Device Description

The CUBAClinical consists of the measurement unit, its power cord and computer or data controller connection cord, foot positioning inserts, and accessories.

The CUBAClinical takes an ultrasound measurement through the patient’s heel. The patient is seated with the foot accurately positioned into the footwell, using the correct positioning insert. The foot and lower part of the leg are secured using two Velcro® straps. Ultrasound gel is applied to the face of the silicone pads and to the sides of the heel to provide acoustic coupling. The silicone pads are brought into contact with each side of the patient’s heel by means of a motorized mechanism. Inaudible sound waves are transmitted from one of the transducers through the heel and received by the other transducer. Quantitative parameters describing the attenuation in the heel are measured.

Patient examination time is short, with a typical measurement time of 1 minute (including a settling period).

Intended Use

The intended use of the CUBAClinical Ultrasonic Bone Sonometer is to perform a quantitative ultrasound measurement of the calcaneus (heel bone), the results of which can be used in conjunction with other clinical risk factors as an aid for the diagnosis of osteoporosis and other medical conditions leading to reduced bone density and ultimately in the determination of fracture risk.

The CUBAClinical measures Broadband Ultrasound Attenuation (BUA in dB/MHz). The BUA output is expressed both as an absolute value and, with reference to the embedded Normative Data, as a T-Score, a Z-Score, and the percent expected (age-matched).

Regulatory Status

The CUBAClinical is fully compliant to the Medical Devices Directive 93/42/EEC and carries the CE 0120 mark.

CUBAClinical is approved by the Food and Drug Administration in the USA.

CUBAClinical is approved by the Ministry of Health and Welfare in Japan
CUBAClinical is approved by the Korean Federal Drug Administration

Individualisation of Treatment

The CUBA Clinical measurement of BUA of the heel is used by the physician to assess skeletal status in the evaluation of patients at risk of osteoporosis and other metabolic bone conditions and / or patients who may have reduced bone density due to medical conditions indirectly affecting bone mineral metabolism, medications prescribed for other conditions, heritable or genetic factors, lifestyle factors, or other reasons. BUA may be used by the physician along with other clinical factors in the diagnosis of osteoporosis and other conditions leading to reduced bone density.

When evaluating individual patients, all relevant risk factors should be considered. (Previous fractures, frame size, smoking, age etc.)