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E100M002 15 GuideD'utilisationFibroScan EN-GB

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51 views82 pages

E100M002 15 GuideD'utilisationFibroScan EN-GB

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E.D.V.

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FibroScan® Device

User Manual
E100M002.15 – Version 15 – 02/2011
(Software version 1.42)
USER MANUAL-DEVICE

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USER MANUAL-DEVICE

TABLE OF CONTENTS

TABLE OF CONTENTS ......................................................................................................................... 3

1. PURPOSE OF THE MANUAL ................................................................................................... 5
2. MISCELLANEOUS INFORMATION .......................................................................................... 7
2.1 Guarantee ........................................................................................................................ 7
2.2 Responsibility ................................................................................................................... 7
2.3 Property and copyright ...................................................................................................... 7
2.4 Reverse engineering ......................................................................................................... 7
2.5 Registered trademarks...................................................................................................... 8
3. RECOMMENDATIONS AND SAFETY ...................................................................................... 9
3.1 Symbols............................................................................................................................ 9
3.2 Electrical safety ................................................................................................................ 9
3.3 Maintenance-related safety ............................................................................................... 9
3.4 Patient safety .................................................................................................................. 10
3.5 Recommendations for use .............................................................................................. 10
3.6 User training ................................................................................................................... 10
4. HARDWARE SUPPLIED ......................................................................................................... 11
4.1 Basic device ................................................................................................................... 11
4.2 Accessories .................................................................................................................... 11
5. EXTERNAL PRESENTATION ................................................................................................. 13
5.1 Purpose of the FibroScan® device................................................................................... 13
5.2 General front view........................................................................................................... 13
5.2.1 The standby button............................................................................................. 14
5.2.2 Monitor ............................................................................................................... 14
5.2.3 Software ............................................................................................................. 14
5.2.4 Keyboard............................................................................................................ 15
5.2.5 Probes................................................................................................................ 15
5.2.6 Tray.................................................................................................................... 16
5.2.7 Computer connectors ......................................................................................... 16
5.2.8 Probe connector ................................................................................................. 17
5.2.9 Casters and brakes ............................................................................................ 17
5.3 Right-hand side view ...................................................................................................... 17
5.3.1 Mains connector ................................................................................................. 17
5.3.2 Main switch ........................................................................................................ 18
5.4 Left-hand side view ......................................................................................................... 19
5.4.1 CD ROM – DVD ROM drive ............................................................................... 19
5.5 Rear view ....................................................................................................................... 19
6. WINDOWS............................................................................................................................... 21
6.1 login window (optional) ................................................................................................... 21
6.2 Archives window ............................................................................................................. 22
6.2.1 Patient examination-related data ........................................................................ 22
6.2.2 Results of the selected examination ................................................................... 22
6.2.3 List of archived examinations and sort criteria .................................................... 22
6.2.4 Control buttons ................................................................................................... 23
6.2.5 Information window ............................................................................................ 24
6.2.6 Acquire button .................................................................................................... 24
6.2.7 Open button ....................................................................................................... 24
6.2.8 Keyboard function keys (Archives window) ......................................................... 25
6.3 Acquisition window ......................................................................................................... 25
6.3.1 Patient-related information ................................................................................. 25
6.3.2 Ultrasound images ............................................................................................. 26
6.3.3 Pressure indicator .............................................................................................. 26
6.3.4 Elastogram ......................................................................................................... 27
6.3.5 Message area .................................................................................................... 29
6.3.6 Results area ....................................................................................................... 30
6.3.7 Measurements scroll button................................................................................ 31
6.3.8 Valid and invalid measurement counters ............................................................ 31
6.3.9 Success rate ...................................................................................................... 32

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6.3.10 Control buttons ................................................................................................... 32

6.3.11 Measurement reset ............................................................................................ 33
6.3.12 Keyboard function keys ...................................................................................... 33
7. EXAMINATION PRELIMINARIES ........................................................................................... 35
7.1 General plan ................................................................................................................... 35
7.2 Choice of probe .............................................................................................................. 36
7.3 Step 1: positioning the device ......................................................................................... 36
7.4 Step 2: connections ........................................................................................................ 37
7.4.1 Connecting the probe ......................................................................................... 37
7.4.2 Mains connection ............................................................................................... 38
7.4.3 Connecting a printer ........................................................................................... 38
7.5 Step 3: Start-up .............................................................................................................. 38
7.6 Step 4: Displayed window ............................................................................................... 39
7.7 Step 5: Entering patient information ................................................................................ 40
7.8 Step 6: patient positioning............................................................................................... 41
7.9 Step 7: operator positioning ............................................................................................ 42
7.10 Step 8: choice of measurement point .............................................................................. 42
7.10.1 Locating the measurement point ........................................................................ 42
7.11 Step 9: holding the probe ................................................................................................ 44
8. PERFORMING A NEW EXAMINATION .................................................................................. 45
8.1 Recommendations for use .............................................................................................. 45
8.2 Operating procedure ....................................................................................................... 45
9. ARCHIVE MANAGEMENT ...................................................................................................... 49
9.1 Keyboard function keys................................................................................................... 49
9.2 Opening the Archives window ......................................................................................... 49
9.3 Archives window ............................................................................................................. 50
9.4 Display the examination list............................................................................................. 50
9.5 Sort the examination list.................................................................................................. 51
9.6 Display an examination's global measurements .............................................................. 51
9.7 Display the details of an examination's measurements ................................................... 51
9.8 Delete an examination .................................................................................................... 52
9.9 Recover a deleted examination....................................................................................... 52
9.10 Print the results of an examination .................................................................................. 53
9.11 Export an examination .................................................................................................... 53
9.12 Import an examination .................................................................................................... 54
9.13 Export all examinations to Excel format .......................................................................... 55
10. F2A OPTION ........................................................................................................................... 57
10.1 Presentation ................................................................................................................... 57
10.2 Connecting the F2A Registration key ............................................................................. 57
10.3 Consulting the F2A Information ...................................................................................... 58
11. TURNING OFF THE DEVICE .................................................................................................. 61
11.1 Between two sessions .................................................................................................... 61
11.2 At the end of the day....................................................................................................... 61
12. CLEANING, MAINTENANCE AND REPAIRS ......................................................................... 63
12.1 Cleaning ......................................................................................................................... 63
12.1.1 Cleaning the FibroScan® device ......................................................................... 63
12.1.2 Probe ................................................................................................................. 63
12.2 Maintenance (probe calibration) ...................................................................................... 64
12.3 Troubleshooting .............................................................................................................. 65
12.4 Software updates ............................................................................................................ 65
13. SYMBOLS DISPLAYED ON THE FIBROSCAN® .................................................................... 67
13.1 Connectors ..................................................................................................................... 67
13.2 warnings ......................................................................................................................... 67
13.3 Marking and electrical safety........................................................................................... 67
14. TECHNICAL PROPERTIES..................................................................................................... 69
15. REGULATIONS ....................................................................................................................... 71
15.1 Electromagnetic emissions ............................................................................................. 72
15.2 Electromagnetic Immunity (1) ......................................................................................... 73
15.3 Electromagnetic Immunity (2) ......................................................................................... 74
15.4 Recommended separation distance ................................................................................ 75
16. INDEX...................................................................................................................................... 77

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USER MANUAL-DEVICE

1. PURPOSE OF THE 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.
Thus, after carefully reading the manual, operators shall be able to:
®
Connect peripheral elements (mains lead, USB devices, probes) and power up the FibroScan
instrument;
Position the probe in accordance with technical and clinical requirements;
Save the results displayed on-screen;
Archive and view examinations;
Disconnect and store the probes.
Echosens SA 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 the manual's incorrect interpretation. Though all efforts have been made to
offer a manual that is as accurate as possible, this latter may nevertheless contain some technical
inaccuracies and/or typographical errors.
Echosens SA 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
the present User Manual, Echosens SA 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 SA on simple request. Should any major modifications be made to the manual, however,
Echosens SA undertakes to send the physician, as rapidly as possible, a new copy of the manual in
hard copy or electronic format. It is stated that this does not involve updating the hardware and/or
software in your possession.
The product owner must keep the present manual for as long as the product is used.
The present manual contains a chapter for troubleshooting the most commonly encountered problems.
Any information or modification requests pertaining to this manual should be sent to:
Echosens SA
153 Avenue d’Italie
F - 75013 PARIS

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2. MISCELLANEOUS INFORMATION

2.1 GUARANTEE
The terms of guarantee are stated in the Echosens SA terms of sale documents.
For any request, Echosens SA remains available to the physician and his/her appointees and shall, if
applicable, transfer the request to a competent local representative.

2.2 RESPONSIBILITY
®
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 SA had been notified, would Echosens be
held responsible for the incorrect interpretation of these results; Echosens SA's liability being limited to
®
making the measurements, displaying them and storing them in the FibroScan .
Thus, it is also the responsibility of the operator, i.e. the physician or one of his appointees, holder of
the user certificate issued by Echosens SA, to ensure that saved examinations are archived.

2.3 PROPERTY AND COPYRIGHT

All manuals and documents of all types are the property of the company Echosens SA 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 SA. Hence, the reproduction,
adaptation or translation of the present manual without prior written consent is prohibited, within the
limits provided by copyright law.
All rights reserved.
Copyright Echosens SA – 2007.
First edition, September 2007.

