Storage Conditions - AREX CHIROBLOC Serie Instrucciones De Uso Y Esterilización

7. Maintenance
Non-applicable.
8. Controls and functional tests
After each cleaning and drying, check the dryness, cleanli-
ness, proper functioning and absence of deterioration of
the devices.
Before each use, carry out the following tests in order to
verify the conformity of the device:
• CHIROBLOC
Visual inspection of the device to identify any damage,
wear and/or signs of degradation: hole, crack, air pocket in
the hand, defect on CHIROBLOC's plugs, broken finger
under the silicon cover.
• CBL
Visual inspection of the device to identify any damage
wear and/or signs of degradation : corrosion
• RING
Visual inspection of the device to identify any damage
wear and/or signs of degradation: crack
9. Packaging
Standard individual packaging compatible with steam
sterilization method must be used (i.e. sealed bags). Make
sure the pouch is enough large to hold the unfolded
instrument without placing stress on the pouch's seal. The
CHIROBLOC Ballast is always packaged separately.
10. Sterilization
CHIROBLOC must be unfold and flattened before ster-
ilization. CHIROBLOC Ballast, CHIROBLOC et RING
are sterilized in a vacuum autoclave according to one of the
following protocols:
Protocol A
- 3 pre-vacuum phases
- Sterilization temperature: 132°C
- Holding time: 4 minutes
- Drying time: 20 minutes
Protocol B
- 3 pre-vacuum phases
- Sterilization temperature: 134°C
- Holding time: 3 minutes
- Drying time: 20 minutes
The instructions of the autoclave's manufacturer must be
followed.
Ensure that the surfaces of the device are not covered dur-
ing sterilisation.
Only the cleaning and sterilization procedures defined
in this IFU have been validated. However, the healthcare
facility can use its standard disinfection and sterilization
protocol, as long as this protocol has been validated for the
disinfection and sterilization of surgical instruments (e.g.
sterilization in instrument holders, manual cleaning, other cleaning
and sterilization parameters).
CHIROBLOC [CBP/CBM/CHIRO3], CHIROBLOC
Ballast and RING must be stored in a dry and clean and
dry environment, at room temperature. Do not store the
instruments near products that may have a corrosive action
(ex: chlorine for CHIROBLOC Ballast).

STORAGE CONDITIONS