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NAM
Date: 2022-01-14 10:33:53

User manual
for the FibroScan 630 ®

E303M007.10 – Version 10 – 11/2020

(software version 4.1)

en-GB
en-GB FIBROSCAN USER MANUAL 630

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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. Peripherals supplied but not manufactured by Echosens ........................................... 9
2.3. Electrical safety ........................................................................................................... 9
2.4. Electromagnetic safety .............................................................................................. 10
2.5. Magnetic resonance safety........................................................................................ 10
2.6. Using the device ........................................................................................................ 10
2.7. Deleting measurements............................................................................................. 11
2.8. Patient safety............................................................................................................. 11
2.9. Using the B-Mode localisation module ...................................................................... 11
2.10. Switching off the unit ................................................................................................. 11
2.11. Cleaning and maintenance........................................................................................ 11
2.12. Cleaning .................................................................................................................... 11
2.13. 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....................................................................................................... 18
4.4. Precautions for use.................................................................................................... 18
4.5. Contraindications....................................................................................................... 19
4.6. Intended environment................................................................................................ 19
4.7. Intended users........................................................................................................... 19
4.7.1. Using the device .......................................................................................... 19
4.7.2. Interpreting the results ................................................................................. 19
4.8. Principle of use .......................................................................................................... 19

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4.9. Principle of operation of the B-Mode localisation module.......................................... 20

4.10. User training .............................................................................................................. 20
4.11. Electrical safety ......................................................................................................... 20
4.12. Maintenance-related safety ....................................................................................... 21
4.12.1.Installation recommandations concerning the B-Mode probe (EXPERT
version only)................................................................................................. 21

5. EXTERNAL PRESENTATION ..................................................................................... 22

5.1. Hardware supplied..................................................................................................... 22
5.2. Probes and peripherals supplied by Echosens, and peripherals not supplied by
Echosens................................................................................................................... 22
5.3. Front view .................................................................................................................. 23
5.4. Rear view................................................................................................................... 25
5.5. Description of the FibroScan probes ......................................................................... 29
5.6. Description of the B-Mode ultrasound localisation probe .......................................... 30
5.7. Description of control pedal ....................................................................................... 31

6. EXAMINATION PROCEDURE..................................................................................... 32
6.1. Selection of the probe and examination type ............................................................ 32
6.1.1. Liver examination......................................................................................... 32
6.1.2. Spleen examination ..................................................................................... 33
6.2. Performing the examination....................................................................................... 33

7. SOFTWARE INTERFACE............................................................................................ 35
7.1. Authentication page................................................................................................... 35
7.2. Home screen ............................................................................................................. 35
7.3. Using the interface keypad ........................................................................................ 36
7.4. Status bar .................................................................................................................. 36
7.5. The patient record screen.......................................................................................... 38
7.6. Acquisition screen ..................................................................................................... 40
7.6.1. Localisation phase ....................................................................................... 41
7.6.2. Acquisition screen for Liver examination ..................................................... 42
7.6.3. Acquisition screen for Spleen examination (only available with the
EXPERT version)......................................................................................... 43
7.6.4. Patient data.................................................................................................. 44
7.6.5. One-dimensional ultrasound localisation ..................................................... 44
7.6.6. B-Mode ultrasound localisation ................................................................... 45
7.6.7. Force indicator ............................................................................................. 47
7.6.8. Elastogram................................................................................................... 48
7.6.9. Valid stiffness measurement counter........................................................... 48
7.6.10.Stiffness results area ................................................................................... 49
7.6.11.CAP-LEVEL (only for CAPc)........................................................................ 50
7.6.12.CAP result zone (option).............................................................................. 50
7.6.13.Measurements displayed as image carrousel.............................................. 51
7.6.14.Displays measurements as vignettes .......................................................... 52
7.6.15.Displaying the B-Mode ultrasound localisation screenshot.......................... 52
7.6.16.Deleting measurements ............................................................................... 52
7.6.17.Adding a comment ....................................................................................... 53
7.6.18.Alert display area ......................................................................................... 54

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7.6.19.Message area .............................................................................................. 55

7.6.20.Examination type selection area .................................................................. 55
7.6.21.View and print the result of the examination ................................................ 58
7.7. Management of patient file archives.......................................................................... 59
7.7.1. Advanced file search.................................................................................... 61
7.7.2. Select and view a patient file ....................................................................... 61
7.7.3. Details of the examination............................................................................ 61
7.8. Resending failed exports ........................................................................................... 62

8. SWITCHING OFF THE DEVICE................................................................................... 63

8.1. Between sessions...................................................................................................... 63
8.2. At the end of the day ................................................................................................. 63

9. CLEANING, MAINTENANCE AND REPAIRS ............................................................. 64

9.1. Cleaning and disinfection .......................................................................................... 64
9.1.1. Cleaning the surfaces of the device............................................................. 64
9.1.2. Disinfecting the FibroScan probe (housing, cable and transducer) ............. 65
9.1.3. Recommended cleaning products for use on the FibroScan probe............. 66
9.1.4. Recommended disinfection products........................................................... 66
9.1.5. Cleaning and disinfectant products that are prohibited for use on the
FibroScan probe .......................................................................................... 66
9.1.6. Disinfection of the B-Mode ultrasound localisation probe (housing, cable
and transducer) ........................................................................................... 66
9.2. Calibrating the FibroScan probe................................................................................ 67
9.3. Troubleshooting......................................................................................................... 67
9.4. Patient leakage current tests: Precautions ................................................................ 68

