Fujifilm SonoSite X-Porte User Manual Supplement

Tipo
User Manual Supplement
rP19xp Transducer
User Guide Supplement
SonoSite, X-Porte, and the SonoSite logo are registered and unregistered trademarks of FUJIFILM SonoSite, Inc. in various jurisdictions.
Value from Innovation is a trademark of FUJIFILM Holdings America Corporation.
All other trademarks are the property of their respective owners.
Patents: US 9,151,832; US 8,956,296; US 8,861,822; US 8,834,372; US 8,805,047; US 8,355,554; US 8,216,146; US 8,213,467; US
8,137,278; US 8,088,071; US 8,066,642; US 7,804,970; US 7,740,586; US 7,604,596; US 7,449,640; US 7,169,108; US 6,962,566;
US 6,648,826; US 6,471,651; US 6,416,475; US 6,383,139; US 6,364,839; US 6,203,498; US 6,135,961; US 5,893,363; US
5,817,024; US 5,782,769; US 5,722,412; AU 727381; AU 730822; CA 2,371,711; CA 2,372,152; CN 103237499; CN 101231457;
CN 97113678.5; CN 98106133.8; CN 98108973.9; DE 60029777.2; DE 60034670.6; DE 69730563.5; DE 69830539.6; DE
69831698.3; EP 0815793; EP 0875203; EP 0881492; EP 1180971; EP 1180970; ES 0881492; ES 2229318; FR 0815793; FR
0875203; FR 0881492; FR 1180970; GB 0815793; GB 0875203; GB 0881492; GB 1180970; GB 1180971; IT 0815793; IT 0881492;
JP 5972258; JP 5782428; JP 4696150; KR 528102; KR 532359; NO 326814 and NO 326202.
Part number: P23130-01
Publication date: January 2017
Copyright © 2016 FUJIFILM SonoSite, Inc. All rights reserved.
Manufacturer
FUJIFILM SonoSite, Inc.
21919 30th Drive SE
Bothell, WA 98021 USA
T: 1-888-482-9449 or
1-425-951-1200
F: 1-425-951-1201
EC Authorized Representative
Emergo Europe
Molenstraat 15
2513 BH, The Hague
The Netherlands
Australia Sponsor
FUJIFILM SonoSite Australasia Pty Ltd
114 Old Pittwater Road
BROOKVALE, NSW, 2100
Australia
Caution United States federal law restricts this device to sale by or on the order of a
physician.
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Introduction 1
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SonoSite X-Porte rP19xp Transducer User Guide
Supplement
Introduction ..................................................................................................................................................... 1
Document conventions ........................................................................................................................................................................... 1
Getting Help .................................................................................................................................................................................................. 2
Imaging modes ................................................................................................................................................ 3
Cleaning and disinfecting .............................................................................................................................. 4
Safety ............................................................................................................................................................... 4
Compatible accessories and peripherals ........................................................................................................................................ 5
Acoustic output .............................................................................................................................................. 5
Guidelines for reducing MI and TI ..................................................................................................................................................... 5
Output display ............................................................................................................................................................................................. 6
Acoustic output tables ............................................................................................................................................................................. 7
Introduction
This user guide supplement provides information on the rP19xp transducer, compatible with the SonoSite
X-Porte ultrasound system.
Document conventions
The document follows these conventions:
A WARNING describes precautions necessary to prevent injury or loss of life.
A Caution describes precautions necessary to protect the products.
A Note provides supplemental information.
Numbered and lettered steps must be performed in a specific order.
Bulleted lists present information in list format but do not imply a sequence.
For a description of labeling symbols that appear on the product, see "Labeling Symbols" in the ultrasound
system user guide.
2 Introduction
Getting Help
For technical support, please contact FUJIFILM SonoSite as follows:
Printed in the U.S.
