echosens FibroScan 502 touch User manual

FibroSca “EA
FibroScan” 502 TOUCH
User Manual
CE
0459
E300M017.4 — Version 4 — 03/2017
(software version C 3.1)

ETS FIBROSCAN 502 TOUCH USER MANUAL FibroScan
2 03/2017 - ECHOSENSTM AND FIBROSCAN® ARE TRADEMARKS © COPYRIGHT ECHOSENS - ALL RIGHTS RESERVED E300M017.4

FibroScan
FIBROSCAN 502 TOUCH USER MANUAL BET
1.
11
12
2.
2.1
2:2;
2.3.
2.4.
2.5.
2.6.
2.7.
2.8
2.9
3.
3.1
3.2
33
34
3.5
3.6
37
4.
4.1.
4.2.
4.3.
4.4.
4.5.
4.6.
4.7.
5.
5.1
5.2
5.3
5.4
5.5
6.
TABLE OF CONTENTS
PURPOSE OF THE USER MANUAL........ ner e onen 6
. Symbols used in the Manual ee 7
. Property and copyright... GR R R R 7
ΜΙΑΒΝΙΝΟΒ. ΟΗΕ εν A σώος 8
; GerisralıInformalleiN siii με με VAE 8
[τι ο Ες anaya NEA 8
Electromagnetic safety .
Using the device.
Deleting measurements.
Switching off the device
Cleaning and maintenance... nenene nenn 9
. Cleaning
. Interpreting the results
MISCELLANEOUS INFORMATION oe 11
. Guarantee
. Liability...
. Essential performance characteristics... 11
. Product life... sens
. Reverse engineering
. Registered trademark:
. Patented technology..
INDICATIONS AND PRECAUTIONS FOR USE
Intended use.
Indications for use
Probeandexaminationselectioncriteria....................................... 16
Precautions for use... 17
User training ....
Electrical safety .
Maintenance-related safely sussa SALES 18
EXTERNAL PRESENTATION
. Hardware supplied
. ACCessories лилии иная
. Front view
. Rear view
. Description of probes.
SOFTWARE INTERFACE...........................rcrrrrcereeeeieire ricer rece AEG REDDE 26
E300M017.4 03/2017 - ECHOSENSTM AND FIBROSCAN® ARE TRADEMARKS © COPYRIGHT ECHOSENS - ALL RIGHTS RESERVED 3

ETS FIBROSCAN 502 TOUCH USER MANUAL FibroScan
6.1.
6.2.
6.3.
6.4.
6.5.
6.6.
6.7.
7. STANDBY AND SHUTTING DOWN THE DEVICE.
τα,
Tdi
8. CLEANING, MAINTENANCE AND REPAIRS
8.1.
8.2.
8.3.
Home:SCresn İŞ YY 26
Usingthekeypad........................................... erene 27
Login Window... sise 27
Status bar
The patient record screen
Acquisition screen
6.6.1. Patient data
6.6.2. Ultrasound images...
6.6.3. Pressure indicator
6.6.4. Shear wave propagation map
6.6.5. Counters: Valid and invalid measurements ...................... n 35
6.6.6. Shear wave speed results area
6.6.7. Stiffness results area
6.6.8. CAP result zone (option)
6.6.9. Deleting measurementS nenene
6:6.10-Adding'a GomMmMEN tisser
6.6.11.Integrate the measurement conditions
6.6.12. Message area...
6.6.13. Examination type selection area.
6.6.14.View and print theresultoftheexamination............................................. 43
Management of patient file archives..
6.7.1. Advanced file search
6.7.2. Selectand view a patient file
6.7.3. Details'of the examination... ο ο P ARE RnR nen Er
Between
sessions
τε
At
the
end
of
the
day
sisi
ob
eee
47
Cleaning
8.1.1. Cleaning the device (painted, metallic, glass, or plastic surfaces and
screen)
8.1.2. Cleaning the probe (housing, cable and transducer)
8.1.3. Recommended cleaning products ce
8.1.4.
Recommended
decontamination
solutions.................................................
Calibrating the probe ..
Troubleshooting
9.
CONFIGURING
THE
FIBROSCAN
ie
52
9.1.
9.2.
9.3.
9.4.
9.5.
9.6.
9.7.
9.8.
9.9.
Entering configuration mode
Localization Tab
Institution tab ....