2.4 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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2.5 REGISTERED TRADEMARKS

® ®
Echosens and FibroScan are registered trademarks of the company Echosens SA.
Microsoft Excel and Windows XP Embedded are registered trademarks of Microsoft Corporation in the
United States and other countries.

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3. RECOMMENDATIONS AND SAFETY

3.1 SYMBOLS
This symbol means:
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:

Additional information with no impact on instrument use.

3.2 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 the
medical device, the user must conform to the indications and symbols contained in the present manual.
Prior to installation, ensure that the usage and mains voltage values match.
®
The electrical power lead provided must be connected to the FibroScan mains connector and to an
®
earthed socket. Correct earthing operation can only be guaranteed if the FibroScan is connected to a
socket compliant with safety standards.
Safe use is no longer guaranteed in the following main, non-exclusive cases:
The device is visibly damaged;
The medical device doesn't work;
After prolonged storage under unfavourable conditions (see chapter 14);
After serious damage incurred during transport.
In the presence of flammable or anaesthetic gasses. This may cause an explosion. Do not take
the device to the operating theatre.
®
When the safe use of the FibroScan is no longer possible, the device must be taken out of operation.
Steps must be taken to avoid its inadvertent use. The medical device is entrusted to authorised
technicians for inspection.

3.3 MAINTENANCE-RELATED SAFETY

For all maintenance operations, the physician and his/her appointees should contact Echosens SA that
will send an authorised technician. These maintenance operations must not be performed by a
third party other than a technician authorised by Echosens. For correct and safe use and for all
maintenance operations, the personnel must conform to normal safety procedures.

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3.4 PATIENT SAFETY

®
The following instructions must be followed in order to ensure patient safety. Hence, the FibroScan
should not be used in the following situations:
On an 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.
On patients with ascites.
The personnel must follow normal safety procedures.

3.5 RECOMMENDATIONS FOR USE

®
The FibroScan is a diagnostic and monitoring assistance device. Echosens SA recommends making
10 measurements per examination in order to obtain a representative stiffness value. Results must
only be interpreted by a physician specialising in liver diseases, who is aware of the patient's pathology
and clinical context.

3.6 USER TRAINING

®
Only those individuals who have received training in the use of the FibroScan and who possess a
user certificate are authorised to conduct a liver stiffness measurement 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.

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4. HARDWARE SUPPLIED

When opening the package, ensure the contents match the following list.

4.1 BASIC DEVICE

The elements included are:
ELEMENTS
Assembled unit (upper chassis, lower chassis, tray fitted with keyboard and trackball, caster)
Mains lead
Case(s) fitted with a probe
Sealed envelope (Windows EULA license and the present FibroScan® User manual)
Tool kit, set of fuses
Installation manual
Configuration manual

4.2 ACCESSORIES
The available accessories are:
M probe.
S probe.
XL probe.
(see following page)

Devices not included Accessories

VGA monitor
M Probe

Overhead projector S Probe

USB support XL Probe

USB printer Other

accessories

Figure
1: elements that can be connected to the FibroScan®

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5. EXTERNAL PRESENTATION

5.1 PURPOSE OF THE FIBROSCAN® DEVICE

®
The FibroScan and its dedicated probes make up an active, non-implantable medical device using
ultrasound. Designed to rapidly measure liver stiffness in a painless and totally non-invasive manner.
®
The FibroScan is based on the one-dimensional pulse elastography technique. Each of the probes in
the range possesses specific properties and is designed for a distinct application.
®
The FibroScan probe comprises a single-element ultrasound transducer fixed to the shaft of the
electrodynamic transducer. This latter generates a transient vibration, which in turn generates an
elastic shear wave. This wave propagates through the skin, subcutaneous tissues, then through the
liver. During shear wave propagation, the ultrasound transducer performs a series of ultrasound
acquisitions (emission / reception) to measure the speed of s-wave propagation. Liver stiffness is
calculated from this s-wave propagation speed value.

Ultrasound transducer

Electrodynamic
transducer

Liver

Figure 2: principle of probe use

5.2 GENERAL FRONT VIEW

®
The FibroScan chassis encloses the electrical power supply, dedicated electronics and a computer. It
also serves as support for a monitor and a tray (keyboard, trackball and two probe holders). The unit is
approximately 135 cm high, 68 cm wide and 31 cm deep, for a weight of 46 kg.
®
The FibroScan is controlled by a dedicated software application that is automatically launched on
power up.

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

Screen

Probe-holder
On/Off button
Keyboard, trackball
Probe-holder
Computer sockets
Tray
Probe socket

Main
switch
Mains connector
Caster with brake

Caster with brake

Figure 3: general view of the FibroScan®

ID See § ID See § ID See §

5.2.2 5.2.8 5.2.6
5.2.6 5.2.9 5.2.1
5.2.6 5.3.1
5.2.7 5.3.2

5.2.1 The standby button

This button is only active if the main switch is in the I position (see
paragraph 5.3.2).

Pressing this button once loads the application; the built-in indicator light turns green. After a few
seconds, the archive window is displayed.
Pressing the button a second time closes the application; the built-in indicator light and monitor are
®
both turned off. This is the usual position when the FibroScan has not been in use for a short period of
®
time (between two patient groups for example). The FibroScan thus consumes less power.

5.2.2 Monitor
This is a 12-inch colour LCD monitor.

5.2.3 Software
®
It is automatically loaded when the FibroScan is turned on. It performs the following functions:
Examination implementation.
Management of archived examinations.
The two main windows are as follows:

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The Archives window that displays measurements made during previous acquisitions.
The Acquisition window that displays the data used to configure an acquisition and performs the
acquisition per se.
Both the Acquisition and Archives windows are covered in chapter 6.

5.2.4 Keyboard
Resting on the tray, it also includes a pointing device (trackball) and two buttons identical to those
found on a mouse.

Keyboard

Trackball
Buttons

Tray

Figure 4: the keyboard, pointing device (trackball) and buttons

5.2.5 Probes
®
A probe is connected to the FibroScan by means of a 1.5 m lead. Several types of probe are
available, each one possessing its own properties. The probes and their use are covered in specific
manuals.
As a general rule, a probe looks as follows:

Connection cable Jack

Ultrasound
transducer

Electrodynamic Button LED

transducer

Figure 5: probe example

®
The probe is the only part of the FibroScan that enters into contact with the patient. It comprises an
electrodynamic transducer (vibrator) and a measurement trigger button.

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Indicator lights (LEDs) display the probe's status as follows:

®
On during FibroScan start-up and when awaiting a measurement.
Off, at the start of a measurement.
On when the operator is applying the correct pressure to the patient's body. It is strongly advised,
however, that operators check the pressure applied on the monitor.

5.2.6 Tray
In addition to the keyboard, the tray features two probe holders placed on the left and right-hand sides.

Probe holder (right)

Keyboard

Probe holder (left)

Tray

Figure 6: the tray contains the keyboard and probe holders

5.2.7 Computer connectors

Located beneath the tray, these connectors are used to connect the following devices:
Ethernet 2 * USB 2.0

VGA monitor Keyboard - mouse

Figure 7: position of the computer connectors

Additional monitor connection: this SVGA outlet allows an additional monitor (retroprojector for
®
example) to be connected. The maximum distance between the FibroScan and the additional
monitor is of approximately 1.80 metres.
Ethernet connector: used by Echosens SA maintenance staff.
Two USB 2.0 connectors: connection of an external backup hard drive, USB key (see examination
export or import procedure on pages 53 and 54), or a USB printer (see printing procedure on page
52).
Keyboard / trackball connector: these connectors are always connected.

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5.2.8 Probe connector

Located under the tray, this connector is used to connect the measurement probe.

Jack
for probe

Figure 8: location of the probe connector

This connector is fragile. See paragraph 7.4.1, page 37, concerning the
probe cable connection and removal procedure.

The operator must follow this manual's recommendations (see paragraph

7.4.1, page 37) concerning plug connection and removal.

5.2.9 Casters and brakes

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

Caster brake

Figure 9: view of a caster with brake

5.3 RIGHT-HAND SIDE VIEW

5.3.1 Mains connector

®
The FibroScan must be connected to a 100 V of 230 V, single phase 50-60 Hz earthed mains outlet
via the power lead connected to the socket at the base of the chassis.
Correct earthing operation can only be guaranteed if the system is
connected to a socket compliant with safety standards.

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Main switch
Fuse location

Mains lead
connection
outlet

Figure 10: view of the main switch and connection outlet

5.3.2 Main switch

Located on the lower right-hand side, this switch has two positions:
®
Position 0: no voltage is present in the internal circuits of the FibroScan ; this latter does not
®
consume any 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 AC main supply is present in the internal circuits of the FibroScan . This is the
®
FibroScan's working position.
®
The top part of this switch unit is removable. It provides access to the two FibroScan protection fuses.
See the Configuration manual for further details.
The bottom part of the switch unit receives the mains lead plug connection outlet.

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5.4 LEFT-HAND SIDE VIEW

5.4.1 CD ROM – DVD ROM drive

Located on the upper left-hand side, this drive is used to re-install the software application.

No CD ROMs other than those provided by Echosens SA should be inserted

into the drive.

CD ROM and
DVD ROM drive

Figure 11: CD ROM – DVD ROM drive location

5.5 REAR VIEW

The rear panel only comprises the air vent.