10. CONFIGURING THE FIBROSCAN.............................................................................. 69

10.1. Entering configuration mode...................................................................................... 69
10.2. Localisation tab.......................................................................................................... 69
10.3. Institution tab ............................................................................................................. 70
10.4. Printer tab .................................................................................................................. 70
10.5. Data tab ..................................................................................................................... 71
10.6. User tab ..................................................................................................................... 71
10.7. Connectivity tab ......................................................................................................... 72
10.8. Examination tab......................................................................................................... 73
10.9. System tab................................................................................................................. 74

11. SYMBOLS ON THE DEVICE ....................................................................................... 77

11.1. Symbols on the B-Mode ultrasound localisation probe and housing......................... 79
11.2. Note ........................................................................................................................... 79

12. TECHNICAL CHARACTERISTICS.............................................................................. 80

12.1. Characteristics of the device ..................................................................................... 80
12.1.1.Computer characteristics ............................................................................. 80
12.1.2.Metrological performance ............................................................................ 80
12.1.3.Electrical characteristics .............................................................................. 82
12.1.4.Mechanical characteristics........................................................................... 82
12.1.5.Environmental characteristics ...................................................................... 82
12.1.6.Additional information .................................................................................. 82

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12.2. Characteristics of the AC/DC power supply .............................................................. 83

12.2.1.Electrical characteristics .............................................................................. 83
12.3. B-Mode ultrasound localisation probe characteristics ............................................... 83
12.3.1.Mechanical characteristics........................................................................... 83
12.4. QR code reader characteristics ................................................................................. 83
12.5. Control pedal characteristics ..................................................................................... 83
12.5.1.Mechanical characteristics........................................................................... 84
12.6. Consumables............................................................................................................. 84

13. ELECTROMAGNETIC COMPATIBILITY..................................................................... 85

13.1. Classification ............................................................................................................. 85
13.2. Immunity .................................................................................................................... 86
13.3. Emissions .................................................................................................................. 86

14. INDEX ........................................................................................................................... 88

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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.

IMPORTANT NOTE: The FibroScan 630 is available in two different versions: PRIME and
EXPERT. The EXPERT version is an extension of the PRIME version, additionally offering
spleen stiffness measurement and the B-Mode localisation module. Unless otherwise
stated, the contents of this User Manual apply to the PRIME and EXPERT variants of
the FibroScan 630 equally.

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.

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Any information or modification requests pertaining to this manual should be sent to:
https://support.echosens.com.

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 – 11/2020 – 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. PERIPHERALS SUPPLIED BUT NOT MANUFACTURED BY

ECHOSENS

When connecting any peripheral supplied but not manufactured by Echosens,

refer to the manufacturer's User Manual to ensure operator and patient safety.

2.3. 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.

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Do not submerge the device or its probes.

With the EXPERT variant fitted with the B-Mode localisation module, to avoid the
risk of electrical shock and fire hazard:

Before using the B-mode probe, inspect the probe face, housing, and cable.
Do not use the probe if the probe or its cable is damaged.
Do not use any B-mode probe that has been immersed beyond the specified
cleaning or disinfection level.

Only the B-Mode ultrasound localisation probe reference ES-C5-2R60S-3 is

compatible with the FibroScan. Under no circumstances should a probe not of this
reference be connected to the FibroScan.

Only the Linemaster GEM SWNO control pedal is compatible with the FibroScan.
Under no circumstances should a probe not of this reference be connected to the
FibroScan.

2.4. ELECTROMAGNETIC SAFETY

The use of accessories not specified in the user guide may cause a non-
compliance in terms of electromagnetic compatibility (EMC).

Avoid using the FibroScan device when placed upon or near a machine that
generates electromagnetic disturbance.

The FibroScan 630 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.

With the EXPERT variant, when the B-Mode localisation probe is not being used,
secure the probe cable safely out of the way using the clip located on the right-
hand side of the device, underneath the probe holder bracket.

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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. USING THE B-MODE LOCALISATION MODULE

The B-Mode ultrasound localisation module is intended solely for anatomical

localisation of the liver and spleen for the purpose of a FibroScan examination.
Under no circumstances may it be used as a medical imaging or diagnosis device.

2.10. SWITCHING OFF THE UNIT

Never switch the unit off during an examination or whilst in configuration mode.
Never disconnect the main power supply when the device is switched on. Failure
to comply with these instructions could cause a malfunction of the machine and/or
loss of data.

2.11. 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.

2.12. CLEANING

To prevent electric shock, switch off the device and disconnect it from the power
supply before cleaning.

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2.13. 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.

No unintentional or excessive production (or lack of production) of ultrasound.

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.

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.

Resale of the software built into the FibroScan is prohibited.

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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 630 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,
spleen stiffness measurements at a shear wave frequency of 100 Hz,
and the Controlled Attenuation Parameter (: CAP) of the liver at 3.5 MHz.

Spleen stiffness measurement is only available with the EXPERT variant.

4.2. INDICATIONS FOR USE

Liver stiffness, spleen stiffness and liver CAP are indicated as an aid to diagnosis and
monitoring of adult patients as part of an overall assessment of liver disease.

Spleen stiffness measurement is only available with the EXPERT variant.

Liver stiffness and liver CAP are indicated as an aid to diagnosis and monitoring of 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]

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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.

[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.

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[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.

[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.

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[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

Liver

The FibroScan device is indicated for adult and paediatric patients.

Spleen (only available with the EXPERT version)

The FibroScan device is indicated for adult patients.

4.4. PRECAUTIONS FOR USE

The following precautions must be observed when using the FibroScan device:

Liver examination
The probe and type of examination must be selected based on the recommendations
detailed in the “Examination procedure” section, page 32.
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.
Spleen examination methods must not be used for the liver.

Spleen examination
The FibroScan device is indicated for use in adult patients for detecting a homogeneous
splenic parenchyma located between 25 mm and 55 mm beneath the surface of the
skin.
Liver examination methods must not be used for the spleen.

