Magnetic Resonance Imaging (Mri) - Limacorporate SMART SPACE 3D Mode D'emploi

Sterilization temperature
Sterilization time
Drying time
Sterilization temperature
Sterilization time
Drying time
Users should validate their specific cleaning, disinfection and sterilization processes and equipment.
5. INFORMATION USEFUL TO INFORM THE PATIENT
Refer to previous sections for any information that allows the patient to be informed of any warnings,
precautions, contra-indications, measures to be taken and limitations of use regarding the device.
The surgeon is asked to inform the patient about any warning, precautions, contraindications, measures to
be taken and limitations of use reported in the previous paragraphs and any additional information that can
be related to specific custom-made features of the device. This possible additional information is shared by
LimaCorporate to the surgeon before the design approval and it is reported in the Case Report.
The surgeon shall notify the patient about any necessary follow-up specific for the patient condition.

5.1. MAGNETIC RESONANCE IMAGING (MRI)

These Instructions For Use are referred only to not-implantable devices. The devices are made in Polyamide
(PA 2200). There are no risks associated with the use of the Smart SPACE 3D Positioners System in the MRI
environment.
6. INCIDENT REPORTING
According to the definition of incident/serious incident given by Regulation EU 2017/745*, users and/
or patients are required to: • report to the manufacturer and to the relevant Competent Authority any
serious incident that has occurred in relation to the device; • report to the manufacturer any incident
and/or event of malfunction of the device or changes in its performance that may affect safety.
*an incident is defined to be any malfunction or deterioration in the characteristics and/or performance of the
device, including use-error due to ergonomic features, as well as any inadequacy in the information supplied
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Table 2 – Method of pre-vacuum steam sterilization
Table 3 – Method of pre-vacuum steam sterilization
134°C (273.2°F)
18 min
20 min
132°C (269.6°F)
4 min
30 min