Make sure that this ventilation is not obstructed, or the electronic equipment
could overheat, causing irreversible damage.

Air vent

Figure 12: rear view

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6. WINDOWS

6.1 LOGIN WINDOW (OPTIONAL)

If the « secured session » option is active when the device starts a login window will appear. This
window allows a secured access to patients data.

The activation of the login window is optional, see Configuration Manual

®
of the FibroScan .

To access the software, please proceed as follows:

Enter User name
Enter Password
Press <Enter> on the keyboard

The trackball is not activated in this window. You must use the Tab key to
change from the User name to the Password field.

Figure 13 : login window.

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6.2 ARCHIVES WINDOW

This window is covered in detail in chapter 9, page 49.

This window displays previous examinations. The data displayed in an archive window are presented
below. The use of this window is covered in chapters 7 and 0.

Sorting
options
Patient
examination-
related data List of
viewable
examinations
performed

Control
buttons
Examination
results
Information
window

Displays the Acquisition window Details of the selected examination

Figure 14: example Archives window

ID See § ID See § ID See §

6.2.1 6.2.3 6.2.6
6.2.2 6.2.4 6.2.7
6.2.3 6.2.5

6.2.1 Patient examination-related data

These data are those of the selected examination. There are completed by an examination duration
line labelled Examination duration. This indicator indicates time (hours, minutes and seconds) elapsed
since the moment the transducer was first applied to the patient.

6.2.2 Results of the selected examination

This window displays the results calculated at the end of the examination. See page 47, step 6.

6.2.3 List of archived examinations and sort criteria

All recorded examinations are displayed in the list. This list can be sorted by five criteria:
Patient code
Patient last name
Patient first name
Patient date of birth
Examination date
Operator name

Sort on patient's first name

Sort on patient's last name Sort by patient's birth year

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Sort by
Sort by patient operator
code name

Sort by
examination
date

Figure 15: selection of sort criteria in the Archives window

6.2.4 Control buttons

Button Function
Synchronises the list displayed with the contents of the hard drive
and restores any deleted examinations into this list. This operation
may take several minutes, depending on the number of
examinations archived. See § 9.9, page 52.
Deletes the selected examination from the displayed list.
Examinations deleted in this manner are not, however, actually
removed from the hard drive. They can be reintegrated into the list
by the <Refresh> button.
Exports the selected examination to a connected USB storage
device. See § 9.11, page 53.Export to Excel format is covered in
paragraph 9.13, page 55.
Imports an examination into the archive list from a USB storage
®
device connected to the FibroScan . See § 9.12, page 54.

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6.2.5 Information window

After selecting an examination from the archives list (Figure 14, ID 4), the series of measurements
made during the selected examination is displayed in the Information window.

The
examination
selected here...

... is displayed
here in detail

Figure 16: Example of examination measurement details

6.2.6 Acquire button

Clicking this button displays a blank Acquisition window (see paragraph 6.3, page 25).

6.2.7 Open button

To open an examination:
Double-click on the selected examination;
Or select the desired examination and click on <Open>.
The examination is displayed in the Acquisition window. Use the buttons to display the
examination's various measurements.

Elastogram.

Click on this arrows

to display other
measurements in
relation to current
exam.

Figure 17: examination view window

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The <Print> button is used to print the displayed elastogram, along with
the other examination-related measurements. See Figure 26, page 33 for
details.

6.2.8 Keyboard function keys (Archives window)

The keys listed below are keyboard shortcuts that avoid clicking the corresponding button with the
trackball.

Key Function Equivalent to

F1 Help - Exit help
F2 Displays the Acquisition window.

F3 Open an examination:

6.3 ACQUISITION WINDOW

A detailed description of the use of this window is given in chapters 7
and 0, pages 35 and 45.

The main data displayed in an acquisition window are presented below. Use of this window is covered
in chapter 0.
Ultrasound images Pressure indicator

Examination Elastogram
information (patient,
etc.)

Message window

Examination
result
Measurements scroll
button

Control button Counters

Figure 18: Acquisition window - example data displayed after an initial examination

ID See § ID See § ID See §

6.3.1 6.3.4 6.3.8
6.3.2 6.3.5 6.3.10
6.3.3 6.3.7 6.3.6

6.3.1 Patient-related information

The information displayed is that entered when starting a new examination (see paragraph 7.7, page
40). There are completed by an examination duration line labelled Examination duration. This indicator
displays time (hours, minutes and seconds) elapsed since the moment the transducer was first applied
to the patient.

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6.3.2 Ultrasound images

As soon as the probe makes contact with the skin, the ultrasound transducer switches to ultrasound
emission/reception mode.
The system displays two ultrasound images used to locate the zone meeting the measurement criteria:
One in time motion (TM) mode, one-dimensional greyscale image.
The other in A mode (current ultrasound signal amplitude).

Ultrasound signal in
Amplitude mode.

Ultrasound signal
in TM mode

Exploration
depth in mm

Display gain

Figure 19: image in TM (left) and Amplitude (right) modes

The display gain for both modes can be adjusted using the cursors in the bottom right-hand corner of A
mode.
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. Ultrasound emission/reception
mode also allows the operator to ensure that the measurement will not be disrupted by the presence of
large structures such as blood vessels.

6.3.3 Pressure indicator

The probe contains a sensor that measures the pressure applied by the operator to the patient. The
pressure level is given by:
The software: three-colour pressure indicator (orange/green/red).
The probe: blue LEDs.
Measurements may only be made when the pressure indicator is in the green zone.

Orange indicators: Green indicators: correct Red indicators: excessive

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insufficient pressure. pressure. pressure.

Figure 20: Example of pressure indicator display

Pressure indicator in red zone

A pressure indicator in the red zone indicates that the pressure applied is too high. The probe's
mechanical protection system may retract the transducer abruptly. The operator is notified by a
warning message displayed in the information window. The probe's LEDs are off and the probe button
is inactive. The Pressure too high message is displayed in the information window if the operator
presses the probe button.

The probe may be damaged if pressure is maintained within the red zone. A
protection procedure suspends the examination for 13 seconds if excessive
pressure is maintained for more than 3 seconds.

Pressure indicator in orange zone

A pressure indicator in the orange zone indicates that the pressure applied is too low to trigger an
stiffness measurement. The probe's LEDs are off and the probe button is inactive. The Pressure too
low message is displayed in the information window if the operator presses the probe button.

Pressure indicator in green zone

A pressure indicator in the green zone indicates that the pressure applied is correct. The blue LEDs
come on. The pressure applied allows an stiffness measurement to be triggered. The probe button is
active and ready to trigger an stiffness measurement.
The following figure shows the positions of the pressure indicator and information message.
Colour indicator Colour indicator
orange red

Insufficient pressure Excessive pressure

message message
Figure 21: Insufficient and excessive pressure messages

6.3.4 Elastogram
This image is displayed once the measurement is complete. It represents the levels of liver deformation
generated by the propagation of the shear wave as a function of time (horizontal axis in milliseconds)
and depth (vertical axis in millimetres).
The colour scale indicates the sign of the deformations (compression or dilatation). 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.

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Contrast button

Figure 22: Elastogram contrast adjustment buttons

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6.3.5 Message area

The following main error messages may be displayed.

Message Information or corrective measure

Electromagnetic disturbances Turn off all peripheral generators, or move the
®
FibroScan .
Printing error Repeat the print job.
Printing fatal error The problem can only be solved by rebooting the
®
FibroScan .
Fatal error during printing Turn the printer off, then on again.
Transfer complete The file has been copied to or from the USB key.
Transfer failure The USB medium is missing.
File not found The examination file cannot be found.
End of examination End of examination message.
Printer off line : check On/Off Connection problem, printer turned off.
switch and USB connection
Printer out of paper Add paper to the printer's tray.
®
No printer installed No printer has been installed on the FibroScan .
Low pressure The pressure exerted by the operator is too low.
High pressure The pressure exerted by the operator is too high.
Probe error. Check probe The lead's jack is not connected, poorly inserted, or
connection and retry the lead has been cut.
Probe not present The probe has been disconnected during
examination.
Probe error The probe is not connected. Connect the right
probe.
Incompatible probe, connect the The probe connected does not match the selected
right probe exam type. Connect the right and click <OK>.
Do not unplug the probe until the The probe must not be disconnected from the time
end of the exam. this message appears until the exam is completed.
Error: select an examination No examination type selected. Select one
examination type and click <OK>.
®
Hardware error Internal FibroScan fault. Contact the after-sales
service.
Printing process still in The previous print job has not finished. Wait for it to
progress… finish before starting the next job.
Probe not found. Connect probe The lead's jack has been disconnected, poorly
and retry. inserted, or the lead has been cut.
Probe over heat The probe's temperature is higher than the defined
limit. The probe is deactivated until its temperature
has dropped.
Vibration error Incorrect transducer movement.

For fee-for-service units equipped with mode F2A

Insert a valid License Key to run
only, insert the registration key into one of the two
exam.
USB ports to carry out an exam.

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6.3.6 Results area

The area for displaying these data is shown below.

Measurement
results area

Figure 23: displaying results

Stiffness (kPa)
Stiffness is expressed in kilopascals (kPa).
The final examination result is displayed in
green in the results window. This value is the
median of all valid measurements performed Stiffness
during the examination. value
To obtain a reliable and representative liver
stiffness measurement, at least ten valid
measurements should be made.

