10
This document is valid only on the date printed. If unsure of the print date, re-print to ensure use of the latest version of the IFU. The onus resides with
the user to ensure that the most up-to-date IFU is used.
The SE sequence showed reduced artifacts (≤ 11 mm).
The attending physician should conduct a careful risk/benefit assessment.
10 Packaging and storage
The product is delivered non-sterile and must be sterilized before its first use. Before a system is used, all components should be meticulously
checked for completeness, damages and defects. Damaged components must not be used.
Corrosion may occur when instruments are stored under unfavorable conditions. In order to avoid this, they should be stored in a dry, dust-free
area. Significant temperature fluctuations are to be avoided, so that no moisture (condensation) accumulates on the instruments.
When directly exposed to metal, chemical substances may destroy this metal or release corrosive fumes. Therefore, instruments must not be
stored together with chemical substances.
The system-specific trays are to be used to store the instruments.
11 Identification and traceability
Implants are labeled with the catalogue number and batch code on the packaging label and, if technically feasible, these are marked on the
implant itself.
To ensure traceability, these data must be correspondingly documented in the hospital.
12 Disposal of used products
Follow country-specific regulations regarding disposal of hospital waste when disposing of used medical devices.
13 Cleaning, disinfection and sterilization
The product is delivered non-sterile and must be sterilized before its first use.
For cleaning, disinfection and sterilization of non-sterile implants and instruments the “Processing manual implants and instruments” UH 1100
that was provided in the overall documentation of the system must be used. For individual instruments which are correspondingly marked
in the surgical technique, the “Assembly and disassembly instructions with special cleaning instructions” that was provided in the overall
documentation of the system have to be considered.
These are also available at:
www.ifu.ulrichmedical.com
.
14 Labeling and symbols
Catalogue number
Caution
Quantity
Batch code
Do not re-use
NON
STERILE
Non-sterile
Manufacturer
Date of manufacture
Do not use if package is
damaged
Consult electronic instructions for use
Consult instructions for use
Caution: U.S. federal law restricts this device to sale by or on the order of a
physician
MR
MR Conditional – A product
which does not demonstrate
any deliberate hazards in the
specific MRI environment
CE mark with identification
number of the notified body
Consult assembly and
disassembly instructions with
special cleaning instructions
2019-09-10
