Echosens FibroScan XL+ Probe User manual

FibroScan

XL+

Probe

User

manual

CE

0459

E117M009.7

—

Version

7

—

02/2016

EU)

XL+

PROBE

USER

MANUAL

2

02/2016

-

ECHOSENS®

AND

FIBROSCAND

ARE

REGISTERED

TRADEMARKS

©

COPYRIGHT

ECHOSENS

ALL

RIGHT

RESERVED

E117M009.7

XL+

PROBE

USER

MANUAL

RSK)

TABLE

OF

CONTENTS

1.

PURPOSE

OF

THE

USER

MANUAL

5

1.1.

Symbols

used

in

the

manual

een

6

1.2.

Property

and

copyright

...0.1.0.1.100

니

이 어

아 아

아 어

아

아 아

아

아 이

이

라

이 이

다

이

아

이

아 아

아

어

아

이

아 이

아

에

이

이 이

이이

6

2.

WARNINGS

7

2.1.

Generality

iii

7

2.2.

Handling

the

probe

.Ne

7

2.3，Maintenance

.ee

7

3.

MISCELLANEOUS

INFORMATION

8

A

E

A

8

3.2.

Registered

trademarks

.ee

8

4.

INDICATIONS

AND

PRECAUTIONS

FOR

USE

9

4.1.

Intended

use...

eee

9

4.2.

Indications

for

use

..…..........................................

essences

10

4.3.

Probeandexamination

selection

criteria...............................................

12

4.4.

Precautions

for

USE..........oconoccncconccoconccnconcancnnonanonncnccnonoo

nono

nnnoonorccconan

cansan

on

rara

rccconnn

cono

13

4.5，User

training

.ee

14

4.6，

Electrical

Safety

.ee

14

4.7.

Maintenance-related

safety

.ee

14

5.

EXTERNAL

PRESENTATION

…

15

5.1.

Hardware

supplied...

sine

κκκκν

κο

15

5.2.

Probe

description...

sise

15

6.

USE

DURING

AN

EXAMINATION

17

6.1，User

recommandations

.ee

17

6.2.

Connecting

/

disconnecting

the

probe

ss

17

6.3.

Handlingtheprobe.....................................................

eee

erereemeseseseran

18

6.3.1.

Probe

resting

position...

nene

ee

eonnné

18

6.3.2.

Gripping

the

probe

sise

18

6.4，End

of

examination

.ee

19

7.

CLEANING,

MAINTENANCE

AND

REPAIRS

20

7.1，Cleaning

.es

20

7.1.1.

Cleaning

the

probe

(housing,

cable

and

transdUucer).................................

20

7.1.2.

Recommended

cleaning

products

ss

21

7.1.3.

Recommended

decontamination

solutions............................................

22

7.2.

Calibrating

the

probe

sas

23

7.3.

Troubleshooting..….........................

esse

23

E117M009.7

02/2016

-

ECHOSENS®

AND

FIBROSCAN®

ARE

REGISTERED

TRADEMARKS

©

COPYRIGHT

ECHOSENS

ALL

RIGHT

RESERVED

3

E117M009.7

XL+

PROBE

USER

MANUAL

FEMTE]

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.

The

present

user

manual

details

all

of

the

information

required

for

the

implementation,

use

and

maintenance

of

the

probe

designed

to

be

connected

to

the

FibroScan.

Interpretation

of

the

displayed

data

is

covered

in

the

FibroScan

user

manual.

Thus,

after

carefully

reading

the

manual,

operators

shall

be

able

to:

и

connect

the

probe

to

the

FibroScan,

=

use

the

probe

in

accordance

with

technical

and

clinical

requirements,

=

carry

out

the

maintenance

work

of

the

probe.

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

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,

the

manual

may

nevertheless

contain

some

technical

inaccuracies

and/or

typographical

errors.

Echosens

cannot,

under

any

circumstances,

be

held

responsible

for

any

loss

of

profit,

loss

of

business,

data

loss,

business

interruption,

or

for

any

indirect,

specific,

accidental

or

consecutive

damages

of

any

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.

02/2016

-

ECHOSENS®

AND

FIBROSCAN®

ARE

REGISTERED

TRADEMARKS

©

COPYRIGHT

ECHOSENS

ALL

RIGHT

RESERVED

5

(SUS)

XL+

PROBE

USER

MANUAL

1.1.

SYMBOLS

USED

IN

THE

MANUAL

个

This

symbol

means:

ATTENTION

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

instrument

use.

1.2.

PROPERTY

AND

COPYRIGHT

All

manuals

and

documents

of

all

types

are the

property

of

the

company

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

O

—

11/2012

—

02/2016

—

Echosens

—

All

rights

reserved.

