STAR Cranial Remolding Orthoses.

The STARscanner Data Acquisition System:

• Non-invasive, non-contact scanning device eliminates using plaster to cast the infants head.
• Digital head shape measurement in less than 2 seconds using eye safe laser.
• Computerized pre- and post-treatment documentation of cranial symmetry.
• Electronic data files securely emailed to Orthomerica and downloaded to a 5-axis carver.
• 3-D model of the infant’s head fabricated using CAD/CAM technology.
• Screening tool for efficacy of orthotic treatment program.
• Screening tools for other interventions such as repositioning efforts, therapy, and pre- and post-operative surgical results.

STARscanner is the only scanner that shows the reshaping progress by comparing the baby’s head shape before, during and after treatment.

The STARscanner is classified and cleared by the Food and Drug Administration (FDA) as a Class I laser-scanning device because it emits very low-power laser energy. Other examples of Class I laser products include laser printers, CD players and CD-ROM devices. Orthomerica developed the STARscanner to meet Class I laser specifications to ensure patients’ safety.

What is an eye safe laser?

Lasers are used everyday, for example laser scanners are used in grocery stores to scan barcodes, in CD-ROMs, in printers and in many other devices. You may have heard about the danger of laser light pens that can cause eye damage; this is because these lasers emit upwards of 100 milliwatts (mW). The FDA has defined an upper limit for lasers at 5 mW. The STARscanner emits only 0.8 mW, well below the defined limits.  The scan takes 2 seconds and the child does not look at the light.

Safety is very important, especially on babies who cannot control their blink reflex. Orthomerica has excellent standards for safety and their STAR family of headbands are all Class II devices, which means they meet rigorous FDA safety and quality controls.

How do you make a cranial helmet?

Steinmann Prosthetics uses the STARscanner Laser Data Acquisition System because it is safe, efficient, and provides the best diagnostic tool for cranial head shape.  We are one of just over 100 facilities in the world that use this system, and it is the same system used at Carrie Tingley Hospital in Albuquerque. We are the only facility in the Southern New Mexico and El Paso region with this system.

Cranial helmets or headbands are classified by the FDA as Class II devices. Headbands are custom-made based on the baby’s unique head measurements. The headband is worn 23 hours/day for three to six months.

During this time, the headband channels the baby’s head growth by applying constant, gentle pressure on the protruding areas of the baby’s head while leaving room for growth in depressed ones. The inside of the band is modified every two to three weeks to account for growth.

More babies around the world have been treated by Orthomerica’s headbands than any other provider. Orthomerica offers a colorful selection of playful headband design patterns and creates the widest array of remolding headbands, which gives parents and clinicians more remolding treatment options to address any severity level of any of the three main head shape problems (plagiocephaly, brachycephaly and scaphocephaly).

What if my child is 18 months old but needs correction?

Sometimes head shape problems are missed. One child had his first haircut at 17 months and it was only then that the problem was noticed. In this case the physician must complete a Letter of Medical Necessity in order for Orthomerica to make a helmet.