Interquartile range (IQR – kPa)

The interquartile range (IQR) is expressed in
kilopascals (kPa). It represents the interval
around the median within which will fall 50% of
all valid measurements.

Interquartile
range

When the number of valid measurements is equal to 1 (see following

paragraphs), the IQR is undefined and is not displayed.

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Current stiffness (CE - kPa)

The current stiffness is expressed in
kilopascals (kPa). It represents the stiffness
value of the last measurement made.
In case of invalid measurement, no value is
displayed.

Current
stiffness

6.3.7 Measurements scroll button

These buttons are available when viewing archived examinations. These arrows allow the operator to
browse from one measurement to another.

Measurements scroll
button

Figure 24: position of the measurement scroll buttons

6.3.8 Valid and invalid measurement counters

This area shows:
The number of the last valid measurement.
The number of valid measurements.
The number of invalid measurements.

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Test number

Number of valid
measurements

Number of invalid
Counters measurements
Figure 25: Counter positions and details

When the number of valid measurements is equal to 1, the IQR is

undefined and is therefore not displayed.

6.3.9 Success rate

The measurement is automatically rejected by the calculation algorithms if the elastograms are
unsatisfactory.
The software thus calculates a "success" rate in %, displayed in the lower left-hand corner of the
window. This value corresponds to the ratio of the number of valid measurements to the total number
of measurements performed.

6.3.10 Control buttons

This area displays the following buttons:

Button Function
Closes the Acquisition window and displays the Archives window
(see paragraph 6.2).
Opens the patient data input window (see paragraph 7.6, page 39)
in view of starting a new examination.
Closes the current examination and displays the summary of
examination results (see page 47).
Prints the patient examination results: elastogram, TM mode, A
mode, stiffness, IQR, along with the validated measurement results.

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Figure 26: printout example

6.3.11 Measurement reset

All examination measurements can be cancelled at any time by pressing the space bar. The patient's
data, displayed in the left-hand part of the window, are saved.

6.3.12 Keyboard function keys

Keyboard function keys

Key Function Equivalent to

F1 Help - Exit help
F2 Displays the Archives window.

F3 Start / End

F4 Print

Space bar Deletes the current measurements

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7. EXAMINATION PRELIMINARIES

7.1 GENERAL PLAN

This paragraph presents a summary of the examination procedure,
providing the operator with a general overview. Paragraphs 7.3 and
subsequent, however, must be read for an exhaustive description of the
procedure.

The liver stiffness measurement examination is conducted by the intercostal route on the right hepatic
lobe. For this, the patient must be lying on an examination bed in a supine position, with the right arm
at maximum abduction.
The TM and A mode display serves to ensure that the probe is correctly positioned.
To obtain reliable results, an area should be selected that presents a portion of liver corresponding at
least to the measurement depth explored by the selected examination (see paragraph 5.2.5, page 15),
with no large vascular structures and sufficiently far from the edges of the liver. The area usually
selected to perform a biopsy puncture may be suitable.
Once a suitable area has been located, the probe should be held perpendicular to the skin surface and
the pressure applied should be progressively increased until the pressure indicator on the monitor
window indicates a correct pressure. The measurement can then be triggered by pressing the probe's
button.
The software automatically rejects any measurements that cannot be interpreted. To obtain a
representative measurement of liver stiffness, 10 valid measurements should be performed and the
median value used.
The patient's examination is then archived and may be called up at a later date.

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7.2 CHOICE OF PROBE

The recommendations for using the M and S probes are defined by the patient's morphological data, in
particular his/her thoracic perimeter (TP). Four types of examination are therefore possible,
corresponding to specific measurement depths that take into account both the liver's depth beneath the
skin and its size.

TP: thoracic perimeter measured at the xiphoid

SCD: skin-to-capsule distance at the point where hepatic stiffness is measured

7.3 STEP 1: POSITIONING THE DEVICE

Proceed as follows:
®
Position the FibroScan as shown in the following figure.

Figure 27: relative patient, operator and device positions

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Lock both caster brakes.

Caster brake

Figure 28: locking the caster brakes

7.4 STEP 2: CONNECTIONS

7.4.1 Connecting the probe

Connect the selected probe to the probe socket on the instrument's front panel, below the tray.
To insert the probe jack: align the probe lead jack's red dot with the socket's red dot and insert
the jack.
Both the jack and socket are fragile elements. Handle with care.

Red dot on project jack Red dot on probe socket

Figure 29: to connect the probe lead, insert the jack after aligning the red dots

To remove the probe jack: first pull the jack's splined sleeve back to unlock it, then pull the
whole jack back.
A probe may be disconnected for replacement with another probe
between two examinations. If the probe is disconnected during an
examination, this latter is automatically closed.

When starting an exam, be sure to follow the instruction in this message:

“Do not unplug the probe until the end of the exam.”

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Jack Splined sleeve

Figure 30: disconnecting the probe

7.4.2 Mains connection

Connect the mains plug to an earthed mains socket.
Correct earthing operation can only be guaranteed if the system is
connected to a socket compliant with safety standards.
®
To avoid disconnecting the mains lead, do not move the FibroScan when
turned on.

7.4.3 Connecting a printer

If necessary, you can connect a USB printer to one of the two USB ports.

USB sockets (2)

Figure 31: position of the two USB sockets

The printer driver must have been previously installed, as described in

the Configuration manual.

7.5 STEP 3: START-UP

1. Flip the main switch to position 1 (Figure 32).
2. Press the On-Off button (Figure 32).
User name and Password are defined during the set up of the device. To change them, see
®
instructions in the Configuration Manual of the FibroScan . The operating system and

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measurement software boot up automatically. The fan is powered up and the On-Off button lights
up.

On-Off
Main switch button

Figure 32: position of the main switch and On-Off button

7.6 STEP 4: DISPLAYED WINDOW

Once the start-up process is complete, the Archives window is displayed.

Figure 33: example Archives window

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Start-up time is dependent upon the number of archived examinations.

For reasons of confidentiality, the currently displayed data should be
erased. For this, click:
- on the <Acquisition> button if the currently displayed window is the
Archives window.
- on the <Start> button if the currently displayed window is the
Acquisition window.

7.7 STEP 5: ENTERING PATIENT INFORMATION

Patient 1. Enter the patient's information as
follows into the form displayed:
NB: only the Last name or Code
fields are required to start the
examination.

Operator
- Last name: last name.
- First name: first name.
Available
examinations - Code: freeform file number for
example.
- Date of birth: date of birth in
numerical form (DDMMYY)
- Operator: name of the operator
conducting the examination.
2. Select the "SMALL 1", "SMALL 2",
"MEDIUM" or “XL” examination
according to the patient's thoracic
perimeter (see § 5.2.5).
Check that the connected probe
corresponds to the selected
examination. If the probe does not
match, the message "Incompatible
probe, connect the right probe" is
Available displayed.
examinations

3. Click on <OK> to validate data

entry.
Clicking on <Cancel> returns to the
Acquisition window.
4. . Follow the instruction in this
message: “Do not unplug the probe
until the end of the exam.”

5. The window now displays the

Patient-related information entered patient's information.
The current date and examination
duration are also displayed.
The probe is activated; the
examination can start.

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Total duration of the current examination

Current date

7.8 STEP 6: PATIENT POSITIONING

The patient must be lying on an examination bed in a supine position, with the right arm at maximum
abduction.

Figure 34: patient positioning, right arm at maximum abduction

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7.9 STEP 7: OPERATOR POSITIONING

®
The operator sits on a height-adjustable chair, facing between the patient's thorax and the FibroScan
®
in such a manner as to be able to simultaneously observe the FibroScan monitor and the probe's
position on the patient. Resting the right elbow on the examination bed allows the probe to be held
steady.

Figure 35: operator positioning

7.10 STEP 8: CHOICE OF MEASUREMENT POINT

7.10.1 Locating the measurement point

®
The FibroScan requires the use of a neutral contact gel for ultrasound
imaging. Before starting an examination, ensure that the recommended
product is available.

To obtain reliable results, an area should be selected that presents a portion of liver corresponding at
least to the measurement depth explored by the selected examination (see paragraph 5.2.5, page 15),
with no large vascular structures and sufficiently far from the edges of the liver. The area usually
selected to perform a biopsy puncture may be suitable.
Proceed as follows:
1. Measurements are performed on the right lobe of the liver by the intercostal route. To locate the
examination area, move from the xiphoid process perpendicular to the median axillary line and
locate the intercostal space (figure 36). Place a drop of gel onto the skin at the measurement
point.

Do not overload the measurement point with gel to avoid it penetrating

into the body of the probe; this latter is not sealed.

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Xiphoid process

Drop of gel

Axillary line

Figure 36: locating the measurement point

2. Hold the probe as shown. During measurements, continuously make sure that the probe is
maintained perpendicular to the skin surface of the patient.

Patient Operator Probe

Figure 37: gripping the probe

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3. On the ultrasound images, simultaneously check that:

- TM Mode area: the detected area presents a uniform liver structure characterised by a lamellar
appearance.
- A Mode area: the amplitude curve is linear.

TM mode shows a A mode is linear

lamellar aspect.

Figure 38: validation of ultrasound signal quality

Do not move the probe when in contact with the patient to avoid exerting
lateral stress on the transducer.