Printer tab… せ em
Data Tab
User Tab
Connectivity Tal
[ЕЕ ος ο ο ο ο ο ener 55
System
4аБ........
ο
ο
ο
ο
ο
55
4
03/2017
-
ECHOSENSTM
AND
FIBROSCAN®
ARE
TRADEMARKS
©
COPYRIGHT
ECHOSENS
-
ALL
RIGHTS
RESERVED
E300M017.4

FibroScan FIBROSCAN 502 TOUCH USER MANUAL ETE]
E IMM rr SA 55
GOD LOGS usas ar ara σος 56
A ο ο ο σος ο v ire eS 56
A ο ο ο ο ο 57
10. syMBoLs oNTHEDEVICE neon eee 에나 58
10.1. Connectors ss 사 아 아아아 58
10.2. Warnings
10.3. Marking and electrical safety
11. TECHNICAL CHARACTERISTICS
11.1. Characteristics of the device ..
11.1.1. Computer characteristics .
11.1.2. Metrological performance
11.1.3. Electrical characteristics iii ent
11.1.4. Mechanical characteristics
11.1.5. Environmental characteristics
11.1.6. Additional information
προ ο ο ο ο ο ο τον ο ο 가 64
12. REGULATIONS rra 65
12.1. Electromagnetic emissions
12.2. Electromagnetic immunity (1)
12.3. Electromagnetic immunity (2)
12.4. Recommended separation distances
E300M017.4 03/2017 - ECHOSENSTM AND FIBROSCANO ARE TRADEMARKS € COPYRIGHT ECHOSENS - ALL RIGHTS RESERVED 5

ETS FIBROSCAN 502 TOUCH USER MANUAL FibroScan
1. PURPOSE OF THE USER MANUAL
This User Manual has no contractual value whatsoever and under no circumstances may
Echosens be held responsible on the basis of the information contained in this Manual.
This User Manual details, on the one hand, all of the information required for the
implementation, use and maintenance of the FibroScan device and, on the other hand, the
list of information displayed.
Thus, after carefully reading the manual, operators will be able to:
= connect peripheral elements (power cable, USB devices, probes) and power up the
FibroScan device,
m configure the device,
в navigate the device's user interface,
m perform basic maintenance.
Echosens
publishes
this
manual
"as
is",
without
guarantees
of
any
nature,
whether
explicit
or
implicit,
including,
but
not
limited
to
implicit
guarantees
or
merchant
conditions,
or
adaptation
for
specific
use
in
view
of
providing
simple
and
accurate
information.
Consequently,
Echosens
SA
cannot
accept
any
responsibility
for
any
incorrect
interpretation
of
the
Manual.
Although
all
efforts
have
been
made
to
offer
a
manual
that
is
as
accurate
as
possible,
this
manual
may
nevertheless
contain
some
technical
inaccuracies
and/or
typographical
errors.
Echosens
cannot,
under
any
circumstances,
be
held
responsible
for
any
loss
of
profit,
loss
of
business,
data
loss,
business
interruption,
or
for
any
indirect,
specific,
accidental
or
consecutive
damages
of
any
type.
In
the
event
of
damages
arising
from
a
defect
(imperfection)
or
error
contained
in
this
User
Manual,
Echosens
undertakes
to
send
the
physician,
as
rapidly
as
possible,
a
hard
copy
or
electronic
document
containing
all
corrections
made
to
this
manual.
This
manual
is
updated
on
a
regular
basis.
The
most
recent
version
of
this
manual
is
available
from
Echosens
on
request.
Should
any
major
modifications
be
made
to
the
manual,
however,
Echosens
undertakes
to
send
the
physician,
as
rapidly
as
possible,
a
new
copy
of
the
manual
in
hard
copy
or
electronic
format.
Note
that
this
does
not
involve
updating
the
hardware
and/
or
software
in
your
possession.
The product owner must keep this manual for as long as the product is used.
This
manual
contains
a
chapter
for
troubleshooting
the
most
commonly
encountered
problems.
Any
information
or
modification
requests
pertaining
to
this
manual
should
be
sent
to:
Echosens,
30
place
d'ltalie,
75013
Paris,
France.