In all cases
The patient must fast for at least 3 hours before the examination.
The clinical personnel must follow normal safety procedures.
The presence of ascites between the probe and the organ to be measured may prevent
measurements from being obtained.

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Spleen stiffness measurement is only available with the EXPERT variant.

Once an optimal image is achieved, the need for prolonging the exposure cannot be justified.

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 (for PRIME version).
On organs other than the spleen or liver (for EXPERT version).
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.

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 or 100Hz, depending on the organ to be
measured. This wave propagates through the skin, the subcutaneous tissues, and then the
organ to be measured. 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 organ. Stiffness in kPa of the organ to be measured 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.

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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 FibroScan probe: A: Ultrasound transducer. B: Electrodynamic actuator. C:

Organ (illustration shows liver).

4.9. PRINCIPLE OF OPERATION OF THE B-MODE LOCALISATION

MODULE
B-Mode localisation module is based on the effect of ultrasound wave reflection from the
tissue edges with different acoustic impedance levels. Ultrasound waves sent out by the
probe head are emitted into the patient’s body. Reflections from the specific types of tissue
and their external surface/edges cause partial reflections of the propagating sound wave.
Return echo comes back to the probe head and after being detected and amplified is
displayed on the monitor screen as a pixel combination with various shades of brightness,
creating an ultrasound image.

4.10. 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.

4.11. 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.

Prior to installation, ensure that the operating and mains voltage values match.

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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 or the probe is visibly damaged,

The device or the probe 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.

4.12. 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.

With the EXPERT variant, to protect the B-Mode probe – notably its transducer –, follow these
precautions:
excessive cables bending or twisting can cause a failure or intermittent operation;
improper cleaning or disinfecting of any system part can cause permanent damage, for
cleaning and disinfecting instructions see chapter Nettoyage, entretien et dépannage;
do not use solvents such as thinner/benzene, or abrasive cleaners on any part of the
system;
do not spill liquid on the system.

4.12.1. Installation recommandations concerning the B-Mode probe

(EXPERT version only)
Keep device from temperature shock.
When you will move the scanner from cold to warm place, please wait 0.5 to 1 hour
before switch on. It is necessary because of water condensation at electronic parts.
Do not use the B-Mode probe close to moisture source or in place with high moisture.
Do not use compressed air or vacuum to clean the device.
Do not drop, hit or shake.
Take care when work with ultrasound probe. Probes should be clean after work from gel
and other deposits. Do not use any aggressive chemicals. To increase life time of
probes, always leave them after work with freeze acquisition.
Probe disconnection can be done only when the device is switched off.
Ultrasonic waves have a low permeability in air and gas within the living body. If air is
present between the probe and the skin, localisation of measurement area may be
impossible. Therefore, it is necessary to apply an acoustic coupler, typically ultrasound
gel so that the probe adheres closely to the skin.

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5. EXTERNAL PRESENTATION

5.1. HARDWARE SUPPLIED

When opening the package, ensure the contents match the following list:
B-Mode ultrasound localisation probe (ref. ES-C5-2R60S-3) – EXPERT version only
FibroScan device installed
Power cable(s) (according to country)
Case(s) fitted with probe(s)
Sealed envelope (Windows EULA license and the present User manual)
Set of 4 fuses, type 5x20mm T2AL 250V

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
Control pedal

Refer to the warnings in Chapter 2 concerning the use of peripherals not supplied
by Echosens.

Refer to the warnings in Chapter 2 concerning the use of peripherals supplied but
not manufactured by Echosens.

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Set of elements that can be connected to the FibroScan unit:

Probes: A: S+ probe. B: M+ probe. C: XL+ probe. D: B-Mode ultrasound localisation probe –

EXPERT variant only.

Peripherals supplied by Echosens: E: Control pedal.

Peripherals not supplied by Echosens: F: USB storage device. G: Printer. H: HDMI

screen.

5.3. FRONT VIEW

The device contains the electrical power supply, dedicated electronics and a computer. It also
supports a monitor, three FibroScan probe holders, and a gel holder.

The following figure presents the instrument's different user-accessible parts.

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General arrangement of the FibroScan device: A: Touch screen. B: Probe holder. C:

Keypad. D: Built-in handle. E: Caster with brake. F: Start-up/standby button. G: Gel holder.

Start-up/standby button

This button is enabled only when the main switch, located at the rear of the device,
is set to "I".

The touch screen button flashes green when the device is starting up or going into standby.
It shows steady green when the device is started up and ready to use.

To switch the device on, press the button until you hear a beep. Release. This button loads
the application. After a few seconds, the home window is displayed.

The touch screen button flashes orange in quick succession in the event of device critical
error. A fast beeping sound is also emitted.

Power indicator
The status of the power indicator is defined as follows:
Off: Device in standby or not connected to power supply.
On: Device started up and ready to use.

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View of the front panel of the FibroScan unit: A: Start-up/standby button. B: Power supply
indicator.

The screen and the software

This is a 19-inch colour LCD 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.

Casters and brakes

The casters are fitted with a brake. The brake is blocked by pressing the latch. The caster is
released by lifting this same latch.

View of a caster with brake: A: Caster brake.

Moving the device

Always release the brakes before moving the device.

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

5.4. REAR VIEW

The following figure presents the instrument's different user-accessible parts.

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Rear view: A: Rear handle. B: Computer connectors. C: Auxiliary connectors. D: B-Mode

ultrasound localisation probe connector – EXPERT variant only. E: Probe connectors. F:
Electrical power supply connector and main switch. G: Earthing connector.

Computer connectors

Location of computer connectors: A: HDMI output. B: 2 USB 3.0 ports.

Two USB 3.0 sockets: To connect an external hard drive for backups, a USB storage device,
or a USB printer.

