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Explains symbols like CAUTION and INFORMATION used for device operation and safety.
Outlines ownership, usage rights, and restrictions for the user manual content.
Details critical safety guidelines regarding the device's electrical connections and grounding.
Provides precautions for electromagnetic compatibility (EMC) and potential interference.
Emphasizes that results must only be interpreted by specialized physicians aware of patient context.
Describes the core function of the FibroScan device in measuring liver stiffness.
Defines the FibroScan as a non-implantable medical device for measuring liver stiffness and CAP.
Guides the selection of the appropriate probe and examination type based on patient morphology.
Lists critical situations where the FibroScan should not be used to ensure patient safety.
Reiterates electrical safety requirements, including proper grounding and connection.
Highlights that only trained personnel with a user certificate can operate the FibroScan.
Details the components of the probe, including the electrodynamic actuator and ultrasound transducer.
Describes the initial screen displayed upon device startup and its main functions.
Details the screen for entering and managing patient data before an examination.
Explains the main display during a measurement, including data and images.
Details the software and probe indicators for measuring applied pressure during examinations.
Presents the results for shear wave speed, including median and interquartile range.
Shows the results for liver stiffness, including median, interquartile range, and IQR/Median.
Covers the functions for displaying, searching, and managing stored patient examination files.
Explains how to view specific measurement details and navigate through examinations for a patient.
Provides the correct sequence for shutting down the FibroScan device completely.
Outlines the procedures for safely cleaning the device probe and its components.
Explains the necessity and procedure for periodic probe calibration to maintain performance.
Lists common events and their corresponding solutions for device issues.
Describes how to access the device's configuration settings using an identifier and password.
Details network configuration, including IP address, DICOM, and Wi-Fi settings.
Explains CE marking, notified body identification, and electrical safety symbols.
Provides quantitative data on shear wave speed and stiffness measurements for different probes.
Details the device's compliance with electromagnetic emission standards.
Specifies immunity levels for electrostatic discharge, spikes, and voltage variations.
Provides guidance on safe distances between the device and RF emitting equipment.
General| Model | FibroScan 502 touch |
|---|---|
| Liver Stiffness Measurement Range | 1.5 to 75 kPa |
| CAP Measurement Range | 100 to 400 dB/m |
| Device Type | Elastography device |
| Technology | Vibration-Controlled Transient Elastography (VCTE) |
| Measurement Parameters | Liver Stiffness (kPa), CAP (Controlled Attenuation Parameter) (dB/m) |
| Probes | M probe |
| Measurement Depth | 25 to 65 mm below the skin surface |
| Result Display | Instantaneous results with liver stiffness (kPa) and CAP (dB/m) values |
| Connectivity | USB, Wi-Fi, Ethernet |
| Power Supply | 100-240 V AC, 50/60 Hz |
| Patient Data Management | Integrated database with export capabilities, patient tracking, and reporting |
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