7.11 STEP 9: HOLDING THE PROBE

The probe must be held perpendicular to the patient's skin. All hand movements must be avoided while
a measurement is in progress.

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8. PERFORMING A NEW EXAMINATION

This chapter describes the different phases constituting an examination. The operator should follow
these instructions once the steps defined in the previous chapter have been performed.

During examination of a patient, the measurements are automatically

saved to the instrument's hard drive. Thus, in the event of a power
failure, any measurements made shall once more be available when the
®
power returns and the FibroScan is turned on.

8.1 RECOMMENDATIONS FOR USE

The following recommendations must be followed during the different phases of an examination.
During the measurements, the probe should be held perpendicular to the patient's skin.
Avoid probe impacts.
Do not immerse the probe, when cleaning for example.
Avoid any liquid projections on the medical device.
The probe must be cleaned and disinfected with a suitable product (see chapter 12, page 63 for
probe maintenance details).
After use, the probe should always be placed on one of the holders.
Do not lean on the tray.

8.2 OPERATING PROCEDURE

Proceed as follows:
Making a measurement
1. The Acquisition window is
displayed.

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2. As soon as the probe is applied to

the patient's skin, the A and TM
mode images are displayed. Check
that the pressure exerted is correct
(the pressure indicator lights are
green) and that the probe is held
perpendicular to the surface of the
patient's skin.

Pressure indicator

3. Avoid any probe movement before

pressing the probe's measurement
button.
4. Press the probe's button to perform
the measurement. Acquisition lasts
less than one tenth of a second.
Hold the probe in place to take a
second measurement if necessary.
Two progress bars are displayed
Button successively in the information
S window (successive File transfer
and Data analysis messages).
Reading the result
5 The following results are displayed:
- Elastogram. Adjust the contrast
using the buttons in order
to improve sensitivity and to better
distinguish the edges of the
elastogram.
- Numerical results: Stiffness,
success rate, IQR, current value
(CS).

Numerical results

Image of the deformation

Contrast adjustment

The IQR value is displayed from the

2nd measurement onwards.
The counters (bottom right) indicate
the numbers of valid and invalid
measurements.
- Ten measurements must be
collected for a full examination. If
not, the probe can be removed.
A33

IQR Counters

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End of examination
6. Click on <End> to deactivate the
probe.
The final result is displayed in
green under the Stiffness (kPa)
line.

Final results <End> button

7 The window displays the results of

the examination.
The final result is displayed on the
Stiffness (kPa) line.
Click on <OK> to close the
examination.
Click on <Export> to export the
examination to a USB stick.

<OK> button <Export> button

8 Remove any excess gel from the

probe and disinfect it, head
pointing downwards, before
placing it on its holder.
9. The Acquisition window is once
more displayed; it displays the last
examination performed.

<End> button

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If measurements need to be
displayed for analysis, click on the
keys in the bottom right-
hand corner of the window.

Last examination measurement

display keys.

Printing the results

10. click on the <Print> button, or press
the [F4] key on the keyboard.

Print results
key.

Starting a new examination

11. Before the arrival of a new patient,
click on <Start> to preserve data
confidentiality.

<Start> button

The new patient information input

window is displayed and the
Acquisition window in the
background is empty.

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9. ARCHIVE MANAGEMENT

This chapter describes the actions that can be performed from the Archives window. This window
displays the list of all archived examinations.

9.1 KEYBOARD FUNCTION KEYS

The keys listed below are keyboard shortcuts that avoid clicking the corresponding button with the
trackball.

Key Function Buttons

F1 Help - Exit help

F2 Displays the Acquisition window.

F3 Open an examination:

F4 Not used.

9.2 OPENING THE ARCHIVES WINDOW

Proceed as follows:
1. When the Acquisition window is
displayed, click on the <Archives>
button. Go to the next paragraph.
NB: the Archives window is
automatically displayed after the
®
FibroScan boots (go to next
paragraph).

Archives button

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9.3 ARCHIVES WINDOW

The window is as shown below:
See the various following paragraphs
depending on the action to perform.

Function See §
Display the examination list 9.4
Sort the examination list 9.5
Update the examination list 9.9
Display an examination's global measurements 9.6
Display the details of an examination's measurements 9.7
Delete an examination 9.8
Print the results of an examination 9.10
Export an examination to FIB format via the USB port 8.2; 9.11
Import an examination from FIB format via the USB port 9.12
Export all examinations to Excel format via the USB port 9.13

9.4 DISPLAY THE EXAMINATION LIST

As soon as the Archives window is
displayed, the list of examinations is
visible.

Examinations list

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9.5 SORT THE EXAMINATION LIST

Sort buttons After displaying the Archives window,
click on the arrow icons located above
the list of examinations.
These icons (from left to right) are used
to sort as follows:
Code (freeform text).
Patient last name.
Patient first name
Patient date of birth
Examination date
Operator name
Examinations list
Clicking the same arrow icon reverses
the sort order.

9.6 DISPLAY AN EXAMINATION'S GLOBAL MEASUREMENTS

Select the examination 1. Select an examination from the list
().
2. The measurements are displayed in
the lower pane ().

to display the
measurements

9.7 DISPLAY THE DETAILS OF AN EXAMINATION'S MEASUREMENTS

Select the examination 1. Select an examination from the list
().
2. The measurements are displayed in
the lower pane ().
3. Click on the <Open> button or
double-click on the desires
examination.

Measurements
displayed Click on Open

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Examination displayed 4. The Acquisition window displays one

of the measurements .
5. You can view the different
measurements by clicking the
buttons ().
6. Return to the Archives window by
clicking on the <Archives> button
().

Back Measurements
next/previous

9.8 DELETE AN EXAMINATION

Select the examination 1. Select an examination to delete from
the list ().
2. Click on the <Delete> button ().
3. A confirmation dialogue is displayed.
Click on <Yes> to confirm.
4. The examination is deleted from the
list.
NB: this examination is not actually
removed from the hard drive. They can
be reintegrated into the list by the
<Refresh> button. ('See paragraph
9.9).

Delete button

9.9 RECOVER A DELETED EXAMINATION

1. Click on <Refresh> to restore an
examination deleted from the
archive list.
2. On receipt of the refresh request,
the message "Do you want to
restore the deleted files" is
displayed.
- Click on Yes to restore the deleted
files (see paragraph 9.8).
- Click on No to cancel the
procedure.

Refresh button

9.10 PRINT THE RESULTS OF AN EXAMINATION

Ensure that a USB printer is connected to the USB port (see paragraph
5.2.7, page 16).

Select the examination 1. Select an examination to print from

the list ().
2. Click on the <Open> button ().

Click on Open

Examination displayed 3. The Acquisition window displays one

of the measurements.
4. Select the measurement for which
the TM and A modes and
elastogram should be printed by
using the keys ( ).
5. Click on the <Print> button. A
summary sheet is printed (see
figure Figure 26, page 33).
6. Return to the Archives window by
clicking on the <Archives> button

Back Print
Measurements
next/previous

9.11 EXPORT AN EXAMINATION

Ensure that a USB storage device is connected to the USB port (see
paragraph 5.2.7, page 16).
The measurement files making up the examination are transferred to the
USB storage device. These files, that possess an FIB extension, can only
®
be read by the FibroScan .
If there is not enough space on the USB storage device, a message is
displayed.
A full examination, normally comprising 10 measurements, takes up
approximately 5 Mb of disc space.

Select the examination 1. Select an examination to export

from the list ().
2. Click on the <Export> button ().
3. A dialogue box displays the
message "Do you wish to render
the data anonymous?".
- Click on <Yes> to transfer the data
without any patient-related
information.
- Click on <No> to transfer all data.
4. Click on <OK> to close the transfer
complete dialogue box.
Click on Export 5. The examination file is now on the
USB storage device.
The following dialogue boxes are displayed during transfer to a USB storage device:

Message Information or corrective measure

Transfer failure : file already exists The file has already been transferred to the USB
on the disk storage device
Transfer failure : export disk full Not enough space on the USB storage device, no
storage device connected to the USB port
Transfer failure : export disk not No USB storage device connected.
found

9.12 IMPORT AN EXAMINATION

Ensure that a USB storage device is connected to the USB port
(see paragraph 5.2.7, page 16).
The measurement files making up the examination are transferred from
the USB storage device.

1. Click on the <Import> button ().

Click on Import

2. If there are several examinations on

the USB storage device, select the
one to import using the <> keys.
3. Click on <Import>.
Transfer is impossible if the file to
be imported already exists on the
Select the examination ®
FibroScan's hard drive.
Click on Import
4. Click on <End> to close the
dialogue box.
5. On return to the Archives window,
sort the files to position the
imported file(s) as desired (by
default, imported files are added to
the bottom of the list).

9.13 EXPORT ALL EXAMINATIONS TO EXCEL FORMAT

Ensure that a USB storage device is connected to the USB port (see
paragraph 5.2.7, page 16).
All examination files present in the Archives list are systematically
transferred to the USB key in Excel format (XLS extension). They can
thus be read by an Excel spreadsheet.

The F2A registration key cannot be used to save data. If there are no
more USB ports available, remove the F2A registration key and insert a
USB data key.

1. On the keyboard successively press

(must be in this order) the Ctrl, right
Shift and X keys.
2. Release the X key, followed by the
other two keys.