Echosens recommends using encrypted hard drives or USB keys protected by

logon code entered using integrated keypad.

Refer to the warning in Chapter 2 concerning cleaning and maintenance.

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Electrical power supply connector

The FibroScan must be connected to a 100 V to 240 V, single phase AC 50/60 Hz earthed
power outlet via the power cable supplied, connected to the socket at the base of the chassis.

View of main switch and power supply connector: A: Main switch and access to fuses. B:
Electrical power supply connector.

Main switch
This switch has two positions:
Position 0: no voltage is present in the internal circuits of the FibroScan, meaning that it
consumes no electrical energy. This is the usual position when the FibroScan is no
longer to be used (at the end of the day for example).
Position 1: the internal electrical circuits of the FibroScan are powered by the AC power
supply. This is the FibroScan's working position.

This switch assembly has a removable part. It provides access to the two FibroScan
protection fuses.

The bottom part of the switch device receives the power cable plug connection outlet.

Earthing connector

Earthing operation: A: Earthing connector.

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Auxiliary connectors

Auxiliary connectors: A: RJ45 network connector. B: 5 V auxiliary jack.

RJ45 network connector: Used for Ethernet connection.. Also used by Echosens
maintenance staff.
5 V auxiliary jack: This jack enables accessories, such as a control pedal, to be
connected.

Probe connectors

Location of probe connectors: A: Probe connectors. B: Location for the connector of the
unconnected probe.

Location (B) is not operational. It protects the connector of the unconnected probe.

Before using the FibroScan device, the operator must be able to recognize the Electrostatic
discharge (ESD) symbol, and must take the appropriate precautionary measurements as
described below:
Do not touch the pins of connectors marked with the ESD warning symbol,
Before making any connections, discharge the static electricity from your body, either by
touching and remaining in contact with a grounded metal object, or using a properly
grounded antistatic bracelet or a potential equalization terminal.

Training in the meaning of the ESD symbol and ESD precautionary procedures is
strongly recommended.

The probe connectors are fragile.

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5.5. DESCRIPTION OF THE FIBROSCAN PROBES

The FibroScan probe contains an electrodynamic actuator (vibrator), an ultrasound
transducer and a measurement trigger button.

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.

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.

If a control pedal is connected, measurement may be launched by using either the

pedal or the probe button.

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.

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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.

5.6. DESCRIPTION OF THE B-MODE ULTRASOUND LOCALISATION

PROBE
The B-Mode ultrasound localisation probe has a convex array of ultrasound transducers.

B-Mode ultrasound localisation probe: A: Convex array of ultrasound transducers. B:

Strain relief. C: Probe lead.

The convex transducer array of the B-Mode ultrasound localisation probe is a “BF Type”
applied part.

Lead

Probe lead: A: Connection cable. B: EX10E-280P HRS connector.

This cable, no more than 3 m long, connects the probe to the FibroScan device by means of
an EX10E-280P HRS foolproof connector.

The probe transducer, the probe jack, and the connector are fragile elements and
must be handled with care.

The serial number marked on the connector identifies the probe uniquely.

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5.7. DESCRIPTION OF CONTROL PEDAL

A control pedal can be connected via the 5 V auxiliary jack. Simply by pressing the central
button of the pedal with the foot, it can be used instead of the probe button to take the
measurement.

Refer to the warning in Chapter 2 concerning cleaning and maintenance.

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6. EXAMINATION PROCEDURE

6.1. SELECTION OF THE PROBE AND EXAMINATION TYPE

6.1.1. Liver examination

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 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.

To guarantee reliable results, it is advisable to refer to the section "Automatic probe

recommendation", page 56. While the decision regarding whether or not to apply
this recommendation remains with the user, you are strongly advised to use the
recommended tool.

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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.

6.1.2. Spleen examination

For Spleen examinations, only the M examination is available. Spleen examinations can
therefore only be performed on the target population using the M+ probe (see section
"Precautions for use", page 18).

6.2. PERFORMING THE EXAMINATION

The examination procedure is completely non-invasive and takes only a few minutes.

Liver examination
For Liver examinations, the stages are as follows:

Using the probe: A: Patient abdomen. B: Probe.

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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 32, and "Automatic probe
recommendation", page 56).
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). If necessary, use the
localisation probe in B-Mode. This phase is formalised by the Localisation 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.

Spleen examination
For Spleen examinations, the stages are as follows:
1. In a quiet environment, lie the patient down on their back with their left 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. Locate the spleen beforehand using the B-Mode ultrasound localisation module.
5. Position the FibroScan probe transducer on the patient’s skin, between the ribs, above
the area previously located using the B-Mode localisation probe.
6. Use the FibroScan probe's ultrasound localisation tools to locate an area of the spleen
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).
7. Take a minimum of 10 valid measurements in each examination, using the same
measurement point each time.

The final stiffness measurement value saved is the median of all of the valid stiffness
measurements performed during the examination.

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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.

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Access to the patient file archives.

Access to the examination.

Return to the home screen by clicking the Home button:

7.3. USING THE INTERFACE 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.

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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.

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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.

Fields can be filled in using the barcode reader . Either by scanning the QR Code available
on the FibroScan examination report – In this case, each field completed in the report will be
copied into the corresponding field on the FibroScan interface. Or by scanning the barcode
on the patient label – In this case, only the Code field will be filled in. Barcode

Deletes the content of the fields.

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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.

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:

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Select M or XL examination type / Select S1 or S2

examination type.
/

Select Liver examination / Select Spleen

examination.
/

Start Liver examination / Start Spleen examination.

/

Spleen examination is only available with the EXPERT version.

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.

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.

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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

For a Liver examination, 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 "One-dimensional
ultrasound localisation" section, page 44, and 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.