Phone
(U.S. or Canada)
877-657-8118
Phone
(outside U.S. or
Canada)
425-951-1330, or call your local representative
Fax 425-951-6700
Email ffss-service@fujifilm.com
Web www.sonosite.com
Europe Service Center Main: +31 20 751 2020
English support: +44 14 6234 1151
French support: +33 1 8288 0702
German support: +49 69 8088 4030
Italian support: +39 02 9475 3655
Spanish support: +34 91 123 8451
Asia Service Center +65 6380-5581
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Imaging modes 3
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Imaging modes
Table 1: Available exam types and imaging modes
Transducer Exam type
Imaging mode
2D
M Mode
Color
a
PW
Doppler
b
CW
Doppler
rP19xp Abdomen CVD, CPD
Cardiac CVD, Var
Lung CVD, CPD
Obstetrics CVD, CPD
Orbital CVD, CPD
Transcranial CVD, CPD
a
Var = Color Doppler Variance, which is available in the cardiac exam only. CPD = Color Power
Doppler, which is available in all exams except the cardiac exam type. CVD = Color Velocity Doppler.
b
For the cardiac exam type, PW TDI is also available.
Note The rP19xp transducer is needle guide-capable. For more information, refer to
Using CIVCO Products with FUJIFILM SonoSite Systems.
4 Cleaning and disinfecting
Cleaning and disinfecting
Safety
Table 2: Approved cleaners
Product Compatible transducer
Minimum wet contact time
a
SaniCloth AF3
b
rP19xp 3 minutes
PI-Spray II rP19xp 10 minutes
a
For maximum effectiveness, the component being cleaned must remain wet with disinfectant for a minimum
period of time.
b
Qualified for use as an intermediate-level disinfectant for mycobacteria.
Refer to the cleaners and disinfection document available at www.sonosite.com for a complete list of the most
current cleaners and disinfectants.
Table 3: Approved high-level compatible disinfectants
Disinfectant
a
Compatible transducer Temperature Disinfectant soak duration
Cidex rP19xp
25
o
C, 77
o
F
45 minutes
Cidex OPA rP19xp
20
o
C, 68
o
F
12 minutes
a
Refer to the cleaners and disinfection document available at www.sonosite.com for a complete list of the most
current cleaners and disinfectants.
WARNING To avoid device damage or patient injury, do not use the rP19xp needle-guide
bracket on patients with pacemakers or medical electronic implants. The needle-
guide bracket for rP19xp contains a magnet that is used to ensure that the bracket
is correctly oriented on the transducer. The magnetic field in direct proximity to the
pacemaker or medical electronic implant may have an adverse effect.
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Acoustic output 5
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Compatible accessories and peripherals
Acoustic output
Guidelines for reducing MI and TI
Table 4: Accessories and peripherals
Description Maximum Cable Length
rP19xp transducer
a
6.0 ft /1.8 m
a
For transducers, maximum cable length is measured between the strain reliefs. The stated lengths do not include
the lengths of cable in the following locations: underneath the strain reliefs, inside the transducer enclosure, or inside
the transducer connector.
Table 5: Guidelines for reducing mechanical index (MI)
Transducer Depth
rP19xp
Decrease or lower setting of parameter to reduce MI.
Increase or raise setting of parameter to reduce MI.
6 Acoustic output
Output display
Table 6: Guidelines for reducing thermal index (TI)
Transducer
CPD Settings
PW
Settings
Box
Width
Box
Height
Box
Depth
PRF Depth Optimize
rP19xp
(PRF)
Decrease or lower setting of parameter to reduce TI.
Increase or raise setting of parameter to reduce TI.
Table 7: TI or MI 1.0
Transducer Index
2D/
M Mode
CPD/
Color
PW
Doppler
CW
Doppler
rP19xp MI Yes Yes Yes No
TIC, TIB, or TIS Yes Yes Yes Yes
Table 8: Transducer Surface Temperature Rise, External Use (°C )
Test rP19xp
Still air 15.8
Simulated use 8.8
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Acoustic output 7
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Acoustic output tables
Table 9: Transducer Model: rP19xp Operating Mode: 2D
Index Label M.I.