6
03/2017
-
ECHOSENSTM
AND
FIBROSCAN®
ARE
TRADEMARKS
©
COPYRIGHT
ECHOSENS
-
ALL
RIGHTS
RESERVED
E300M017.4

FibroScan
FIBROSCAN 502 TOUCH USER MANUAL EET
1.1. SYMBOLS USED IN THE MANUAL
个 This symbol means: CAUTION
Warning: See the instructions before using the medical device.
Instructions preceded by this symbol may cause injuries or damage the medical
device and installation if not correctly followed.
This symbol means: INFORMATION
Additional information with no impact on device use.
1.2. PROPERTY AND COPYRIGHT
All manuals and documents of all kinds are the property of Echosens and are protected
by copyright, all rights reserved. Your right to copy this documentation is limited to legal
copyright. These manuals cannot be distributed, translated or reproduced, either in whole or
in part, in any manner or in any form, without prior written consent from Echosens. Hence,
the reproduction, adaptation or translation of this manual without prior written consent is
prohibited, within the limits provided by copyright law.
Copyright © — 09/2015 — 03/2017 — Echosens — All rights reserved.
E300M017.4
03/2017 - ECHOSENSTM AND FIBROSCAN® ARE TRADEMARKS © COPYRIGHT ECHOSENS - ALL RIGHTS RESERVED
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FibroScan
FIBROSCAN 502 TOUCH USER MANUAL TRUE]
concerning electromagnetic compatibility (EMC). It must be installed and set up
according to the EMC information given in this manual.
A The FibroScan 502 TOUCH device requires special precautions to be taken
2.4. USING THE DEVICE
个 Do not push or lean on the top of the FibroScan device.
To avoid tipping the FibroScan when moving it, move it slowly sideways and steer
it firmly by holding the decorative rods on the front and back of the device.
To avoid tipping the FibroScan when lowering it down a step, the operator must go
in front of the device and guide it on the way down.
2.5. DELETING MEASUREMENTS
All measurements taken before the one chosen for deletion will be eliminated from
the examination after confirmation.
2.6. SWITCHING OFF THE DEVICE
Never switch the device off during an examination or whilst in configuration mode.
A Never disconnect the main power supply when the device is switched on. Failure
to comply with these instructions may cause a malfunction of the device and/or
loss of data.
2.7. CLEANING AND MAINTENANCE
These maintenance operations must not be performed by a third party other than
a technician authorized by Echosens.
The opening or modification of the device by any person other than an authorized
Echosens technician is strictly prohibited.
No CD ROMs or DVD ROMs other than those provided by Echosens should be
inserted into the drive.
The probe must be calibrated periodically. Beyond this period, the manufacturer
no longer guarantees the performance characteristics of the probe.
2.8. CLEANING
To prevent electric shock, switch off the device and disconnect it from the power
supply before cleaning.
E300M017.4 03/2017 - ECHOSENSTM AND FIBROSCAN® ARE TRADEMARKS © COPYRIGHT ECHOSENS - ALL RIGHTS RESERVED
o

EE FIBROSCAN 502 TOUCH USER MANUAL FibroScan
2.9. INTERPRETING THE RESULT:
Results must only be interpreted by a physician specializing in liver diseases, who
is aware of the patient's pathology and clinical context.
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FibroScan
FIBROSCAN 502 TOUCH USER MANUAL [ETUE
3. MISCELLANEOUS INFORMATION
3.1. GUARANTEE
The terms of guarantee are stated in the Echosens terms of sale documents.
For any requests, Echosens is at the disposal of the physician and their assistants and shall,
if necessary, pass the aforementioned request on to the competent local representative.
3.2. LIABILITY
The information displayed on the FibroScan screen is the result of complex calculations
performed by the software application built into the FibroScan. These results are then
interpreted by the physician in charge. Under no circumstances, and even if Echosens had
been notified, could Echosens be held responsible for the incorrect interpretation of these
results; Echosens' liability being limited to making the measurements, displaying them and
printing them via the FibroScan.
The data from each examination are saved on the device's hard disk. The user is responsible
for saving the data on a regular basis. Echosens cannot under any circumstances be held
liable for the partial or total loss of FibroScan data.
3.3. ESSENTIAL PERFORMANCE CHARACTERISTICS
The essential performance of the FibroScan device is the medically-usable measurement
of liver stiffness. The measurement is taken at 50 Hz shear wave frequency. When the
optimum conditions, particularly relating to electromagnetic disturbance, cannot be obtained,
the FibroScan device does not display any measurements, but displays a warning message
to notify the user that measurements are not possible.