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7.6.2. Acquisition screen for Liver examination

CAP value (dB/m) is only displayed for a liver examination, if this option is installed.

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7.6.3. Acquisition screen for Spleen examination (only available with

the EXPERT version)

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7.6.4. Patient data

Shows/Hides the patient data.

7.6.5. One-dimensional ultrasound localisation

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.

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These two modes serve to ensure that the probe is correctly positioned to perform a
measurement on a sufficiently thick portion of the organ to be measured, 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.

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 only functions on a liver examination, with the M+ and XL+ probes.

7.6.6. B-Mode ultrasound localisation

B-Mode ultrasound localisation is only available with the EXPERT variant.

For Liver examinations, when A and TM Modes do not allow for an area of the liver that
meets measurement criteria to be located, B-Mode, which shows a 2D image of the tissues
examined, can help the user to locate a measurement point suitable for stiffness and/or CAP
measurement.

For Spleen examinations, B-Mode, which shows a 2D image of the tissues examined, is
strongly recommended to help locate the spleen.

See warning in Chapter 2 on use of the B-Mode ultrasound localisation module.

Switches to the B-Mode ultrasound

localisation module.

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B-Mode ultrasound localisation module: A: Ultrasound signal shown in B-Mode. B:

Median axis. C: Adjustable gain.

As soon as the probe comes into contact with the patient’s skin, B-Mode displays a real-time,
B-Mode ultrasound signal of the area examined.

For Spleen examination, the median axis makes it possible to ensure that spleen thickness
is sufficient on the measurement line to ensure that the stiffness measurements are of the
correct quality.

Three presets are available according to the dimensions of the organ being screened and/or
depth of examination:
Standard: Central frequency = 3.0 MHz Focus = 70 mm Depth = 120 mm
Depth 1: Central frequency = 3.0 MHz Focus = 70 mm Depth = 150 mm
Depth 2: Central frequency = 2.0 MHz Focus = 70 mm Depth = 150 mm

To select the preset, click on the following button:

General gain can be used to adjust image brightness.

Once you have screened a measurement area suitable for stiffness measurement, use the
following button to capture the image:

Ultrasound image capture.

This tool must only be used as an aid to locate an area suitable for stiffness and/
or CAP measurement for the purpose of a FibroScan examination.

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Before performing a Spleen examination, users are strongly recommended

to use the B-Mode ultrasound localisation module to ensure that the spleen
is sufficiently thick at the measurement point to provide a stiffness
measurement of the correct quality.

Go back to FibroScan examination.

You can go back to the FibroScan examination by placing the FibroScan probe transducer
directly onto the patient’s skin. Doing so automatically disables the B-Mode ultrasound
localisation probe.

7.6.7. 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.

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7.6.8. Elastogram

This image is displayed once the measurement is complete. It represents the levels of liver/
spleen 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 into the tissues with time.

7.6.9. 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.

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7.6.10. Stiffness results area

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 or spleen stiffness measurement, at least 10 valid measurements must
be performed.

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
only displayed for Liver examinations, and is recalculated after each new valid measurement.

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7.6.11. 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.

7.6.12. CAP result zone (option)

Note: The CAP value is displayed only if the option is installed.

Refer to the warning in Chapter 2 concerning interpretation of the result.

first generation CAP

The CAP is only displayed on a liver examination, with the M+ and XL+ probes.

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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 on a Liver examination, 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.

7.6.13. Measurements displayed as image carrousel.

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7.6.14. Displays measurements as vignettes

7.6.15. Displaying the B-Mode ultrasound localisation screenshot

7.6.16. Deleting measurements

Some or all of the measurements in the current examination may be cancelled at any time
during the examination.

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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.

7.6.17. 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 touch panel.

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.

The entered information will appear on the examination report.

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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 ,

7.6.18. Alert display area

If the symbol is displayed, click on it to view the following messages:

Calibrate the probe.

Electromagnetic disturbances.

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7.6.19. Message area

The following messages can be displayed above the elastogram.

Connect the probe.

Overheat.

Repeat measurement.

7.6.20. 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'.

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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.

For Spleen examinations, only the M examination is available.

Automatic probe recommendation (Liver examination only)

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 only functions for Liver examinations, with the M+ and XL+ probes.

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.

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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.

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7.6.21. View and print the result of the examination

Press the button to end the examination.

The result of the examination is displayed.

Description of contextual buttons displayed on-screen:

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.

Description of keypad buttons:

Blocks/Unblocks session.

Adjusts beep volume.

Adjusts keypad button sensitivity.

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Adjusts beep volume.

Locks the keypad.

Starts/stops the examination.

Selects the type of FibroScan examination / Selects the preset

for the B-Mode ultrasound localisation module – EXPERT
variant only.

Switches between FibroScan examination / B-Mode ultrasound

localisation – EXPERT variant only.

Launches FibroScan measurement / Captures B-Mode

ultrasound image – EXPERT variant only.

Selects the type of FibroScan examination – PRIME variant

only.

Launches FibroScan measurement – PRIME variant only.

Deletes measurements – PRIME variant only.

Selection of the display type.

Add a comment.

7.7. MANAGEMENT OF PATIENT FILE ARCHIVES

To display the patient file archives, press the button in the home screen.

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Using the keypad to select files: [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.

Displays the last / first page of archives.

Refines the advanced file search.

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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.

Description of contextual buttons:

Back to the Archives screen.

Deletes the examination.

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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.

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8. SWITCHING OFF THE DEVICE

8.1. BETWEEN SESSIONS

Put the device in standby mode by pressing the standby button at the bottom left-hand corner
of the touch screen, or the standby button on the interface if no user is connected.

8.2. AT THE END OF THE DAY

Always put the machine in standby mode by applying the following sequence:
1. Put the device in standby mode by pressing the standby button at the bottom left-hand
corner of the touch screen, or the standby button on the interface if no user is
connected.
2. Cut the power supply by setting the main switch to 0.

