Limacorporate SMART SPACE 3D Mode D'emploi page 10

Do not apply excessive force on the devices. Marking on the devices used for indicating anatomical references
and identification number for the specific Case Report must be legible. Notify your representative if the
markings are not legible or if the identification number do not correspond to the intended patient. If you are
not sure of the correspondence of the surgical case, do not use the Smart SPACE 3D Positioners System.
A univocal identification code is indicated on each device belonging to the Smart SPACE 3D Positioners
System. The code links the device unambiguously to the patient case, since the same identification code is
present in the Case Report. Before using the Smart SPACE 3D Positioners System, check the correspondence
with the case code.
3.2.1. USE OF 3D ANATOMICAL MODELS
3D Anatomical Models are only a 3D representation of patient anatomical condition, as previously evaluated
by the surgeon. The model must be used as a surgical planning aid.
3.2.2. FITTING OF THE 3D POSITIONERS
3D Positioners are designed to fit the patient's anatomy planned implant and the dedicated metal instruments.
The supporting surface (bone, cartilage, soft tissue) should be completely congruent to what is described in the
Case Report, to assure proper fit of the 3D Positioner. Take sufficient time to fit the 3D Positioner on the patient.
The Case Report indicates the position of the 3D Positioner relative to the surrounding anatomy. Try different
positions and check whether the 3D Positioner stays in place. Choose the most stable position, in which the
least pressure must be applied in order to keep the 3D Positioner in place. Don't push the 3D Positioner down
too hard. Make sure critical anatomical structures are not damaged during fitting. Fitting the 3D Positioner can
be tried on the 3D Anatomical Model before surgery.
When a stable position of the 3D Positioner is obtained, fixate it by means of fixation pins or screws (if present).
If it is not possible to place the 3D Positioner on the patient in a unique and stable position, the device does not
guarantee an accurate transfer of the pre-operative planning. Even in a stable position, it is possible that the
3D Positioner may not make contact with the bone over its full length, since it not always possible to resolve
all of the undercuts. The undercuts depend on the shape of the patient's anatomy. During the design of the
3D Positioner the number of undercuts is kept to a minimum in order to ensure maximal contact between
bone surface and the device. This is important to perform a correct implant positioning. The correct seating/
placement of the implant is extremely important. Improper selection, positioning, alignment and fixation of the
implant components may result in unusual stress conditions which may negatively affect system performance
and the survival rate of the implant.
3.2.3. CUTTING AND/OR DRILLING PHASE
Whether a cutting and/or drilling is needed, make sure that the 3D Positioner maintains its position on the
contact surface during cutting and/or drilling.
All necessary measures should be taken to avoid excessive heat generation during cutting and/or drilling.
Please consult the procedures shown in the Case Report provided by the manufacturer.
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