Pediatric Use: Summary of Safety Instructions
When setting an acquisition, the estimated X-ray dose emission is displayed on the acquisition interface so that you can evaluate if the benefit of the X-ray imaging outweighs the risks.
The representative dose information associated with each radiological exam on the CS 9600 and the corresponding patient size is provided in the X-ray Dose Emission Information section of the CS 9600 Safety, Regulatory and Technical Specifications User Guide (SMA17).
The following features will help you to simplify the X-ray imaging of children and adolescents:
Children and adolescents can be more still and stable in the seated position. The CS 9600 can be lowered for an exposure in the seated position.
To allow proper positioning of a pediatric patient, and where relevant, depending on the patient size, you can use the 3D child bite block accessory instead of the standard 3D bite block.
You can use on the acquisition interface to launch a radiation free test cycle at any time to do some preliminary demonstrations and explanations to assure the patient.
Face to face positioning helps to minimize the fear of confined space in the unit for children and adolescent patients.
The following resources provide information about pediatric imaging radiation safety and radiation safety for dental cone-beam computed tomography devices:
FDA Pediatric X-ray Imaging web page: https://www.fda.gov/radiation-emittingproducts/radiationemittingproductsandprocedures/medicalimaging/ucm298899.htm
FDA Dental Cone-beam Computed Tomography web page: https://www.fda.gov/Radiation-EmittingProducts/RadiationEmittingProductsandProcedures/MedicalImaging/MedicalX-Rays/ucm315011.htm
Additional recommendations for safer and more effective pediatric patient imaging is provided by the Alliance for Radiation Safety in Pediatric Imaging (Image Gently Alliance): www.imagegently.org
We recommend that you consult the ‘Image Gently Back to Basics’ campaign materials at: https://www.imagegently.org/LinkClick.aspx?fileticket=kyzGxOMxTFo%3d&tabid=754&portalid=6&mid=1939
To ensure that the device functions properly across the entire range of patient size for which it may be used, follow the recommendations made in the Maintenance section of this user guide.