CLAV
3. Select an export option: anonymous
or not
4. Select the decimal separator <.> or
<,>.
5. Click on <OK> to export or <Cancel>
to cancel the operation

5. All examination files are now on the

USB key. File names are defined as
follows:
List_Date_Time.XLS
6. Remove the USB key and open the
file on a PC running Excel.
See the following paragraph for
additional details of the Excel files
generated.

The resulting Excel file is a table containing the following sections:

Title Meaning
LASTNAME : Patient information
FIRSTNAME :
CODE :
BIRTHDATE :
OPERATOR : Generally the operator's initials.
DATE : Examination date.
TIME : Examination start time.
DURATION : Duration of the examination.
EXAMINATION : Type of examination performed.
STIFFNESS : Median stiffness of valid measurements.
IQR : Interquartile range of valid measurements.
TOTAL : Total number of measurements made.
VALID : Number of valid measurements.
SUCCESS RATE : Displayed as a percentage (corresponds to the number of
valid measurements divided by the total number of
measurements for this examination).
Each column corresponds to one stiffness measurement.

10. F2A OPTION

10.1 PRESENTATION
Option F2A is only available on units configured in the fee-for-service mode.
A registration key containing exams credits and an expiry date for validity is required to use this mode.
®
The registration key must be connected to the FibroScan unit if exams are to be carried out. The <F2A
info> key allows the user to consult the number of exams remaining and the expiry date of the
registration key. An alarm that can be programmed will alert you when there are no more exams credits
left (see 10.3). The registration key will expire when the number of remaining exams is zero, or when
the period of validity has expired. When this happens, connect a new registration key.
®
When FibroScan is in use, we recommend that the key remain connected in one of the USB ports.
For information on setting up the fee-for-service mode, contact the Echosens Customer Service
department.

Do not use the registration key for any other function than the one
intended by Echosens SA, or else the credits will disappear.

10.2 CONNECTING THE F2A REGISTRATION KEY

Connect the registration key to one of the two USB ports (see Figure 39), preferably before turning on
®
the FibroScan unit or in the Archives window. Leave the key connected for the entire time that the unit
is being used.

Connecteurs (2) USB

Figure 39 : USB Connectors

The F2A registration key cannot be used to save data.

If there are no USB ports available for connecting a key to save data, you
can disconnect the registration key, rather than the printer.

If the registration key is not connected to the exam launch, you will see the message “Insert a valid
License Key to run exam.” appear on the screen.
The credits are debited when the exam is launched. If no valid measurement is made, the exam will not
be counted.

If the registration key is disconnected during the exam, it will be debited

even if no valid measurement is made.

10.3 CONSULTING THE F2A INFORMATION

The <F2A info> key lets you consult the number of exams remaining and validity date of the
registration key (see Figure 40).

Bouton <F2A info>

40: Archive screen with <F2A info> key

1. Click on <F2A info>.

2. “Remaining exams” indicates the
available exam credits.
3. “Remaining days” indicates the
number of days remaining before
the registration key expires.
4. A message will appear when there
are no more exams remaining on
the registration key, or when the
expiry date is close: “The license
key will expire soon.”
1. If the registration key is not
connected, the message “Key
absent” will appear.
- Click on <OK> to close the
window.
- Connect the registration key into
one of the two USB ports.
2. Click on <F2A info> to view the
information.

®
The registration key is write-protected for FibroScan only.

The warning message can be programmed. Consult your Echosens

maintenance service for help if the timing of the message is not suitable
for you.

A new registration key should be obtained in advance so that you are

always ready to carry out an exam.

11. TURNING OFF THE DEVICE

11.1 BETWEEN TWO SESSIONS

®
Turn the FibroScan off by pressing the On/Off button in the bottom right-hand corner of the monitor.

On-Off
button

Figure 41: position of the On/Off button on the monitor

11.2 AT THE END OF THE DAY

®
Always start the FibroScan shutdown phase by pressing the On/Off
button in the bottom right-hand corner of the monitor.

®
The FibroScan powers down once the On/off button, in the bottom right-hand corner of the monitor
has been pressed.
Cut the power supply by setting the main switch to 0.

On-Off
button Main switch

Figure 42: position of the On/Off button on the monitoring and of the main switch on the lower part of the
chassis

12. CLEANING, MAINTENANCE AND REPAIRS

In the event of failure, only the staff of Echosens SA or its local

®
representative is authorised to work on the FibroScan and its
accessories. Any work by non-qualified personnel will lead to termination
of guarantee.

12.1 CLEANING

12.1.1 Cleaning the FibroScan® device

This shall be limited to regularly wiping the instrument using a wipe soaked with a non-aggressive,
alcohol-free product.

12.1.2 Probe
As the probe is not completely sealed, it should never be immersed. The
probe cannot be sterilised.

Between two patients, remove any excess gel and decontaminate the end
of the probe

Remove any excess gel

At the end of each examination:
Hold the probe with the transducer pointing downwards.
Gently remove the gel with a wipe.

Wipe

Figure 43: cleaning the probe with a wipe

Decontaminating the probe

Wipe the tip of the probe (transducer and probe body) with a paper wipe soaked in one of the following
solutions:
Sodium hypochlorite,
Ammonium propionate (type Anios surface haute or Dakin).

Do not use alcohol-containing solutions.

12.2 MAINTENANCE (PROBE CALIBRATION)

The probe contains mechanical parts that may shift slightly over time. Consequently, it should be
calibrated every 6 months, or every 20,000 vibrations (whichever occurs first).

As soon as one of these two deadlines is reached, an icon representing the probe in red is displayed in
the information window.
The user then has one month to send the probe to Echosens SA for calibration.
Despite the presence of the icon, the operator can perform examinations as usual. We strongly
recommend, however, sending the probe for calibration as rapidly as possible.

Calibration icon

Figure 44: position of the calibration icon

12.3 TROUBLESHOOTING
Event Solutions
The probe is no longer Contact Echosens SA or its local representative.
calibrated

The On/Off button doesn't Check that the instrument is connected to a

work. When pressed, the correctly powered mains socket (test another
instrument won't turn on. electrical device on this same socket) and that the
main switch is in the I position.
Have the main switch's fuses checked by the
maintenance department.

The On/Off button is lit, but Turn the instrument off, then on again.
the software doesn't boot.

"Hardware error" message. Check that the probe is correctly connected.

"Vibration error" message. Incorrect transducer movement.

In the event of a failure or malfunction, please contact Echosens SA (http://www.echosens.com) or its

local representative.

12.4 SOFTWARE UPDATES

Software updates may only be applied by qualified personnel.

13. SYMBOLS DISPLAYED ON THE FIBROSCAN®

13.1 CONNECTORS

VGA outlet

Ethernet connector RJ45

USB connector

Probe connector

13.2 WARNINGS

Do not block the vents

To be open by qualified maintenance staff only

13.3 MARKING AND ELECTRICAL SAFETY

CE marking and notify body identification number
nd
Certificate affixed on 2 December 2003

®
The FibroScan uses a flat lithium 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 the city waste processing service for the
address of the nearest battery deposit location.
®
Do not discard the FibroScan and it(s) probe(s) with ordinary household
waste. Contact the local electrical and electronic waste processing service for
instructions.

Protective earth (ground)

Warning high voltage

Alternating current

4.0 AT temporized fuses

Applied part type B

Standby mode

I
On/Off
O

14. TECHNICAL PROPERTIES

0459
Manufacturer Echosens, SA
153 Avenue d’Italie
75013 Paris – France
®
Model FibroScan 502

Computer properties
Operating system Windows XP Embedded.
Hard drive Minimum 80 Gb

Metrological performance
NB: the measured variable is stiffness, referred to as "S".
Ultrasound transducer See specific instructions.
Metrological performance S min.: 1.5 kPa
S max.: 75 kPa
Precision: ± 0.5 kPa

Classification Class IIa according to directive 93/42/EC

Electrical classification Class I, type B

Group I class A relative to CISPR 11.

IPX0: The instrument without probe is not
protected against liquids.

Operating mode Uninterrupted service, with intermittent charging.

Charge time = Tcharge = 10 min.
Rest time = Trest = 15 min.

Electrical properties
Power supply 100 - 230 V (+10%/-15%) ~ 50–60 Hz
Usable power 250 VA
Fuse 2 x 4.0 AT

Mechanical properties
Dimensions 1.35 x 0.68 x 0.61 m (H x W x D)
Weight 46 kg (without probes)

Environmental properties
Operating temperature +10 to +40 °C (+50 to +104 °F)
Operating humidity 30 to 75% relative humidity, non-condensed.
Storage temperature -20 to +70 °C (-4 to +158 °F)
Storage humidity 10 to 85% relative humidity, non-condensed.

Hardware supplied
Cables provided 1 x CEE22 mains lead (length 2 m)
1 x Probe cable (length 1.5 m)

15. REGULATIONS

Electromagnetic interference (EMI) is a signal or emission, conveyed through open space or through
electrical or signal conductors, which may severely disrupt radionavigation 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, radiodetection, air traffic control, radio paging and GSM
systems. These authorised services, along with unwilling disrupters, 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.

15.1 ELECTROMAGNETIC EMISSIONS

The FibroScan 502 is designed for use in the electromagnetic environment defined below. FibroScan
customers or users must ensure that it is indeed used in such an environment.

