FibroScan M Plus Probe User manual

FibroScan

M+

User

Probe

manual

CE

0459

E117M008.7 — Version 7 —

02/2016

M+

PROBE

USER

MANUAL

2

02/2016 - ECHOSENS®

AND

FIBROSCAN®D

ARE

REGISTERED

TRADEMARKS © COPYRIGHT

ECHOSENS

ALL

RIGHT

RESERVED

E117M008.7

M+

PROBE

USER

MANUAL

fines

TABLE

1.

PURPOSE

1.1.

Symbols

1.2.

Property

2.

WARNINGS

2.1.

Generality

2.2.

Handling

2.3，Maintenance

3.

MISCELLANEOUS

OF

THE

USER

used

in

the

manual

and

copyright.........................

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the

probe

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INFORMATION

CA

3.2.

Registered

4.

INDICATIONS

4.1.

Имепдед

4.3.

Probe

4.4.

2[606841015

4.5.

User

46.

Electricalsafety..........................................

4.7.

Maintenance-relatedsafety................................. e een

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101

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PRECAUTIONS

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MANUAL

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14

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E117M008.7

5.

EXTERNAL

5.1.

Hardware

5.2.

РгоБе

6.

USE

6.1.

User

6.2.

Connecting / disconnecting

6.3.

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

6.4.

End

7.

CLEANING,

7.1.

Cleaning

7.2.

Calibrating

7.3.

Troubleshooting

02/2016 - ECHOSENS®

PRESENTATION

supplied..............................L

дезспрНОп..............

DURING

6.3.1.

6.3.2.

AN

EXAMINATION

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7.1.1.

Cleaning

7.1.2.

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7.13.

Recommendeddecontamination

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TRADEMARKS © COPYRIGHT

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ECHOSENS

ALL

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RESERVED

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M+

PROBE

USER

8.

8.1.

MANUAL

TECHNICAL

Ultrasound

CHARACTERISTICS

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02/2016 - ECHOSENS®

AND

FIBROSCAN®

ARE

REGISTERED

TRADEMARKS © COPYRIGHT

ECHOSENS

ALL

RIGHT

RESERVED

E117M008.7

M+

THE

and

required

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manual.

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requirements,

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Et17M908.7

02/2016 - ECHOSENSO

AND

FIBROSCANO

ARE

REGISTERED

TRADEMARKS O COPYRIGHT

ECHOSENS

ALL

RIGHT

RESERVED

5

[ETF]

M+

PROBE

USER

MANUAL

1.1.

AN

1.2.

All

manuals

protected

to

legal

whole

Hence,
is

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SYMBOLS

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Warning:

Instructions

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PROPERTY

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Copyright © —

11/2012 — 02/2016 — Echosens — All

rights

reserved.

6

02/2016 - ECHOSENS®

AND

FIBROSCAN®

ARE

REGISTERED

TRADEMARKS © COPYRIGHT

ECHOSENS

ALL

RIGHT

RESERVED

E117M008.7

M+

2.1.

GENERALITY

个

2.2.

A

Caution:

HANDLING

The

and

holder

stored

probe

kept

on the

in

Federal

THE

is a fragile

away

from

FibroScan.

its

case.

law

restricts

PROBE

electromechanical

liquids.

In

this

device

Between

the

event

to

two

of

prolonged

PROBE

sale

by

device

examinations,

2.

or

on

that

must

non-use,

USER

MANUAL

WARNINGS

the

order

of a physician.

be

handled

it

should

be

placed

the

probe

FRETE]

with

care

on

should

its

be

2.3.

MAINTENANCE

Maintenance

technician

The

calibration
characteristics

probe

authorized

must

certificate,

operations

by

Echosens.

be

calibrated

the

of

the

probe.

must

not

periodically.

manufacturer

be

performed

no

Beyond

longer

by a third

the

period

guarantees

party

other

indicated

the

performance

than

a

on the

E117M008.7

02/2016 - ECHOSENS®

AND

FIBROSCAN®

ARE

REGISTERED

TRADEMARKS © COPYRIGHT

ECHOSENS

ALL

RIGHT

RESERVED

u

(U5)

M+

PROBE

USER

3.

