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Regulatory

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FibroScan® medical devices

  FibroScan® 430 Mini/Mini+ FibroScan® 530 Compact FibroScan® 630 (Expert and Prime)
Intended use The FibroScan device is intended to provide:
– liver stiffness measurements at a shear wave frequency of 50 Hz,
– and the Controlled Attenuation Parameter (: CAP) of the liver at 3.5 MHz.		    
Indications for use Measurement of liver stiffness and liver CAP is indicated in the diagnosis and monitoring of adult and paediatric patients as part of the assessment of liver disease.
Note: the parameters listed in Table 1, known to influence liver stiffness, shall be considered when interpreting liver stiffness.		    
Target population The FibroScan device is indicated for adult and paediatric patients.    
Precautions for use The following precautions must be observed when using the FibroScan device:
– The probe and type of examination must be selected based on the recommendations detailed in the “Examination procedure” section, page 28.
– With SmartDepth option enabled, measurements should not be performed if the device displays the “Liver too deep” warning. In this case, the operator can change the probe and/or measurement point.
– With SmartDepth option disabled, with the M+ probe: measurements should not be performed if the PCD (probe-to-capsule distance) is more than 25 mm. In this case, the operator can change the probe and/or measurement point.
– With SmartDepth option disabled, with the XL+ probe: measurements should not be performed if the Probe-to-capsule distance is more than 35 mm. In this case, the operator can change the measurement point.
– The presence of ascites between the probe and the liver may prevent measurements from being obtained.
– The patient must fast for at least 3 hours before the examination.
– The clinical personnel must follow normal safety procedures.		    
Contra-indications To ensure patient safety, the FibroScan device must not be used in the following situations:
– On an organ other than the liver.
– On the eyes and mucosa.
– On wounds.
Use of the M+ probe is not approved for patients under 14 years old.		    
Intended users

Using the device
The FibroScan device is intended for use by healthcare professionals. No prior knowledge or experience of using ultrasound imaging equipment is necessary. Operators must be duly trained and approved by the manufacturer

Interpreting the results
The measurements obtained from the device are intended to be interpreted by a physician experienced in the management of liver diseases.

    
Environment of use The FibroScan device is intended for use in hospitals, clinics, and other types of healthcare centre.    
Claims NA