When a stiffness or CAP (Controlled Attenuation Parameter) value is displayed by FibroScan,
this value is correct within the range of error specified by Echosens.
Free from the production of unintended or excessive transducer assembly surface
temperature.
3.4. PRODUCT LIFE
Echosens guarantees the specifications and performance characteristics of the FibroScan
device for seven years, provided that all necessary precautions for use and maintenance
have been taken in accordance with the recommendations of the user manuals provided.
E300M017.4
03/2017 - ECHOSENSTM AND FIBROSCAN® ARE TRADEMARKS © COPYRIGHT ECHOSENS - ALL RIGHTS RESERVED 11

EE
FIBROSCAN
502
TOUCH
USER
MANUAL
FibroScan
3.5. REVERSE ENGINEERING
The software license is individual and cannot, under any circumstances, be transferred in
any manner to a third party. This software cannot be distributed, reproduced, translated,
disassembled, decompiled, analyzed, modified, incorporated or combined with another
software application, with the exception of cases allowed by law.
Resale of the software built into the FibroScan is prohibited.
3.6. REGISTERED TRADEMARKS
Echosens and FibroScan are registered trademarks of Echosens.
Microsoft Excel and Windows Embedded are registered trademarks of Microsoft Corporation
in the United States and other countries.
3.7. PATENTED TECHNOLOGY
FibroScan is covered by one or more patents, both in the United States and in other countries.
Patents: www.echosens.com/patents
12
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FibroScan
FIBROSCAN 502 TOUCH USER MANUAL ΓΠΕΤΕ]
4. INDICATIONS AND PRECAUTIONS FOR USE
4.1. INTENDED USE
The FibroScan and its probes form an active, non-implantable medical device using
ultrasound. This device is designed to be used in a physician's office.
The FibroScan system is designed to provide 50 Hz shear wave speed measurements and
estimates of tissue stiffness as well as a 3.5 MHz ultrasound coefficient for the Attenuation
Parameter (CAP: Controlled Attenuation Parameter) in internal structures of the body.
The FibroScan device is based on Vibration-Controlled Transient Elastography (VCTE M).
The FibroScan probe comprises a single-element ultrasound transducer mounted on the
shaft of the electrodynamic transducer. This transducer generates a transient vibration,
which in turn generates an elastic shear wave. This wave propagates through the skin, the
subcutaneous tissues, and then the liver. During shear wave propagation, the ultrasound
transducer performs a series of ultrasound acquisitions (emission/reception) to measure the
speed of shear wave propagation (Vs) in m/s. This measurement corresponds to the spatial
and temporal average speed of propagation of the shear wave through the liver region of
interest, which can be approximated by a cylinder with a diameter of 1 cm and a length of
4 cm (corresponding to approx. 3 cm’).
Additionally, assuming that the liver is a pure elastic, linear and isotropic medium, the
device converts shear wave speed Vs into equivalent stiffness E in kPa using the equation
E = 3 xp x Vs? with p the medium density assumed to be 1000 kg/m*. The values for shear
wave speed and equivalent stiffness (or Young’s modulus) are relative indexes intended only
for the purpose of comparison with other measurements performed using FibroScan devices.
Concomitantly, the ultrasound acquisitions are used to assess the Controlled Attenuation
Parameter (CAP). Ultrasound attenuation corresponds to the loss of energy as ultrasound
propagates through the medium. Due to attenuation, the intensity of emitted ultrasound (lo)
decreases exponentially with depth (z): Iz = lo x exp (- a(f) x z) where Iz is the ultrasound
intensity at depth z and a is the frequency- (f) dependent attenuation coefficient. Ultrasound
attenuation depends principally on (i) the ultrasound frequency, and (ii) the properties of the
medium of propagation. CAP assesses the value of a at the frequency f = 3.5 MHz and is
expressed in dB/m.
Absolute values for these measurements may vary between measurement devices produced
by different manufacturers.