Emission test Compliance Electromagnetic Environment - Recommendations

The FibroScan 502 uses RF energy for its internal
functions only. Consequently, its RF emissions are
RF CISPR11 emissions Group 1
very low and unlikely to cause any interference with
nearby electronic equipment.
RF CISPR11 emissions Class A
Harmonic emissions The FibroScan 502 may be used on all premises
Class A
EN 61000-3-2 other than domestic premises and those directly
Voltage fluctuations/Oscillating connected to the public low voltage energy grid used
emissions Applicable to supply domestic buildings.
EN 61000-3-3

15.2 ELECTROMAGNETIC IMMUNITY (1)

The FibroScan 502 is designed for use in the electromagnetic environment defined below. FibroScan
customers or users must ensure that it is indeed used in such an environment.

Immunity test IEC 60601 test level Compliance Electromagnetic Environment -

Recommendations
Electrostatic Discharge ±6 kV contact ±6 kV on contact Floors should be wooden, concrete
IEC 61000-4-2 or ceramic. If the floor is covered
±8 kV air ±8 kV through air with a synthetic material, the relative
humidity must be of at least 30%.
Spike/Burst ±2 kV supply ±2 kV supply The quality of the electrical network
IEC 61000-4-4 must be that of a typical commercial
±1 kV input/output ±1 kV input/output or hospital environment.
Voltage shocks Differential mode Differential mode The quality of the main supply must
EN 61000-4-5 ±1 kV ±1 kV be that of a typical commercial or
hospital environment.
Common mode Common mode
±2 kV ±2 kV
Voltage drops, short <5% UT The quality of the electrical network
interruptions and supply For 10ms <5% UT must be that of a typical commercial
inlet voltage variation For 10ms or hospital environment. If the
IEC 61000-4-11 40% UT FibroScan 502 user requires
For 100ms 40% UT continuous operation during mains
For 100ms power cuts, the FibroScan 502
70% UT should be connected to an
For 500ms 70% UT uninterruptible power supply or
For 500ms battery.
<5% UT
For 5s <5% UT
For 5s

Magnetic field immunity 3A/m 3A/m Supply frequency magnetic fields

at supply frequency (50- must be those of a typical
60 Hz) commercial or hospital environment.
IEC 61000-4-8
NB: UT is the mains supply voltage measured before conducting the test

15.3 ELECTROMAGNETIC IMMUNITY (2)

The FibroScan 502 is designed for use in the electromagnetic environment defined below. FibroScan
customers or users must ensure that it is indeed used in such an environment.

IEC 60601 Electromagnetic Environment -

Immunity test Compliance
test level Recommendations
Portable and mobile RF
communication devices must be kept
away from the FibroScan 502
(including its cables), at a greater
distance that the recommended value
calculated from the equation
applicable to the emitter frequency.

Recommended separation distance

Conducted RF
IEC 61000-4-6
3 Vrms 3V
150 kHz to 180 kHz d=1.17 P

0.1 Vrms 0.1 V

180kHz to 22MHz d=35 P

3 Vrms 3V
22MHz to 80 MHz
d=1.17 P

Radiated RF 3V/m 3 V/m

IEC 61000-4-3 80 MHz to 2.5 GHz
d=1.17 P 80 MHz to 800 MHz

d=2.33 P 800 MHz to 2.5 GHz

where P is the maximum emitter

power in Watts (W), as specified by
the emitter manufacturer and d is the
recommended separation distance in
metres (m).

The EM field force for fixed emitters,

as defined by an electromagnetic
A
study of the site, must be less than
the compliance level in each of the
B
frequency bands .

Interference may occur in the vicinity

of devices bearing the following
symbol:

NB 1: at 80 MHz and 800 MHz, the upper frequency band is applicable

NB 2: These recommendations may not be applicable in all cases. Electromagnetic propagation is affected by
absorption and reflection caused by structures, objects and individuals.
A
The force of EM fields for fixed emitters such as commercial AM/FM radio broadcasting services, television,
cell phone services, radiodetection, 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 force of the fields measured at the location where the FibroScan 502 is used exceeds the
above-mentioned compliance levels, correct operation of the FibroScan 502 must be checked. If abnormal
performance is observed, additional measurements may be required after, for example reorienting or moving the
FibroScan 502.
B
Beyond the 150 kHz – 80 MHz band, the force of EM fields must be less than 3V/m

15.4 RECOMMENDED SEPARATION DISTANCE

(between portable or mobile RF communication devices and the FibroScan 502)
The FibroScan 502 is designed for use in an electromagnetic environment in which RF disturbance is
controlled. FibroScan 502 customers or users may prevent interference by maintaining a minimum
distance between portable or mobile (transmitter) RF communication devices and the FibroScan 502,
as recommended below according to the transmitter's maximum power.

Maximum Separation distance according to transmitter frequency (m)

transmitter 150kHz to 180kHz to 22MHz to 80MHz to 800MHz to
emission power 180 kHz 22MHz 80MHz 800MHz 2.5GHz
(W) d=1.17 P d=35 P d=1.17 P d=1.17 P d=2.33 P
0.01 0.12 3.50 0.12 0.12 0.23
0.1 0.37 11.01 0.37 0.37 0.74
1 1.17 35.00 1.17 1.17 2.33
10 3.70 110.70 3.70 3.70 7.37
100 11.70 350.00 11.70 11.70 23.30
For emitters whose maximum power is not listed above, the recommended separation distance d can be
estimated using the equation applicable to the transmitter's frequency, where P is the maximum transmitter
power in Watts (W) as specified by the transmitter manufacturer.

NB 1: at 80 MHz and 800 MHz, the upper frequency band is applicable

NB 2: These recommendations may not be applicable in all cases. Electromagnetic propagation is affected
by absorption and reflection caused by structures, objects and individuals.

16. INDEX

A mode Code, 56 Operating procedure, 45

Gain (adjustment), 26 Connection Operator position, 41
Accessories, 11 Main, 37 Patient data input, 39
Acquisition Printer, 38 Patient position, 40
Control buttons, 32 Probe, 36 Preliminary manipulations, 35
F1, F2, keys etc., 33 Connector Print results, 48
Acquisition window., 25 Keyboard, 17 Reading results, 46
Additional monitor, 16 Probe, 17 Recommendations, 45
Trackball, 17 Results, 46
Ammonium propionate, 64
USB, 38, 57 Small1, 40
Amplitude, 43
USB2, 17 Small2, 40
Amplitude curve, 43 Start new examination, 48
Anomymous (data), 58 Connectors, 16
Connexion Start-up, 38
Application Taking measurements, 45
PRINTER, 57
Update, 65 View, 24
Won't boot, 65 Control buttons
Acquisition, 32
Examination date, 22
Archives, 49 Examination duration, 22, 25
Archives, 23
Control buttons, 23 Examination result
Delete, 23 COPYRIGHT, 7
Current stiffness, 31 Archives, 22
Examination result, 22 Examinations list
Examinations list, 22 Dakin, 64
Sort, 22
Export, 23 Date, 56
Excel, 8, 55, 58
F1, F2, keys etc., 25 Date of birth, 22
Excel spreadsheet, 55
Import, 23 Date of birth, 56
Information window, 24 Excel Spreadsheet, 58
Decontaminate the probe, 64
Open, 24, 25 Eyes, 10
Defibrillator, 10
Open button, 24 F1, 49
Dimensions, 69
Patient information, 22 F1, F2, etc., 25, 33
Disc space, 53
Refresh, 23 F2, 49
Disconnecting
Sort criteria, 23
Probe, 37
F3, 49
Archives button, 32 Fenêtre de login, 21
Drop of gel, 41
Archives screen, 49
Duration, 56 FibroScan®
Access, 49 Brand, 8
DVD ROM, 19
Delete an examination, 52 built-in software, 15
Display measurements, 51
Echosens, 8
Cleaning, 63
Examination details, 51 Web, 65
Complete shutdown, 61
Export an examination, 53 Web site, 65
Connectors, 16
Export an examination (Excel), EchoSens General front view, 14
55 Address, 69 Keyboard, 15
Function keys, 49 Elastogram, 28 LCD monitor, 14
Import an examination, 54 Print, 32 Left-hand view, 19
List examinations, 50 Electrical power, 69 Lock casters, 36
Print results, 53 Electrical power lead, 9 Main switch, 18
Restoring a deleted examination, Electrical safety, 9 Malfunction, 65
52 Electromagnetic compatibility, 71 Off, 61
Sort examinations, 51 Electromagnetic Compatibility, 9 Position, 36
When called, 50 Electromagnetic Immunity, 73 Probe, 15
Archives Screen EMC, 9 Probe holder, 16
Export an exam (Excel), 58 EMI, 71 Rear view, 19
Archives window, 22 Emission/reception mode, 26 Right-hand view, 18
Blood vessels, 26 Standby, 14
End button, 32
Button Trackball, 15
Error messages, 29 Tray, 16
Start, 32, 48 Ethernet, 16
Cancel measurements, 33 Turn off, 61
Ethernet connector, 16 Won't turn on, 65
Casters, 17 Examination, 56
Block, 17 FibroScan® Front view, 13
Choice of probe, 35 First name, 56
Brake, 17
Connections, 36 Fuse, 69
Unblock, 17
Display, 39 Fuses, 18
CC, 35 End of examination, 47
CD ROM, 19 Gain
Equipment positioning, 36
CD-DVD drive, 19 Adjustment, 26
General plan, 35
CE - kPa, 31 Holding the probe, 43
Gain adjustment
Thoracic perimeter, 35 Locating the measurement point, A and MT modes, 26
Choice of probe, 35 41 Gel
Class, 69 Medium, 40 Drop, 41
Classification, 69 New examination, 45 Green indicator light, 14