6

02/2016

-

ECHOSENS®

AND

FIBROSCAN®

ARE

REGISTERED

TRADEMARKS

©

COPYRIGHT

ECHOSENS

ALL

RIGHT

RESERVED

E117M009.7

XL+

PROBE

USER

MANUAL

ΕΠΕΤΕ]

2.

WARNINGS

2.1.

GENERALITY

个

Caution:

Federal

law

restricts

this

device

to

sale

by

or

on the

order

of

a

physician.

2.2.

HANDLING

THE

PROBE

The probe

is

a

fragile

electromechanical

device

that

must

be

handled

with

care

A

and

kept

away

from

liquids.

Between

two

examinations,

it

should

be

placed

on

its

holder

on

the

FibroScan.

In

the

event

of

prolonged

non-use,

the

probe

should

be

stored

in

its

case.

2.3.

MAINTENANCE

Maintenance

operations must

not

be

performed

by

a

third

party

other

than

a

technician

authorized

by

Echosens.

The

probe

must

be

calibrated

periodically.

Beyond

the

period

indicated

on

the

calibration

certificate,

the

manufacturer

no

longer

guarantees

the

performance

characteristics

of

the

probe.

E117M009.7

02/2016

-

ECHOSENS®

AND

FIBROSCAN®

ARE

REGISTERED

TRADEMARKS

©

COPYRIGHT

ECHOSENS

ALL

RIGHT

RESERVED

7

EET

XL*

PROBE

USER

MANUAL

3.

MISCELLANEOUS

INFORMATION

3.1.

GUARANTEE

The

terms

of

guarantee

are

stated

in

the

Echosens

terms

of

sale

documenis.

For

any

reguest,

Echosens

remains

available

to

the

physician

and

his/her

appointees

and

shall,

if

applicable,

transfer

the

request

to

a

competent

local

representative.

3.2.

REGISTERED

TRADEMARKS

Echosens

and

FibroScan

are

registered

trademarks

of

the

company

Echosens.

8

02/2016

-

ECHOSENS®

AND

FIBROSCAN®

ARE

REGISTERED

TRADEMARKS

©

COPYRIGHT

ECHOSENS

ALL

RIGHT

RESERVED

E117M009.7

XL+

PROBE

USER

MANUAL

[BIS]

4.

INDICATIONS

AND

PRECAUTIONS

FOR

USE

4.1.

INTENDED

USE

The

FibroScan

system

with

the

XL+

probe

is

an

active,

non-implantable

medical

device

using

ultrasound.

This

device

is

designed

to

be

used

in

a

doctor's

office.

The

FibroScan

system

with

the

XL+

probe

is

intended

to

provide

50

Hz

shear

wave

speed

measurements

and

estimates

of

tissue

stiffness

as

well

as

3.5

MHz

ultrasound

coefficient

of

attenuation

parameter

(CAP:

Controlled

Attenuation

Parameter)

in

internal

structures

of

the

body.

The

FibroScan

device

is

based

on the

Vibration-Controlled

Transient

Elastography

principle

(VOTE

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

(which

corresponds

to

about

3

cm?).

In

addition,

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=3xpx

Vs?

with

p

the

medium

density

assumed

to

be

1000

kg/m3.

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):

lz

=

lo

x

exp

(-

a(f)

x

z)

where

Iz

is

the

ultrasound

intensity

at

depth

z,

a

is

the

frequency

(f)

dependent

attenuation

coefficient.

Ultrasound

attenuation

depends

principally

on

(i)

the

ultrasound

frequency,

(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

among

measurement

devices

produced

from

different

manufacturers.

E117M009.7

02/2016

-

ECHOSENS®

AND

FIBROSCAN®

ARE

REGISTERED

TRADEMARKS

©

COPYRIGHT

ECHOSENS

ALL

RIGHT

RESERVED

9

(0S

xL+

PROBE

USER

MANUAL

4.2.

INDICATIONS

FOR

USE

FibroScan

is

indicated

for

noninvasive

measurement

in

the

liver

of

50

Hz

shear

wave

speed

and

estimates

of

stiffness

as

well

as 3.5

MHz

ultrasound

coefficient

of

attenuation

(CAP:

Controlled

Attenuation

Parameter).

The

shear

wave

speed

and

stiffness,

and

CAP

may

be

used

as

an

aid

to

clinical

management

of

adult

patients

with

liver

disease.

Shear

wave

speed

and

stiffness

may

be

used

as

an

aid

to

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

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

때

[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

intraclass

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

both

in

adults

and

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.

10

02/2016

-

ECHOSENS®

AND

FIBROSCAN®

ARE

REGISTERED

TRADEMARKS

©

COPYRIGHT

ECHOSENS

ALL

RIGHT

RESERVED

E117M009.7

echosens FibroScan XL+ Probe User manual

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