Operator’s Manual 2 - 1
2 System Overview
2.1 Intended Use
Hepatus 7/Hepatus 6/Hepatus 5/Hepatus 7S/Hepatus 6S/Hepatus 5S/Hepatus 7T/Hepatus 6T/
Hepatus 5T/Fibrous 7/Fibrous 6/Fibrous 5 Diagnostic Ultrasound System is applicable for adults,
pregnant women, pediatric patients and neonates. It is intended for use in fetal, abdominal,
Pediatric and Peripheral vessel exams.
It is intended to provide 50 Hz shear wave speed measurements (ViTE: Visual Transient
Elastography) and estimates of tissue stiffness as well as 3.5 MHz ultrasound coefficient of
attenuation (LiSA: Liver Ultra-Sound Attenuation) in internal structures of the body.
The ViTE and stiffness, and LiSA may be used as an aid to diagnosis and monitoring of adult
patients with liver disease, as part of an overall assessment of liver.
The ViTE and stiffness may be used as an aid to clinical management of pediatric patients with liver
disease.
The clinical applications include: Fetal, Abdominal, Pediatric and Peripheral vessel.
This device is a general purpose diagnostic ultrasound system intended for use by qualified and
trained healthcare professionals for ultrasound imaging, measurement, display and analysis of the
human body and fluid, which is intended to be used in a hospital or medical clinic.
Modes of operation include: B, M, PW Doppler, Color Doppler, Amplitude Doppler, Tissue
Harmonic Imaging, Biopsy guidance, Color M, Contrast imaging(Contrast agent for Liver), ViTE,
LiSA and Combined mode: B+M, PW+M, Color+B, Power+B, PW+Color+B, Power+PW+B.
The system is not intended for central cardiovascular or central nervous system use.
2.2 Contraindication
• Not intended for ophthalmic use
• For ViTE imaging mode, do not use this system in the following case:
– Patients with implants, such as cardiac pacemakers, or with post-operation metal clip or
metal bracket
– Patients with unhealed abdominal wounds
– Severe ascites
–Pregnant women
2.3 Safety Classifications
• According to the type of protection against electric shock:
Class I equipment + internally powered equipment
• According to the degree of protection against electric shock:
Type-BF applied part
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