Refer to the warning in Chapter 2 concerning switching off the device.

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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 warnings 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.

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Do not use paper towels or abrasive products for cleaning, as they may scratch the surface
of the screen.

9.1.2. Disinfecting the FibroScan 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
representative: https://support.echosens.com.

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.

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9.1.3. Recommended cleaning products for use on the FibroScan

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

9.1.4. Recommended disinfection products

The list of disinfection agents recommended for FibroScan (VCTE) probes and B-Mode
ultrasound localisation probes can be found here: 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:
https://support.echosens.com.

9.1.5. Cleaning and disinfectant products that are prohibited for use
on the FibroScan probe
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

9.1.6. Disinfection of the B-Mode ultrasound localisation probe

(housing, cable and transducer)

Do not submerge transducers above the probe strain relief.

Refer to the warnings in Chapter 2 concerning cleaning.

Chemicals that damage the transducer

Some of these chemicals (phenol, benzethonium chloride, hexachlorophene, benzoyl
peroxide, hydrogen peroxide) are routinely used in hospitals or clinics; others are found in
anti-bacterial skin sanitiser products. Using these chemicals can damage the transducer.

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Recommended procedures for probe maintenance

Inspect the probe cable, connector and transducer surface. The probe connector contacts
must not be kinked. The probe transducer surface must be clean and free from any residues
or bubbles. Check that there are no cracks through which liquid could penetrate the probe
(pay particular attention to cable/connector and cable/probe joints). Do not use the probe if
you find any cracks; it must be replaced.

Take care to prevent any solution from entering the probe connector. Protect the connector
with a plastic bag to prevent it from coming into contact with liquids.

Use an EPA-registered germicide suitable for plastic medical devices (2 % solutions of

surfactant-free glutaraldehyde are recommended). Follow germicide manufacturer
instructions on its concentration, time in contact with the device, storage and disposal.

Do not use alcohol or alcohol-based solutions. After wiping the germicide off the probe, rinse
it thoroughly with sterile distilled water to remove any possible residues. Do not use isopropyl
alcohol to wipe the strain relief, the joint between the probe cable and housing, or the cable.
Isopropyl alcohol can damage these components of the transducer.

Transducer general cleaning instructions

The following procedures must be used when cleaning the transducer and cable:
1. At the end of an examination, wipe any residues of ultrasound gel off the transducer.
2. Wipe the transducer and cable down with a damp or dry soft cloth.
3. Wipe the transducer down with a recommended disinfectant.
4. The cable can also be wiped down with a recommended disinfectant. Do not use
isopropyl alcohol on the cable and strain relief joint with the probe housing.

9.2. CALIBRATING THE FIBROSCAN 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.

The B-Mode ultrasound localisation probe does not require regular calibration.

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.

9.3. TROUBLESHOOTING

Events Solutions

The probe is no longer Contact Echosens or its local representative:

calibrated. https://support.echosens.com

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Events Solutions

The start-up/standby button is Check that the instrument is connected to a correctly powered
inoperative. When pressed, AC supply socket (test another electrical device on this same
the instrument will not turn on. socket) and that the main switch is in the I position.
Have the main switch's fuses checked by the maintenance
department.

The start-up/standby button is Put device into standby and then reboot.
on, but the software is not
booting.

In the event of a failure or malfunction, please contact Echosens or its local representative:
https://support.echosens.com.

9.4. 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
representative: https://support.echosens.com.

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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.

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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.

For a FibroScan Administrator

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.

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[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.

For a FibroScan Administrator

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.

For a FibroScan Administrator

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.

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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.

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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.

For a FibroScan Administrator

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.

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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 (CPU, 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

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application closing period may range from 5 to 55 minutes..

Barcode

Barcode reader activation Enables and resets the barcode reader.

For a FibroScan Administrator

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.

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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.

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11. SYMBOLS ON THE DEVICE

Ethernet connector RJ45

USB connector

Elastography probe connection

Connection 5 V

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

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CE marking and notified body identification number

Obtained in September 2019

Medical Device

NRTL cBVus mark

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.

Alternating current

Applied part type B

Start-up/standby button.

Class 1 laser device

IEC 60825-1 Ed. 3

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Device incompatible with magnetic resonance (MR).

Caution, this symbol does not appear on devices manufactured

before 2020.

11.1. SYMBOLS ON THE B-MODE ULTRASOUND LOCALISATION

PROBE AND HOUSING

Applied part type BF

Manufacturing date

Disposal of the B-Mode ultrasound localisation probe

To reduce the risk of pollution by electrical and electronic waste, and
within the framework of European Directive 2011/65/EC, the B-Mode
ultrasound localisation probe must not be discarded with ordinary
household waste. Contact the local electrical and electronic waste
processing service for instructions.

CE marking and notified body identification number

It is essential to refer to the User Manual to ensure operator and

patient safety.

11.2. NOTE
The serial number and Data Matrix marked on the device identify the FibroScan uniquely.

The Serial Number and Data Matrix shown on the B-Mode ultrasound localisation probe are
the unique identifiers of this probe.

