Contraindications

The device could not be used in following conditions:

—Pregnant women or women after pregnancy but before return of the menstrual period

—Patients with skin disease such as skin cancer, psoriasis or a history of skin disease

—Patients with a fracture or wound that affects the application of SCN201 during scanning

—Patients with surgery done for the spine

—Patients with winged scapulae or other irregularity of back contours that preclude satisfactory skin contact of the machine probe during the scanning procedure

—Patients who cannot stand steadily during the examination

—Patient with an allergy to aqueous gel used for ultrasound scanning

Intended purpose

Scolioscan Air SCN201 provides a new imaging modality for the assessment of spinal deformity using a 3D ultrasound technique. It provides a coronal view of spine for the evaluation of severity of scoliosis.

Intended users

The intended users are the personnel with required training. In order to safely and effectively operate Scolioscan Air, the user should have the following qualifications:

— Training as required by local, state, provincial, and national regulations, if applicable

— Additional training as required by the authorized distributor or TMIL

— A thorough knowledge and understanding of the material presented in the manual

Intended patient population

The intended patient population are children and adults, who meet following conditions:

— Between 8-40 years old

— Body mass index (BMI) < 23 kg/m²

— Standing height between 1m – 2m