E332M006.6 UserGuide FS430 MINI MINI+ STEP2 en-GB

User manual
for the FibroScan 430 MINI / MINI +

®
E332M006.6 – Version 6 – 02/2021
(software version 4.1)
en-GB
en-GB FIBROSCAN USER MANUAL 430 MINI / MINI +
2
FIBROSCAN USER MANUAL 430 MINI / MINI + en-GB
TABLE OF CONTENTS
1. PURPOSE OF THE USER MANUAL............................................................................. 7

1.1. Symbols used in the manual ....................................................................................... 8
1.2. Property and copyright ................................................................................................ 8
2. WARNINGS .................................................................................................................... 9
2.1. Peripherals not supplied by Echosens ........................................................................ 9
2.2. Electrical safety ........................................................................................................... 9
2.3. Electromagnetic safety ................................................................................................ 9
2.4. Battery safety............................................................................................................. 10
2.5. Magnetic resonance safety........................................................................................ 11
2.6. Using the device ........................................................................................................ 11
2.7. Deleting measurements............................................................................................. 11
2.8. Patient safety............................................................................................................. 11
2.9. Switching off the unit ................................................................................................. 11
2.10. Cleaning and maintenance........................................................................................ 12
2.11. Cleaning .................................................................................................................... 12
2.12. Interpreting the result................................................................................................. 12
3. MISCELLANEOUS INFORMATION ............................................................................ 13

3.1. Guarantee.................................................................................................................. 13
3.2. Liability....................................................................................................................... 13
3.3. Essential performance characteristics....................................................................... 13
3.4. Product life................................................................................................................. 13
3.5. Reverse engineering ................................................................................................. 13
3.6. Registered trademarks .............................................................................................. 14
3.7. Patented technology.................................................................................................. 14
4. INDICATIONS AND PERFORMANCE......................................................................... 15

4.1. Intended use.............................................................................................................. 15
4.2. Indications for use ..................................................................................................... 15
4.3. Target population....................................................................................................... 17
4.4. Precautions for use.................................................................................................... 18
4.5. Contraindications....................................................................................................... 18
4.6. Intended environment................................................................................................ 18
4.7. Intended users........................................................................................................... 18
4.7.1. Using the device .......................................................................................... 18
4.7.2. Interpreting the results ................................................................................. 18
4.8. Principle of use .......................................................................................................... 18
4.9. User training .............................................................................................................. 19
E332M006.6 02/2021 - ECHOSENS TM AND FIBROSCAN® ARE REGISTERED TRADEMARKS © COPYRIGHT ECHOSENS ALL RIGHTS RESERVED
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4.10. Electrical safety ......................................................................................................... 19

4.11. Maintenance-related safety ....................................................................................... 20
5. EXTERNAL PRESENTATION ..................................................................................... 21

5.1. Hardware supplied..................................................................................................... 21
5.2. Probes and peripherals supplied by Echosens, and peripherals not supplied by
Echosens................................................................................................................... 21
5.3. Front view .................................................................................................................. 22
5.4. Right side view .......................................................................................................... 24
5.5. Rear view................................................................................................................... 24
5.6. Stand ......................................................................................................................... 26
5.7. Battery hatch ............................................................................................................. 26
5.8. Description of probes................................................................................................. 27
6. EXAMINATION PROCEDURE..................................................................................... 29
6.1. Selection of the probe and examination type ............................................................ 29
6.2. Performing the examination....................................................................................... 30
7. SOFTWARE INTERFACE............................................................................................ 32
7.1. Authentication page................................................................................................... 32
7.2. Home screen ............................................................................................................. 32
7.3. Using the keypad....................................................................................................... 33
7.4. Status bar .................................................................................................................. 33
7.5. The patient record screen.......................................................................................... 35
7.6. Acquisition screen ..................................................................................................... 37
7.6.1. Localisation phase ....................................................................................... 37
7.6.2. Patient data.................................................................................................. 38
7.6.3. Ultrasound images ....................................................................................... 39
7.6.4. Force indicator ............................................................................................. 40
7.6.5. Elastogram................................................................................................... 41
7.6.6. Valid stiffness measurement counter........................................................... 41
7.6.7. Stiffness results area ................................................................................... 41
7.6.8. CAP-LEVEL (only for CAPc)........................................................................ 42
7.6.9. CAP result zone ........................................................................................... 42
7.6.10.Measurements displayed as image carrousel.............................................. 43
7.6.11.Displays measurements as vignettes .......................................................... 44
7.6.12.Deleting measurements ............................................................................... 44
7.6.13.Adding a comment ....................................................................................... 44
7.6.14.Alert display area ......................................................................................... 45
7.6.15.Message area .............................................................................................. 45
7.6.16.Examination type selection area .................................................................. 46
7.6.17.View and print the result of the examination ................................................ 47
7.7. Management of patient file archives.......................................................................... 48
7.7.1. Advanced file search.................................................................................... 49
7.7.2. Select and view a patient file ....................................................................... 49
7.7.3. Details of the examination............................................................................ 49
7.8. Resending failed exports ........................................................................................... 50
8. STANDBY AND SHUTTING DOWN THE MACHINE .................................................. 51

8.1. Between sessions...................................................................................................... 51
02/2021 - ECHOSENS TM AND FIBROSCAN® ARE REGISTERED TRADEMARKS © COPYRIGHT ECHOSENS ALL RIGHTS RESERVED E332M006.6
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8.2. At the end of the day ................................................................................................. 51
9. CLEANING, MAINTENANCE AND REPAIRS ............................................................. 52

9.1. Cleaning and disinfection .......................................................................................... 52
9.1.1. Cleaning the surfaces of the device............................................................. 52
9.1.2. Disinfecting the probe (housing, cable and transducer)............................... 53
9.1.3. Recommended cleaning products ............................................................... 54
9.1.4. Recommended disinfection products........................................................... 54
9.1.5. Prohibited cleaning and disinfection products.............................................. 54
9.2. Calibrating the probe ................................................................................................. 54
9.3. Replacing the battery................................................................................................. 55
9.4. Troubleshooting......................................................................................................... 55
9.5. Patient leakage current tests: Precautions ................................................................ 55
10. CONFIGURING THE FIBROSCAN.............................................................................. 56

10.1. Entering configuration mode...................................................................................... 56
10.2. Localisation tab.......................................................................................................... 56
10.3. Institution tab ............................................................................................................. 57
10.4. Printer tab .................................................................................................................. 57
10.5. Data tab ..................................................................................................................... 58
10.6. User tab ..................................................................................................................... 58
10.7. Connectivity tab ......................................................................................................... 59
10.8. Examination tab......................................................................................................... 60
10.9. System tab................................................................................................................. 61
11. SYMBOLS ON THE DEVICE ....................................................................................... 64

11.1. Markings on the device.............................................................................................. 64
11.2. Markings on the battery ............................................................................................. 66
11.3. Note ........................................................................................................................... 66
12. TECHNICAL CHARACTERISTICS.............................................................................. 67

12.1. Characteristics of the device ..................................................................................... 67
12.1.1.Computer characteristics ............................................................................. 67
12.1.2.Metrological performance ............................................................................ 67
12.1.3.Electrical characteristics .............................................................................. 68
12.1.4.Mechanical characteristics........................................................................... 68
12.1.5.Environmental characteristics ...................................................................... 68
12.1.6.Additional information .................................................................................. 69
12.2. Battery characteristics ............................................................................................... 69
12.3. External power supply characteristics ....................................................................... 69
12.4. Consumables............................................................................................................. 69
13. REGULATIONS............................................................................................................ 70
13.1. Electromagnetic emissions........................................................................................ 70
13.2. Electromagnetic immunity (1) .................................................................................... 71
13.3. Electromagnetic immunity (2) .................................................................................... 71
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13.4. Recommended separation distances ........................................................................ 73
14. ELECTROMAGNETIC COMPATIBILITY..................................................................... 74

14.1. Classification ............................................................................................................. 74
14.2. Immunity .................................................................................................................... 75
14.3. Emissions .................................................................................................................. 76
15. INDEX ........................................................................................................................... 77
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1. PURPOSE OF THE USER MANUAL
The present User Manual has no contractual value whatsoever and under no circumstances
may Echosens be held responsible on the basis of the information contained in the present
manual.
The present User Manual details, on the one hand, all of the information required for the
implementation, use and maintenance of the FibroScan instrument and, on the other hand,
the list of information displayed.
After carefully reading the manual, operators shall be able to:

Connect peripheral elements (mains lead, USB devices, probes) and power up the
FibroScan instrument,
Configure the device,
Navigate the machine's user interface,
Perform basic maintenance.
Echosens SA publishes this manual "as is'", without guarantees of any nature, whether
explicit or implicit, including, but not limited to, implicit guarantees concerning merchantability
or fitness for a particular use, for the purpose of providing simple and accurate information.
Consequently, Echosens SA cannot accept any responsibility for any incorrect interpretation
of the manual. Though all efforts have been made to offer a manual that is as accurate
as possible, the manual may nevertheless contain some technical inaccuracies and/or
typographical errors.
Echosens cannot, under any circumstances, be held responsible for any loss of profit,
loss of business, data loss, business interruption, or for any indirect, specific, accidental
or consecutive damages of any kind. In the event of damages arising from a defect
(imperfection) or error contained in the present User Manual, Echosens undertakes to send
the physician, as rapidly as possible, a hard copy or electronic document containing all
corrections made to the present manual.
This manual is updated on a regular basis. The most recent version of this manual is available
from Echosens on simple request. Should any major modifications be made to the manual,
however, Echosens undertakes to send the physician, as rapidly as possible, a new copy of
the manual in hard copy or electronic format. Note that this does not involve updating the
hardware and/or software in your possession.
The product owner must keep the present manual for as long as the product is used.
The present manual contains a chapter for troubleshooting the most commonly encountered
problems.
Any information or modification requests pertaining to this manual should be sent to:
https://support.echosens.com.
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1.1. SYMBOLS USED IN THE MANUAL
This symbol means: ATTENTION

Instructions preceded by this symbol may cause injuries or damage the medical
device and installation if not correctly followed.
This symbol means: INFORMATION

Additional information with no impact on instrument use.
1.2. PROPERTY AND COPYRIGHT

All manuals and documents of all kinds are the property of Echosens and are protected
by copyright, all rights reserved. Your right to copy this documentation is limited to legal
copyright. These manuals cannot be distributed, translated or reproduced, either in whole or
in part, in any manner or in any form, without prior written consent from Echosens. Hence,
the reproduction, adaptation or translation of the present manual without prior written consent
is prohibited, within the limits provided by copyright law.
Copyright © – 03/2020 – 02/2021 – Echosens – All rights reserved.
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2. WARNINGS
2.1. PERIPHERALS NOT SUPPLIED BY ECHOSENS
When connecting any peripheral not supplied by Echosens to the FibroScan, refer
to the manufacturer's User Manual to ensure operator and patient safety.
2.2. ELECTRICAL SAFETY
To avoid the risk of electric shock, this device must be connected to an earthed
power supply only.
Multi-socket adapters and extension leads must not be connected to the device.
The power cable socket is intended for use as an isolating device and must be
easily accessible to prevent connection problems.
All peripherals connected to signals input/output must be certified according to

standard IEC 60950-1.
Any parts not specified in the user manual must not be connected to the system.
Correct grounding operation can only be guaranteed if the system is connected to

a socket compliant with safety standards.
Make sure that the vents are not obstructed. If they are, the electronic equipment
could overheat, causing irreversible damage.
Do not submerge the device or its probes.
2.3. ELECTROMAGNETIC SAFETY
The use of accessories not specified in the user guide may cause a non-
compliance in terms of electromagnetic compatibility (EMC).
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Avoid using the FibroScan device when placed upon or near a machine that
generates electromagnetic disturbance.
2.4. BATTERY SAFETY
Your battery has been designed for a specific application. Do not use it for any
other application. Misusing the battery may cause the battery to overheat, rupture,
or ignite and cause serious injury.
Be sure to follow the safety rules listed below:
Do not place the battery in fire or heat the battery.

Do not install the battery backwards causing the polarity to be reversed.
Do not connect the positive terminal and the negative terminal of the battery
to each other with any metal object (such as wire).
Do not store or carry the batteries together with necklaces, hairpins, or other
metal objects.
Do not pierce the battery with nails, strike the battery with a hammer or step
on the battery.
Do not expose the battery to water or salt water, or allow the battery to get
wet.
Do not connect batteries in series or in parallel. Irreversible damage can be
done.
Do not apply pressure that will deform the battery.
Do not place the battery in a microwave oven, high-pressure containers, or
on induction cookware.
Do not disassemble or modify the battery. The battery contains safety and
protection devices which, if damaged, may cause the battery to generate heat,
rupture or ignite.
Do not place the battery on or near fires, stoves, or other high-temperature

locations. Do not place the battery in direct sunshine or use or store the battery
inside cars in hot weather. Doing so may cause the battery to generate heat,
rupture or ignite. Using the battery in this manner may also result in a loss of
performance and shortened life expectancy.
Immediately discontinue use of the battery if, while using, charging or storing the
battery, the battery emits an unusual smell, feels hot, changes colour, changes
shape, or appears abnormal in any other way. Contact Echosens or its local
representative: https://support.echosens.com.
5. In the event that the battery leaks and the fluid gets into your eye, do not rub the
eye. Rinse well with water and immediately seek medical care. If left untreated the
battery fluid could cause damage to the eye.
Do not plug the battery directly into the power supply. Use the specific external
power supply provided with the device to charge the battery, otherwise irreparable
damage to the battery could occur.
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The FibroScan 430 MINI / MINI + device requires special precautions to be taken
regarding to electromagnetic compatibility (EMC). It must be installed and put into
service in accordance with the EMC information given in this guide.
2.5. MAGNETIC RESONANCE SAFETY
The FibroScan device is incompatible with magnetic resonance (MR). Under no

circumstances should it be taken into a room dedicated to Magnetic Resonance
Imaging (MRI).
2.6. USING THE DEVICE
Do not push or lean on the top of the FibroScan unit.
If the housing of the device is chipped or cracked by mechanical impact, do not

use the device until it has been repaired by Echosens.
If the device is not sufficiently charged, it may cut out during an examination. This
power outage may lead to loss of unsaved data.
2.7. DELETING MEASUREMENTS
All measurements performed before the one chosen for deletion will be eliminated
from the examination after confirmation.
If second generation CAP (CAPc) is enabled on your device, the CAPc
measurements performed prior to the stiffness measurement you have selected
for deletion will also be deleted.
2.8. PATIENT SAFETY
If the excessive pressure warning is displayed during the examination, immediately

reduce the pressure exerted by the probe on the patient.
2.9. SWITCHING OFF THE UNIT
Never switch the unit off during an examination or whilst in configuration mode.
Never switch off the main power supply or disconnect the battery when the unit is
switched on. Failure to comply with these instructions could cause a malfunction
of the machine and/or loss of data.
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2.10. CLEANING AND MAINTENANCE
These maintenance operations must not be performed by a third party other than
a technician authorised by Echosens.
The opening or modification of the device by a person other than an authorised

Echosens technician is strictly prohibited.
The probe must be calibrated periodically. Beyond the period indicated on the
calibration certificate, the manufacturer no longer guarantees the performance
characteristics of the probe.
2.11. CLEANING
To prevent electric shock, switch off the unit before cleaning.
2.12. INTERPRETING THE RESULT
Results must only be interpreted by a physician specialising in liver diseases, who

is aware of the patient's pathology and clinical context.
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3. MISCELLANEOUS INFORMATION
3.1. GUARANTEE
The terms of guarantee are stated in the Echosens terms of sale documents.
For any claims, Echosens is at the disposal of the physician and their assistants and shall, if
necessary, pass the aforementioned claim on to the competent local representative.
3.2. LIABILITY
The information displayed on the FibroScan screen is the result of complex calculations
performed by the software application built into the FibroScan. These results are then
interpreted by the physician in charge. Under no circumstances, and even if Echosens had
been notified, can Echosens be held responsible for the incorrect interpretation of these
results; Echosens' liability being limited to making the measurements, displaying them and
printing them via the FibroScan.
The data from each examination are saved on the machine's hard disk. The user is
responsible for saving the data on a regular basis. Echosens cannot under any circumstances
be held responsible for the partial or total loss of FibroScan data.
3.3. ESSENTIAL PERFORMANCE CHARACTERISTICS

When a stiffness or CAP (Controlled Attenuation Parameter) value is displayed by FibroScan,
this value is considered correct within the range of error specified by Echosens.
Free from the production of unintended or excessive transducer assembly surface

temperature.
3.4. PRODUCT LIFE

Echosens guarantees the specification and performance characteristics of the FibroScan
device for seven years, provided that all necessary precautions for use and maintenance
have been taken in accordance with the recommendations of the user manuals provided.
The battery product life is defined by: 60 % of initial capacity at 500 cycles, with standard
charge and discharge at 40 °C (104 °F).
3.5. REVERSE ENGINEERING

The software license is individual and cannot, under any circumstances, be transferred in
any manner to a third party. This software cannot be distributed, reproduced, translated,
disassembled, decompiled, analysed, modified, incorporated or combined with another
software application, with the exception of cases allowed by law.
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Resale of the software built into the FibroScan is prohibited.
3.6. REGISTERED TRADEMARKS

Echosens and FibroScan are registered trademarks of Echosens.
Microsoft Excel and Windows Embedded are registered trademarks of Microsoft Corporation
in the United States and other countries.
3.7. PATENTED TECHNOLOGY

FibroScan is covered by one or more patents, both in the United States and in other countries.
Patents: www.echosens.com/patents
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4. INDICATIONS AND PERFORMANCE
The FibroScan 430 MINI / MINI + and its probes form an active, non-implantable medical
device using ultrasound.
4.1. 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.
4.2. INDICATIONS FOR USE

Liver stiffness and liver CAP are indicated as an aid to diagnosis and monitoring of adult and
paediatric patients as part of an overall assessment of liver disease.
Note: the parameters listed in Table 1, known to influence liver stiffness, shall be considered
when interpreting liver stiffness.
Table 1: parameters influencing liver stiffness.
Parameter Reference
Liver fibrosis, cirrhosis [1-15]
Acute hepatitis, inflammation, ALT flares, excessive alcohol intake [16-19, 20, 21, 22, 23]
Portal pressure [24, 25]
Extra-hepatic cholestasis [26-28]
Hepatic congestion, central venous pressure [29, 30, 31]
Amyloidosis [32-34]
Food intake [35-39]
References:
[1] (EASL), E.A.f.t.S.o.t.L. and A.L.p.e.E.d.H. (ALEH), EASL-ALEH Clinical Practice

Guidelines: Non-invasive tests for evaluation of liver disease severity and prognosis. Journal
of Hepatology, 2015. 63(1): p. 237-64.
[2] Wong, V.W., et al., Diagnosis of fibrosis and cirrhosis using liver stiffness measurement in
nonalcoholic fatty liver disease. Hepatology, 2010. 51(2): p. 454-462.
[3] Pavlov, C.S., et al., Systematic review with meta-analysis: diagnostic accuracy of transient
elastography for staging of fibrosis in people with alcoholic liver disease. Alimentary
Pharmacology & Therapeutics, 2016. 43(5): p. 575-85.
[4] Li, Y., et al., Systematic review with meta-analysis: the diagnostic accuracy of transient
elastography for the staging of liver fibrosis in patients with chronic hepatitis B. Aliment
Pharmacol Ther, 2016. 43(4): p. 458-69.
15
[5] Chon, Y.E., et al., Performance of transient elastography for the staging of liver fibrosis in
patients with chronic hepatitis B: a meta-analysis. PLoS One, 2012. 7(9): p. e44930.
[6] Tsochatzis, E.A., et al., Elastography for the diagnosis of severity of fibrosis in chronic
liver disease: a meta-analysis of diagnostic accuracy. Journal of Hepatology, 2011. 54(4): p.
650-9.
[7] Sanchez-Conde, M., et al., Comparison of transient elastography and liver biopsy for the
assessment of liver fibrosis in HIV/hepatitis C virus-coinfected patients and correlation with
noninvasive serum markers. Journal of viral hepatitis, 2010. 17(4): p. 280-6.
[8] Castera, L., et al., Prospective comparison of transient elastography, Fibrotest, APRI, and
liver biopsy for the assessment of fibrosis in chronic hepatitis C. Gastroenterology, 2005.
128(2): p. 343-50.
[9] Corpechot, C., et al., Noninvasive elastography-based assessment of liver fibrosis

progression and prognosis in primary biliary cirrhosis. Hepatology, 2012. 56(1): p. 198-208.
[10] Hartl, J., et al., Transient elastography in autoimmune hepatitis: Timing determines the
impact of inflammation and fibrosis. Journal of Hepatology, 2016. 65(4): p. 769-75.
[11] Siddiqui, M.S., et al., Vibration-controlled Transient Elastography to Assess Fibrosis and
Steatosis in Patients With Nonalcoholic Fatty Liver Disease. Clinical gastroenterology and
hepatology, 2019. 17(1): p. 156-163.
[12] Afdhal, N.H., et al., Accuracy of fibroscan, compared with histology, in analysis of
liver fibrosis in patients with hepatitis B or C: a United States multicenter study. Clinical
Gastroenterology & Hepatology, 2015. 13(4): p. 772-779 e3.
[13] Nguyen-Khac, E., et al., Non-invasive diagnosis of liver fibrosis in patients with alcohol-
related liver disease by transient elastography: an individual patient data meta-analysis. The
lancet. Gastroenterology & hepatology, 2018. 3(9): p. 614-625.
[14] Eddowes, P.J., et al., Accuracy of FibroScan Controlled Attenuation Parameter and Liver
Stiffness Measurement in Assessing Steatosis and Fibrosis in Patients With Nonalcoholic
Fatty Liver Disease. Gastroenterology, 2019. 156(6): p. 1717-1730.
[15] Lee, C.K., et al., Validation of Transient Elastography Cut Points to Assess Advanced
Liver Fibrosis in Children and Young Adults: The Boston Children's Hospital Experience. J
Pediatr, 2018. 198: p. 84-89 e2.
[16] Arena, U., et al., Acute viral hepatitis increases liver stiffness values measured by
transient elastography. Hepatology, 2008. 47(2): p. 380-4.
[17] Coco, B., et al., Transient elastography: a new surrogate marker of liver fibrosis
influenced by major changes of transaminases. Journal of Viral Hepatitis, 2007. 14(5): p.
360-9.
[18] Sagir, A., et al., Transient elastography is unreliable for detection of cirrhosis in patients
with acute liver damage. Hepatology, 2008. 47(2): p. 592-5.
[19] Vigano, M., et al., Transient elastography assessment of the liver stiffness dynamics
during acute hepatitis B. European Journal of Gastroenterology & Hepatology, 2010. 22(2):
p. 180-4.
[20] Wong, G.L., et al., Increased liver stiffness measurement by transient elastography in
severe acute exacerbation of chronic hepatitis B. Journal of Gastroenterology & Hepatology,
2009. 24(6): p. 1002-7.
[21] Mueller, S., et al., Increased liver stiffness in alcoholic liver disease: differentiating fibrosis
from steatohepatitis. World Journal of Gastroenterology, 2010. 16(8): p. 966-72.
16
[22] Trabut, J.B., et al., Rapid decline of liver stiffness following alcohol withdrawal in heavy
drinkers. Alcoholism, clinical and experimental research, 2012. 36(8): p. 1407-11.
[23] Bardou-Jacquet, E., et al., Effect of alcohol consumption on liver stiffness measured by
transient elastography. World Journal of Gastroenterology, 2013. 19(4): p. 516-22.
[24] Carrion, J.A., et al., Transient elastography for diagnosis of advanced fibrosis and
portal hypertension in patients with hepatitis C recurrence after liver transplantation. Liver
Transplantation, 2006. 12(12): p. 1791-8.
[25] Vizzutti, F., et al., Liver stiffness measurement predicts severe portal hypertension in
patients with HCV-related cirrhosis. Hepatology, 2007. 45(5): p. 1290-7.
[26] Millonig, G., et al., Extrahepatic cholestasis increases liver stiffness (FibroScan)
irrespective of fibrosis. Hepatology, 2008. 48(5): p. 1718-23.
[27] Harata, M., et al., Liver stiffness in extrahepatic cholestasis correlates positively with
bilirubin and negatively with alanine aminotransferase. Hepatology Research, 2011. 41(5): p.
423-9.
[28] Trifan, A., et al., Increased liver stiffness in extrahepatic cholestasis caused by
choledocholithiasis. Hepatitis Monthly, 2011. 11(5): p. 372-5.
[29] Colli, A., et al., Decompensated chronic heart failure: increased liver stiffness measured
by means of transient elastography. Radiology, 2010. 257(3): p. 872-8.
[30] Lebray, P., et al., Liver stiffness is an unreliable marker of liver fibrosis in patients with
cardiac insufficiency. Hepatology, 2008. 48(6): p. 2089.
[31] Millonig, G., et al., Liver stiffness is directly influenced by central venous pressure.
Journal of Hepatology, 2010. 52(2): p. 206-10.
[32] Janssens, F., et al., Hepatic amyloidosis increases liver stiffness measured by transient
elastography. Acta Gastroenterologica Belgica, 2010. 73(1): p. 52-4.
[33] Lanzi, A., et al., Liver AL amyloidosis as a possible cause of high liver stiffness values.
European Journal of Gastroenterology & Hepatology, 2010. 22(7): p. 895-7.
[34] Loustaud-Ratti, V.R., et al., Non-invasive detection of hepatic amyloidosis: FibroScan, a

new tool. Amyloid, 2011. 18(1): p. 19-24.
[35] Mederacke, I., et al., Food intake increases liver stiffness in patients with chronic or
resolved hepatitis C virus infection. Liver International, 2009. 29(10): p. 1500-6.
[36] Arena, U., et al., Liver stiffness is influenced by a standardized meal in patients with
chronic hepatitis C virus at different stages of fibrotic evolution. Hepatology, 2013. 58(1): p.
65-72.
[37] Berzigotti, A., et al., Effect of meal ingestion on liver stiffness in patients with cirrhosis
and portal hypertension. PLoS One, 2013. 8(3): p. e58742.
[38] Kjaergaard, M., et al., High risk of misinterpreting liver and spleen stiffness using 2D
shear-wave and transient elastography after a moderate or high calorie meal. PLoS One,
2017. 12(4): p. e0173992.
[39] Vuppalanchi, R., et al., Is Fasting Necessary for Individuals With Nonalcoholic Fatty Liver
Disease to Undergo Vibration-Controlled Transient Elastography? Am J Gastroenterol, 2019.
114(6): p. 995-997.
4.3. TARGET POPULATION

The FibroScan device is indicated for adult and paediatric patients.
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4.4. 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 29.
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.
4.5. CONTRAINDICATIONS
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.
4.6. INTENDED ENVIRONMENT

The FibroScan device is intended for use in hospitals, clinics, and other types of healthcare
centre.
4.7. INTENDED USERS
4.7.1. 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.
4.7.2. Interpreting the results

The measurements obtained from the device are intended to be interpreted by a physician
experienced in the management of liver diseases.
4.8. PRINCIPLE OF USE

The FibroScan operates based on the vibration-controlled transient elastography method.
18
The FibroScan probe comprises a single-element ultrasound transducer mounted on the

shaft of an electrodynamic actuator. This transducer generates a transient vibration, which
in turn generates an elastic shear wave at 50 Hz. This wave propagates through the skin,
the subcutaneous tissues, and then the liver. During shear wave propagation, the ultrasound
transducer performs a series of ultrasound acquisitions (emission/reception) to measure the
speed of shear wave propagation in the liver. Stiffness in kPa of the liver is calculated using
this shear wave propagation speed value.
The CAP (Controlled Attenuation Parameter) in dB/m is a measure of the attenuation of

ultrasound signals in the tissue.
first generation CAP is measured at the same time as the stiffness measurement, and
concerns the same explored volume. This measurement is available with the M+ and XL+
probes only.
second generation CAP (CAPc) uses the same ultrasound acquisition sequences (emission/
reception) as those used for measuring liver stiffness. Ultrasound data is continuously
collected during the examination. The sequences retained are those that meet predefined
quality criteria. For second generation CAP, more data is therefore used than for first
generation CAP. This mechanism thus permits better CAP measurement repeatability. This
measurement is available with the S+, M+ and XL+ probes.
CAP measurement is not available in all territories.
How to use a probe: A: Ultrasound transducer. B: Electrodynamic actuator. C: Liver.
4.9. USER TRAINING

Only persons who have received training in the use of the FibroScan device and who possess
a user certificate are authorised to conduct a FibroScan examination. Training is essential for
correct equipment use and in order to obtain reliable and reproducible measurements.
This manual is not intended to provide user training.
4.10. ELECTRICAL SAFETY

FibroScan is manufactured and tested in accordance with IEC electromagnetic compatibility
(EMC) and electrical safety standards. It leaves the factory in full compliance with safety and
performance requirements. In order to maintain this compliance and to guarantee the safe
use of the medical device, the user must conform to the indications and symbols contained in
this manual.
19
Prior to installation, ensure that the operating and mains voltage values match.
The electrical power lead provided must be connected to the FibroScan mains connector and
to an earthed socket. Correct earthing operation can only be guaranteed if the FibroScan is
connected to a socket compliant with safety standards.
Refer to the warnings in Chapter 2 concerning electrical safety.
Safe use is no longer guaranteed in the following main, non-exclusive cases:

The device is visibly damaged,
The device is inoperative,
After prolonged storage in unfavourable conditions,
After serious damage incurred during transport,
When the safe use of the FibroScan is no longer possible, the device must be taken out of
operation. Steps must be taken to prevent its inadvertent use. The medical device is entrusted
to authorised technicians for inspection.
4.11. MAINTENANCE-RELATED SAFETY

For all maintenance operations, the physician and their appointees should contact Echosens,
who will send an authorised technician, at: https://support.echosens.com.
For correct and safe use and for all maintenance operations, personnel must conform to the
user precautions.
20
5. EXTERNAL PRESENTATION
5.1. HARDWARE SUPPLIED

When opening the package, ensure the contents match the following list:
FibroScan device installed
Case(s) fitted with probe(s)
Sealed envelope (Windows EULA license and the present User manual)
Battery
External power supply and power cable
Probe holder
5.2. PROBES AND PERIPHERALS SUPPLIED BY ECHOSENS, AND

PERIPHERALS NOT SUPPLIED BY ECHOSENS
The probes and peripherals supplied by Echosens are:
S+ probe
M+ probe
XL+ probe
Refer to the warnings in Chapter 2 concerning the use of peripherals not supplied
by Echosens.
21
Set of elements that can be connected to the FibroScan unit:
Probes: A: S+ probe. B: M+ probe. C: XL+ probe.
Peripherals not included: D: USB storage device. E: Printer.
5.3. FRONT VIEW

The device contains the electrical power supply, dedicated electronics and a computer. It also
serves as support for a monitor and a probe holder.
The following figure presents the instrument's different user-accessible parts.
22
General arrangement of the FibroScan: A: Battery charge level indicator. B: Power supply
indicator. C: Touch screen. D: Probe holder.
To switch the device on or off, press the button at the rear of the device (see Rear View
paragraph). This button loads the application. After a few seconds, the home window is
displayed.
Battery charge indicator

The battery charge indicator may show the following statuses:
Not lit: Connected to external power source, not battery-powered.
Flashing green: Connected to external power source, battery charging.
Steady green: Not connected to external power source and battery charge above 33%.
Orange: Not connected to external power source and battery charge between 20% and
33%.
Red: Not connected to external power source and battery charge below 20%.
Power indicator
The status of the power indicator is defined as follows:
Not lit: device off.
Green: device on.
The screen and the software

This is a 12.1-inch colour touch screen.
To protect the screen from any risk of damage, take care not to hang the power
cable on the top of the machine.
The FibroScan runs on dedicated software.
The software is automatically launched when the FibroScan is switched on. It is used to:
perform examinations,
manage examinations saved in archives.
23
5.4. RIGHT SIDE VIEW
Probe connectors.
Location of probe connectors: A: Probe connectors. B: USB connectors.
The probe connectors are fragile.
5.5. REAR VIEW

The following figure presents the instrument's different user-accessible parts.
24
Rear view: A: Standby button. B: Battery hatch. C: Side handle. D: External power supply
connector. E: Computer connectors.
The standby button
This button is only active if the external power supply is connected to the power
network and to the FibroScan, or if it is battery-powered.
Moving the device

Use the FibroScan's side handle to move it.
External power supply and computer connectors
External power supply and computer connectors: A: External power supply KPJX-4SS
connector. B: RJ45 network connector. C: USB connectors.
Ethernet connector: also used for connectivity. Used by Echosens maintenance staff.
Two USB 2.0 sockets: to connect an external hard disk for backups, a USB key, or a
USB printer.
25
Echosens recommends using encrypted hard drives or USB keys protected by

logon code entered using integrated keypad.
External power supply primary connector.

The external power supply must be connected to a 100 V or 240 V AC single-phase 50-60 Hz
grounded mains socket using the power cord supplied.
5.6. STAND
The FibroScan device is mounted on a fold-away stand.
The figure below shows the device with the stand in folded-out position.
Use of device on its stand: A: Stand in folded-out position.
Fold-away stand
Before resting the device on its stand, always make sure that the stand is fully
folded out to keep the device stable and prevent it from falling over.
5.7. BATTERY HATCH

The FibroScan is battery-powered.
The following figure presents the access to the battery.
26
Access to battery: A: Battery access hatch. B: Battery hatch cover. C: Screw.
The battery
If the battery must be replaced, you are strongly advised to use procedure in the
Cleaning, maintenance and repairs chapter of this document.
The serial number shown on the battery lead is its unique identification.
Keep the battery clean and dry.

The battery needs to be charged before use. Always use the correct charger and
refer to the instructions manual for proper charging instructions.
Do not leave the battery on prolonged charge when not in use.
After extended periods of storage, it may be necessary to charge and discharge
battery several times to obtain maximum performance.
Use the battery only in the application for which it was intended.
When possible, remove the battery from the device when not in use.
Storage 15% < Capacity < 50% under 30°C.
The cells inside may vent or rupture.
5.8. DESCRIPTION OF PROBES

The probe contains an electrodynamic actuator (vibrator), an ultrasound transducer and a
measurement trigger button.
27
Probe: A: Electrodynamic actuator. B: Measurement button. C: Light indicator (LED). D:

Ultrasonic transducer. E: Probe lead.
The ultrasound transducer of the probe is a "Type B" applied part, and is the only component
of the FibroScan unit in contact with the patient.
Measurement button
As soon as this button is pressed (if sufficient force is placed on the transducer), the
electrodynamic transducer generates a shear wave (s-wave) that painlessly impacts the
patient's skin. At the same time, the ultrasound transducer performs a series of acquisitions
(emission/reception) to measure the propagation speed of this shear wave. Acquisition lasts
less than one tenth of a second.
Indicators
The indicator lights (LEDs) display a status as follows:
Lit up blue during FibroScan start-up and when standing by to launch an examination.
Flashing blue lights for the probe selected when an examination starts.
Not lit up during an examination when the operator is not applying correct force on
patient’s body.
Lit up blue during an examination when the operator is applying the correct force to the
patient's body. It is however strongly recommended that you view the force exerted by
looking at the on-screen force indicator.
Lead
Probe lead: A: Connection cable. B: Connector.
This 1.5 m lead connects the probe to the FibroScan by means of a multi-pin jack with guide
pin.
The probe transducer, the probe jack, and the FibroScan connector are fragile
elements and must be handled with care.
The probe jack has a red dot that should be aligned with the red dot on the FibroScan socket
before insertion.
The serial number marked on the connector identifies the probe uniquely.
28
6. EXAMINATION PROCEDURE
6.1. SELECTION OF THE PROBE AND EXAMINATION TYPE

Four types of examination are available: S1, S2, M and XL. They correspond to specific
measurement depths that take into account the liver's depth beneath the skin. S1 and S2
examinations must be performed using the S+ probe, M examinations using the M+ probe,
and XL examinations using the XL+ probe.
For patients younger than 18 years old, the type of examination depends on the patient's
thoracic perimeter (TP), as per the following recommendations:
If the thoracic perimeter is more than 75 cm, an M examination should be performed.
If the thoracic perimeter is between 45 and 75 cm, an S2 examination should be
performed.
If the thoracic perimeter is less than 45 cm, an S1 examination should be performed.
For adult patients, the examination should be selected based on the following
recommendations:
Start with an M examination.
If the FibroScan device recommends the XL examination, the XL+ probe should be
used. Otherwise, the M examination can be performed.
With SmartDepth 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 disabled: measurements should not be performed if the PCD
(probe-to-capsule distance) is more than 35 mm. In this case, the operator can change
the measurement point.
To guarantee reliable results, it is advisable to refer to the section "Automatic probe

recommendation", page 46. While the decision regarding whether or not to apply
this recommendation remains with the user, you are strongly advised to use the
recommended tool.
29
Choice of the probe and examination type: TP: Thoracic Perimeter.
* With SmartDepth option enabled, the “Liver too deep” warning may be displayed on the
screen. If SmartDepth option is disabled, PCD should be monitored by A and TM Mode
ultrasound signals to avoid performing measurements with PCD higher than 35 mm.
6.2. PERFORMING THE EXAMINATION

The examination procedure is completely non-invasive and takes only a few minutes.
Its stages are as follows:
Using the probe: A: Patient abdomen. B: Probe.

1. In a quiet environment, lie the patient down on their back with their right arm behind
their head, fully abducted.
2. Leave the patient to rest for at least 5 minutes so that they are completely relaxed.
3. Start the FibroScan examination.
4. Select the probe and type of examination appropriate for the patient (see section
“Selection of the probe and examination type”, page 29, and "Automatic probe
recommendation", page 46).
30
5. Position the FibroScan probe transducer on the patient’s skin, between the ribs above
the liver, along the midaxillary line.
6. Use the FibroScan probe's ultrasound localisation tools to locate an area of the liver
that meets the FibroScan examination quality criteria: Homogeneous tissue with
optimum ultrasound signal throughout the entire measurement depth (for further
details, please refer to the FibroScan training material). This phase is formalised by the
Targeting phase.
7. Take a minimum of 10 valid measurements in each examination, using the same
measurement point each time. If second generation CAP (CAPc) is enabled, maintain
the probe positioned on the patient until 100 % of the CAP measurement is attained.
The final stiffness and CAP (if first generation CAP is enabled) values saved are the median
of all valid stiffness and CAP measurements performed during the examination. If second
generation CAP is enabled, the final CAP value is calculated as the mean of all CAP values
measured.
31
7. SOFTWARE INTERFACE
The software loaded when the FibroScan unit is started up is used to:
perform examinations,
print the results,
manage the archives,
export the data in several formats.
If the device is connected to the hospital network, the software also makes it possible to:
import the lists of patients,
export the results of the FibroScan examination.
When the device is switched on, access to functions must be authenticated.
Before you reach the authentication page, the following messages may be displayed:
No probe connected
Probe out of calibration (see the Probe Calibration section)
7.1. AUTHENTICATION PAGE

If secure session opening has been enabled, all the user accounts are displayed. The login
window allows a secured access to the patient data in the device. Otherwise, the application
connects automatically to the default Operator account.
Restricted user accounts (Manufacturer and Distributor) can be accessed by clicking on the
button.
The enabling of secure session opening and the user accounts are configurable.
See the Configuration section.
Beyond a certain idle time, the user is disconnected and the application returns to the login
page.
This duration is configurable (see Configuration/General).
7.2. HOME SCREEN
Description of the home menu
Access to FibroScan configuration. See the Configuration section.
32
Access to the patient file archives.
Access to the examination.
Return to the home screen by clicking the Home button:
7.3. USING THE KEYPAD

The keypad is displayed whenever an input is required.
Description of keypad:
Shift.
Displaying the special characters keypad.
Delete the character immediately before the cursor.
Tab. To move from one input field to another.
Special characters are accessible by pressing and holding a letter. Example:
7.4. STATUS BAR

Once authenticated, a status bar located at the top of the home screen gives the user
information about the device.
List of options available and enabled on the device: SmartDepth,

CAPc, CAP, Clinical Research Mode, RAW Mode.
33
The CAP (first generation) option is not compatible with SmartDepth.
The CAPc and SmartDepth options are enabled simultaneously. These two
options together are called SmartExam.
Results of FibroScan examination pending USB or network

transfer (see paragraph on Resending failed exports) and
connectivity status for each export configured on the device: a
symbol is displayed in the event of a connectivity error.
Calibration status of probes connected to the device.
Activating and viewing Tips.
Status of peripherals connected to the device via USB.
FibroScan identifiers on the network.
Available disk space.
Name of user logged on.
Device date and time.
Battery charge level.
34
7.5. THE PATIENT RECORD SCREEN

If the patient exists in the patient list, the data will be displayed automatically after the name
is entered. Select the patient.
Complete the fields. At least the 'Name' or 'Code' field must be filled in to start the
examination.
Deletes the content of the fields.
Cancels the patient entry.
Takes you to the examination data entry screen
Patient waiting list

A Dicom work list downloads the patient demographic information from the hospital network.
If the Dicom option is enabled, this information is then input just once and then sent
automatically at every stage concerning the examination.
If a Worklist-type DICOM or FibroView connection (patient waiting list) is enabled (Refer to

the Configuration chapter, Connectivity tab ), the device automatically queries the network to
import the patients waiting for an examination.
However, to import a patient waiting for an examination in the coming days, a manual patient
search must be performed by clicking the magnifying glass button in the Worklist
window.
35
Deletes the selected patient from the worklist.
A patient file is automatically deleted from the worklist if an examination with at

least one valid measurement has been made, or if the patient file has been on the
worklist for more than three days.
Examination data entry

Having selected the patient, fill in the parameters for the scheduled examination as shown in
the window below:
Select M or XL examination type / Select S1 or S2

examination type.
/
Starts the examination.
On this page, the operator's name can be changed and the patient details can be filled
in: Select indication from the list of illnesses specified in Configuration, and fill in fields on
Compliance with food intake recommendations (Fasting > 3 hrs), Weight and Size.
RAW Mode
The RAW Mode button can be used to enable / disable Raw Data saving for the scheduled
examination (only available if RAW Mode has been enabled in Configuration). In RAW Mode,
the results and conditions of all individual measurements can be saved, whether valid or not.
In addition, RAW Mode saves all of the raw data acquired via ultrasound examinations and
used for calculation of all individual measurements, whether valid or not.
Saving Raw Data can slow the application down considerably. Enable it only for
clinical studies that explicitly require it.
Clinical Research Mode

In a clinical trial, the Clinical Research Mode can be enabled for the scheduled examination.
In this case, the "Study Code" and "Patient Code" must be filled in.
36
The Patient Code entered governs how the examination can be searched for in
the Archives. Particular care should be taken when entering this code in order to
prevent duplication of the clinical trial data concerned.
Additional fields
If the FibroScan is connected to FibroView Gateway, additional fields are available via the
examination's data entry window. Click on the button to edit their content. The names and
data entry rules for each field are defined on the Gateway.
Additional fields can be enabled in Configuration.
7.6. ACQUISITION SCREEN
After five minutes of idle time during an acquisition, a message tells the user, who
then has five additional minutes before the examination is automatically halted.
Beyond this time, if no action has been taken, the examination is saved and then
stopped.
Uncalibrated probe
If the probe is uncalibrated, the following message is displayed:
Probe calibration days overdue: n.

Contact Echosens support service or your local representative.
Where n is the number of days.
Unless examination blockage has been activated on the device, the examination may still
be performed, but with the proviso that probe performance is not guaranteed by the
manufacturer..
7.6.1. Localisation phase

Before proceeding to the actual acquisition, a localisation phase is launched. This enables
the liver to be located, along with a measurement zone meeting the FibroScan examination
quality criteria: homogeneous tissue with optimum ultrasound signal throughout the entire
measurement depth (for further details, refer to the FibroScan training material).
During this localisation phase, only stiffness measurement values are displayed. The smallest
of these values is displayed.
Once the optimum measurement zone has been identified, press the following button to
proceed to the examination:
The main data displayed in an acquisition window is presented below.
37
The CAP value (dB/m) is displayed only if the option is installed.
The acquisition window comprises the following elements:
7.6.2. Patient data
Shows/Hides the patient data.
38
7.6.3. Ultrasound images
TM and Amplitude Modes
Ultrasound signals in TM (left) and Amplitude (right) modes: A: Depth explored (mm). B:
Ultrasound signal represented in TM (Time-Motion) mode. C: Ultrasound signal represented
in A (Amplitude) mode.
As soon as the probe makes contact with the skin, i.e. when a force change is detected, the
ultrasound transducer makes ultrasound acquisitions.
The system displays two ultrasound signals used to locate a zone that satisfies the
measurement criteria:
One in Time-Movement (TM) mode, one-dimensional information that shows, in
greyscale and according to time, the different elements detected by the ultrasound
probe in the course of its scan.
And the other in A-Mode, one-dimensional information on the amplitude of the
ultrasound signal collected by the probe according to depth.
These two modes serve to ensure that the probe is correctly positioned to perform a
measurement on a sufficiently thick portion of liver, visible throughout the explored depth.
They also allow the operator to ensure that the measurement will not be disrupted by the
presence of structures not of interest, such as blood vessels.
Ultrasound signal quality indicator

The ultrasound signal quality indicator enables the user to position the probe on an area
suitable for stiffness and/or CAP measurement.
As soon as the probe comes into contact with the patient’s skin, the ultrasound signal quality
indicator shows the quality of the ultrasound signals passing through the liver by means of an
indicator light.
39
Indicator light: Off: The quality of the ultrasound signals is low. Green: The quality of the
ultrasound signals is high.
The greener the liver indicator, the higher the quality of the ultrasound signals, and the better
the position of the measurement point.
This tool functions with the M+ and XL+ probes only.
7.6.4. Force indicator
The probe contains a sensor that measures the force applied by the operator to the patient.
The force level is given by:
Software: The force indicator (green/orange/red).
The probe: blue LEDs.
Measurements may only be made when the force indicator is in the green zone.
Force too high (red). Force too low (orange). Force correct (green).
Probe LEDs off. Probe LEDs off. Probe LEDs lit.

Measurement impossible. Measurement impossible. Measurement possible.
40
7.6.5. Elastogram
This image is displayed once the measurement is complete. It represents the levels of liver
deformation generated by the propagation of the shear wave as a function of time (horizontal
axis in milliseconds) and depth (vertical axis in millimetres).
The stiffness value is displayed if the measurement is valid.
The colour scale indicates the sign of the deformations (compression or expansion). Black
areas correspond to negative deformation and pale areas to positive deformation. The black
strip through the image represents deformations associated with the passage of the shear
wave, which penetrates progressively deeper with time.
7.6.6. Valid stiffness measurement counter
When the number of valid stiffness measurements is equal to 1, the IQR and the
IQR/median ratio are undefined; they are therefore not displayed.
7.6.7. Stiffness results area
41
Median
Stiffness is expressed in kilopascal (kPa). This value is the median of all valid measurements
performed during the examination.
If the repeat measurement is invalid, the median is not re-computed. To obtain a reliable
and representative liver stiffness measurement, at least ten valid measurements should
be made.
Refer to the warning in Chapter 2 concerning interpretation of the result.
Interquartile range (IQR)

The interquartile range (IQR) is expressed in kilopascal (kPa). It represents the interval
around the median within which will fall 50% of all valid measurements. It is re-computed after
each new valid measurement.
IQR/Median
This value, expressed as a percentage, is the ratio of the IQR to the median stiffness. It is
re-computed after each new valid measurement.
7.6.8. CAP-LEVEL (only for CAPc)
CAP-LEVEL indicates whether a sufficient amount of data has been acquired to provide a
CAP result (CAPc only). This amount is expressed in %. A CAP result is displayed when
CAP-LEVEL reaches 50 %. The examination should be continued until CAP-LEVEL
reaches 100 %. Below this level, insufficient data has been acquired and the examination will
only be saved if the operator confirms that they wish to save it.
7.6.9. CAP result zone
Note: The CAP value is displayed only if the option is installed.
Refer to the warning in Chapter 2 concerning interpretation of the result.
42
first generation CAP
The CAP is displayed with the M+ and XL+ probes only.
CAP is calculated for each valid stiffness measurement.
Median
The CAP (Controlled Attenuation Parameter) is expressed in decibels per metre (dB/m). This
value is the median of all valid measurements performed during the examination.
Interquartile range (IQR)

The interquartile range (IQR) is expressed in decibels per metre (dB/m) and represents the
range in which 50 % of valid measurements either side of the median are located. It is re-
computed after each new valid measurement.
second generation CAP (CAPc)
The CAPc is displayed with the M+, S+ and XL+ probes.
Mean
CAPc is continuously calculated once a valid measurement has been made. The result is
displayed once the CAP-LEVEL value has reached 50 %. The examination will be saved by
default once the CAP-LEVEL value reaches 100 %. If it is below this value, the operator will
be asked if they wish to save the examination.
The CAP-LEVEL increases when the ultrasound signal quality is sufficient in terms of
homogeneity throughout the entire measurement depth. To assess the homogeneity of the
area being examined, ultrasound localisation tools should be used in A and TM Modes, along
with the ultrasound signal quality indicator: if not shown in steady green, the CAP-LEVEL
value will take longer to reach 100 %.
Standard Deviation (STD)

Standard Deviation (STD) is expressed in decibels per metre (dB/m) and measures the
dispersion of CAP values. It is continuously recalculated while CAPc is being measured.
7.6.10. Measurements displayed as image carrousel.
43
7.6.11. Displays measurements as vignettes
7.6.12. Deleting measurements

Some or all of the measurements in the current examination may be cancelled at any time
during the examination.
Press the last measurement to be deleted and

then the following button:
A confirmation request is displayed and indicates

the number of measurements remaining if deletion
is confirmed.
Refer to the warning in Chapter 2 concerning deletion of measurements.
7.6.13. Adding a comment
Comments can be added and measurement conditions can be entered during the
examination:
Click on the following button ,

Enter comments using the touchpanel.
If the option is enabled in Configuration, the conditions under which the examination was
conducted can be filled in immediately after finishing the examination. The following input
fields are offered:
patient position,
Choice of optimal measurement position,
Thick subcutaneous tissues.
44
The entered information will appear on the examination report.
Comments cannot be added to or modified during an examination review.
To display comments or examination conditions during an examination review:
Click on the following button ,
7.6.14. Alert display area
If the symbol is displayed, click on it to view the following messages:
Calibrate the probe.
Electromagnetic disturbances.
7.6.15. Message area
The following messages can be displayed above the elastogram.
Connect the probe.
45
Overheat.
Repeat measurement.
7.6.16. Examination type selection area

The examination type selection criteria according to patient morphology are described in the
section on 'Criteria for selecting the probe and the type of examination'.
Click on the following button to change the

examination type.
The choice of examination type is governed by the selection of M/XL or S1/S2 when
examination data is entered.
For example, if an M+ probe and an S+ probe are connected to the device, S1/S2
examinations will not be available if M/XL was selected while entering the examination data.
If only an M+ probe is connected to the device, only M examinations will be available.
If only an XL+ probe is connected to the device, only XL examinations will be available.
If only an S+ probe is connected to the device, only S1 or S2 examinations will be available.
If an M+ probe and an XL+ probe are connected to the device, the examination type will be M
by default.
Automatic probe recommendation

The automatic probe recommendation tool is based on the PCD (probe - to-capsule distance)
measurement using ultrasound signals received by the device’s probe. This feature operates
in real time as soon as the probe detects ultrasound signals (probe in contact with patient
skin).
This tool functions for the M+ and XL+ probes only.
The result of this feature is displayed at the top right-hand side of the screen and may be one
of the following three cases:
1. "M": The tool measures a PCD that justifies the use of the M+ probe. The M
examination icon flashes.
2. "XL": The tool measures a PCD that justifies the use of the XL+ probe. The XL
examination icon flashes.
3. “Liver too deep” warning only with SmartDepth enabled: The tool detects a PCD that is
too large. In this case, the operator can change the probe and/or measurement point.
46
With SmartDepth enabled, the warning that the liver is located too deeply beneath the skin is
shown with the symbol:
If the tool is able to recommend a probe, three situations are possible:

No recommendation is made: the operator continues the examination without changing
the probe.
The probe being used does not match the recommendation: the operator replaces the
probe as explained in the above paragraph.
PCD is too high (the liver is located too deeply beneath the skin): if unable to locate a
more suitable measurement zone, the operator should consider abandoning the
examination.
Be sure to use enough gel for this tool to function properly.
You are strongly advised to use the recommended tool, to guarantee reliable
results. The decision whether or not to apply this recommendation, however, rests
with the user.
Change of probe during an examination

To change the probe during an Examination:
1. select the new probe type. The following message is displayed: Changing the
examination type. Changing examination type causes all previous measurements to be
definitively erased.
2. Click OK (warning: all measurements performed using the previous probe will be
deleted), the following message is displayed: Examination type has changed. Connect
the appropriate probe to continue.
3. Connect the appropriate probe if necessary and resume the examination.
Changing the probe during an examination is only feasible if an M/XL examination

type has been selected.
7.6.17. View and print the result of the examination
Press the button to end the examination.
47
The result of the examination is displayed.
Description of contextual buttons:
Back to the home window.
Prints the patient examination result.
Opens the tool for exporting the patient file and examination report.
Starts a new examination.
7.7. MANAGEMENT OF PATIENT FILE ARCHIVES
To display the patient file archives, press the button in the home screen.
File selection when a keyboard is connected: [CTRL]+click to select non-consecutive files,

[SHIFT]+click the first and last to select a series of files, and [CTRL]+[A] to select all files.
Deletes the selected files.
Displays the next / previous page of archives.
48
Displays the last / first page of archives.
Refines the advanced file search.
Selects all patient files displayed.
Excel patient database summary file

The patient database summary file is created in the root directory of the removable USB
storage device. The file name contains:
the serial number of the machine,
date and time the Excel file was created.
The Excel file has two data sheets (Data and Parameters) and may contain all or part of the
patient database.
7.7.1. Advanced file search

Enter one or more search criteria. The list of matching files is displayed.
Deletes the input.
Closes the advanced search.
Opens the examination of the displayed patient.
Searching for an examination performed in a clinical trial

To search for an examination performed for a clinical trial (Clinical Research Mode enabled),
filter by Study Code and/or Patient Code.
7.7.2. Select and view a patient file

To view the examination summary for a patient, click the label and then .
To view the details of an examination, click the summary of the examination.
7.7.3. Details of the examination

To display the measurements, click a value in the list of valid measurements.
49
Description of contextual buttons:
Back to the Archives screen.
Deletes the examination.
Prints the result of the examination.
Opens the tool for exporting the patient file and examination report.
Starts a new examination.
7.8. RESENDING FAILED EXPORTS

Export of an examination file or report may fail. The resend option is on the home screen
and can be used by clicking on the button. The superscript number shows the number of
queued exports.
A single click lists the connections configured on the device. If at least one of these
connections is marked with a green symbol (active connection), a [Retry] button is displayed.
Clicking on this button displays the list of all examinations queued for export for each active
connection.
The [Send all again] button lets you attempt the export again.
If the export is successful, the following symbol is displayed next to each exported
examination. If it is not, the following symbol is displayed.
A connection with a problem is indicated by a red symbol. You should restore this
connection before attempting to retry export.
You may need to click on the button to refresh the status of connections.
Lastly, the [Clear list] button lets you clear the list of queued exports.
50
8. STANDBY AND SHUTTING DOWN THE

MACHINE
8.1. BETWEEN SESSIONS

Put the machine in standby mode by pressing the standby button at the rear of the machine
or the shutdown button on the interface.
8.2. AT THE END OF THE DAY

Always shut the machine down by applying the following sequence:
1. Turn the FibroScan off by pressing the standby button at the rear of the machine or the
shutdown button on the interface.
2. Cut the power supply by disconnecting the external power supply from the electrical
network.
Refer to the warning in Chapter 2 concerning switching off the device.
51
9. CLEANING, MAINTENANCE AND REPAIRS
In the event of malfunction, only the staff of Echosens or its local representative is authorised
to work on the FibroScan and its accessories. Any work performed by an unqualified person
will terminate the guarantee.
9.1. CLEANING AND DISINFECTION
After opening the package, the device and probes must be cleaned and disinfected
as per the recommendations below.
Apply the following recommendations to clean or disinfect the device, probes, and
accessories.
Failure to observe these recommendations may result in damage to the device and the
probes, which will then no longer be covered by the guarantee.
Recommendations
Always wear eye protection and gloves to prevent injury.
Do not use disinfectant product beyond its expiry date.
Carefully follow the instructions for use that come with the cleaning or disinfectant
product.
Ensure appropriate concentration of cleaning or disinfection product used and time left
in contact with the surface of the device, probes or accessories.
Carefully read the recommendations from the Association for Professionals in Infection
Control and Epidemiology (APIC) and the Food and Drug Administration (FDA), if
applicable in the country. We also recommend careful reading of the “Guideline for
Disinfection and Sterilization in Healthcare Facilities (CDC)”.
9.1.1. Cleaning the surfaces of the device
Refer to the warning in Chapter 2 concerning cleaning.
Whether surfaces are glass, metal or plastic, they must be cleaned strictly in the order
described below:
1. clean using a soft cloth soaked in the recommended cleaning product,
2. wipe down with a soft cloth dampened with water,
3. dry carefully with a clean, soft and absorbent cloth.
Precautions
Do not spray any cleaning or disinfectant product directly on the device. Leaks may damage
the system, which would then no longer be covered by the guarantee.
52
Do not use paper towels or abrasive products for cleaning, as they may scratch the surface
of the screen.
9.1.2. Disinfecting the probe (housing, cable and transducer)

It is not necessary to switch off the device before cleaning and disinfecting the probe.
Surfaces of the probe must be cleaned and disinfected strictly in the order described below:
1. Point the probe and transducer downwards.
Cleaning and disinfecting the probe: A: Wipe.

2. Remove any remaining traces of gel with a soft cloth
3. Clean surfaces with a soft cloth or wipe dampened with recommended cleaning
product.
Note: if necessary, wipe down the surfaces with a soft cloth dampened with water.
4. Dry the probe with a soft, dry cloth.
5. Wipe the surfaces using a soft cloth or wipe soaked in the recommended disinfectant
solution.
6. Dry the probe with a soft, dry cloth.
7. Examine the transducer and probe cable for any damage such as cracks, breakage, or
liquid leakage.
If any damage is observed, stop using the probe and contact Echosens or its local
Precautions
Do not submerge or soak the probe.
Apply the cleaning product and disinfectant solution to the soft cloth, not directly on the
surface to be cleaned.
The probe must be cleaned and disinfected between patients. Prior cleaning is necessary in
order to ensure effective disinfection.
Do not use surgical brushes or abrasive products to clean the probe, as they may damage it.
Even the use of soft brushes could damage the probe.
Take care not to introduce any cleaning product or disinfectant solution into the probe
connector.
53
9.1.3. Recommended cleaning products

Echosens recommends use of the following products:
Purified water
Soapy water
Recommended disinfectant products (see below)
9.1.4. Recommended disinfection products

Recommended products for disinfecting probes are listed on the following website page:
https://www.fibroscan.com/en/disinfection.
Quaternary ammonium compounds may generally be used for disinfecting probes.
Users accept sole and full responsibility should they use any disinfectant product
not featured in list of products recommended by Echosens.
If you are unsure, contact Echosens or its local representative:
9.1.5. Prohibited cleaning and disinfection products

Any product not specifically intended for cleaning or disinfecting medical devices must not
be used.
The products listed below must not be used on the device, probes or accessories:
Sodium hydroxide and/or sodium hypochlorite disinfectant products
Hydrogen peroxide disinfectant products
Household products, particularly scouring powders or alkaline detergents (pH > 9)
containing bleach, caustic soda, potash or ammonia
Pure or dilute acid solutions of whatever type, including household vinegar
Hydrocarbon solvents: alkanes, alkenes, benzene, toluene, xylene, gasoline
Oxygenated solvents: ethanol, methanol (methylated spirits), acetone, MIBK, acetic
acid, butyl acetate, ethyl acetate (nail varnish remover), ether, glycol ethers, DMF,
DMSO, HMPT
Halogenated solvents: perchloroethylene, trichlorethylene, dichloromethane, chloroform,
tetrachloromethane
9.2. CALIBRATING THE PROBE

The probe contains mechanical parts that may shift slightly over time.
The probe must therefore be calibrated periodically. Beyond the period indicated
on the calibration certificate, the manufacturer no longer guarantees the
performance characteristics of the probe.
When an examination is opened, a window displays the expiry of the calibration of your probe.
When this is displayed, contact Echosens or its local representative to arrange calibration:
https://support.echosens.com
During the examination, the message "Calibrate the probe" is displayed in the message zone.
At the end of an examination, the message "Probe out of calibration" is displayed on the
printed examination report.
54
9.3. REPLACING THE BATTERY

Battery replacement must be performed in precisely the following order and manner:
1. Turn the device around to access the battery hatch, taking care not to damage or
scratch the screen,
2. unscrew the hatch screw using a suitable screwdriver,
3. Pull the strip to lift the battery out,
4. Insert the new battery having first identified the position of the locating pin,
5. Close the hatch and screw it back in position,
6. Put the device back in position.
9.4. TROUBLESHOOTING
Events Solutions
The probe is no longer calibrated. Contact Echosens or its local representative:

https://support.echosens.com
The standby button is inoperative. Check that the instrument is connected to a correctly
When pressed, the instrument powered supply socket (test another electrical device on
won't turn on. this same socket).
If the device is powered by battery only, make sure that the
battery is correctly inserted in its compartment.
In the event of a failure or malfunction, please contact Echosens or its local representative:
9.5. PATIENT LEAKAGE CURRENT TESTS: PRECAUTIONS
Refer to the warning in Chapter 2 concerning electrical safety.
If patient leakage current tests are carried out, take the utmost care not to immerse any
part of the probe other than the transducer.
After drying, return the probe to its resting position with the transducer facing downwards.
Drying the probe: A: Soft dry cloth.
If any damage is observed, stop using the probe and contact Echosens or its local
55
10. CONFIGURING THE FIBROSCAN
10.1. ENTERING CONFIGURATION MODE
To enter Configuration mode, press on the Home screen.
A screen then asks for an identifier and password.
The available passwords and identifiers are in ascending order of the features to which they
give access:
Operator Level
User Name: Operator
Password: U S E R 1
FibroScan Administrator Level

User Name: FibroScan Administrator
Password: F S C O N F 1
Pay attention to upper/lower case!
In general, click [Apply] to confirm the input and save the new data.
10.2. LOCALISATION TAB

This tab is used to set the date, time, language and user interface.
For an Operator
Language
Select the interface language and examination report from the list.
Date and time

Press [Modify] and then enter the system date and time, and press [Save] to save the data.
For a FibroScan Administrator
Report URL
Gives the address of the examination report accessible by QR Code, according to
geographical area.
56
10.3. INSTITUTION TAB

This tab lets you input the institution contact details.
Information concerning the institution

The information entered will be displayed on the report.
Logo
Press [Modify]. If an image file named logo_institution.png is present in the root of the
USB storage device connected to the machine, the logo is automatically modified. The logo
appears on the examination report.
[Reset] deletes the logo from the examination report.
10.4. PRINTER TAB

This tab lets you configure examination report printing.
For an Operator
Auto-print count
Enter a digit corresponding to the number of reports to automatically print at the end of each
examination.
This number is set at 0 by default.
Anonymised auto-print
Activates anonymisation when printing off an examination report.
Printing format
A4 / Letter Printing format of the examination report. The Letter format matches
the American US Letter paper format.
The Letter format matches the American paper format.
Printer available
Enables the manual print button displayed during examination review.
Printers
[Update] Update the list of printers.
[Add printer] Lets you add a printer. You can add by Port, by IP address or
by selecting a shared printer.
[Set as default] Lets you define a printer as the default printer.
[Delete printer] Lets you delete a printer. Follow the on-screen instructions.
57
[Search for printer Makes it possible to add a printer patch supplied by

patch] Echosens.
[Stop any printing Lets you cancel current printing operations.

in progress]
10.5. DATA TAB

This tab lets you manage examination file imports and exports.
For an Operator
Import
Imports examination files in FIBX/.FIBX2 format from a USB storage device.
The files are stored in the root directory of the storage device.
Examination files created with a software version prior to 2.0 cannot be imported
into version 4.0.
Export
Launches manual and automatic exports of examination files (FIBX2 format) and examination
reports (PDF format) to a USB storage device upon completion of each examination. The files
are stored in the root directory of the storage device and can be anonymised if necessary.
10.6. USER TAB

This tab lets you define user accounts and link specific rights to them according to account
type: Operator or FibroScan Administrator.
For an Operator
By selecting their own account, the user can change their password by clicking the
button.
Resetting user accounts

Resets all user accounts.
Password control policy

Enables password control. When this mode is enabled, the password for each user account
must contain at least two characters, comprising at least one letter and at least one number.
The maximum number of characters is 15..
[Add Adds a user account to the list.
58
user]
[Import] Imports a list of user accounts created on a FibroScan from a USB

storage device.
[Export] Exports the list of user accounts on the device to a USB storage device.
10.7. CONNECTIVITY TAB

The configuration of network connections is accessible only through the FibroScan
Administrator level.
This operation must only be performed by personnel trained in network

management.
Network
This tab is used to specify the network parameters of the device. This includes: The Name of
the device stated on network (host name), IP address, sub-network mask, gateway, primary
and secondary DNS. A host name, IP address and sub-network mask must be entered.
The IP address of the FibroScan can be configured statically or dynamically via the DHCP
protocol. To configure the IP address manually, click [Manual] and complete the fields.
Directory
Directory sharing consists of making the contents of a directory available via the network. This
tab lets you define a shared directory on the network. To do so, simply specify the absolute
access path of the directory (\\computer\name_of_share), as well as the associated login and
password.
Once directory sharing has been correctly configured, according to the option chosen
(Examination file and/or Examination result), examination results are automatically exported
to the shared directory at the end of each examination. Manual export from Archives is also
available by clicking on the button.
The [Check] button lets you test the connection with the shared directory.
DICOM
This tab is used to specify the DICOM connections of the device.
A key is required to enable the DICOM connectivity (to obtain this activation key,
contact ECHOSENS or its local representative).
The hospital IT department will provide user support for the configuration of these
parameters. If necessary, refer to the FibroScan Device DICOM Conformance Statement.
Worklist Specify the server through which the device carries out patient searches.
To filter the list of available patients on the DICOM server, you can query
by element (DICOM tag 0008,0060). It is filtered by AE Title by default.
To add patients to the FibroScan Worklist automatically, select the

[Automatic] option. Otherwise, you must add patients manually.
59
Storage Specify the server through which the device exports the examination
reports as a JPG and/or a PDF document.
The parameters Name, IP address, Port and AE Title must be entered for each
of the DICOM servers defined. These parameters are generally available from the
network administrator.
The AE Title is a unique identifier of the device, and of each of the servers defined.
Please note that it is case-sensitive.
The [Check] button lets you test the connection with the selected server.
FibroView
This tab is used to activate the connection with FibroView.
The network address of the FibroView server must be entered, starting with http://. The
[Check] button lets you test the connection with FibroView.
Additional Enables the additional fields configured with FibroView Gateway.

fields
Worklist To add patients to the FibroScan Worklist automatically, enable the

Patient Worklist option. Otherwise, you must add patients manually.
Automatic addition of patients to the Worklist from FibroView is not compatible with
automatic addition from a DICOM server. Enabling one disables the other.
10.8. EXAMINATION TAB

This tab lets you enable different examination options.
For an Operator
Clinical Research
Lets you view the studies created for the Clinical Research Mode.
Indications
Lets you fill in, edit, and reset the list of indications.
A key is required to enable the CAP (to obtain this activation key, contact
ECHOSENS or its local representative).
Options
CAP Activates optional CAP display.
60
Calibration
Lets you enter the name and details of the person at Echosens, or the local representative,
to contact when a probe is due for calibration.
Options
Measurement Automatically displays the form for entering measurement

conditions conditions at the end of the examination.
Condition for Minimum number of valid measurements required for an

saving examination to be saved. This number is between 3 and 10. This
examinations number is set at 10 by default.
Clinical Research
Lets you enable the Clinical Research Mode and then create, edit, delete, and conceal study
codes.
10.9. SYSTEM TAB
For an Operator
[Export log Exports log files to a USB storage device.

files]
DICOM log Exports the log files for DICOM connectivity if a DICOM connection
is active.
From all user account types, export log files by clicking on the button [Export log files], having
first connected a USB storage device to the device. Log files are shown as compressed files
copied to the root directory.
Their name contains:

The device's serial number,
The date and time the file was created.
The USB storage device may not be recognised immediately after insertion. In that
case, press [Export log files] again if an error message is displayed.
Information
This tab provides information on the device: Serial numbers (device and connected probes),
software version number, firmware versions (AlimEE, FPGA, eSW, Examination Engine),
remaining disk space and total disk space, device use time.
Logs
The log file tracks system activity and gives the operator a history of the events that occurred
during use of the FibroScan software. This tab lets you view and export the log files.
General
Delay before Period of idle time after which the application logs out. This
61
application closing period may range from 5 to 55 minutes..
Barcode
Barcode reader activation Enables and resets the barcode reader.
Service
This tab lets you access the options required for device maintenance and updates.
[Launch Execution of an ECHOSENS-certified programme stored on a USB

Program] storage device.
A removable USB storage device must be connected.
[Screen Touch screen calibration.

Calib.]
[Upgrade Update of device software using a USB storage device supplied by

Device] Echosens.
Remote Allows Echosens to access your device remotely. Once launched,

access make a note of the TeamViewer identifier so you can pass it on to
your Echosens contact person.
[Check Hard drive check.

Disk]
[Probe Displays information (serial number, model, date of manufacture, date

Memory] of last calibration, identifier of calibration operator) on the probes
connected to the device.
[Export Exports screenshots from the FibroScan interface to a USB storage

screenshot] device. A pop-up will appear, asking if you would like to delete the
screenshots once they have been exported.
[Clear Clears the database. Note that the examination files remain
Database] physically present on the hard drive.
General
Patient Conceals patient data available in archives or during acquisition. To

data display the list of patients or information on a particular patient, click on
security the [Display patients] button.
62
Anti-malware
Anti-malware Protects the system from malware. Enabling Anti-malware

software protection unlocks UpdateMode.
activation
UpdateMode Allows the system to check for Anti-malware software updates at

regular intervals in order to ensure maximum protection against
malware attacks.
63
11. SYMBOLS ON THE DEVICE
11.1. MARKINGS ON THE DEVICE
Ethernet connector RJ45
USB connector
Elastography probe connection
Warning: Only Echosens-approved maintenance personnel are

authorised to open and modify the FibroScan device.
It is essential to refer to the User Manual to ensure operator and

patient safety.
Manufacturer
Year of manufacture
64
Anti-theft device
CE marking and notified body identification number

FIBROSCAN 430 MINI: Obtained in July 2016
FIBROSCAN 430 MINI +: Obtained in November 2017
Medical Device
Direct current power supply
NRTL cBVus mark
Electrical voltage delivered by the external power supply
Electrical power delivered by the external power supply
Scrapping the button cell battery

The FibroScan uses a 'button cell' battery. This is a long-life battery
and it may never need replacing.
In the event of replacement, however, do not discard the old battery

with ordinary household waste. Contact your local waste processing
department for the address of the nearest battery disposal location.
Scrapping the FibroScan and its probe(s)
To reduce the risk of pollution by electrical and electronic waste,

and within the framework of European Directive 2011/65/EC, the
FibroScan device and its probe(s) must not be discarded with ordinary
household waste. Contact the local electrical and electronic waste
processing service for instructions.
65
Applied part type B
Battery charge indicator
Device incompatible with magnetic resonance (MR).
Caution, this symbol does not appear on devices manufactured before

2020.
11.2. MARKINGS ON THE BATTERY
Disposing of the battery

The FibroScan uses a Lithium-ion battery. This is a long-life battery
and it may never need replacing.
In the event of replacement, however, do not discard the old battery

with ordinary household waste. Contact your local waste processing
department for the address of the nearest battery disposal location.
CE marking
It is essential to refer to the User Manual to ensure operator and

patient safety.
11.3. NOTE
The serial number marked on the device identifies the FibroScan uniquely.
66
12. TECHNICAL CHARACTERISTICS
12.1. CHARACTERISTICS OF THE DEVICE
Model FIBROSCAN 430 MINI / MINI +
Medical device Class IIa according to Rule 10 of Appendix IX of Directive 93/42/EC.

classification
Class of protection Class I

against electric shock
Type of part applied B
Software security class B
Class and group Group I Class B

according to CISPR 11
IP Code IPX0: The instrument without probe is not protected against liquids.
Operating mode Continuous operation
Mechanical Index MI < 1.0 for all operating modes.
Thermal Index TI < 1.0 for all operating modes.
12.1.1. Computer characteristics

Operating system Windows Embedded
Permanent storage Hard drive

system
IT security guaranteed Local network security rules (firewall, DMZ, etc.)

by
Windows firewall
Anti-malware filter
Software library The software uses the Qt library licensed under LGPL.
12.1.2. Metrological performance

NB.: The measured value is stiffness, referred to as "E".
Stiffness Min.: 2.0 kPa

Max.: 75 kPa
Stiffness E (kPa)*
M+ XL+ S+
E (kPa) Trial Bias** Precision** Bias** Precision** Bias** Precision**

number (in %) (in %) (in %) (in %) (in %) (in %)
Zone 1 1 − 1.5 2.3 − 5.1 0.0 − 2.1 3.3

3.9 2 27.2 2.9 − 3.6 1.4 − 1.5 3.4
67
Stiffness E (kPa)*
M+ XL+ S+
E (kPa) Trial Bias** Precision** Bias** Precision** Bias** Precision**

number (in %) (in %) (in %) (in %) (in %) (in %)
Zone 2 1 − 14.8 1.4 − 23.1 0.5 − 17.3 0.6

9.6 2 − 22.5 0.6 − 22.1 1.7 − 17.7 1.3
Zone 3 1 − 14.5 2.2 − 6.6 0.7 − 10.5 2.5

23.3 2 − 4.5 2.6 − 10.5 2.5 − 8.3 0.9
* Values obtained with CIRS E-1493-1 phantom
** As defined by ISO 5725-1 1994
CAP Minimum: 100 dB/m

Maximum: 400 dB/m
Controlled Attenuation Parameter CAP (dB/m)*

S1 S2 M XL
CAP (dB/ Bias** Preci- Bias** Preci- Bias** Preci- Bias** Preci-
m) (in %) sion** (in %) sion** (in %) sion** (in %) sion**
(in %) (in %) (in %) (in %)
142 1.8 6.3 1.0 6.9 4.2 0.7 11.7 0.4

249 4.3 1.2 4.3 0.2 6.7 0.2 10.0 5.5
339 12.4 4.7 7.9 3.5 10.1 2.0 5.0 1.2
* Values obtained with Gammex phantoms 940041-4803, 940043-4805, 940045-4831
** As defined by ISO 5725-1 1994
Only second generation CAP (CAPc) is available with the S probe, and only in
certain geographical locations.
12.1.3. Electrical characteristics

Power supply 100-240 V ~ 50–60 Hz
Apparent power 100 W
12.1.4. Mechanical characteristics

Dimensions 275 mm x 400 mm x 95 mm (H x W x D)
Weight 6 kg (with accessories)
12.1.5. Environmental characteristics

Operating temperature + 10 °C to + 40 °C (+ 50 °F to + 104 °F)
Operating humidity 30 % to 75 % relative humidity, not condensed.
Maximum operating 3000 m

altitude
Operating atmospheric 700 hPa to 1060 hPa

pressure
68
Storage and - 20 °C to + 50 °C (- 4 °F to + 122 °F)

transportation
temperature
Storage and 10 % to 85 % relative humidity, not condensed.

transportation humidity
Maximum altitude for 5000 m

storage and
transportation
Storage and 540 hPa to 1060 hPa

transportation
atmospheric pressure
12.1.6. Additional information

Power cables Power cable(s) (according to country)
(according to country) -
Length < 3 metres
12.2. BATTERY CHARACTERISTICS
Model ARTS Energy (ref.4 INR19/66-2)

Part number 806957 / M300002

Rated voltage 14.4 V
Capacity 6 A.h

Dimensions 99 mm x 46 mm x 70 mm (length x width x height)
Weight 475 grams
12.3. EXTERNAL POWER SUPPLY CHARACTERISTICS
Model XP Power L L C (ref. AHM100PS19-XE1026)

Power supply 100-240 V ~ 1.2 A 50/60 Hz
Output signal 19 V 5.26 A
Apparent power 100 W

Dimensions 160 mm x 64 mm x 37 mm (length x width x height)
Weight 500 grams
12.4. CONSUMABLES
Not applicable.
69
13. REGULATIONS
Electromagnetic interference (EMI) is a signal or emission, conveyed through open space

or through electrical or signal conductors, which may severely disrupt radio navigation or
Only applicable to 430 MINI+ devices whose serial number (SN) is LESS than 92256, and 430 MINI
other safety services, or seriously and frequently damage, obstruct or interrupt an authorised
radio communication service. These communication services include, but are not limited to,
commercial AM/FM radio services, television, cellular telephone services, radio detection,
air traffic control, radio paging and GSM systems. These authorised services, along with
unintentional sources of disturbance, such as digital equipment, including computer systems,
contribute to the electromagnetic environment.
Electromagnetic compatibility is the ability of the elements of an electronic device to interact

devices whose serial number is LESS than F96085
correctly with the electronic environment. Although this computer system has been designed
to conform to the restrictions of the EMI regulatory body, there is no guarantee concerning
interference that may occur in a specific installation. Should the device generate interference
with radio communication services (this may be determined by turning the device off and on),
users are encouraged to attempt to correct this phenomenon by adopting one or all of the
following measures:
Change the orientation of the reception aerial.
Reposition the computer relative to the receiver.
Move the computer away from the receiver.
Connect the computer to a different power socket such that the computer and receiver
are on different branch circuits.
13.1. ELECTROMAGNETIC EMISSIONS

The FibroScan 430 MINI / MINI + is designed for use in the electromagnetic environment
defined below. The customer or the user of the FibroScan 430 MINI / MINI + must ensure that
it is used in that type of environment.
Emissions testing Compliance Electromagnetic Environment - Directives
RF CISPR 11 Group 1 The FibroScan 430 MINI / MINI + uses RF energy for its
emissions internal functions only. Consequently, its RF emissions
are very low and unlikely to cause any interference with
nearby electronic equipment.
RF CISPR 11 Class B The FibroScan 430 MINI / MINI + may be used on all
emissions premises, including domestic premises and those directly
connected to the public low voltage energy grid used to
Harmonic Class A supply domestic buildings.
emissions
IEC 61000-3-2
Voltage Compliant
fluctuations/flicker
IEC 61000-3-3
NOTE: The use of cables and/or accessories not specified in the user guide may increase the
device's emissions.
70
13.2. ELECTROMAGNETIC IMMUNITY (1)

In the following cases, electrostatic charges may be generated:
By triboelectric effect, by rubbing two different materials together (conductive or
insulating), one gains a positive charge and the other a negative charge. The further the
two materials are from each other on the triboelectric series, the greater the charge is
likely to be.
by electrostatic effect: Shift of electrostatic charges due to proximity of another charge.
Immunity IEC 60601 test Compliance Electromagnetic Environment -

test level Recommendations
Electrostatic ± 6 kV contact ± 6 kV contact Floors should be wooden,

Discharge ± 8 kV air ± 8 kV through air concrete or ceramic. If the floor is
IEC covered with a synthetic material,
61000-4-2 the relative humidity must be at

least 30 %.
Spike/Burst + 2 kV supply + 2 kV supply The quality of the electrical

IEC ± 1 kV input/output ± 1 kV input/output network must be that of a typical
61000-4-4 commercial or hospital
environment.
Voltage Differential mode Differential mode The quality of the main supply
shocks ± 1 kV ± 1 kV must be that of a typical
IEC Common mode Common mode commercial or hospital
61000-4-5 ± 2 kV ± 2 kV environment.
Voltage < 5% U T 1 for < 5 % U T, for The quality of the electrical

drops, short 10 ms. network must be that of a typical
interruptions 10 ms. commercial or hospital
and supply 40 % U T, for 40 % U T, for environment. If the user of the
inlet voltage 100 ms. FibroScan unit 430 MINI / MINI +
100 ms.
variation requires uninterrupted operation
IEC 70% U T, for 70% U T, for during electrical power cuts, it is
61000-4-11 500 ms. 500 ms. recommended that the FibroScan
unit 430 MINI / MINI + be powered
< 5 % U T, for 5 s. < 5 % U T, for 5 s.
by an uninterruptible power supply
or battery.
Magnetic 3 A/m 3 A/m Supply frequency magnetic fields

field must be those of a typical
immunity at commercial or hospital
supply environment.
frequency
(50-60 Hz)
IEC
61000-4-8
13.3. ELECTROMAGNETIC IMMUNITY (2)

1. U : network power supply voltage measured before the test

T
71
Immunity test IEC Compliance Electromagnetic Environment - Directives

60601
test level
Portable and mobile RF communication

equipment must be kept far away from the
FibroScan unit 430 MINI / MINI + (including its
cables), at a distance greater than the
recommended distance calculated using the
equation applicable to the emitter frequency.
Recommended separation distance
Conducted RF 3 V rms 3 V rms d = 1.17

IEC 61000-4-6 150 kHz
to
80 MHz
Radiated RF 3 V/m 3 V/m d = 1.17

IEC 61000-4-3 80 MHz 80 MHz to 800 MHz
to
2.5 GHz d = 2.33
800 MHz to 2.5 GHz
where P is the maximum emitter power in watts

(W), as specified by the emitter manufacturer,
and d is the recommended separation distance
in metres (m).
The strength of EM fields for fixed emitters, as
determined by a study 2 electromagnetic of the
site must be less than the compliance level in
each of the frequency bands. 3
Interference may occur in the vicinity of devices
bearing the following symbol:
NB 1: At 80 MHz and 800 MHz, the upper frequency band is applicable.
NB 2: These recommendations may not be applicable in all cases. Electromagnetic

propagation is affected by absorption and reflection caused by structures, objects and
individuals.
NB 3: The use of cables and/or accessories not specified in the user guide may reduce the
device's immunity.
NB 4: In case of any disturbance in the electromagnetic environment of the FibroScan 430

MINI / MINI +a message is displayed (see the Message Area chapter) and no measurements
can be carried out.
2. The strength of EM fields for fixed emitters such as commercial AM/FM radio broadcasting services,
television, cell phone services, radio detection, air traffic control, radio paging receivers and GSM services
cannot be accurately predicted. To assess the EM environment caused by fixed emitters, a site EM study
must be conducted. If the field strength measured at the location where the FibroScan unit 430 MINI / MINI +
is used exceeds the compliance levels mentioned above, correct operation of the FibroScan unit 430 MINI /
MINI + must be checked. If abnormal performance is observed, additional measurements may be required
after, for example reorienting or moving the FibroScan 430 MINI / MINI +.
3. In the frequency range 150 kHz - 80 MHz, field intensity should ideally be less than 3 V/m.
72
13.4. RECOMMENDED SEPARATION DISTANCES

(between portable or mobile RF communication devices and the FibroScan ) 430 MINI / MINI
+)
The FibroScan 430 MINI / MINI + is designed for use in an electromagnetic environment in
which RF disturbance is controlled. The customer or the user of the FibroScan 430 MINI /
MINI + can take precautions against interference by maintaining a minimal distance between
the portable or mobile RF communication equipment (transmitters) and the FibroScan 430
MINI / MINI + as recommended below according to the maximum power of the communicative
device.
Maximum Separation distance according to transmitter frequency (m)

transmitter
output power 150 kHz to 80 MHz 80 MHz to 800 MHz 800 MHz to 2.5 GHz
(W)
d = 3.5/3 d = 3.5/3 d = 7/3
0.01 0.12 0.12 0.23
0.1 0.37 0.37 0.74

1 1.17 1.17 2.33
10 3.69 3.69 7.38
100 11.67 11.67 23.33
For emitters whose maximum power is not listed above, the recommended separation
distance in metres (m) can be estimated using the applicable equation at the transmitter's
frequency, where P is the maximum transmitter power in watts (W) as specified by the
transmitter manufacturer.
NB 1: At 80 MHz and 800 MHz, the upper frequency band is applicable for the separation
distance.
NB 2: These recommendations may not be applicable in all cases. Electromagnetic

individuals.
73
14. ELECTROMAGNETIC COMPATIBILITY
Electromagnetic interference (EMI) is a signal or emission, conveyed through open space

or through electrical or signal conductors, which may severely disrupt radio navigation or
Only applicable to 430 MINI+ devices whose serial number (SN) is GREATER than or equal to 92256,
other safety services, or seriously and frequently damage, obstruct or interrupt an authorised
radio communication service. These communication services include, but are not limited to,
commercial AM/FM radio services, television, cellular telephone services, radio detection,
and 430 MINI devices whose serial number is GREATER than or equal to F96085
air traffic control, radio paging and GSM systems. These authorised services, along with
unintentional sources of disturbance, such as digital equipment, including computer systems,
contribute to the electromagnetic environment.
Electromagnetic compatibility is the ability of the elements of an electronic device to interact

correctly with the electronic environment. Although this computer system has been designed
to conform to the restrictions of the EMI regulatory body, there is no guarantee concerning
interference that may occur in a specific installation. Should the device generate interference
with radio communication services (this may be determined by turning the device off and on),
users are encouraged to attempt to correct this phenomenon by adopting one or all of the
following measures:
Change the orientation of the reception aerial.
Reposition the computer relative to the receiver.
Move the computer away from the receiver.
Connect the computer to a different power socket such that the computer and receiver
are on different branch circuits.
defined in the following chapter. The customer or the user of the FibroScan 430 MINI / MINI
+ must ensure that it is used in that type of environment.
The use of cables and/or accessories not specified in the User Manual may damage the
device's electromagnetic performance.
The FibroScan device 430 MINI / MINI + complies with standard IEC 60601-1-2:2014.
14.1. CLASSIFICATION
Compliance Electromagnetic environment
Group 1 The FibroScan 430 MINI / MINI + uses RF energy for its internal functions only.
Consequently, its RF emissions are very low and unlikely to cause any
interference with nearby electronic equipment.
Class B The FibroScan430 MINI / MINI + may be used on all premises, including domestic
premises and those directly connected to the public low voltage energy grid used
to supply domestic buildings.
74
14.2. IMMUNITY
The FibroScan 430 MINI / MINI + is intended for use in professional healthcare centre
environments and in home healthcare environments.
In the following cases, electrostatic charges may be generated:

By triboelectric effect, by rubbing two different materials together (conductive or
insulating), one gains a positive charge and the other a negative charge. The further the
two materials are from each other on the triboelectric series, the greater the charge is
likely to be.
by electrostatic effect: Shift of electrostatic charges due to proximity of another charge.
Immunity test Test level
Electrostatic Discharge ± 8 kV contact
IEC 61000-4-2 ± 2 kV, ± 4 kV, ± 8 kV, ± 15 kV air
Radiant RF fields and proximity to 10 V/m from 80 MHz to 2.7 GHz

wireless networks 80% in 1 kHz amplitude modulation
IEC 61000-4-3
Near-field RF emitted by wireless 9 V/m at 710 MHz, 745 MHz, 780 MHz, 5240 MHz,
communication equipment 5550 MHz and 5785 MHz
IEC 61000-4-3 provisional method
27 V/m at 385 MHz
28 V/m at 450 MHz, 810 MHz, 870 MHz, 930 MHz,
1720 MHz, 1845 MHz, 1970 MHz and 2450 MHz
Spike / Burst ± 2 kV for electrical power cables

IEC 61000-4-4 100 kHz burst frequency
Over-voltages Differential mode

IEC 61000-4-5 ± 0.5 kV, ± 1 kV
Common mode
± 0.5 kV, ± 1 kV, ± 2 kV
Conducted disturbances induced by 3 V from 150 kHz to 80 MHz

RF fields
6 V in ISM band, from 150 kHz to 80 MHz
IEC 61000-4-6
80% in 1 kHz amplitude modulation
Magnetic field immunity at supply 30 A/m

frequency (50-60 Hz)
IEC 61000-4-8
Voltage drops, short interruptions 0 % UT 4, over 0.5 cycles for 0°, 45°, 90°, 135°, 180°,
and supply inlet voltage variation
IEC 61000-4-11 225°, 270° and 315° phase shifts.
0 % UT, over 1 cycle
70 % UT, over 25 cycles at 50 Hz and 30 cycles at 60 Hz,
for a 0° phase shift
Power input voltage interruptions 0 % UT

IEC 61000-4-11 over 250 cycles at 50 Hz and 300 cycles at 60 Hz
NOTE: In case of any disturbance in the electromagnetic environment of the FibroScan

430 MINI / MINI +, a message is displayed (see the Message Area chapter) and no
measurements can be carried out.
4. U : Mains power voltage measured prior to execution of test

T
75
14.3. EMISSIONS
The FibroScan 430 MINI / MINI + is intended for use in professional healthcare centre
environments and in home healthcare environments.
Test Emission limits
Conducted emissions 79 dB μV quasi-peak

from 150 kHz to 500 kHz
73 dB μV quasi-peak
from 0.5 MHz to 5 MHz
73 dB μV quasi-peak
from 5 MHz to 30 MHz
Radiant emissions 40 μV/m quasi-peak

from 30 MHz to 230 MHz
47 μV/m quasi-peak
from 230 MHz to 1 GHz
Portable and mobile RF communications equipment (including peripherals such as aerial

cables and external aerials) must not be used at a distance of less than 30 cm (12 inches)
from any part of the FibroScan device 430 MINI / MINI +, including cables specified by
Echosens. Otherwise, device performance may suffer.
Test Compliance
Voltage fluctuations/flicker Compliant

IEC 61000-3-3
Harmonic distortion Compliant

IEC 61000-3-2
NOTE: These recommendations may not be applicable in all cases. Electromagnetic

individuals.
76
15. INDEX
Archive 33, 48, 49, 50, 58 Connectivity 59 Examination type 46

Advanced search 48 DICOM 34, 35, 59 Export
Delete 48 Directory sharing 59 Anonymisation 58
Export 48 FibroScan identifiers 34 Automatic export 58
Archives 49 FibroView 34, 35, 60 DICOM 60
Clinical Research 49 File share 34 DICOM format 48, 50
Barcode reader Status 34 DICOM log 61
Configuration 62 TeamViewer 62 Examination file 48, 50, 58
Battery 25, 26 USB 34 Examination report 48, 50, 58
battery charge indicator 23 Contraindications 18 Excel 49
Characteristics 69 Copyright 8 FIBX format 48, 50
Charge level. 34 Date and time 34, 56 Gateway 60
Product life 13 Disinfection PDF format 48, 50
Troubleshooting 55 Probe 53 Retry 50
Calibrating the probe 54 Shared directory 48, 50
Electromagnetic compatibility
Message 45 70, 74 USB storage device 48, 50
Calibration Classification 74 External power supply 25, 25
Status 34 Emissions 76 69
Immunity 71, 75 Connection 26
Cancel measurement 44
CAP 19, 33, 42 Electromagnetic disturbance Fold-away stand. 26
Activation 60 Message 45 Force indicator 40
CAP-LEVEL 42 EMI 70, 74 Gateway
Interquartile range 43 Essential performance Additional fields 37, 60
second generation 19 characteristics 13 Examination 37
Standard Deviation 43 Examination 33 Worklist 60
CAPc 33 Acquisition screen 37 Guarantee 13
Clinical Research Mode 33, Additional fields 37 Home 48
36 Archive 58 Status bar 33
Clinical Research Blockage in the event of a probe Indications
being uncalibrated 37 Configuration 60
Activation 60
Change of probe 47
Configuration 61 Intended environment 18
Clinical Research Mode 33, 36
Configuration 56 Intended use 15
Comments 44
Automatic logout 32, 62 Intended users 18
Configuration 60
Barcode reader 62 Interquartile range 42, 42
Delete 48, 50, 58
Calibration 61 CAP 43
Details of examination 48
CAP 60 IQR 42, 43
Examination type 46
Clinical Research 60, 61
Measurement vignette 44 IQR/Median 42
Date and time 56
Measurements carrousel 43 Liability 13
DICOM 60
Options 60, 60, 61 Log files 61
Examination 60, 60
Print 48, 50 Export 61
Indications 60
Programmed stop 37 Login 32, 34
Maintenance 62
RAW Data 33 Automatic logout 32
Measurement conditions 61
RAW Mode 36 Password 32
Network 59
Options 60, 61
Save condition 61 Maintenance 62
Uncalibrated probe 37 Measurement conditions
Print 57
Examination file Configuration 44, 61
QR Code 56
QR Code 56 Measurement
Save condition 61
Software protection 63, 63 Examination procedure 29 Cancel 44
Software update 62 Selection of the examination Elastogram 44
type 29 Reset 44
User accounts 58, 58
Network parameters
Gateway 59
77
Host name 59, 59 Maintenance 20 User Accounts 56

IP address 59 Selection of the examination User accounts 58
Sub-network mask 59 type 29 Password 58
Patents 14 Recommendations 18 Resetting 58
Patient leakage current tests SmartDepth 33 User training 19
Precautions 55 SmartExam 34 VCTE technique 18
Patient Software protection 63, 63
DICOM import 59 Software update 62
FibroView 60 Standard Deviation STD 43
Gateway 60 Standard Deviation
Patient data display 38 CAP 43
Patient data security 62 Standby 51
Patient display 62 Button 25
Record 35
Stiffness 19, 41, 42
Worklist 59, 60 Elastogram 41
Power cable 69 Measurement 40
Power indicator 23 Switching off the machine 51
Precautions for use 18 System 61
Examination type 18 Available disk space 34, 61
Principle of use 18 Identifiers 61
Print 48, 50, 57 Target population 17
Probe 27, 32 Technical characteristics of
Calibration 55 the device 67
Calibration 37, 54 Electrical characteristics 68
Change 47 Environmental characteristics
Disinfection 53 68
Indicators 28 Mechanical characteristics 68
Lead 28 Tips 34
Measurement button 27 Troubleshooting
Troubleshooting 55 Battery 55
Probes Probe 55
Calibration status 34 Standby 55
Product life 13 TeamViewer 62
Property 8 Ultrasound images 39
RAW Mode 36 Ultrasound signals
Region A-Mode 39
Language 56 Signal quality indicator 39
Registered trademarks 14 TM Mode 39
Regulations 70, 74 USB 34

Removing power 51 Use
Contraindications 18
Result
CAP 42 Indications 15
Examination report 57 Intended environment 18
Interquartile range 42, 43 Intended users 18
IQR/Med 42 Precautions 18
Standard Deviation 43 Principle of use 18
Stiffness 42 Target population 17
VCTE technique 18
Reverse engineering 13
Safety
Electrical safety 19
78
79
blank
Echosens
6 rue Ferrus
75014 PARIS
France
Tel: +33 (0)1 44 82 78 50
Fax: +33 (0)1 44 82 78 60
Website: www.echosens.com
Email: info@echosens.com

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User manual

for the FibroScan 430 MINI / MINI +

E332M006.6 – Version 6 – 02/2021

(software version 4.1)

1. PURPOSE OF THE USER MANUAL............................................................................. 7

3. MISCELLANEOUS INFORMATION ............................................................................ 13

4. INDICATIONS AND PERFORMANCE......................................................................... 15

4.10. Electrical safety ......................................................................................................... 19

5. EXTERNAL PRESENTATION ..................................................................................... 21

8. STANDBY AND SHUTTING DOWN THE MACHINE .................................................. 51

8.2. At the end of the day ................................................................................................. 51

9. CLEANING, MAINTENANCE AND REPAIRS ............................................................. 52

10. CONFIGURING THE FIBROSCAN.............................................................................. 56

11. SYMBOLS ON THE DEVICE ....................................................................................... 64

12. TECHNICAL CHARACTERISTICS.............................................................................. 67

13.4. Recommended separation distances ........................................................................ 73

14. ELECTROMAGNETIC COMPATIBILITY..................................................................... 74

15. INDEX ........................................................................................................................... 77

1. PURPOSE OF THE USER MANUAL

After carefully reading the manual, operators shall be able to:

1.1. SYMBOLS USED IN THE MANUAL

This symbol means: ATTENTION

This symbol means: INFORMATION

1.2. PROPERTY AND COPYRIGHT

Copyright © – 03/2020 – 02/2021 – Echosens – All rights reserved.

2.1. PERIPHERALS NOT SUPPLIED BY ECHOSENS

2.2. ELECTRICAL SAFETY

All peripherals connected to signals input/output must be certified according to

Correct grounding operation can only be guaranteed if the system is connected to

Do not submerge the device or its probes.

2.3. ELECTROMAGNETIC SAFETY

2.4. BATTERY SAFETY

Be sure to follow the safety rules listed below:

Do not place the battery in fire or heat the battery.

Do not place the battery on or near fires, stoves, or other high-temperature

2.5. MAGNETIC RESONANCE SAFETY

The FibroScan device is incompatible with magnetic resonance (MR). Under no

2.6. USING THE DEVICE

Do not push or lean on the top of the FibroScan unit.

If the housing of the device is chipped or cracked by mechanical impact, do not

2.7. DELETING MEASUREMENTS

2.8. PATIENT SAFETY

If the excessive pressure warning is displayed during the examination, immediately

2.9. SWITCHING OFF THE UNIT

2.10. CLEANING AND MAINTENANCE

The opening or modification of the device by a person other than an authorised

To prevent electric shock, switch off the unit before cleaning.

2.12. INTERPRETING THE RESULT

Results must only be interpreted by a physician specialising in liver diseases, who

3.3. ESSENTIAL PERFORMANCE CHARACTERISTICS

Free from the production of unintended or excessive transducer assembly surface

3.4. PRODUCT LIFE

3.5. REVERSE ENGINEERING

Resale of the software built into the FibroScan is prohibited.

3.6. REGISTERED TRADEMARKS

3.7. PATENTED TECHNOLOGY

4. INDICATIONS AND PERFORMANCE

4.1. INTENDED USE

4.2. INDICATIONS FOR USE