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12. TECHNICAL CHARACTERISTICS

12.1. CHARACTERISTICS OF THE DEVICE

Model FIBROSCAN 630

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 A

according to CISPR 11

IP Code IP20: 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 (Liver) Min: 1.5 kPa

Max.: 75 kPa

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Stiffness E* (kPa)

S+ (S1 S+ (S2 M+ XL+

examination) examination)

E Trial Bias** Preci- Bias** Preci- Bias** Preci- Bias** Preci-

(kPa) number (in %) sion** (in %) sion** (in %) sion** (in %) sion**
(in %) (in %) (in %) (in %)

Zone 1 1 − 37 2 − 38 3 − 22 2 − 22 2
3.0 2 − 37 1 − 33 0 − 35 2 − 29 3

Zone 2 1 − 31 2 − 32 2 − 32 1 − 32 1
10.0 2 − 30 2 − 32 2 − 31 1 − 30 1

Zone 3 1 − 30 1 − 28 1 − 29 1 − 29 1
16.9 2 − 29 2 − 27 3 − 26 1 − 29 1

Zone 4 1 − 19 1 − 12 1 − 15 3 − 15 3
25.0 2 − 17 1 − 10 2 − 20 1 − 21 3

* Values obtained with CIRS phantoms E-1930-1, 12-807/E703-4, E-1930-2, 6220-1-3-2

** As defined by ISO 5725-1 1994

Stiffness (Spleen) Min. 6 kPa

Max. 100 kPa

Stiffness E* (kPa)

M+

E (kPa) Trial Bias** Precision**

number (in %) (in %)

Zone 1 1 − 41 1
9.6 2 − 40 1

Zone 2 1 − 43 1
14.6 2 − 44 0

Zone 3 1 − 39 1
21.7 2 − 38 0

Zone 4 1 − 31 1
50.9 2 − 31 1

* Values obtained with CIRS phantoms 6220-1-9, 6220-1-10, 6220-1-11, 6220-1-12

** 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

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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 %)

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 90-170 V·A

12.1.4. Mechanical characteristics

Dimensions 642mm x 584mm x 1365mm (length x width x height)

Weight 46 kg (with accessories)

12.1.5. Environmental characteristics

Operating temperature + 10 °C to + 40 °C (+ 50 °F to + 104 °F)

Operating humidity 35 % to 75 % relative humidity, not condensed.

Maximum operating 3000 m

altitude

Operating atmospheric 700 hPa to 1060 hPa

pressure

Storage and − 10 °C to + 50 °C (14 °F to + 122 °F)

transportation
temperature

Storage and 35 % to 85 % relative humidity, not condensed

transportation humidity

Maximum altitude for 5000 m

storage and
transportation

Storage and 700 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

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12.2. CHARACTERISTICS OF THE AC/DC POWER SUPPLY

Model XP Power (ref. CHD250PS12-A)

12.2.1. Electrical characteristics

Power supply 115-230 V ~ 2.4/1.3 A 50/60 Hz

Output signal 12 V 20.8 A

Output power 250 W

12.3. B-MODE ULTRASOUND LOCALISATION PROBE

CHARACTERISTICS

Model ES-C5-2R60S-3

Type of part applied BF

Connector model EX10E-280P HRS

IP Code IPX7

Mechanical Index MI < 1.0 for all operating modes.

Thermal Index TI < 1.0 for all operating modes.

Central frequency of 3.5 MHz

the probe

System frequencies 3.0 MHz (Standard and Depth1 presets)

2.0 MHz (Depth2 preset)

Radius of Curvature 60 mm

Field of View 64°

12.3.1. Mechanical characteristics

Probe dimensions 145.5mm x 77.0mm x 27.6mm (length x width x height)

Connector dimensions 71.0mm x 85.5mm x 19.1mm (length x width x height)

Weight 300 grams

12.4. QR CODE READER CHARACTERISTICS

Model Datalogic DSE0421-R-K

Laser device class Class 1: Safe-use laser devices, including when looking directly at the beam for
(IEC 60825-1 Ed. 3) prolonged periods, even when exposure takes place during use of telescopic optical
devices. Looking at laser beams produced by Class 1 laser devices that emit visible
radiant energy may cause visual dazzling, particularly in low lighting conditions.

12.5. CONTROL PEDAL CHARACTERISTICS

Model Linemaster GEM SWNO

IP Code IP68

Mechanical Index MI < 1.0 for all operating modes.

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12.5.1. Mechanical characteristics

Dimensions 97 mm x 33 mm (Diameter x height)

Weight 450 grams

Power cable length <3m

12.6. CONSUMABLES
Not applicable.

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13. 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
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

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.

The FibroScan 630 is designed for use in the electromagnetic environment defined in the
following chapter. The customer or the user of the FibroScan 630 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 630 complies with standard IEC 60601-1-2:2014.

13.1. CLASSIFICATION

Compliance Electromagnetic environment

Group 1 The FibroScan 630 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 A The FibroScan 630 may be used on all premises other than domestic premises
and those directly connected to the public low voltage energy grid used to supply
domestic buildings.

NOTE: The emissions characteristics of this device permit its use in industrial zones and
hospital environments (Class A as defined in CISPR 11). When used in residential
environments (for which Class B as defined in CISPR 11 is normally required), this device
may interfere with radio frequency communications services. The user may need to take

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corrective action, such as reinstalling or reorienting the device.

13.2. IMMUNITY
The FibroScan device 630 is intended for use in professional 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 3 V/m from 80 MHz to 2.7 GHz

wireless networks 80% in 1 kHz amplitude modulation
IEC 61000-4-3

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 RF 3 V from 150 kHz to 80 MHz

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 and 0 % UT 1, over 0.5 cycles for 0°, 45°, 90°, 135°, 180°,
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 630, a
message is displayed (see the Message Area chapter) and no measurements can be carried
out.

13.3. EMISSIONS
The FibroScan device 630 is intended for use in professional healthcare environments.

Test Emission limits

Conducted emissions 79 dB μV quasi-peak

from 150 kHz to 500 kHz

1. U : Mains power voltage measured prior to execution of test

T

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Test Emission limits

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 630, 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

propagation is affected by absorption and reflection caused by structures, objects and
individuals.