TIS TIB
TIC
Scan
Non-scan
Non-scan
A
aprt
1 A
aprt
>1
Global Maximum Index Value 1.5 1.2 2.9
Associated Acoustic
Parameter
p
r.3
(MPa) 1.95
W
0
(mW) 120.0 190.8
min of [W
.3
(z
1
),I
TA.3
(z
1
)] (mW)
z
1
(cm)
Z
bp
(cm)
Z
sp
(cm)
z@PII
.3max
2.6
d
eq
(z
sp
) (cm)
F
c
(MHz) 1.72 2.02 1.80
Dim of A
aprt
X (cm) 1.92 1.92
Y (cm) 1.15 1.15
Other Information
PD (μsec) 1.227
PRF (Hz) 2933
p
r
@PII
max
(MPa) 2.30
d
eq
@Pll
max
(cm)
Focal Length FL
x
(cm) 3.42 3.42
FL
y
(cm) 9.00 9.00
I
PA.3
@MI
max
(W/cm
2
)
225
Operating
Control
Conditions
Control 1: Exam Type Crd Abd Abd
Control 2: Optimization Gen Pen Gen
Control 3: Depth 7 cm 5 cm 5 cm
Control 4: THI On Off On
Control 5: Sector Width Full N/A N/A
Data are not applicable for this transducer/mode.
8 Acoustic output
Table 10: Transducer Model: rP19xp Operating Mode: M Mode
Index Label M.I.
TIS TIB
TIC
Scan
Non-scan
Non-scan
A
aprt
1 A
aprt
>1
Global Maximum Index Value 1.5 1.1 0.9 3.0
Associated Acoustic
Parameter
p
r.3
(MPa) 1.95
W
0
(mW) 105 9.8 25.4 180.5
min of [W
.3
(z
1
),I
TA.3
(z
1
)] (mW)
z
1
(cm)
Z
bp
(cm)
Z
sp
(cm) 3.02
z@PII
.3max
2.6
d
eq
(z
sp
) (cm) 0.444
F
c
(MHz) 1.72 2.09 2.09 1.732 1.75
Dim of A
aprt
X (cm) 1.92 0.78 1.02 1.92
Y (cm) 1.15 1.15 1.15 1.15
Other Information
PD (μsec) 1.227
PRF (Hz) 2693
p
r
@PII
max
(MPa) 2.30
d
eq
@Pll
max
(cm) 0.427
Focal Length FL
x
(cm) 4.56 4.56 2.25
FL
y
(cm) 9.00 9.00 9.00
I
PA.3
@MI
max
(W/cm
2
)
225
Operating
Control
Conditions
Control 1: Exam Type Crd Abd Crd Abd
Control 2: Optimization Gen Pen Gen Gen
Control 3: Depth 7 cm 7 cm 13 cm 5 cm
Control 4: THI On Off On On
Data are not applicable for this transducer/mode.
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Acoustic output 9
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Table 11: Transducer Model: rP19xp Operating Mode: Color/CPD
Index Label M.I.
TIS TIB
TIC
Scan
Non-scan
Non-scan
A
aprt
1 A
aprt
>1
Global Maximum Index Value 1.5 1.6 3.8
Associated Acoustic
Parameter
p
r.3
(MPa) 2.15
W
0
(mW) 134.3 174.1
min of [W
.3
(z
1
),I
TA.3
(z
1
)] (mW)
z
1
(cm)
Z
bp
(cm)
Z
sp
(cm)
z@PII
.3max
4.3
d
eq
(z
sp
) (cm)
F
c
(MHz) 2.05 2.60 2.09
Dim of A
aprt
X (cm) 1.34 0.63
Y (cm) 1.15 1.15
Other Information
PD (μsec) 1.662
PRF (Hz) 1526
p
r
@PII
max
(MPa) 2.91
d
eq
@Pll
max
(cm)
Focal Length FL
x
(cm) 4.56 2.25
FL
y
(cm) 9.00 9.00
I
PA.3
@MI
max
(W/cm
2
)
355
Operating
Control
Conditions
Control 1: Exam Type Lung OB Crd
Control 2: Mode CVD CVD CVD
Control 3: 2D Optimization/Depth Gen/
13 cm
Gen/
5 cm
Pen/
5 cm
Control 4: Sector Width/THI N/A N/A/Off Med/On
Control 5: Color Optimization/PRF Low/
273 Hz
High/
2841 Hz
High/
3571 Hz
Control 6: Color Box Position/Size Def/
Narrow
Bottom/
Small
Def/
Narrow
Data are not applicable for this transducer/mode.
10 Acoustic output
Table 12: Transducer Model: rP19xp Operating Mode: PW Doppler
Index Label M.I.
