Additional Instructions - AREX CHIROBLOC Serie Instrucciones De Uso Y Esterilización

Any instrument that is broken, damaged or at the end of its
life must not be used. It must be destroyed like any medical
waste according to current regulations.

ADDITIONAL INSTRUCTIONS

1. General Information
CHIROBLOC [CBM/CBP/CHIRO3], CHIROBLOC
Ballast and RING are provided non-sterile.
Devices must be used by surgeon and qualified personnel.
Instruments must be used only for the surgical purpose and
type for which they have been designed (see indications).
Any failure to respect these rules cancels the guarantee:
- CHIROBLOC [CBM/CBP/CHIRO3]: 1 year
- CHIROBLOC Ballast: 5 years
- RING: 1 year
If for any reason, some instrument needs to be returned to
us, it must be first decontaminated. AREX
right to request a decontamination proof.
2. Precautions for use
- CHIROBLOC [CBM/CBP/CHIRO3], CHIROBLOC
Ballast and RING must be used in accordance with this
Instruction for Use. All the information related to use
of these instruments is available on the AREX
www.arex.fr
- Read all the sections of this IFU before use.
- The instruments should be cleaned immediately after use.
- Before use, inspect devices to verify its condition and
proper functioning.
3. Incident declaration
Any serious incident that has occurred in relation to
CHIROBLOC and its accessories should be reported to
®
AREX ‚ and the competent authority of the Member
State in which the user and/or patient is established.
Reminder: A serious incident or risk of serious incident is
any incident or risk of incident involving a medical device
which led or might have led to death or serious deteriora-
tion in state of health of patient, end-user and third party.
These instructions have been validated by the medical device's
manufacturer as being appropriate for preparing a medical device
for reuse. The department is still responsible for ensuring the
sterilization process achieves the intended result by involving the
sterilization facility's staff, materials and equipment. This generally
requires routine verification and control of the procedures. Similarly,
any deviation from the instructions provided should be evaluated to
determine the effectiveness and possible adverse consequences.
DISPOSAL
IFU Revision date: August 2020
®
reserves the
®
website: