FibroSca “EA

FibroScan” 502 TOUCH

User Manual
CE
0459
E300M017.4 — Version 4 — 03/2017
(software version C 3.1)
ETS FIBROSCAN 502 TOUCH USER MANUAL FibroScan

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FibroScan FIBROSCAN 502 TOUCH USER MANUAL BET

TABLE OF CONTENTS

1. PURPOSE OF THE USER MANUAL........ ner e onen 6

11 . Symbols used in the Manual ee 7
12 . Property and copyright...
GR RRR 7

2. ΜΙΑΒΝΙΝΟΒ. ΟΗΕ εν A σώος 8

2.1 ; GerisralıInformalleiN siii με με VAE 8
2:2; [τι ο Ες anaya NEA 8
2.3. Electromagnetic safety .
2.4. Using the device.
2.5. Deleting measurements.
2.6. Switching off the device
2.7. Cleaning and maintenance...
nenene nenn 9
2.8 . Cleaning
2.9 . Interpreting the results

3. MISCELLANEOUS INFORMATION oe 11
3.1 . Guarantee
3.2 . Liability...
33 . Essential performance characteristics... 11
34 . Product life...
sens
3.5 . Reverse engineering
3.6 . Registered trademark:
37 . Patented technology..

4. INDICATIONS AND PRECAUTIONS FOR USE

4.1. Intended use.
4.2. Indications for use
4.3. Probeandexaminationselectioncriteria....................................... 16
4.4. Precautions for use... 17
4.5. User training ....
4.6. Electrical safety .
4.7. Maintenance-related safely sussa SALES 18

5. EXTERNAL PRESENTATION
5.1 . Hardware supplied
5.2 . ACCessories лилии иная
5.3 . Front view
5.4 . Rear view
5.5 . Description of probes.

6. SOFTWARE INTERFACE...........................rcrrrrcereeeeieire
ricer rece AEG REDDE 26

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ETS FIBROSCAN 502 TOUCH USER MANUAL FibroScan

6.1. Home:SCresn İŞ YY 26
6.2. Usingthekeypad........................................... erene 27
6.3. Login Window... sise 27
6.4. Status bar
6.5. The patient record screen
6.6. Acquisition screen
6.6.1. Patient data
6.6.2. Ultrasound images...
6.6.3. Pressure indicator
6.6.4. Shear wave propagation map
6.6.5. Counters: Valid and invalid measurements ......................
n 35
6.6.6. Shear wave speed results area
6.6.7. Stiffness results area
6.6.8. CAP result zone (option)
6.6.9. Deleting measurementS nenene
6:6.10-Adding'a GomMmMEN tisser
6.6.11.Integrate the measurement conditions
6.6.12. Message area...
6.6.13. Examination type selection area.
6.6.14.View and print theresultoftheexamination............................................. 43
6.7. Management of patient file archives..
6.7.1. Advanced file search
6.7.2. Selectand view a patient file
6.7.3. Details'of the examination... ο ο P ARE RnR nen Er

7. STANDBY AND SHUTTING DOWN THE DEVICE.

τα, Between sessions τε

Tdi At the end of the day sisi ob eee 47

8. CLEANING, MAINTENANCE AND REPAIRS

8.1. Cleaning
8.1.1. Cleaning the device (painted, metallic, glass, or plastic surfaces and
screen)
8.1.2. Cleaning the probe (housing, cable and transducer)
8.1.3. Recommended cleaning products ce
8.1.4. Recommended decontamination solutions.................................................
8.2. Calibrating the probe ..
8.3. Troubleshooting

9. CONFIGURING THE FIBROSCAN ie 52

9.1. Entering configuration mode
9.2. Localization Tab
9.3. Institution tab ....
9.4. Printer tab… せ em
9.5. Data Tab
9.6. User Tab
9.7. Connectivity Tal
9.8. [ЕЕ ος ο ο ο ο ο ener 55
9.9. System 4аБ........ ο ο ο ο ο 55

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FibroScan FIBROSCAN 502 TOUCH USER MANUAL ETE]

E IMM rr SA 55
GOD LOGS usas ar ara σος 56
A ο ο ο σος ο v ire eS 56
A ο ο ο ο ο 57

10. syMBoLs oNTHEDEVICE neon eee 에나 58

10.1. Connectors ss 사 아 아아아 58
10.2. Warnings
10.3. Marking and electrical safety

11. TECHNICAL CHARACTERISTICS

11.1. Characteristics of the device ..
11.1.1. Computer characteristics .
11.1.2. Metrological performance
11.1.3. Electrical characteristics iii ent
11.1.4. Mechanical characteristics
11.1.5. Environmental characteristics
11.1.6. Additional information
προο ο ο ο ο ο τον ο ο 가 64

12. REGULATIONS rra 65

12.1. Electromagnetic emissions
12.2. Electromagnetic immunity (1)
12.3. Electromagnetic immunity (2)
12.4. Recommended separation distances

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ETS FIBROSCAN 502 TOUCH USER MANUAL FibroScan

1. PURPOSE OF THE USER MANUAL

This User Manual has no contractual value whatsoever and under no circumstances may
Echosens be held responsible on the basis of the information contained in this Manual.

This User Manual details, on the one hand, all of the information required for the
implementation, use and maintenance of the FibroScan device and, on the other hand, the
list of information displayed.
Thus, after carefully reading the manual, operators will be able to:
= connect peripheral elements (power cable, USB devices, probes) and power up the
FibroScan device,

m configure the device,

в navigate the device's user interface,

m perform basic maintenance.

Echosens publishes this manual "as is", without guarantees of any nature, whether explicit or
implicit, including, but not limited to implicit guarantees or merchant conditions, or adaptation
for specific use in view of providing simple and accurate information. Consequently,
Echosens SA cannot accept any responsibility for any incorrect interpretation of the Manual.
Although all efforts have been made to offer a manual that is as accurate as possible, this
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 type. In the event of damages arising from a defect
(imperfection) or error contained in this User Manual, Echosens undertakes to send the
physician, as rapidly as possible, a hard copy or electronic document containing all
corrections made to this manual.

This manual is updated on a regular basis. The most recent version of this manual is available
from Echosens on 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 this manual for as long as the product is used.

This manual contains a chapter for troubleshooting the most commonly encountered
problems.
Any information or modification requests pertaining to this manual should be sent to:
Echosens, 30 place d'ltalie, 75013 Paris, France.

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FibroScan FIBROSCAN 502 TOUCH USER MANUAL EET

1.1. SYMBOLS USED IN THE MANUAL

个 This symbol means: CAUTION

Warning: See the instructions before using the medical device.
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 device 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 this manual without prior written consent is
prohibited, within the limits provided by copyright law.
Copyright © — 09/2015 — 03/2017 — Echosens — All rights reserved.

E300M017.4 03/2017 - ECHOSENSTM AND FIBROSCAN® ARE TRADEMARKS © COPYRIGHT ECHOSENS - ALL RIGHTS RESERVED
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FibroScan FIBROSCAN 502 TOUCH USER MANUAL TRUE]

A The FibroScan 502 TOUCH device requires special precautions to be taken

concerning electromagnetic compatibility (EMC). It must be installed and set up
according to the EMC information given in this manual.

2.4. USING THE DEVICE

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

To avoid tipping the FibroScan when moving it, move it slowly sideways and steer
it firmly by holding the decorative rods on the front and back of the device.
To avoid tipping the FibroScan when lowering it down a step, the operator must go
in front of the device and guide it on the way down.

2.5. DELETING MEASUREMENTS

All measurements taken before the one chosen for deletion will be eliminated from
the examination after confirmation.

2.6. SWITCHING OFF THE DEVICE

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

2.7. CLEANING AND MAINTENANCE

These maintenance operations must not be performed by a third party other than
a technician authorized by Echosens.

The opening or modification of the device by any person other than an authorized
Echosens technician is strictly prohibited.

No CD ROMs or DVD ROMs other than those provided by Echosens should be

inserted into the drive.

The probe must be calibrated periodically. Beyond this period, the manufacturer
no longer guarantees the performance characteristics of the probe.

2.8. CLEANING

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

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EE FIBROSCAN 502 TOUCH USER MANUAL FibroScan

2.9. INTERPRETING THE RESULT:

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

is aware of the patient's pathology and clinical context.

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FibroScan FIBROSCAN 502 TOUCH USER MANUAL [ETUE

3. MISCELLANEOUS INFORMATION

3.1. GUARANTEE
The terms of guarantee are stated in the Echosens terms of sale documents.
For any requests, Echosens is at the disposal of the physician and their assistants and shall,
if necessary, pass the aforementioned request 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, could 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 device's hard disk. The user is responsible
for saving the data on a regular basis. Echosens cannot under any circumstances be held
liable for the partial or total loss of FibroScan data.

3.3. ESSENTIAL PERFORMANCE CHARACTERISTICS

The essential performance of the FibroScan device is the medically-usable measurement
of liver stiffness. The measurement is taken at 50 Hz shear wave frequency. When the
optimum conditions, particularly relating to electromagnetic disturbance, cannot be obtained,
the FibroScan device does not display any measurements, but displays a warning message
to notify the user that measurements are not possible.

When a stiffness or CAP (Controlled Attenuation Parameter) value is displayed by FibroScan,

this value is correct within the range of error specified by Echosens.

Free from the production of unintended or excessive transducer assembly surface

temperature.

3.4. PRODUCT LIFE

Echosens guarantees the specifications 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.

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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, analyzed, 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.

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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FibroScan FIBROSCAN 502 TOUCH USER MANUAL ΓΠΕΤΕ]

4. INDICATIONS AND PRECAUTIONS FOR USE

4.1. INTENDED USE

The FibroScan and its probes form an active, non-implantable medical device using
ultrasound. This device is designed to be used in a physician's office.
The FibroScan system is designed to provide 50 Hz shear wave speed measurements and
estimates of tissue stiffness as well as a 3.5 MHz ultrasound coefficient for the Attenuation
Parameter (CAP: Controlled Attenuation Parameter) in internal structures of the body.

The FibroScan device is based on Vibration-Controlled Transient Elastography (VCTE M).

The FibroScan probe comprises a single-element ultrasound transducer mounted on the
shaft of the electrodynamic transducer. This transducer generates a transient vibration,
which in turn generates an elastic shear wave. This wave propagates through the skin, the
subcutaneous tissues, and then the liver. During shear wave propagation, the ultrasound
transducer performs a series of ultrasound acquisitions (emission/reception) to measure the
speed of shear wave propagation (Vs) in m/s. This measurement corresponds to the spatial
and temporal average speed of propagation of the shear wave through the liver region of
interest, which can be approximated by a cylinder with a diameter of 1 cm and a length of
4 cm (corresponding to approx. 3 cm’).
Additionally, assuming that the liver is a pure elastic, linear and isotropic medium, the
device converts shear wave speed Vs into equivalent stiffness E in kPa using the equation
E = 3 xp x Vs? with p the medium density assumed to be 1000 kg/m*. The values for shear
wave speed and equivalent stiffness (or Young’s modulus) are relative indexes intended only
for the purpose of comparison with other measurements performed using FibroScan devices.

Concomitantly, the ultrasound acquisitions are used to assess the Controlled Attenuation
Parameter (CAP). Ultrasound attenuation corresponds to the loss of energy as ultrasound
propagates through the medium. Due to attenuation, the intensity of emitted ultrasound (lo)
decreases exponentially with depth (z): Iz = lo x exp (- a(f) x z) where Iz is the ultrasound
intensity at depth z and a is the frequency- (f) dependent attenuation coefficient. Ultrasound
attenuation depends principally on (i) the ultrasound frequency, and (ii) the properties of the
medium of propagation. CAP assesses the value of a at the frequency f = 3.5 MHz and is
expressed in dB/m.

Absolute values for these measurements may vary between measurement devices produced
by different manufacturers.

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[ETS FIBROSCAN 502 TOUCH USER MANUAL FibroScan

4.2. INDICATIONS FOR USE

The FibroScan is indicated for non-invasive measurement in the liver of 50 Hz shear wave
speed and estimates of stiffness as well as determining a 3.5 MHz ultrasound coefficient
for the Attenuation Parameter (CAP: Controlled Attenuation Parameter). The shear wave
speed, stiffness, and CAP may be used as an aid in the clinical management of adult patients
with liver disease. Shear wave speed and stiffness may be used as an aid in the clinical
management of pediatric patients with liver disease.

How to use a probe: A: Ultrasound transducer. B: Electrodynamic transducer. C: Liver.

The values obtained must be interpreted by a physician experienced in dealing with liver
disease, taking into account the complete medical record of the patient and the potential
presence of different factors known to influence liver shear wave speed or equivalent stiffness
and CAP. Based on the existing literature, the following table 1 provides a list of parameters
known to increase liver shear wave speed and stiffness.

Table 1: Parameters related to shear wave speed and stiffness.

Parameter Reference
Liver fibrosis, cirrhosis [1-9]

Acute hepatitis, inflammation, ALT flares | [10-13]

Portal pressure, central venous pressure | [14-16]
Extra-hepatic cholestasis [17]
Congestion (heart failure) [18]
Meal intake [19]
Amyloidosis [20-22]

For shear wave speed measurement, the intra- and inter-operator agreement has been
assessed in a cohort of 200 adult patients with chronic liver disease of various etiologies [23].
The intra-class correlation coefficient was 0.98 both within and between operators. Moreover,
in a cohort of 31 NASH children, a 0.96 inter-operator intra-class correlation coefficient
was found [24]. This demonstrates that intra-operator reproducibility is excellent for shear
wave speed and stiffness measurements, and that changing the operator does not increase
measurement variability in either adults or children.

[1] Friedrich-Rust, M., et al., Performance of transient elastography for the staging of liver
fibrosis: a meta-analysis. Gastroenterology, 2008. 134(4): p. 960-74.

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FibroScan FIBROSCAN 502 TOUCH USER MANUAL [RUE]

[2] Musso, G., et al., Meta-analysis: Natural history of non-alcoholic fatty liver disease
(NAFLD) and diagnostic accuracy of non-invasive tests for liver disease severity. Annals of
Medicine, 2011. 43(8): p. 617-49.

[3] Shaheen, et al., FibroTest and FibroScan for the Prediction of Hepatitis C-Related
Fibrosis: A Systematic Review of Diagnostic Test Accuracy. American Journal of
Gastroenterology, 2007: p. 1-12.

[4] Shi, K.Q., et al., Transient elastography: a meta-analysis of diagnostic accuracy in

evaluation of portal hypertension in chronic liver disease. Liver Int, 2013. 33(1): p. 62-71.

[5] Smith, J.O. and R.K. Sterling, Systematic review: Non-invasive methods of fibrosis
analysis in chronic hepatitis C. Alimentary Pharmacology and Therapeutics, 2009. 30(6): p.
557-76. [6] Stebbing, J., et al., A Meta-analysis of Transient Elastography for the Detection of
Hepatic Fibrosis. Journal of Clinical Gastroenterology, 2010. 44(3): p. 214-9.

[7] Talwalkar, J.A., et al., Ultrasound-based transient elastography for the detection of hepatic
fibrosis: systematic review and meta-analysis. Clinical Gastroenterology and Hepatology
2007. 5(10): p. 1214-20.
[8] 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.
[9] Lee, C.K., et al, Serum Biomarkers and Transient Elastography as Predictors of
Advanced Liver Fibrosis in a United States Cohort: The Boston Children's Hospital
Experience. The Journal of pediatrics, 2013. 163(4): p. 1058-64.

[10] Arena, U., et al., Acute viral hepatitis increases liver stiffness values measured by
transient elastography. Hepatology, 2008. 47(2): p. 380-4.

[11] 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.

[12] 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.

[13] 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.

[14] Carrión, 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.

[15] Millonig, G., et al., Liver stiffness is directly influenced by central venous pressure.
Journal of Hepatology, 2010. 52(2): p. 206-10.

[16] Vizzutti, F., et al., Liver stiffness measurement predicts severe portal hypertension in
patients with HCV-related cirrhosis. Hepatology, 2007. 45(5): p. 1290-7.

[17] Millonig, G., et al., Extrahepatic cholestasis increases liver stiffness (FibroScan)
irrespective of fibrosis. Hepatology, 2008. 28(5).

[18] Lebray, P., et al., Liver stiffness is an unreliable marker of liver fibrosis in patients with
cardiac insufficiency. Hepatology, 2008. 48(6): p. 2089.

[19] 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.

[20] Janssens, E., et al., Hepatic amyloidosis increases liver stiffness measured by transient
elastography. Acta Gastroenterologica Belgica, 2010. 73(1): p. 52-4.

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[21] Lanzi, A., et al., Liver AL amyloidosis as a possible cause of high liver stiffness values.
European Journal of Gastroenterology and Hepatology, 2010. 22(7): p. 895-7.

[22] Loustaud-Ratti, V.R., et al, Non-invasive detection of hepatic amyloidosis: FibroScan, a

new tool. Amyloid, 2011. 18(1): p. 19-24.

[23] Fraquelli, M., et al., Reproducibility of transient elastography in the evaluation of liver
fibrosis in patients with chronic liver disease. Gut, 2007. 56(7): p. 968-73.

[24] Nobili, V., et al., Accuracy and reproducibility of transient elastography for the diagnosis
of fibrosis in pediatric nonalcoholic steatohepatitis. Hepatology, 2008. 48(2): p. 442-8.

4.3. PROBE AND EXAMINATION SELECTION CRITERIA

The recommendations for choosing the probes are defined by the patient's morphological
data:

m TP: Thoracic Perimeter measured at the xiphoid using a tape measure.

= SCD: Skin-to-Capsule Distance assessed with an ultrasound scanner or by the

automatic probe selection tool.

When using ultrasound, SCD should be measured at the point where the shear wave speed
is measured with a pressure similar to the one used with the FibroScan probe.

In case of using the automatic probe selection tool, please refer to chapter 6.5.11.
Examination type selection area.

Compressing the soft tissues to reduce the SCD is not recommended.

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.

FibroScan® Probe Choice Algorithm

No YES
AGEz18 YEARS

Thoracic Skin Capsula

Perimeter (TP) Distance (SCD)
measurement measurement

[Cu
S1EXAM XLEXAM RECOMMENDED

In every case, Echosens recommends performing 10 valid FibroScan measurements.

Use of the S* probe is not approved for patients over 18 years old. Use of the M +
probe is not approved for patients under 14 years old. Use of the XL*probe is not
approved for patients under 18 years old.

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FibroScan FIBROSCAN 502 TOUCH USER MANUAL ERETE]

4.4. PRECAUTIONS FOR USE

The following instructions must be followed in order to ensure patient safety. The FibroScan
should not be used in the following situations:
On any organ other than the liver. The eyes and mucosa must absolutely be avoided.

On patients with active implants such as pacemakers, defibrillators, pumps, etc.

On wounds.

On pregnant women.

Moreover, the presence of ascites between the probe and the liver may prevent from
obtaining measurements with the device.

The clinical personnel must follow normal safety procedures.

The FibroScan examination should be performed carefully using the principle of

ALARA (As Low As Reasonably Achievable).

4.5. USER TRAINING

Only persons having received training in the use of the FibroScan and in possession of a user
certificate are authorized to conduct an examination using the FibroScan. 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.

4.6. ELECTRICAL SAFETY

The FibroScan is manufactured and tested in accordance with IEC electromagnetic
compatibility (EMC) and electrical safety standards. It leaves the plant in full compliance with
safety and performance requirements. In order to maintain this compliance and to guarantee
the safe use of this medical device, the user must comply with the indications and symbols
contained in this manual.

A Refer to the warnings in Chapter 2 concerning electrical safety.

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

The electrical power cable provided must be connected to the FibroScan mains connector
and to a grounded socket. Correct grounding can only be guaranteed if the FibroScan is
connected to a socket compliant with safety standards.

Safe use is no longer guaranteed in the following main, non-exhaustive cases:

the device is visibly damaged,

the device is inoperative,

after prolonged storage in unfavorable conditions,

after serious damage incurred during transport,

in the presence of flammable or anesthetic gases. This may cause an explosion. Do not
take the device to the operating room.

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EE FIBROSCAN 502 TOUCH USER MANUAL FibroScan

If the FibroScan can no longer be used safely, the device must be decommissioned. Steps
must be taken to prevent its inadvertent use. The medical device must only be inspected by
authorized technicians.

4.7. MAINTENANCE-RELATED SAFETY

For all maintenance operations, the physician and their appointees should contact Echosens,
who will send an authorized technician.

For correct and safe use and any maintenance operations, personnel must comply with
normal safety procedures.

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FibroScan FIBROSCAN 502 TOUCH USER MANUAL [GEIE]

5. EXTERNAL PRESENTATION

5.1. HARDWARE SUPPLIED

When opening the package, ensure the contents match the following list:
FibroScan device installed
Power cables according to country

Case(s) fitted with probe(s)

Sealed envelope (Windows EULA license and this user manual)

Software installation CD ROM

Set of four fuses, type 5x20 T2.0AH 250V

5.2. ACCESSORIES
The available accessories are:

= S* probe
u MY probe
= XL? probe

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

FibroScan

Devices not included: A: DVI-I screen. B: Overhead projector. C: USB storage device. D:
USB printer.

Accessories: E: S* probe. F: M* probe. G: XL* probe. H: Other accessories.

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EE FIBROSCAN 502 TOUCH USER MANUAL FibroScan

5.3. FRONT VIEW

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

The following figure presents the device's various user-accessible parts.

_ CT

General arrangement of the FibroScan device: A: Touch screen. B: Caster with brake.
C: Gel holder. D: Standby button with power indicator. E: CD ROM / DVD ROM drive. F:
Computer sockets. G: Probe holder.

Standby button

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

The button flashes when power is on.

Press this button once to load the application; the built-in indicator light turns green. After a
few seconds, the home window is displayed.

Press this button again to close the application; the built-in indicator light and monitor are
both turned off. This is the usual state when the FibroScan will not be in use for a short time
(between two groups of patients, for example). The FibroScan consumes very little power in
this mode.

The screen and the software

This is a 17- or 19-inch color LCD touch screen, depending on the model year.

To protect the screen from any risk of damage, make sure not to hang the power
cable on the top of the device.

The FibroScan runs on dedicated software.

The software is automatically launched when the FibroScan is switched on. It is used to:

m perform examinations,

и manage examinations in archives.

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FibroScan FIBROSCAN 502 TOUCH USER MANUAL [RUE]

Computer connectors
Two USB 2.0 sockets : To connect an external hard disk for backups, a USB key, or a USB
printer.

CD ROM — DVD ROM drive

This drive can be used to reinstall or update the software.

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

Casters and brakes

The two front 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 unlock the brakes before moving the device.

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

To avoid tipping the FibroScan when moving it, move it slowly sideways and steer it firmly by
holding the decorative rods on the front and back of the device.

To avoid tipping the FibroScan when lowering it down a step, the operator must go in front of
the device and guide it on the way down.

Xx, ”~ 门

Moving the device: A: Decorative rod.

5.4. REAR VIEW

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

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EE FIBROSCAN 502 TOUCH USER MANUAL FibroScan

Rear view: A: Computer sockets. B: Probe sockets. C: Power connector. D: Perforated

ventilation plates.

Power connector
The FibroScan must be connected to a 100V to 240V single phase AC 50-60 Hz grounded
power outlet via the power cable connected to the socket at the base of the chassis.

View of the main switch and connection outlet: A: Main switch. B: Location of the fuses.
C: Mains lead connection socket.

Main switch
This switch has two positions:

= Position O: 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).

m 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.

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FibroScan FIBROSCAN 502 TOUCH USER MANUAL ENEE]

Computer connectors

Location of computer connectors: A: Ethernet. B: 2 USB 2.0 ports. C: DVI-I output.

m Ethernet connector: also used for connectivity. Used by Echosens maintenance staff.

= Two USB 2.0 sockets : To connect an external hard disk for backups, a USB key, or a
USB printer.
= DVI-I output : This output is used to connect an additional monitor (e.g. an overhead
projector). The maximum distance between the FibroScan and the additional monitor is
of approximately 1.80 meters.

Probe connectors

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

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

四 The probe connectors are fragile.

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ES FIBROSCAN 502 TOUCH USER MANUAL FibroScan

5.5. DESCRIPTION OF PROBES

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

Probe: A: Electrodynamic actuator. B: Measurement button. C: Indicator light (LED). D:

Ultrasonic transducer. E: Probe lead.

The ultrasound transducer of the probe is a "Type B" applied part, and is the only component
of the FibroScan device in contact with the patient.

Measurement button
As soon as this button is pressed (if sufficient force is placed on the transducer), the
electrodynamic transducer generates a shear wave 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 pressure on
the patient's body.

= Lit up blue during an examination when the operator is applying the correct pressure to
the patient's body. It is however strongly recommended that you view the pressure
exerted by looking at the on-screen pressure indicator.

Lead
A B

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.

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

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FibroScan FIBROSCAN 502 TOUCH USER MANUAL BE)

The probe jack has a red dot that should be aligned with the red dot on the FibroScan socket
before insertion.

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

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EE FIBROSCAN 502 TOUCH USER MANUAL FibroScan

6. SOFTWARE INTERFACE

6.1. HOME SCREEN

The software loaded when the FibroScan device is started up is used to:

perform examinations,

print the results,

manage the archives,

export the data in several formats.

If the software is connected to the hospital network (optional):

import the list of patients,

export the results of the examination.

When the device is switched on, the home screen is displayed.

Description of the home menu

© Access to FibroScan configuration. See the Configuration section.

人 Access to the patient file archives..

> Access to the examination.

The following messages can be displayed in the home window:

No probe connected

Probe out of calibration (see the Probe Calibration section)

Return to the home screen by clicking the Home button: A

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FibroScan FIBROSCAN 502 TOUCH USER MANUAL BEETS)

6.2. USING THE KEYPAD

The keypad is displayed whenever an input is required.

Description of keypad:

Shift.

Display 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 :

6.3. LOGIN WINDOW

If secure session opening has been enabled, all the users are displayed. The login window
allows a secured access to the patient data in the device.

The enabling of secure session opening and the user accounts are configurable.
See the Configuration section.

User name/Password
The user name and password are defined when the device is installed. To change the
password, see the Configuration section.

Beyond a certain idle time, the current user is disconnected and the application returns to the
home window.
This duration is configurable (see Configuration/General)

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EX FIBROSCAN 502 TOUCH USER MANUAL FibroScan

6.4. STATUS BAR

When a user is logged in, a status bar located at the top of the home screen gives information
about the device. This includes:

ο 98 % Percentage of disk space available.

> O 2 Results of FibroScan examination waiting for

<= network transfer.

oa Options enabled: CAP, Clinical Mode,

Anonymization of automatic export to USB.

YA Profile type and user name of connected user.

© Pay per Use key input.

8/29/2016
Device date and time.
2:06 PM

Refer to the Configuration chapter to modify these parameters.

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 FIBROSCAN 502 TOUCH USER MANUAL BET

6.5. 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.

Patient data
Results: 6 會 )
Lastname

Firstname i
| | | | Date of birth 12/12/1953 Date of birth 6/26/1944
} | (code : REFS Male Code : REFS
Date of birth
|
| / U
Date of birth 3/21/1973
Code : REF2 Male

Indication | at
]
-M SI Date of birth 7/16/2003
Code : REF6 Female
Operator
Operator PUBLI

Reterring physician Date of birth 5/3/1921

| Code : REF3 Male

Te
Date of birth 12/1/1982
Exam options Code : REFI Female

1/1

Complete the fields. At least the ‘Name’ or ‘Code’ field must be filled in to start the
examination.

CAP ) Enables/disables the CAP option for the examination about to start.

) Enables/disables the saving of Raw Data for the examination about to

Så ES start (available only if Clinical Mode was enabled in the Configuration).

Saving Raw Data can slow the application down considerably. Enable it only for
clinical studies that explicitly require it.

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 MANUAL FibroScan

~
+2 \ Add the selected patient to the list of patients waiting for an examination.
[= An examination can be performed on this patient later.

Shows/hides the worklist

) Deletes the content of the fields.

會 Cancels the patient entry.

> Starts the examination.

After data input, if the probe is out of calibration, the following message appears:

m Probe calibration days overdue: n. Contact your local support team. -

Where n is the number of days.

Patient waiting list

The patient waiting list (Worklist) allows information on patients waiting for a FibroScan
examination to be retrieved on the hospital network. If the DICOM or FibroView options are
enabled, this information is entered just once and then sent automatically at every stage
relating to 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 CD in the Worklist
window.

o ~
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 taken, or if the patient file has been on the
worklist for more than three days.

~
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 Pee 一 = | en-US
~

m)
MEDIAN

Vs (m/s)
MEDIAN * IQR
] 3 8 0.02
u

The CAP value (dB/m) is displayed only if the option is installed.

Ex After five minutes of idle time during an acquisition, a message tells the user, who
i i 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.

m,

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ES FIBROSCAN 502 TOUCH USER MANUAL FibroScan
~

The acquisition window comprises the following elements:

6.6.1. Patient data

(© ) Shows/Hides the patient data.

6.6.2. Ultrasound images

TM and Amplitude Modes

= an,

Image 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. D: Display gain adjustment. E: Current CAP value.

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

PS

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 FIBROSCAN 502 TOUCH USER MANUAL [STEVE]

As soon as the probe makes contact with the skin, i.e. when a pressure change is detected,
the ultrasound transducer makes ultrasound acquisitions.

The system displays two ultrasound images used to locate a zone that satisfies the
measurement criteria:

m One in Time-Motion (TM) mode, two-dimensional grayscale image.

m The other in A mode (ultrasound signal amplitude).

The gain on the display of both modes can be adjusted using the cursor under the ultrasound
images.

These two modes serve to ensure that the probe is correctly positioned to perform a
measurement on a sufficiently thick portion of liver, visible throughout the explored depth.
They also allow the operator to ensure that the measurement will not be disrupted by the
presence of structures not of interest, such as blood vessels.

Liver targeting tool

A B
Liver targeting tool: A: Liver indicator history. B: Real-time liver indicator.

The user can use the liver targeting tool to position the probe at an appropriate point for
measuring the liver stiffness and/or CAP.

As soon as the probe is in contact with the patient's skin, the liver targeting tool characterizes
the quality of the ultrasound signals propagating in the liver using a color scale.

Color scale: Black: 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.

四 Liver targeting tool is available with the M* and XL* probes only.

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EE FIBROSCAN 502 TOUCH USER MANUAL FibroScan

6.6.3. Pressure indicator

The probe contains a sensor that measures the pressure applied by the operator to the
patient. The pressure level is given by:

и The software: Pressure indicator (green/orange/red).

The probe: Blue LEDs.

Measurements may only be made when the pressure indicator is in the green zone.

Pressure too high (red). Pressure too low (orange). Correct pressure (green).

Probe LEDs off. Probe LEDs off. | Probe LEDs ON.

Measurement disabled. Measurement disabled. | Measurement possible.

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FibroScar 1 FIBROSCAN 502 TOUCH USER MANUAL [BIS

6.6.4. Shear wave propagation map

This image is displayed once the measurement is complete. It represents the levels of liver
deformation generated by the propagation of the shear wave as a function of time (horizontal
axis in milliseconds) and depth (vertical axis in millimeters).

The shear wave speed value is displayed if the measurement is valid.

The color scale indicates deformations (compression or expansion). Black areas correspond
to negative deformation and pale areas to positive deformation. The black strip through
the image represents deformations associated with the passage of the shear wave, which
penetrates progressively deeper with time.

6.6.5. Counters: Valid and invalid measurements

Valid measurements
From top to bottom: First to last measurement in kPa.

When the number of valid measurements is egual to 1, the IOR and the IOR/
median ratio are undefined. They are therefore not displayed.

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Invalid measurements
The measurement is automatically rejected by the algorithms if the pulse sent out by the
transducer could not be delivered successfully and/or if the shear wave propagation maps
are not satisfactory.

The message 'INVALID' is then displayed above the shear wave propagation map.

6.6.6. Shear wave speed results area

Median
Shear wave speed is expressed in meters per second (m/s). This value is the median of all
valid measurements performed during the examination.

If the repeat measurement is invalid, the median is not recalculated. To obtain a reliable and
representative shear wave speed measurement in the liver, at least 10 valid measurements
must be taken.

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

Interquartile range (IQR)

The interquartile range (IQR) is expressed in meters per second (m/s). It represents the
interval around the median within which will fall 50% of all valid measurements. It is
recalculated after each new valid measurement.

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6.6.7. 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 recalculated. To obtain a reliable and
representative liver stiffness measurement, at least 10 valid measurements must be taken.

个 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 recalculated 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
recalculated after each new valid measurement.

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[SETE FIBROSCAN 502 TOUCH USER MANUAL FibroScan

6.6.8. CAP result zone (option)

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

Ea The CAP is displayed with the M* and XL* probes only.

Median
The CAP (Controlled Attenuation Parameter) is expressed in decibels per meter (dB/m). This
value is the median of all valid measurements performed during the examination.

The CAP is calculated when the stiffness measurement is valid.

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

Interquartile range (IQR)

The interquartile range (IQR) is expressed in decibels per meter (dB/m). It represents
the interval around the median within which will fall 50% of all valid measurements. It is
recalculated after each new valid measurement.

6.6.9. Deleting measurements

Some or all of the measurements in the current examination may be canceled at any time
during the examination. The patient's data, displayed in the left-hand part of the window, are
saved.

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Fibroscan
μμ —°}] FIBROSCAN 502 TOUCH USER MANUAL [STEVE]

>| 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.

A Refer to the warning in Chapter 2 concerning deletion of measurements.

6.6.10. Adding a comment

You can add comments to the current examination :

m Press the ‘Comments’ field,

= Enter comments using the touchpanel.

Information entered in the ‘Comments’ field will appear on the examination result printout.

l The ‘Comments’ field cannot be added to or modified during an examination

review.

6.6.11. Integrate the measurement conditions

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 available:

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ET FIBROSCAN 502 TOUCH USER MANUAL
Perches
= patient weight,

# patient height,

= observance of dietary recommendations,

в patient position,

m measurement point search method,

= narrow intercostal space,

= thick subcutaneous wall,

= quality of ultrasound signal,

m presence of vascular structures.

The measurement conditions will appear on the examination result printout.

The measurement conditions cannot be added to or modified during an

examination review.

6.6.12. Message area

The following main messages can be displayed above the elastogram.

`
1
+

1 Connect the probe.

1
4

SS
N Replace the probe.

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 FIBROSCAN 502 TOUCH USER MANUAL GiT

Calibrate the probe.

Electromagnetic disturbances.
ZÁ

Overheating.

6.6.13. 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’.

If the S* probe is connected, select examination type S1 or S2.

If only the M* or XL* probe is connected, the corresponding examination type is selected
automatically by the device software.

If several probes are connected, choose the examination type.

Automatic probe recommendation

The automatic probe recommendation tool is based on the Skin-to-Capsule Distance
— (SCD) 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's skin).

ER This tool functions for the M* and XL* probes only.

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[ETS FIBROSCAN 502 TOUCH USER MANUAL FibroSc an

The result of this tool is displayed at the bottom of the screen and may be one of the following
three cases:

1. "Recommended probe: in progress": the tool cannot currently measure the SCD
because the probe is not correctly positioned in front of the liver and/or the ultrasound
signals are of poor quality.
2. ‘Recommended probe: M': The tool measures a SCD that justifies the use of the M*
probe. The box containing the M examination type icon flashes.
3: "Recommended probe: XL': The tool measures a SCD that justifies the use of the XL*
probe. The box containing the XL examination type icon flashes.

If the tool is able to recommend a probe (case 2 or 3), two situations are possible:

m The probe currently in use is the recommended probe: The operator continues the
examination without changing probes and, if they wish, can confirm the probe choice by
pressing the icon of the examination type concerned. The probe recommendation tool is
then disabled until the end of the current examination.

m The probe currently in use is not the recommended probe: The operator changes the
probe by applying the procedure explained in the paragraph below.

加 Be sure to use enough gel for this tool to function properly.

四 You are strongly advised to use the recommended tool, to guarantee reliable
results. The decision regarding whether or not to apply this recommendation,
however, remains 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:

= Change of examination type. Changing examination type causes all previous
measurements to be definitively erased.

2. Click OK (warning: all measurements taken 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.

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FibroScan FIBROSCAN 502 TOUCH USER MANUAL (STEVE)

6.6.14. 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:

> Back to the home window.

= Prints the patient examination result.

F Exports the patient examination result in FIBX format (a proprietary

FibroScan format) to a removable USB storage device.

j Exports the patient examination report in PDF format to a removable

USB storage device.

© Starts a new examination.

If the DICOM option is enabled, in case of failure of automatic examination result

export to the DICOM network, the following button is displayed

Click this button to try exporting again.
Note that this retry can also be reguested via the status bar in the home window.

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EE FIBROSCAN 502 TOUCH USER MANUAL Fibro

σα JAGEMENT OF PATIENT FILE ARCHIVES

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

Results : 6 0 selected patients 会

CHAEL 2
Michael に
Date of birth 12/12/1953
Code: REF¢ ne
DOE 1
John am
Date of birth 3/21/1973
[Code : REF2 Male
KATZ 1
Robin om
Date of birth 7/16/2003 |
Code : REFS E Female |

PUBLIC 1
Henry man
Date of birth 5/3/1921
Code : REF3 Male

ROE 1
Jane —
Date of birth 12/1/1982
Code : REFL =
МАМ 1
Suzy can
Date of birth 6/26/1944
Code: REFS ο Female

„xls 1/1 ( 888

Folder selection when a keyboard is connected: [CTRL]+click to select non-consecutive files,

[SHIFT]+click the first and last to select a series of files, and [CTRL]+[A] to select all files.

Deletes the selected files.

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FibroScan FIBROSCAN 502 TOUCH USER MANUAL ERETE]

Exports the selected examination files to a file in FIBX format on

a removable USB storage device. You can export the last
examination or all the examinations for one patient.

Exports all the results from all files to a file in XLS format on a
) removable USB storage device.

= > > Displays the next or previous page of archives.

Displays the last or first page of archives.

po
( ) Refines the advanced file search.

( sss | Selects all patient files displayed.

Closes the screen and displays the home screen (keyboard

shortcut: [Esc] key).

Excel file
The file is generated in the root of the removable USB storage device. The file name contains:

и the serial number of the device,

= the date and time the Excel file was created.

The Excel file comprises two data sheets (Data and Parameters).

6.7.1. Advanced file search

Enter one or more search criteria. The list of matching files is displayed.

x
e | Deletes the input.

EE
2 ) Closes the advanced search.
Se

( b ) Opens the examination of the displayed patient.

6.7.2. Select and view a patient file

To view the examination summary for a patient, click the label and then 다

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EE FIBROSCAN 502 TOUCH USER MANUAL FibroScan

To view the details of an examination, click the summary of the examination.

6.7.3. Details of the examination

To display the measurements, click a value in the list of valid measurements.

Description of contextual buttons:

<> Lets you view the previous examination or the next examination
for the patient (keyboard shortcut: left arrow or right arrow).

Back to the Archives screen.

B Deletes the examination.

Prints the result of the examination.

Exports the result of the examination to a file in FIBX format.

Exports the result of the examination to a file in PDF format.

ES Exports the result of the examination on the DICOM network.

© Starts a new examination.

de Displays the previous or next result in the list of measurements

v
(keyboard shortcut: Up or down arrows). Displayed only in the
presence of more than 12 measurements.

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FibroScan FIBROSCAN 502 TOUCH USER MANUAL [SETE]

7. STANDBY AND SHUTTING DOWN THE

DEVICE

7.1. BETWEEN SESSIONS

Turn the device off by pressing the standby button in the bottom left-hand corner of the
monitor or the shutdown button on the interface.

7.2. AT THE END OF THE DAY

Always shut the device down by applying the following sequence:

1. Turn the FibroScan off by holding down the standby button in the bottom left-hand
corner of the monitor or the shutdown button on the interface.
2; Cut the power supply by setting the main switch to 0.

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

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EX FIBROSCAN 502 TOUCH USER MANUAL FibroScan

8. CLEANING, MAINTENANCE AND REPAIRS

In the event of a malfunction, only Echosens staff or local representatives are authorized to
work on the FibroScan and its accessories. Any work performed by an unqualified person will
terminate the guarantee.

8.1. CLEANING
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.

= Observe the expiry dates of cleaning products and decontamination solutions.

= Ensure that the contact time and concentration of the cleaning product and
decontamination solution are appropriate for the equipment used. Carefully apply the
instructions given on the label of the cleaning product and the decontamination solution.

= 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.

8.1.1. Cleaning the device (painted, metallic, glass, or plastic

surfaces and screen)

A Refer to the warning in Chapter 2 concerning cleaning.

Surfaces must be cleaned in strict compliance with the following procedures:

clean using a soft cloth soaked in the recommended cleaning product,

2: if necessary, rinse using a soft cloth soaked in water,
wipe the surface using a soft cloth soaked in the recommended decontamination
solution,
4. if necessary, dry carefully using a soft, clean, 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.

Do not scratch the screen.

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8.1.2. Cleaning the probe (housing, cable and transducer)

E It is not necessary to switch off the device before cleaning the probe.

Surfaces must be cleaned in strict compliance with the following procedures:

1. Gently remove the gel using a soft cloth or wipe.

Cleaning the probe: A: Wipe.

5 Remove all traces of bodily fluid by cleaning the surfaces using a soft cloth or wipe
soaked in the recommended cleaning product.
3. If necessary, rinse the cleaned surfaces using a soft cloth soaked in water.
Dry, if necessary, using a dry cloth.
5. Wipe the surfaces using a soft cloth or wipe soaked in the recommended
decontamination solution.
Dry, if necessary, using 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: [email protected]

Precautions
Do not submerge or soak the probe.

Apply the cleaning product and decontamination solution to the soft cloth, not directly on the
surface to be cleaned.

The probe must be cleaned after every use or between patients. Prior cleaning is necessary
in order to ensure effective decontamination.

Do not use a surgical brush to clean the probe. Even the use of flexible brushes could
damage the probe.

Take care not to introduce any cleaning product or decontamination solution into the probe
connector.

8.1.3. Recommended cleaning products

Echosens recommends use of the following products :

m Pure water, soapy water.

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[ETS FIBROSCAN 502 TOUCH USER MANUAL FibroScan

= Detergent with neutral pH (5 to 8).

= Recommended decontamination solutions (see below).

Cleaning products which must not be used are:

= Abrasive products (such as “Cif’ and scouring powders).

= Alkaline detergents (pH > 9), bleach, etc.

= Sulfuric, acetic, nitric, hydrochloric, and oxalic acid, etc.

m Soda, potash, ammonia, etc.

= Alcohols: Methanol, ethanol, etc.

и Hydrocarbons and solvents: Unleaded petrol, acetone, MED, MIBK, toluene, xylene,
benzene, trichloroethylene, diluent, nail varnish solvent, etc.

8.1.4. Recommended decontamination solutions

The decontamination solutions recommended below are suitable for use on the device and
probes.