Green zone, 26, 27 On/Off switch Recommendations, 9

Guarantee, 7 Inoperative, 65 Use, 10
Hard drive, 53, 69 Operating system, 69 Recommendations for use, 10
Hours, minutes, 22, 25 Operation Red zone, 26, 27
Humidity Humidity, 69 Registered trademarks, 8
Operation, 69 Temperature, 69 Regulations, 71
Storage, 69 Operator, 56 Remove the gel from the probe,
Icon Operator name, 22 63
Calibration, 64 Orange zone, 26, 27 Reset
IEC, 9 Pacemaker, 10 Measurements, 33
Information window, 24 Package, 11 Responsibility, 7
Installation manual, 11 Patient Result, 47
Interquartile range, 30 Code, 22, 39 Interquartile range, 30, 31
Invalid measurements Date of birth, 22, 39 Stiffness, 30
Counter, 31 Defibrillator, 10 Results
Number, 31 Examination date, 22 Results area, 30
IP, 69 First name, 22, 39 Results area, 30
IQR, 56 information displayed, 25 Results window, 47
IQR - kPa, 30 Last name, 22, 39 Reverse engineering, 7
Operator, 39
Keyboard, 17 Safety, 9
Operator name, 22
Keyboard keys, F1, etc., 25, 33 Maintenance, 9
Pacemaker, 10
Keyboard shortcuts, 25, 33 Patient, 10
Pregnant woman, 10
Keyboard, F1, etc., 25, 33 Screen
Pump, 10
kPa, 30, 31 Archives, 49
Safety, 10
Last name, 56 Wound, 10 Scroll buttons
LCD, 14 Patient code, 22 Measurements, 31
LCD monitor, 14 Patient information Shortcut keys, 25, 33
Liver Archives, 22 Signal
stiffness measurement, 27 Patient last name, 22 Quality, 43
Stiffness measurement, 27 Power supply, 69 Signal quality, 43
Main switch Pregnant woman, 10 SMALL1, 40
Fuses, 18 Pressure indicator, 26 SMALL2, 40
Location, 18 Green zone, 27
Sodium hypochlorite, 64
Mains Orange zone, 27 Software
Lead, 11 red zone, 27 Update, 65
Main switch, 18 Pressure too high, 27 Won't boot, 65
Mains lead, 11 Pressure too low, 27 Standby
Maintenance Print, 32 Button, 14
Safety, 9 Result, 48 Standby button, 14
Training, 9 Print button, 32 Start, 48
Manual Printing, 33 Stiffness, 30, 56
Purpose, 5 probe Results window, 47
Manufacturer, 69 Protection (15 sec.), 27 Stiffness measurement, 27
Manufacturer's address, 69 Probe, 15 Storage
Mb, 53 Active button, 27 Humidity, 69
Measurement Applied pressure, 26 Temperature, 69
Frequency, 35 Button inactive, 27 Structures, 26
Memory usage, 53 Calibration, 64, 65 Success
Measurement depth, 35 Calibration icon, 64 Display rate, 32
Measurement frequency, 35 Choice, 35 Rate, 32
Measurement pressure, 26 Cleaning, 63 Success rate, 32, 56
Measurements Connection, 36 Low (poor), 33
Cancel, 33 Connector, 17 Symbols, 9
Print, 32 Decontaminate, 64 Technical properties, 69
Reset, 33 Disconnecting, 37 Temperature
Scroll buttons, 31 Disconnecting the jack, 37 Operation, 69
Valid/invalid counters, 31 Gripping, 42 Storage, 69
Measurements performed, 32 Insert connector, 36 Time, 56
Medium, 40 Mechanical protection, 27 TM mode, 26, 43
Memory usage Pressure too high, 27 Gain (adjustment), 26
Measurement, 53 Remove gel, 63 Total, 56
Message Stop measurement, 27 Trackball, 15, 17
Troubleshooting, 65
Pressure too high, 27 Training
Unlock, 37
Pressure too low, 27 Maintenance, 9
Usage limit reached, 64
Message area, 29 Transducer
Probe button inactive, 27
Messages, 54 Abrupt retraction, 27
Probe holder, 16
Message area, 29 Tray, 16
Metrological performance, 69 Probe pressure, 26
Ultrasound images, 26
MHz, 35 Probe troubleshooting, 65
A zone, 43
Model, 69 Properties TM zone, 43
Computer, 69
Mucosa, 10 Ultrasound transducer, 69
Electrical, 69
Number of Ultrasounds images, 26
Environmental, 69
Invalid measurements, 31 Mechanical, 69
Unlock
Valid measurements, 31 Probe, 37
Property, 7
On/Off Protective cover, 11 USB, 38, 57
Inoperative, 65 External hard drive, 17
Pump, 10
On/Off button Key, 17
Purpose of the manual, 5 Messages, 54
Inoperative, 65

Printer, 17, 53 Counter, 31 Xiphoid, 35

Storage device, 53, 54, 55 Number, 31 XLS, 55, 57, 58, 59
USB printer, 53 VGA, 16 XLS format, 55
USB support, 53, 54, 55 VGA connector, 16 XLS Format, 55
USB2 View XLS Format, 57
Connector, 17 Examination, 24 XLS Format, 58
User training, 10 Warning messages, 29 XLS Format, 58
Valid, 56 Weight, 69 XLS Format, 59
Valid measurement, 31 Windows, 8, 69 XLS Format, 59
Valid measurement number, 31 EULA License, 11
Valid measurements Wound, 10

E100M002.15
®
02/2011 - ECHOSENS AND FIBROSCAN ARE REGISTERED TRADEMARKS © COPYRIGHT ECHOSENS ALL RIGHTS RESERVED 81
Echosens SA
153 Avenue d’Italie
75013 PARIS
Tel: +33 1 44 82 78 50
Fax: +33 1 44 82 78 60
Web site: www.echosens.com
Email: [email protected]

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E100M002 15 GuideD'utilisationFibroScan EN-GB

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E100M002 15 GuideD'utilisationFibroScan EN-GB

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FibroScan® Device

TABLE OF CONTENTS ......................................................................................................................... 3

6.3.10 Control buttons ................................................................................................... 32

1. PURPOSE OF THE MANUAL

2.3 PROPERTY AND COPYRIGHT

2.4 REVERSE ENGINEERING

2.5 REGISTERED TRADEMARKS

3. RECOMMENDATIONS AND SAFETY

This symbol means:

3.2 ELECTRICAL SAFETY

3.3 MAINTENANCE-RELATED SAFETY

3.4 PATIENT SAFETY

3.5 RECOMMENDATIONS FOR USE

3.6 USER TRAINING

4.1 BASIC DEVICE

Devices not included Accessories

Overhead projector S Probe

USB support XL Probe

USB printer Other

5.1 PURPOSE OF THE FIBROSCAN® DEVICE

Figure 2: principle of probe use

5.2 GENERAL FRONT VIEW

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

 Caster with brake

Figure 3: general view of the FibroScan®

ID See § ID See § ID See §

5.2.1 The standby button

Figure 4: the keyboard, pointing device (trackball) and buttons

Connection cable Jack

Electrodynamic Button LED

Figure 5: probe example

Indicator lights (LEDs) display the probe's status as follows:

Probe holder (right)

Probe holder (left)

Figure 6: the tray contains the keyboard and probe holders

5.2.7 Computer connectors

VGA monitor Keyboard - mouse

Figure 7: position of the computer connectors

5.2.8 Probe connector

Figure 8: location of the probe connector

The operator must follow this manual's recommendations (see paragraph

5.2.9 Casters and brakes

Figure 9: view of a caster with brake

5.3 RIGHT-HAND SIDE VIEW

5.3.1 Mains connector

Figure 10: view of the main switch and connection outlet

5.3.2 Main switch

5.4 LEFT-HAND SIDE VIEW

5.4.1 CD ROM – DVD ROM drive

No CD ROMs other than those provided by Echosens SA should be inserted

Figure 11: CD ROM – DVD ROM drive location

5.5 REAR VIEW

Figure 12: rear view

6.1 LOGIN WINDOW (OPTIONAL)

The activation of the login window is optional, see Configuration Manual

To access the software, please proceed as follows:

Figure 13 : login window.

6.2 ARCHIVES WINDOW

Displays the Acquisition window Details of the selected examination

ID See § ID See § ID See §

6.2.1 Patient examination-related data

6.2.2 Results of the selected examination

6.2.3 List of archived examinations and sort criteria

Sort on patient's first name

Sort on patient's last name Sort by patient's birth year

Figure 15: selection of sort criteria in the Archives window

6.2.4 Control buttons

6.2.5 Information window

Figure 16: Example of examination measurement details

6.2.6 Acquire button

6.2.7 Open button

Click on this arrows

Figure 17: examination view window

6.2.8 Keyboard function keys (Archives window)

Key Function Equivalent to

6.3 ACQUISITION WINDOW

Caster with brake