21
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 attending physician should conduct a careful risk/benefit assessment.
9 Packaging and storage
The product is delivered sterile. Sterility remains guaranteed provided the packaging is not opened or damaged and the expiry date has not
been exceeded. The product must be stored dry until it is 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.
10 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. For sterile-packed implants, corresponding adhesive
labels are included for documentation.
11 Disposal of used products
Follow country-specific regulations regarding disposal of hospital waste when disposing of used medical devices.
12 Cleaning, disinfection and sterilization
Reusability of tezo implants:
The implants are supplied sterile and may not be processed or sterilized again. Processing can lead to material damage that can impair the
function of the implants.
For cleaning, disinfection and sterilization of non-sterile 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 surgi-
cal 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:
.
13 Labeling and symbols
Catalogue number
Batch code
Quantity
Manufacturer
Date of manufacture
Use-by date
Do not use if package is
damaged
Do not re-use
Sterilized using irradiation
Caution: U.S. federal law restricts this device to sale by or on the order of a
physician
Caution
Consult assembly and disassembly instructions with special cleaning
instructions
Consult instructions for use
CE mark with identification number of the notified body
Non-sterile
MR
MR Conditional
– A product which does not demonstrate any deliberate hazards in the specific MRI environment
NON
STERILE
2019-07-02