E300M017.4 03/2017 - ECHOSENSTM AND FIBROSCAN® ARE TRADEMARKS © COPYRIGHT ECHOSENS - ALL RIGHTS RESERVED 13

[ETS FIBROSCAN 502 TOUCH USER MANUAL FibroScan
4.2. INDICATIONS FOR USE
The FibroScan is indicated for non-invasive measurement in the liver of 50 Hz shear wave
speed and estimates of stiffness as well as determining a 3.5 MHz ultrasound coefficient
for the Attenuation Parameter (CAP: Controlled Attenuation Parameter). The shear wave
speed, stiffness, and CAP may be used as an aid in the clinical management of adult patients
with liver disease. Shear wave speed and stiffness may be used as an aid in the clinical
management of pediatric patients with liver disease.
How to use a probe: A: Ultrasound transducer. B: Electrodynamic transducer. C: Liver.
The values obtained must be interpreted by a physician experienced in dealing with liver
disease, taking into account the complete medical record of the patient and the potential
presence of different factors known to influence liver shear wave speed or equivalent stiffness
and CAP. Based on the existing literature, the following table 1 provides a list of parameters
known to increase liver shear wave speed and stiffness.
Table 1: Parameters related to shear wave speed and stiffness.
Parameter Reference
Liver fibrosis, cirrhosis [1-9]
Acute hepatitis, inflammation, ALT flares | [10-13]
Portal pressure, central venous pressure | [14-16]
Extra-hepatic cholestasis [17]
Congestion (heart failure) [18]
Meal intake [19]
Amyloidosis [20-22]
For shear wave speed measurement, the intra- and inter-operator agreement has been
assessed in a cohort of 200 adult patients with chronic liver disease of various etiologies [23].
The intra-class correlation coefficient was 0.98 both within and between operators. Moreover,
in a cohort of 31 NASH children, a 0.96 inter-operator intra-class correlation coefficient
was found [24]. This demonstrates that intra-operator reproducibility is excellent for shear
wave speed and stiffness measurements, and that changing the operator does not increase
measurement variability in either adults or children.
[1] Friedrich-Rust, M., et al., Performance of transient elastography for the staging of liver
fibrosis: a meta-analysis. Gastroenterology, 2008. 134(4): p. 960-74.
14
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FibroScan
FIBROSCAN 502 TOUCH USER MANUAL [RUE]
[2] Musso, G., et al., Meta-analysis: Natural history of non-alcoholic fatty liver disease
(NAFLD) and diagnostic accuracy of non-invasive tests for liver disease severity. Annals of
Medicine, 2011. 43(8): p. 617-49.
[3] Shaheen, et al., FibroTest and FibroScan for the Prediction of Hepatitis C-Related
Fibrosis: A Systematic Review of Diagnostic Test Accuracy. American Journal of
Gastroenterology, 2007: p. 1-12.
[4] Shi, K.Q., et al., Transient elastography: a meta-analysis of diagnostic accuracy in
evaluation of portal hypertension in chronic liver disease. Liver Int, 2013. 33(1): p. 62-71.
[5] Smith, J.O. and R.K. Sterling, Systematic review: Non-invasive methods of fibrosis
analysis in chronic hepatitis C. Alimentary Pharmacology and Therapeutics, 2009. 30(6): p.
557-76. [6] Stebbing, J., et al., A Meta-analysis of Transient Elastography for the Detection of
Hepatic Fibrosis. Journal of Clinical Gastroenterology, 2010. 44(3): p. 214-9.
[7] Talwalkar, J.A., et al., Ultrasound-based transient elastography for the detection of hepatic
fibrosis: systematic review and meta-analysis. Clinical Gastroenterology and Hepatology
2007. 5(10): p. 1214-20.
[8] Tsochatzis, E.A., et al., Elastography for the diagnosis of severity of fibrosis in chronic
liver disease: A meta-analysis of diagnostic accuracy. Journal of Hepatology, 2011. 54(4): p.
650-9.
[9] Lee, C.K., et al, Serum Biomarkers and Transient Elastography as Predictors of
Advanced Liver Fibrosis in a United States Cohort: The Boston Children's Hospital
Experience. The Journal of pediatrics, 2013. 163(4): p. 1058-64.
[10] Arena, U., et al., Acute viral hepatitis increases liver stiffness values measured by
transient elastography. Hepatology, 2008. 47(2): p. 380-4.
[11] Coco, B., et al., Transient elastography: a new surrogate marker of liver fibrosis
influenced by major changes of transaminases. Journal of Viral Hepatitis, 2007. 14(5): p.
360-9.