Cleaning and | Origin Type Active ingredient

decontamination solution |
Certainty Disinfectant Wipes Canada | Wipes Quaternary ammonium |
(DIN:02325853) |
Clorox Disinfectant Wipes | Canada Wipes Quaternary ammonium
(DIN:02319462)
Zep Clean'ems Spirit II Canada Wipes Quaternary ammonium |
Disinfectant Towels
(DIN:02290588)
105 Spray ーー USA i Vaporizer Quaternary ammonium

Ascend USA Liquid Quaternary ammonium

Control III USA i Liquid Quaternary ammonium |

| Coverage Spray | USA m Vaporizer Quaternary ammonium

End-Bac Il USA Liquid Quaternary ammonium

| PI-Spray USA © ーー Vaporizer Quaternary ammonium

Pl-Spray II USA - Vaporizer Quaternary ammonium

Thericide Plus USA Liquid Quaternary ammonium

Thericide Plus USA Vaporizer Quaternary ammonium

Clinell Wipes United Kingdom Wipes Quaternary ammonium

Tristel Wipes System m United Kingdom i Wipes Chlorine dioxide

Tuffie m United Kingdom Wipes Quaternary ammonium

Surfanios Premium France Liquid Quaternary ammonium

| Aniosurf Premium | France | Liquid Quaternary ammonium

Wip’Anios ーー France | Wipes Quaternary ammonium

Wip'Anios Premium France Wipes Quaternary ammonium

| surasafe SH ーー France Vaporizer Quaternary ammonium

Viraclean France | Vaporizer Quaternary ammonium

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FibroScan FIBROSCAN 502 TOUCH USER MANUAL ES

In addition to the list of recommended decontamination products, any alcohol-free

decontamination product using quaternary ammonium as its active ingredient may be used to
decontaminate the probes.

8.2. CALIBRATING THE PROBE

The probe contains mechanical parts that may shift slightly over time.

四 The probe must therefore be calibrated periodically. Beyond the period indicated
on the calibration certificate, the manufacturer no longer guarantees the
performance characteristics of the probe.

When an examination is opened, a window displays the expiry of the calibration of your probe.
When this is displayed, contact Echosens or its local representative to arrange calibration:
[email protected]

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.

8.3. TROUBLESHOOTING
Events Solutions
The probe is no longer Contact ECHOSENS or its local representative:
calibrated. [email protected]

The standby pushbutton is Check that the device is connected to a correctly powered AC
inoperative. When pressed, supply socket (test another electrical device on this same socket)
the device won't turn on. and that the main switch is in the | position.
Have the main switch's fuses checked by the maintenance
department.

The standby pushbutton is Turn the device off, then on again.

on, but the software is not
booting.

In the event of a failure or malfunction, please contact Echosens or its local representative:
[email protected].

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ET FIBROSCAN 502 TOUCH USER MANUAL FibroScan

9. CONFIGURING THE FIBROSCAN

9.1. ENTERING CONFIGURATION MODE

To enter Configuration mode, press © in 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 (Note: case-sensitive) :

Operator Level
User name : Operator

Password : 0 P3 R

FibroScan Administrator Level

User name : FibroScan Administrator

Password:5UP374DM1N

In general, click [Apply] to confirm the input and save the new data.

9.2. LOCALIZATION TAB

This tab is used to configure date, time and user interface language.

Date and time

Press [Modify] and then enter the system date and time, and press [Save] to save the data.

Language
Select the interface language and examination report from the list.

9.3. INSTITUTION TAB

This tab lets you input the institution contact details.

Information concerning the institution

The information entered will be displayed on the report.

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FibroScan FIBROSCAN 502 TOUCH USER MANUAL EFATE)

Logo
Press [Modify]. If an image filed called logo.bmp is present in the root of the USB device
connected to the device, the logo is automatically modified. The logo appears on the
examination report.

[Reset] deletes the logo from the examination report.

9.4. 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 print at the end of each examination.

The digit 0 is input by default.

For a FibroScan Administrator

Printing format
A4 or Letter

The Letter format matches the American paper format.

Printers

[Update] Update the list of printers.

Lets you add a printer. You can add by port, by IP address or

{Add printer] by selecting a shared printer.

[Set as default] Lets you define a printer as default printer.

[Delete printer] Lets you delete a printer. Follow the on-screen instructions.

[Search for printer

patch] Lets you add a printer patch supplied by Echosens.

{Stop any printing in

progress] Lets you cancel current printing operations.

9.5. DATA TAB

This tab is used to import, export and archive examination files. It can only be accessed by
users with FibroScan administrator rights.

0 A removable USB storage device must be connected.

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EE FIBROSCAN 502 TOUCH USER MANUAL FibroScan

Archive
Lets you copy examinations and examination reports (PDF) for the period selected onto a
removable USB storage device. The files are saved in a folder named "backup". An .xIs file
containing the examination results for the period selected can also be exported.

Export
Lets you enable automatic or manual export of examinations in .fibx format to a USB storage
device at the end of each examination. The files are stored in the root directory of the storage
device and can be anonymized..

Import
Lets you import .fibx examination files from a removable USB storage device.

四 The files are stored in the root directory of the storage device.

9.6. USER TAB

This tab lets you define user accounts and link specific rights to them according to account
type: Operator or FibroScan Administrator. The configuration of user accounts is accessible
only with FibroScan Administrator level.

9.7. 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.

IP address This can be configured statically or dynamically via the DHCP protocol. To
configure the IP address manually, click [Manual] and complete the fields.

Network
This tab is used to specify the network parameters of the device. This includes: Device name,
IP address, Sub-network mask, and Gateway.

Directory
File 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.

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 Devices DICOM Conformance Statement.

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Lets you define the server through which the device will perform a patient
[Worklist] search. If necessary, it is possible to filter the patient list by use
(0008,0060). By default, it is filtered by AE Title.

Lets you define the servers to which the device will export the examination
[Storage] report. It is possible to choose the format of the report: JPEG image and/or
PDF document.

7 The Name, IP address/Host name, Port and AE Title must be input for each of the
DICOM connections defined. These parameters are generally available from the
network administrator.

The AE Title is a unique identifier of the device. 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 the FibroView Data Solution.

The network address of the FibroView Data Solution server must be entered, starting with
http://. The [Check] button lets you test the connection with the Data Solution.

To enable Wi-Fi, the wireless network name (SSID) and password must be defined. The
security level of the connection is defined by choosing a protocol (WPA or WPA2, with or
without pre-shared key, PSK) and completed with an encryption method (TKIP or AES).

The hospital IT department will help users to configure the Wi-Fi connection, particularly as
regards choosing the correct security level.

9.8. EXAMINATION TAB

This tab is used to enable or disable the available software options. It can only be accessed
by users with FibroScan administrator rights.

CAP activation
Enables or disables the optional CAP display.

A key is required to enable the CAP (to obtain this activation key, contact
Echosens or its local representative).

Measurement conditions
Enables the transfer of the measurement conditions to the examination report.

9.9. SYSTEM TAB

9.9.1. Information
This tab displays information about the system and the software: serial numbers (device,
probes, etc.), software and firmware version numbers,remaining disk space and total disk
space,device use time.

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9.9.2. Logs
For a FibroScan Administrator

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.

[Export] Exports the log file.

From any user account, save the Log file by pressing the [Export] button after connecting a
back-up device (usually a USB key connected to one of the device's USB ports). The file is
exported to the root directory, and its name contains:

m the device's serial number,

m the date and time the file was created.

The USB device may not be recognized immediately after insertion. In that case,
press [Export] again if an error message is displayed.

9.9.3. Service
This tab gives access to the troubleshooting options.

For an Operator

[Eject CD] To eject the CD from the drive.

For a FibroScan Administrator

[Launch To execute an ECHOSENS-certified program present on a USB storage

Program] device.

20) A removable USB device must be connected.

[Probe Displays the characteristics of the probes connected to the device.

Memory]

[Screen —
Calib.] Touch screen calibration.

[Check :
Disk] Hard disk check.

[Clear Clears the database. Note that the examination files remain
Database] physically present on the hard disk.

Upgrade : . . .
DS Update of device software using a USB device supplied by Echosens.

Remote Enables Echosens to access your device remotely. Once launched, make
Access a note of the TeamViewer identifier so you can pass it on to your
Echosens contact person.

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9.9.4. General

For an Operator

Delay before application lock

The delay before disconnection is the idle period after which the application will disconnect.
This period may range from 5 to 55 minutes.

For a FibroScan Administrator

Patient data security

If this security is activated, by default no patient data will be displayed in Archive and
Acquisition modes. In this case, to display patient list or specific patient details, click on the
[Display patients] or [Display patient details], respectively.