TIS TIB
TIC
Scan
Non-scan
Non-scan
A
aprt
1 A
aprt
>1
Global Maximum Index Value 1.5 1.9 4.0 3.2
Associated Acoustic
Parameter
p
r.3
(MPa) 2.17
W
0
(mW) 192.5 211.8
min of
[W
.3
(z
1
),I
TA.3
(z
1
)]
(mW) 108.3
z
1
(cm) 1.9
Z
bp
(cm) 2.5
Z
sp
(cm) 5.10
z@PII
.3max
0.5
d
eq
(z
sp
) (cm) 0.60
F
c
(MHz) 2.08 3.69 2.06 2.04
Dim of A
aprt
X (cm) 1.92 1.92 1.92
Y (cm) 1.15 1.15 1.15
Other Information
PD (μsec) 1.141
PRF (Hz) 1562
p
r
@PII
max
(MPa) 2.24
d
eq
@Pll
max
(cm) 0.54
Focal Length FL
x
(cm) 11.51 11.51
FL
y
(cm) 9.00 9.00
I
PA.3
@MI
max
(W/cm
2
)
156
Operating
Control
Conditions
Control 1: Exam Type Abd Crd Abd Abd
Control 2: Sample Volume Size 1 mm 7 mm 1 mm 1 mm
Control 3: Sample Volume Position Zone 0
(13 mm)
Zone7
(115 mm)
Zone 6
(96 mm)
Zone 7
(115 mm)
Control 4: PRF 1562 Hz 1008 Hz 1562 Hz 1562 Hz
Control 5: TDI Off On Off Off
Data are not applicable for this transducer/mode.
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Acoustic output 11
English Deutsch Español Français Italiano Português Nederlands
Table 13: Transducer Model: rP19xp Operating Mode: CW Doppler
Index Label M.I.
TIS TIB
TIC
Scan
Non-scan
Non-scan
A
aprt
1 A
aprt
>1
Global Maximum Index Value (a) 1.2 4.0 3.1
Associated Acoustic
Parameter
p
r.3
(MPa) #
W
0
(mW) 130.6 134.7 125.7
min of [W
.3
(z
1
),I
TA.3
(z
1
)] (mW)
z
1
(cm)
Z
bp
(cm)
Z
sp
(cm) 3.40
z@PII
.3max
#
d
eq
(z
sp
) (cm) 0.47
F
c
(MHz) # 2.00 2.00 2.00
Dim of A
aprt
X (cm) 0.90 0.90 0.72
Y (cm) 1.15 1.15 1.15
Other Information
PD (μsec) #
PRF (Hz) #
p
r
@PII
max
(MPa) #
d
eq
@Pll
max
(cm) 0.47
Focal Length FL
x
(cm) 22.01 1.30
FL
y
(cm) 9.00 9.00
I
PA.3
@MI
max
(W/cm
2
)
#
Operating
Control
Conditions
Control 1: Exam Type Crd Crd Crd
Control 2: Sample Volume Position Zone 11
(220 mm)
Zone 10
(189 mm)
Zone 0
(13 mm)
(a) This index is not required for this operating mode; value is <1.
# No data are reported for this operating condition since the global maximum index value is not reported for the
reason listed. (Reference Global Maximum Index Value line.)
Data are not applicable for this transducer/mode.
12 Acoustic output
Table 14: Transducer Model: rP19xp (Orbital use) Operating Mode: 2D
Index Label M.I.
TIS TIB
TIC
Scan
Non-scan
Non-scan
A
aprt
1 A
aprt
>1
Global Maximum Index Value 0.17 0.026 0.057
Associated Acoustic
Parameter
p
r.3
(MPa) 0.26
W
0
(mW) 2.35 3.88
min of [W
.3
(z
1
),I
TA.3
(z
1
)] (mW)
z
1
(cm)
Z
bp
(cm)
Z
sp
(cm)
z@PII
.3max
4.00
d
eq
(z
sp
) (cm)
F
c
(MHz) 2.34 2.33 2.34
Dim of A
aprt
X (cm) 1.92 1.92
Y (cm) 1.15 1.15
Other Information
PD (μsec) 0.59
PRF (Hz) 2317
p
r
@PII
max
(MPa) 0.45
d
eq
@Pll
max
(cm)
Focal Length FL
x
(cm) 16.77 16.77
FL
y
(cm) 9.00 9.00
I
PA.3
@MI
max
(W/cm
2
)
3.41
Operating
Control
Conditions
Control 1: Exam Type Orb Orb Orb
Control 2: Optimization Gen Gen Gen
Control 3: Depth 31 cm 31 cm 31 cm
Control 4: THI Off Off Off
Data are not applicable for this transducer/mode.