[12] Mueller, S., et al., Increased liver stiffness in alcoholic liver disease: differentiating fibrosis
from steatohepatitis. World Journal of Gastroenterology, 2010. 16(8): p. 966-72.
[13] Sagir, A., et al., Transient elastography is unreliable for detection of cirrhosis in patients
with acute liver damage. Hepatology, 2008. 47(2): p. 592-5.
[14] Carrión, J.A., et al., Transient elastography for diagnosis of advanced fibrosis and
portal hypertension in patients with hepatitis C recurrence after liver transplantation. Liver
Transplantation, 2006. 12(12): p. 1791-8.
[15] Millonig, G., et al., Liver stiffness is directly influenced by central venous pressure.
Journal of Hepatology, 2010. 52(2): p. 206-10.
[16] Vizzutti, F., et al., Liver stiffness measurement predicts severe portal hypertension in
patients with HCV-related cirrhosis. Hepatology, 2007. 45(5): p. 1290-7.
[17] Millonig, G., et al., Extrahepatic cholestasis increases liver stiffness (FibroScan)
irrespective of fibrosis. Hepatology, 2008. 28(5).
[18] Lebray, P., et al., Liver stiffness is an unreliable marker of liver fibrosis in patients with
cardiac insufficiency. Hepatology, 2008. 48(6): p. 2089.
[19] Mederacke, I., et al., Food intake increases liver stiffness in patients with chronic or
resolved hepatitis C virus infection. Liver International, 2009. 29(10): p. 1500-6.
[20] Janssens, E., et al., Hepatic amyloidosis increases liver stiffness measured by transient
elastography. Acta Gastroenterologica Belgica, 2010. 73(1): p. 52-4.
E300M017.4 03/2017 - ECHOSENSTM AND FIBROSCAN® ARE TRADEMARKS © COPYRIGHT ECHOSENS - ALL RIGHTS RESERVED 15

EE FIBROSCAN 502 TOUCH USER MANUAL FibroScan
[21] Lanzi, A., et al., Liver AL amyloidosis as a possible cause of high liver stiffness values.
European Journal of Gastroenterology and Hepatology, 2010. 22(7): p. 895-7.
[22] Loustaud-Ratti, V.R., et al, Non-invasive detection of hepatic amyloidosis: FibroScan, a
new tool. Amyloid, 2011. 18(1): p. 19-24.
[23] Fraquelli, M., et al., Reproducibility of transient elastography in the evaluation of liver
fibrosis in patients with chronic liver disease. Gut, 2007. 56(7): p. 968-73.
[24] Nobili, V., et al., Accuracy and reproducibility of transient elastography for the diagnosis
of fibrosis in pediatric nonalcoholic steatohepatitis. Hepatology, 2008. 48(2): p. 442-8.
4.3. PROBE AND EXAMINATION SELECTION CRITERIA
The recommendations for choosing the probes are defined by the patient's morphological
data:
m TP: Thoracic Perimeter measured at the xiphoid using a tape measure.
= SCD: Skin-to-Capsule Distance assessed with an ultrasound scanner or by the
automatic probe selection tool.
When using ultrasound, SCD should be measured at the point where the shear wave speed
is measured with a pressure similar to the one used with the FibroScan probe.
In case of using the automatic probe selection tool, please refer to chapter 6.5.11.
Examination type selection area.
Compressing the soft tissues to reduce the SCD is not recommended.
Four types of examination are available: S1, S2, M and XL. They correspond to specific
measurement depths that take into account the liver's depth beneath the skin.
FibroScan® Probe Choice Algorithm
No YES
AGEz18 YEARS
Thoracic Skin Capsula
Perimeter (TP) Distance (SCD)
measurement measurement
[Cu
RECOMMENDED
S1EXAM XLEXAM
In every case, Echosens recommends performing 10 valid FibroScan measurements.
Use of the S* probe is not approved for patients over 18 years old. Use of the M +
probe is not approved for patients under 14 years old. Use of the XL*probe is not
approved for patients under 18 years old.
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FibroScan
FIBROSCAN 502 TOUCH USER MANUAL ERETE]
4.4. PRECAUTIONS FOR USE
The following instructions must be followed in order to ensure patient safety. The FibroScan
should not be used in the following situations:
On any organ other than the liver. The eyes and mucosa must absolutely be avoided.
