Limacorporate SMART SPACE 3D Mode D'emploi page 6

1.1.1. MEDICINAL SUBSTANCES AND TISSUE
The device does not contain or incorporate any:
• medicinal substances, including a human blood or plasma derivative, • tissues or cells, or their derivatives,
of human origin, • tissues or cells of animal origin, or their derivatives, as referred to in Regulation (EU) No
722/2012.
1.2. HANDLING, STORAGE AND SAFE DISPOSAL
Smart SPACE 3D Positioners System is provided NON-STERILE. The devices should be stored at ambient
temperature (indicative range 0-50° C / 32-122° F) in their protective closed packaging in controlled rooms
(properly cleaned and dry place), protected from exposure to light, heat and sudden changes in temperature.
Once the package is opened, ensure that the identification numbers on the devices correspond to the
description printed on the labels. The same identification number is shown on the Case Report. Open the
packaging only before preparing the 3D Positioner(s) and 3D Anatomical Model(s) for surgery.
Avoid any contact between the devices and objects or substances that can alter the surface integrity and,
if applicable, the sterile condition. Careful visual examination of each device is recommended before use in
order to verify that the device is not damaged. Components removed from the package should not be
used if they are dropped or suffer other accidental trauma/impacts. Devices should not be modified
in any way.
Reuse of Smart SPACE 3D Positioners System is not allowed. Risks associated with re-use of single
use devices are: • damage of device in case of reprocessing (the execution of reprocessing is not
applicable); • the incorrect placement of the implantable medical device.
After their use, the devices should be handled in conformity with the proper and validated hospital procedures.
The disposal of the Smart SPACE 3D Positioners System is to be performed by the hospitals in conformity
with applicable laws.
1.3. DEVICE PERFORMANCE
Smart SPACE 3D Positioners System is designed according to internal procedures which allow the
development process to be followed in accordance with the applicable standards and regulations.
The devices are designed by means of the Smart SPACE Shoulder Planner, which allows the surgeon to create
3D Positioners and 3D Anatomical Models, reproducing patient anatomy. The design of 3D Positioners is
developed by the software on the basis of patient anatomy. The surgeon visualizes the output 3D Positioner(s)
model and verifies its placement through Smart SPACE Shoulder Planner. The order of the Smart SPACE 3D
Positioners System is performed through the digital signing of the output report of the Smart SPACE Shoulder
Planner. The software therefore creates a case manufacturing archive (anonymized data files) sufficient to
proceed with the manufacturing of the devices.
The request of Smart SPACE 3D Positioners System is received by LimaCorporate and the consolidated
process for the provision of custom-made devices is then followed. A dedicated LimaCorporate engineer
evaluates the case and, in case of necessity, performs the adequate improvements to the design and
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