Limacorporate SMART SPACE 3D Mode D'emploi page 9

These patient-specific devices have been manufactured based on CT-scan data. Over time, the
patient's anatomy can change. If a significant amount of time has elapsed from the time of collection of
the patient data (date of CT-scan) to the time of surgery, Smart SPACE 3D Positioners System should
not be used. The surgeon is advised not use the Smart SPACE 3D Positioners System in case that the
time frame between the CT-scan used for the design and the use of the device is higher than 6 months.
Smart SPACE 3D Positioners System should be used only by surgeons familiar with the implant,
its design features, method of application, instruments and specific surgical technique prior to
performing surgery. All the above-mentioned information is shared with the surgeons in the Case
Report.
In all cases, proper orthopedic practices are to be followed, and the surgeon's selection of the type of device
and its design features must be appropriate for treatment.
LimaCorporate's specialized technical staff are available to provide advice regarding pre-operative planning,
the surgical technique, and product and instrumentation assistance both prior to and during surgery.
The surgeon should be aware of possible allergic reactions to the material used for manufacturing Smart
SPACE 3D Positioners System. The patient should be informed on this matter by the surgeon.
The possible impact of the factors mentioned in sections "GENERAL INFORMATION ON INDICATIONS,
CONTRAINDICATIONS AND RISK FACTORS" and "POSSIBLE ADVERSE EFFECTS" should be considered
preoperatively and the patient informed as to what steps he/she can take to reduce the possible effects of
these factors.
The devices included in the Smart SPACE 3D Positioners System are patient-specific, single use,
disposable devices: do not re-use or recondition the devices.
Do not re-use a device that has previously come into contact with the body fluid or tissue of another
person. Do not use any device from a package that has been previously opened or appears to be
damaged. Do not use any device if it is broken, cracked or visibly contaminated.
The devices included in the Smart SPACE 3D Positioners System are designed for a named patient and
must not be used to treat any other patient.
3.2. INTRAOPERATIVE
Devices should not be modified in any way. Altering the size of the 3D Positioner(s) may result in an inadequate
fit to the patient's anatomy. It is the responsibility of the surgeon if the 3D Positioner(s) is altered in any way
prior to, or during surgery.
Smart SPACE 3D Positioners System is intended to be used by a physician in the performance of the surgery.
The devices in the package are provided NON-STERILE. They must be sterilized prior to use in surgery.
Use only in combination with instruments belonging to the LimaCorporate SMR Shoulder System and SMR TT
Hybrid Glenoid System. The use of instruments from other manufacturers or the use of instruments designed
for use with other systems can lead to inappropriate preparation of the implant site, incorrect positioning,
alignment and fixation of the devices followed by loosening of the system, loss of functionality, reduction of the
durability of the implant, and the need for further surgery.
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