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EE FIBROSCAN 502 TOUCH USER MANUAL FibroScan

10. SYMBOLS ON THE DEVICE

. CONNECTORS

(0) DVI-I output

デー Ethemet connector RJ45

de USB connector
USB

Elastography probe connection

Location for the connector of the unconnected probe.

10.2. WARNINGS

Só q Holder not intended for a FibroScan probe

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FibroScan FIBROSCAN 502 TOUCH USER MANUAL (BİRİ

Do not cover the vents

(CAUTION: This symbol does not appear on devices manufactured

before 2013).

Warning: Only Echosens-approved maintenance personnel are

authorized to open and modify the FibroScan device.

Refer to the user manual to ensure operator and patient safety.

(CAUTION: This symbol does not appear on devices manufactured

before 2013).

Year and country of manufacture

(CAUTION: This symbol does not appear on devices manufactured

[20XX] before 2017).

Weight of device with accessories

(CAUTION: This symbol does not appear on devices manufactured

before 2013).

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

To avoid tipping the FibroScan when moving it, move it slowly

sideways and steer it firmly by holding the decorative rods on the front
and back of the device.

To avoid tipping the FibroScan when lowering it down a step, the

operator must go in front of the device and guide it on the way down.

(CAUTION: This symbol does not appear on devices manufactured

before 2013).

10.3. MARKING AND ELECTRICAL SAFETY

С € CE marking and notified body identification number

0459 Certificate affixed on July 21, 2011

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EE FIBROSCAN 502 TOUCH USER MANUAL FibroScan

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.

Equipotential terminal

Protective ground

Alternating current

5x20
2-A accessible time-delay fuses

T 2A H250V

Applied part type B

Standby pushbutton

Main switch

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10.4. NOTE:
The following symbols appear on devices manufactured before 2013.

Do not cover the vents.

WARNING: WARNING: only Echosens-approved maintenance

>
Re

personnel are authorized to open and modify the FibroScan device.

2-A accessible time-delay fuses

»
4
o
>
P

Applied part type B

The serial number marked on the device identifies the FibroScan uniguely.

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ENS FIBROSCAN 502 TOUCH USER MANUAL FibroScan

11. TECHNICAL CHARACTERISTICS

11.1. GHARACTERISTICS OF THE DEVICE

Manufacturer Echosens
30 place d'Italie

75013 PARIS - France

Model FIBROSCAN 502 TOUCH

MDD Classification Class Ila according to directive 93/42/EC

Class of protection Class |

against electric shock

Type of part applied B

Software security class B

Class and group Group | Class A

according to CISPR 11

IP code IPXO: The device without probe is not protected against liquids.

Operating mode Continuous operation

Charge time = Tcharge = 10 min.

Rest time = Trest = 15 min.

Mechanical Index MI < 1.0 for all operation modes.

Thermal Index τις 1.0

11.1.1. Computer characteristics

Operating system Windows Embedded

Permanent storage Hard disk

system

11.1.2. Metrological performance

Note: The quantities measured are shear wave speed written as ‘Vs’ and stiffness written as
El.

Shear wave speed Min.: 0.8 m/s

Max.: 5.0 m/s

Shear wave speed Vs (m/s)*

st MT XL*
Vs (m/ | Phantom | Bias** (%) | Precision** (%) | Bias** (%) | Precision** (%) | Bias** (%) | Precision** (%)
s) number
Zone 1 -0.8 0.8 0.7 0.6 13 0.0
1 2 - 5.8 0.8 -47 0.8 - 3.9 0.0

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FibroScan FIBROSCAN 502 TOUCH USER MANUAL [RUE]

Shear wave speed Vs (m/s)*

s* MT XL
Vs (m/ | Phantom | Bias** (%) | Precision** (%) | Bias** (%) | Precision** (%) | Bias** (%) | Precision** (%)
s) number
1.14 |

Zone |1 |-9.0 0.8 -113 0.9 |- 124 14

2 2 - 13.5 2.0 - 11.5 0.9 - 13.9 1.4
1.79

Zone 1 - 4.5 0.7 - 4.3 0.9 = 170 3.1

3 |2 3.6 0.7 -34 19 -92 22

2.77 |
|
* Values obtained with CIRS phantoms E-1493-1 (1) and E-1493-2 (2)
** As defined by ISO 5725-1 1994

Stiffness Min.: 2.0 kPa

Max.: 75 kPa

Stiffness E (kPa)*
s* m* XL
E (kPa) | Phantom | Bias** (%) | Precision** (%) | Bias** (%) | Precision** (%) | Bias** (%) | Precision** (%)
number

Zone 1 |1 =1,5 1.7 1.3 1.3 26 0.0

39 |2 -113 16 -9.2 15 -77 0.0

Zone2 |1 - 17.0 1.7 -213 17 -23.1 2.8

9.6 2 5251 4.0 - 21.6 [1.7 -25.7 2.8

Zone3 |1 Bm 1.4 - 8.3 1.8 — 20.5 6.3

23.3 2 | 7.6 1.4 - 5.9 3.8 - 17.3 4.4

1 —

* Values obtained with CIRS phantoms E-1493-1 (1) and E-1493-2 (2)
** As defined by ISO 5725-1 1994

CAP Minimum: 100 dB/m

Maximum: 400 dB/m

Controlled Attenuation Parameter CAP (dB/m)* |

MT XE
CAP (dBim) | Bias** (%) | Precision" (%) | Bias** (%) | Precision** (%)
145 (1) -14 0.0
| 6.5 1.0
235 (2) -0.4 0.0 -34 0.4
340 (3) -49 04 -35 0.4
* Values obtained with Madsen phantoms Ph1150 (1) Ph,250 (9) ang ph1350 (3)
** As defined by ISO 5725-1 1994

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11.1.3. Electrical characteristics

Power supply 100-240 V — 50-60 Hz

Apparent power 70-75 V-A or 130-150 V A, depending on year of production

Fuse 2 x type 5x20 T2.0AH 250V

11.1.4. Mechanical characteristics

Dimensions 1350 mm x 680 mm x 610 mm (H xL x D)

Weight 41 kg (with accessories)

11.1.5. Environmental characteristics

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

Operating humidity 30% to 75% relative humidity, not condensed.

Maximum operating 3000 m

altitude

Operating atmospheric 700 hPa to 1060 hPa

pressure

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

transportation
temperature

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

transportation humidity

Maximum altitude for 5000 m

storage and
transportation

Storage and 540 hPa to 1060 hPa

transportation
atmospheric pressure

11.1.6. Additional information

Power cables 1 x Australia power cable

according to country) -
an 29 m » 1 x Brazil power cable
1 x China power cable

1x Switzerland power cable

1 x EU power cable

1 x UK power cable

1 x US/CA Hospital Grade power cable

11.2. GONSUMABLE
Not applicable.

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12. REGULATIONS

Electromagnetic interference (EMI) is a signal or emission, conveyed through open space

or through electrical or signal conductors, which may severely disrupt radio navigation or
other safety services, or seriously and frequently damage, obstruct or interrupt an authorized
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 authorized 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:

m Change the orientation of the reception aerial.

и Reposition the computer relative to the receiver.

m 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.

12.1. ELECTROMAGNETIC EMISSIONS

The FibroScan 502 TOUCH is designed for use in the electromagnetic environment defined
below. The customer or the user of the FibroScan 502 TOUCH must ensure that it is used in
this type of environment.

Emissions testing Compliance Electromagnetic Environment - Directives |

CISPR RF Group 1 The FibroScan 502 TOUCH uses RF energy for its
emissions 11 internal functions only. Consequently, its RF emissions
are very low and unlikely to cause any interference with
nearby electronic equipment. |

CISPR RF Class A The FibroScan 502 TOUCH may be used on all premises |
emissions 11 other than domestic premises and those directly
~ connected to the public low voltage energy grid used to
Harmonic Class A supply domestic buildings.
emissions
IEC 61000-3-2

Voltage Compliant
fluctuations/flicker
IEC 61000-3-3

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[ZEUS FIBROSCAN 502 TOUCH USER MANUAL FibroScan

NOTE: The use of cables and/or accessories not specified in the User Manual may increase
the device's emissions.

12.2. ELECTROMAGNETIC IMMUNITY

In the following cases, electrostatic charge 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.

The FibroScan 502 TOUCH is designed for use in the electromagnetic environment defined
below. The customer or the user of the FibroScan 502 TOUCH must ensure that it is used in
this type of environment.

Immunity IEC 60601 test Compliance Electromagnetic Environment -

test level Recommendations

Electrostatic +6 kV contact +6 KV on contact Floors should be wooden,

Discharge +8 KV air | +8 kV through air concrete or ceramic. If the floor is
IEC | covered with a synthetic material,
61000-4-2 | the relative humidity must be at
least 30%. %.
Spike/Burst + 2 kV Power +2 kV Power The quality of the electrical
IEC supply supply network must be that of a typical
61000-4-4 + 1 kV Input/Output +1 kV Input/Output commercial or hospital
environment.
Voltage Differential mode Differential mode The quality of the main supply
shocks +1kV ょ 1kV must be that of a typical
IEC Common mode Common mode commercial or hospital
61000-4-5 +2kV +2kV environment.