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14. INDEX

AC/DC power supply Options 73, 74 Examination type 55

Characteristics 83 Print 70 Measurement vignette 52
Archive 36, 59, 61, 61, 71 QR Code 69 Measurements carrousel 51
Advanced search 59 Save condition 74 Options 73, 73, 74
Delete 59 Software protection 76, 76 Print 58, 62
Export 59 Software update 75 Programmed stop 40
Archives 61 User accounts 71, 71 RAW Data 36
Clinical Research 61 Connection RAW Mode 40
Ethernet 28 Results display 59
B-Mode localisation
Probe characteristics 83 Network 28 Save condition 74
Connectivity 72 Start using keypad 59
B-Mode probe 30
DICOM 37, 39, 72 Taking a measurement 59, 59
Disinfection 66
Directory sharing 72 Uncalibrated probe 41
Lead 30
Measurement button 30 FibroScan identifiers 37 Examination file
FibroView 37, 39, 73 QR Code 69
B-Mode ultrasound
localisation 45 File share 37 Examination procedure 32
Image capture 59, 59 Status 37 Selection of the examination
TeamViewer 75 type 32
Keypad 59, 59
Presets 46 USB 37 Examination type 55
Selection of the preset 59, 59 Contraindications 19 Export
Control pedal Anonymisation 71
Barcode reader
Configuration 75 Characteristics 83 Automatic export 71
Connection 28 DICOM 73
Calibrating the probe 67
Operation 29 DICOM format 58, 62
Message 54
Copyright 8 DICOM log 74
Calibration
Examination file 58, 62, 71
Status 37 Date and time 37, 69
Examination report 58, 62, 71
Cancel measurement 52 Disinfection
Excel 61
CAP 19, 36, 50 B-Mode probe 66
FIBX format 58, 62
Activation 73 Probe 65
Gateway 73
CAP-LEVEL 50 Electromagnetic compatibility
PDF format 58, 62
Interquartile range 51 85
Retry 62
second generation 20 Classification 85
Shared directory 58, 62
Standard Deviation 51 Emissions 86
USB storage device 58, 62
Immunity 86
CAPc 36
FibroScan probe 29
Clinical Research Mode 36, Electromagnetic disturbance
Indicator lights 29
40 Message 54
Lead 29
Clinical Research EMI 85
FibroScan Probe
Activation 73 Essential performance
Measurement button 29
Configuration 74 characteristics 13
Examination 36 Force indicator 47
Configuration 69
Acquisition screen 40 Gateway
Automatic logout 35, 75
Add a comment 59 Additional fields 40, 73
Barcode reader 75
Additional fields 40 Examination 40
Calibration 74
Archive 71 Worklist 73
CAP 73
Clinical Research 73, 74 B-Mode 52 Guarantee 13
Date and time 69 Blockage in the event of a probe Home 58
being uncalibrated 41 Status bar 36
DICOM 73
Change of probe 57 Indications
Examination 73, 73
Clinical Research Mode 36, 40 Configuration 73
Indications 73
Comments 53
Maintenance 75
Configuration 73
Measurement conditions 74
Delete 59, 61, 71
Network 72
Details of examination 59

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Intended environment 19 Worklist 72, 73 Standby 63

Intended use 15 Power cable 82 Button 24
Intended users 19 Power indicator 24 Stiffness 19, 49, 49
Interquartile range 49, 49 Precautions for use 18 Elastogram 48
CAP 51 Examination type 18 Measurement 47
IQR 49, 51 Principle of use 19 Switch on
IQR/Median 49 Print 58, 62, 70 Button 24
Keypad Probe 35 Switching off the device 63
B-Mode ultrasound localisation Calibration 67 System 74
59, 59 Calibration 41, 67 Available disk space 37, 74
Locked 59 Change 57 Identifiers 74
Selection of the examination Disinfection 65 Target population 18
type 59, 59 Troubleshooting 67 Technical characteristics of
Sensitivity 58
Probes the device 80
Session blocked 58 Electrical characteristics 82
Calibration status 37
Start examination 59 Environmental characteristics
Product life 13
Volume 58, 59 82
Property 8
Liability 13 Mechanical characteristics 82
QR code reader
Liver localisation 46 Characteristics 83 Tips 37
Log files 74 Troubleshooting
RAW Mode 40
Export 74 Probe 67
Region
Login 35, 37 Software 68
Language 69
Automatic logout 35 Start-up 68
Registered trademarks 14
Password 35 TeamViewer 75
Regulations 85
Maintenance 75 Ultrasound localisation
Removing power 63 B-Mode 45
Measurement conditions
Configuration 53, 74
Result TM and A Modes 44
CAP 50
Measurement Ultrasound signals
Examination report 70
Cancel 52 A-Mode 44
Interquartile range 49, 51
Elastogram 52 Signal quality indicator 45
IQR/Med 49
Reset 52 TM Mode 44
Standard Deviation 51
Network 28 USB 37
Stiffness 49
Network parameters Use
Reverse engineering 13
Gateway 72 Contraindications 19
Safety Indications 15
Host name 72, 72
Electrical safety 20
IP address 72 Intended environment 19
Maintenance 21
Sub-network mask 72 Intended users 19
Selection of the examination Precautions 18
Patents 14
type 32 Principle of use 19
Patient leakage current tests Keypad 59, 59
Precautions 68 Target population 18
Recommendations 18
VCTE technique 19
Patient SmartDepth 36
Barcode reader 38 User Accounts 69
SmartExam 37
DICOM import 72 User accounts 71
Software protection 76, 76 Password 71
FibroView 73
Gateway 73
Software update 75 Resetting 71
Patient data display 44 Spleen localisation 46 User training 20
Patient data security 75 Standard Deviation STD 51 VCTE technique 19
Patient display 75 Standard Deviation
Record 38 CAP 51

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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