On patients with active implants such as pacemakers, defibrillators, pumps, etc.
On wounds.
On pregnant women.
Moreover, the presence of ascites between the probe and the liver may prevent from
obtaining measurements with the device.
The clinical personnel must follow normal safety procedures.
The FibroScan examination should be performed carefully using the principle of
ALARA (As Low As Reasonably Achievable).
4.5. USER TRAINING
Only persons having received training in the use of the FibroScan and in possession of a user
certificate are authorized to conduct an examination using the FibroScan. Training is essential
for correct equipment use and in order to obtain reliable and reproducible measurements.
This manual is not intended to provide user training.
4.6. ELECTRICAL SAFETY
The FibroScan is manufactured and tested in accordance with IEC electromagnetic
compatibility (EMC) and electrical safety standards. It leaves the plant in full compliance with
safety and performance requirements. In order to maintain this compliance and to guarantee
the safe use of this medical device, the user must comply with the indications and symbols
contained in this manual.
A Refer to the warnings in Chapter 2 concerning electrical safety.
Prior to installation, ensure that the operating and mains voltage values match.
The electrical power cable provided must be connected to the FibroScan mains connector
and to a grounded socket. Correct grounding can only be guaranteed if the FibroScan is
connected to a socket compliant with safety standards.
Safe use is no longer guaranteed in the following main, non-exhaustive cases:
the device is visibly damaged,
the device is inoperative,
after prolonged storage in unfavorable conditions,
after serious damage incurred during transport,
in the presence of flammable or anesthetic gases. This may cause an explosion. Do not
take the device to the operating room.
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EE FIBROSCAN 502 TOUCH USER MANUAL FibroScan
If the FibroScan can no longer be used safely, the device must be decommissioned. Steps
must be taken to prevent its inadvertent use. The medical device must only be inspected by
authorized technicians.
4.7. MAINTENANCE-RELATED SAFETY
For all maintenance operations, the physician and their appointees should contact Echosens,
who will send an authorized technician.
For correct and safe use and any maintenance operations, personnel must comply with
normal safety procedures.
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AND
FIBROSCAN®
ARE
TRADEMARKS
©
COPYRIGHT
ECHOSENS
-
ALL
RIGHTS
RESERVED
E300M017.4

FibroScan
FIBROSCAN 502 TOUCH USER MANUAL [GEIE]
5. EXTERNAL PRESENTATION
5.1. HARDWARE SUPPLIED
When opening the package, ensure the contents match the following list:
FibroScan device installed
Power cables according to country
Case(s) fitted with probe(s)
Sealed envelope (Windows EULA license and this user manual)
Software installation CD ROM
Set of four fuses, type 5x20 T2.0AH 250V
5.2. ACCESSORIES
The available accessories are:
= S* probe
u MY probe
= XL? probe
Set of elements that can be connected to the FibroScan device:
A
FibroScan
Devices not included: A: DVI-I screen. B: Overhead projector. C: USB storage device. D:
USB printer.
Accessories: E: S* probe. F: M* probe. G: XL* probe. H: Other accessories.
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EE FIBROSCAN 502 TOUCH USER MANUAL FibroScan
5.3. FRONT VIEW
The device contains the electrical power supply, dedicated electronics and a computer. It also
supports a monitor, three probe holders, and a gel holder.
The following figure presents the device's various user-accessible parts.
_ CT
G
General arrangement of the FibroScan device: A: Touch screen. B: Caster with brake.
C: Gel holder. D: Standby button with power indicator. E: CD ROM / DVD ROM drive. F:
Computer sockets. G: Probe holder.
Standby button
This button is enabled only when the main switch, located at the rear of the device,
is set to "I".
The button flashes when power is on.
Press this button once to load the application; the built-in indicator light turns green. After a
few seconds, the home window is displayed.
Press this button again to close the application; the built-in indicator light and monitor are
both turned off. This is the usual state when the FibroScan will not be in use for a short time
(between two groups of patients, for example). The FibroScan consumes very little power in
this mode.
The screen and the software
This is a 17- or 19-inch color LCD touch screen, depending on the model year.
To protect the screen from any risk of damage, make sure not to hang the power
cable on the top of the device.
The FibroScan runs on dedicated software.
The software is automatically launched when the FibroScan is switched on. It is used to:
m perform examinations,
и manage examinations in archives.
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