✓
✓
\
MAX 50
MAX 50
TIMES
TIMES
23
10a
11
✓
✓
✓
✓
✓
✓
✓
✓
MAX 300
MAX 300
TIMES
TIMES
\
\
✓
✓
MAX 50
MAX 50
TIMES
TIMES