Safety Information
Indications for Use
The CS 9600 is an extraoral system intended to produce two-dimensional and three-dimensional digital X-ray images of the dento-maxillofacial, ENT (Ear, Nose and Throat), cervical spine and wrist regions at the direction of healthcare professionals as diagnostic support for pediatric and adult patients.
The CS 9600 can be upgraded to produce cephalometric digital X-ray images. This includes imaging the hand and wrist to obtain a carpus image for growth and maturity assessment.
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CAUTION: Do NOT use on patients who are about 5 years old and below, and who are less than about 21 kg (46 lb) in weight and 113 cm (44.5 in) in height. |
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CAUTION: Do NOT use cone beam imaging for routine or screening examinations. Consider using other diagnostic tools. You must justify that the imaging method that you use to examine each patient demonstrates that the benefit outweighs the risks. |
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CAUTION: Where it is likely that evaluation of soft tissues will be required as part of the patient’s radiological assessment, the appropriate imaging should be conventional medical CT or MR, rather than 3D imaging using Cone Beam technology. |
Clinical benefits and performance characteristics
The CS 9600 benefits healthcare professionals by allowing them to acquire digital X-ray images (two-dimensional and three-dimensional) of the dento-maxillofacial, ENT (Ear, Nose and Throat), cervical spine and wrist regions. The outcomes allow the healthcare professional to support image diagnosis, establish relevant treatment plan and thus improve the clinical patient management. The clinical benefits of CS 9600 brings positive impact to patient management.
The clinical performances of the CS 9600 stem from the technical characteristics of the extraoral X-ray equipment defined in IEC/EN 60601-2-63 standard. The characteristics are:
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Accuracy of loading factors (X-ray tube voltage, X-ray tube current, irradiation time and current time product.
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Reproducibility of the radiation output.