|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.
Using the device
Interpreting the results
|Environment of use||The FibroScan device is intended for use in hospitals, clinics, and other types of healthcare centre.|