Voltage <5% Ur ‘for <5 % UT, for The quality of the electrical
drops, short 10 10 ms. network must be that of a typical
interruptions no commercial or hospital
and supply 40 % Ur, for 40 % Ur, for environment. If the user of the
inlet voltage 100 ms. 100 ms. FibroScan device 502 TOUCH
variation o requires uninterrupted operation
IEC 70 % Ur, for 10% Un, for during electrical power cuts, it is
61000-4-11 | 500 ms. 500 ms. recommended that the FibroScan
o <5 % Ut, for5s. device 502 TOUCH be powered
vu т by an uninterruptible power supply
or battery.
Magnetic 3 A/m 3 Alm Supply frequency magnetic fields
field must be those of a typical
immunity at commercial or hospital
supply environment.
frequency
(50-60 Hz)
lec |
61000-4-8 |

te Ur : network power supply voltage measured before the test

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FibroScan FIBROSCAN 502 TOUCH USER MANUAL [3

. ELECTROMAGNETIC IMMUNITY (2)

The FibroScan 502 TOUCH is designed for use in the electromagnetic environment defined
below. The customer or the user of the FibroScan 502 TOUCH must ensure that it is used in
this type of environment.

Immunity test | IEC Compliance Electromagnetic Environment - Directives |

60601
test level

Portable and cellular RF communication

equipment must be kept far away from the
FibroScan device 502 TOUCH (including its
cables), at a distance greater than the
recommended distance calculated using the |
equation applicable to the emitter frequency.
Recommended separation distance

Conducted RF 3 Vrms 3 Vrms d=1.17 VP

IEC 61000-4-6 | 150 kHz
to
80 MHz
Radiated RF 3V/m 3 Vim d=117VP
IEC 61000-4-3 | 80 MHz 80 MHz to 800 MHz
to
2.5 GHz d= 2.33 VP
800 MHz to 2.5 GHz

where P is the maximum emitter power in watts |

(W), as specified by the emitter manufacturer,
and dis the recommended separation distance
in meters (m).
The strength of EM fields for fixed emitters, as
determined by a study. 2The electromagnetic
range of the site must be within the compliance
level reguired in each freguency band. 3 |
Interference may occur in the vicinity of devices
bearing the following symbol:

(©)
NOTE 1: At 80 MHz and 800 MHz, the higher frequency band is applicable.

NOTE 2: These recommendations may not be applicable in all cases. Electromagnetic

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

NOTE 3: The use of cables and/or accessories not specified in the User Manual may reduce
the device's immunity.

2. The strength of EM fields for fixed emitters such as commercial AM/FM radio broadcasting services,
television, cellular telephone services, radio detection, air traffic control, radio paging receivers and GSM
services cannot be accurately predicted. To assess the EM environment caused by fixed emitters, a site EM
study must be conducted. If the field strength measured at the location where the FibroScan device
502 TOUCH is used exceeds the compliance levels mentioned above, correct operation of the FibroScan
device 502 TOUCH must be checked. If abnormal performance is observed, additional measurements may
be required after, for example reorienting or moving the FibroScan 502 TOUCH.
3. In the frequency range 150 kHz — 80 MHz, field strengths should ideally be lower than 3 V/m.

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EE FIBROSCAN 502 TOUCH USER MANUAL FibroScan

NOTE 4: In case of any disturbance in the electromagnetic environment of the FibroScan

502 TOUCHa message is displayed (see the Message Area chapter) and no measurements
can be carried out.

12.4. RECOMMENDED SEPARATION DISTANCES

(Between portable or cellular RF communication devices and the FibroScan 502 TOUCH)

The FibroScan 502 TOUCH is designed for use in an electromagnetic environment in which
RF disturbance is controlled. The customer or the user of the FibroScan 502 TOUCH can
take precautions against interference by maintaining a minimal distance between the portable
or cellular RF communication equipment (transmitters) and the FibroScan 502 TOUCH as
recommended below according to the maximum power of the communicative device.

Maximum Separation distance according to transmitter frequency (m)

transmitter
output power 150 kHz to 80 MHz 80 MHz to 800 MHz 800 MHz to 2.5 GHz
(w) d=3.5/3 VP d= 3.5/3 VP d=7/3 VP
0.01 | 0.12 0.12 0.23

o1 0.37 | 037 ー 0.74

1 1.17 | 1.17 2.33

10 3.69 | 3.69 7.38

100 11.67 | 11.67 23.33

For emitters whose maximum power is not listed above, the recommended separation
distance in meters (m) can be estimated using the applicable equation at the transmitter's
frequency, where P is the maximum transmitter power in watts (W) as specified by the
transmitter manufacturer.

NOTE 1: At 80 MHz and 800 MHz, the separation distance for the highest frequency range is
applicable.

NOTE 2: 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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68
FibroScan FIBROSCAN 502 TOUCH USER MANUAL (ETİ

INDEX

Archive , 26, 44, 45, 46, 53 Home , 26, 43 Registered trademarks , 12

Advanced search , 44 Status bar , 28 Regulations , 65
Delete , 44 Indications , 13, 14, 17 Removing power , 47
Export , 44 Indications for use , 14 Results , 36
Calibrating the probe , 51 Intended use , 13 Results area , 36
Message , 40 Interguartile range , 36, 37 Result
Cancel measurement , 38 CAP,38 CAP , 38
CAP , 14, 28, 38 IQR , 36, 37, 38 Interquartile range , 37, 38
Activation , 29, 55 IQR/Median , 37 Interquartile range , 36
Interquartile range , 38 Liability , 11 IQR/Med , 37
Cleaning , 48 Log File , 56 PDF report, 53
Probe , 49 Export , 56 Shear wave speed , 36
Connectivity , 54 Login , 27, 28 Stiffness , 37
DICOM , 28, 30, 54 Automatic logout , 27 Reverse engineering , 12
FibroView , 28, 30 Password , 27 Safety
FibroView Data Solution , 55 Measurement conditions Electrical safety , 17
File share , 28, 54 Configuration , 39, 55 Maintenance, 18
TeamViewer , 56 Measurement Selection criteria
Wi-Fi, 2! Cancel , 38 Examination type , 16
Copyright , 7 Reset, 38 Probe , 16
Date and time , 28, 52 Network parameters Shear Wave Speed
Electromagnetic compatibility Gateway , 54 Measurement , 34
, 65 Host name , 54 Propagation map , 35
Immunity , 66 IP address , 54 Shear wave speed median , 36
Electromagnetic disturbance Sub-network mask , 54 Standby , 47
Message , 40 Patents , 12 Button , 20
EMI, 65 Patient Stiffness , 13, 37, 37
Essential performance DICOM import , 55 Interquartile range , 37
characteristics , 11 Patient data display , 32, 57 Switching off the device , 47
Examination , 26 Record , 29 System , 55
Acquisition screen , 31 Worklist , 30, 55 Available disk space , 28, 55
Archive , 53 Pay per Use , 28 Identifiers , 55
Change of probe , 42
Power cable , 64 Technical characteristics of
Clinical Mode , 28, 29
Precautions , 13, 17, 17 the device , 62
Comments , 39 Electrical characteristics , 64
Precautions for use , 17
Configuration , 55 Environmental characteristics ,
Pressure indicator , 34
Delete , 44, 46, 53 64
Print , 43, 46, 53
Details of examination , 44 Mechanical characteristics , 64
Probe , 24, 26
Display , 46 Troubleshooting
Calibration , 51, 51
Examination type , 41 Log File , 56
Calibration , 30
Measurement conditions , 39 Probe , 51
Change , 42
Print, 43, 46 Software , 51
Cleaning , 49
Programmed stop , 31 Standby , 51
Indicators , 24
Examination type , 41 TeamViewer , 56
Lead, 24
Export Measurement button, 24 Ultrasound images ,32
Anonymization , 28, 54 Liver targeting tool , 33
Troubleshooting , 51
DICOM , 43, 46, 55 Mode A, 33
Product life , 11
Excel , 45 TM Mode , 33
Property , 7
FIBX , 28, 43, 46, 54 User Accounts , 52, 54
PDF , 43, 46
Regionalism
Language , 52
User training , 17
Guarantee , 11

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© ecHosens
Echosens
30 place d'Italie
75013 PARIS
FRANCE
Tel.: +33 (0)1 44 82 78 50
Fax: +33 (0)1 44 82 78 60
Website: www.echosens.com
Email: [email protected]