3.1.

The

For

shall,

3.2.

MANUAL

MISCELLANEOUS

GUARANTEE

terms

of

guarantee

any

request,

if

applicable,

REGISTERED

are

Echosens

transfer

TRADEMARKS

stated

remains

the

request

in

the

Echosens

available

to a competent

INFORMATION

terms

of

sale

to

the

physician

local

and

representative.

documents.

his/her

appointees

and

Echosens

and

FibroScan

are

registered

trademarks

of

the

company

Echosens.

8

02/2016 - ECHOSENS®

AND

FIBROSCAN®

ARE

REGISTERED

TRADEMARKS © COPYRIGHT

ECHOSENS

ALL

RIGHT

RESERVED

E117M008.7

4.

INDICATIONS

4.1.

INTENDED

The

FibroScan

ultrasound.

The
measurements
attenuation
body.

The

This

FibroScan

parameter

FibroScan

(VCTETM).

system

device

system

and

estimates

device

USE

with

the

is

designed

with

(CAP:

is

based

AND

M+

probe

to

the

M+

probe

of

tissue

Controlled

on

the

PRECAUTIONS

is

an

active,

non-implantable

be

used

in a doctor's

is

intended

stiffness

Attenuation

Vibration-Controlled

as well

Parameter)

to

as

office.

provide

3.5

MHz

in

Transient

FOR

medical

50

Hz

shear

ultrasound

internal

Elastography

USE

device

wave

coefficient

structures

principle

using

speed

of

of

the

The

FibroScan

shaft

of

the

which

in

turn

subcutaneous

transducer

speed
and
interest,
4

cm

In

addition,
device
E=3xpx
wave
for

the

Concomitantly,
Parameter
propagates
decreases
intensity
attenuation

medium

expressed

Absolute
from

performs a series

of

shear

temporal

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corresponds

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converts

Vs?

speed

and

purpose

(CAP).

through

exponentially

at

depth
depends

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propagation.

in

values

different

probe

comprises a single-element
electrodynamic
generates

tissues,

wave

average

can

shear

with p the

of

the

an

and

propagation

speed

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approximated

to

that

wave

equivalent

comparison

ultrasound

Ultrasound

the

medium.

with

z, a is

principally

medium

the

CAP

dB/m.

for

these

measurements

manufacturers.

transducer.

elastic

shear

then

the

liver.

of

ultrasound

(Vs)

of

propagation

by a cylinder

about 3 cm).

the

liver

is a pure

speed

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density

stiffness

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with

other

acquisitions

attenuation

Due

to

depth

(z):

frequency

on

(i)

assesses

ultrasound

This

transducer

wave.

This

wave

During

shear

acquisitions

in

m/s.

This

of

into

equivalent

assumed

Young’s

measurements

are

corresponds

attenuation,

Iz = lo x exp

(f)

dependent

the

ultrasound frequency,

the

value

may

vary

(emission / reception)

measurement

the

shear

with a diameter

elastic,

stiffness E in

to

be

modulus)

used

to

the

(-

of a at

among

transducer

generates a transient

propagates

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wave

linear

1000
are

relative

performed

assess

to

the loss

intensity

a(f) x z)

attenuation

the

frequency f =

measurement

through

propagation,

corresponds

through

and

kg/m*.

the

where

the

of 1 cm

isotropic

kPa

using

The

indexes

using

FibroScan

Controlled

of

energy

of

emitted

Iz is

coefficient.

(ii)

the

devices

mounted

vibration,

the

skin,

the

ultrasound

to

measure

to

the

liver

region

and a length

medium,

the

equation

values

for

intended

devices.

Attenuation

as

ultrasound

ultrasound

the

ultrasound

Ultrasound

properties

3.5

MHz

produced

on

the

the

the

spatial

of
of

the

shear

only

(Io)

of

the

and

is

E117M008.7

02/2016 - ECHOSENS®

AND

FIBROSCAN®

ARE

REGISTERED

TRADEMARKS © COPYRIGHT

ECHOSENS

ALL

RIGHT

RESERVED

9