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Acoustic output 13
English Deutsch Español Français Italiano Português Nederlands
Table 15: Transducer Model: rP19xp (Orbital use) Operating Mode: M Mode
Index Label M.I.
TIS TIB
TIC
Scan
Non-scan
Non-scan
A
aprt
1 A
aprt
>1
Global Maximum Index Value 0.17 0.025 0.012 0.055
Associated Acoustic
Parameter
p
r.3
(MPa) 0.26
W
0
(mW) 1.848 0.84 3.68
min of [W
.3
(z
1
),I
TA.3
(z
1
)] (mW) 0.41
z
1
(cm) 2.80
Z
bp
(cm) 2.52
Z
sp
(cm) 3.8
z@PII
.3max
4.00
d
eq
(z
sp
) (cm) 0.85
F
c
(MHz) 2.34 2.37 2.37 2.34 2.37
Dim of A
aprt
X (cm) 1.92 1.92 1.92 1.92
Y (cm) 1.15 1.15 1.15 1.15
Other Information
PD (μsec) 0.59
PRF (Hz) 1600
p
r
@PII
max
(MPa) 0.45
d
eq
@Pll
max
(cm) 0.58
Focal Length FL
x
(cm) 14.0 14.0 14.0
FL
y
(cm) 9.0 9.0 9.0
I
PA.3
@MI
max
(W/cm
2
)
3.41
Operating
Control
Conditions
Control 1: Exam Type Orb Orb Orb Orb
Control 2: Optimization Gen Gen Gen Gen
Control 3: Depth 31 cm 25 cm 31 cm 25 cm
Control 4: THI Off Off Off Off
Data are not applicable for this transducer/mode.
14 Acoustic output
Table 16: Transducer Model: rP19xp (Orbital use) Operating Mode: Color/CPD
Index Label M.I.
TIS TIB
TIC
Scan
Non-scan
Non-scan
A
aprt
1 A
aprt
>1
Global Maximum Index Value 0.20 0.055 0.12
Associated Acoustic
Parameter
p
r.3
(MPa) 0.28
W
0
(mW) 5.55 5.77
min of
[W
.3
(z
1
),I
TA.3
(z
1
)]
(mW)
z
1
(cm)
Z
bp
(cm)
Z
sp
(cm)
z@PII
.3max
0.4
d
eq
(z
sp
) (cm)
F
c
(MHz) 2.07 2.068 2.068
Dim of A
aprt
X (cm) 0.96 0.96
Y (cm) 1.15 1.15
Other Information
PD (μsec) 1.55
PRF (Hz) 6301
p
r
@PII
max
(MPa) 0.29
d
eq
@Pll
max
(cm)
Focal Length FL
x
(cm) 1.3 1.3
FL
y
(cm) 9.0 9.0
I
PA.3
@MI
max
(W/cm
2
)
2.58
Operating
Control
Conditions
Control 1: Exam Type Orb Orb Orb
Control 2: Mode CVD CVD CVD
Control 3: 2D Optimization/Depth Gen/5 cm Gen/
5
cm
Gen/
5
cm
Control 4: Color Optimization/PRF Med/
2778 Hz
Med/
2778 Hz
Med/
2778 Hz
Control 5: Color Box Position/Size Default/Top Default/
Top
Default/
Top
Data are not applicable for this transducer/mode.
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Acoustic output 15
English Deutsch Español Français Italiano Português Nederlands
Table 17: Transducer Model: rP19xp (Orbital use) Operating Mode: PW Doppler
Index Label M.I.
TIS TIB
TIC
Scan
Non-scan
Non-scan
A
aprt
1 A
aprt
>1
Global Maximum Index Value 0.19 0.22 0.56 0.51
Associated Acoustic
Parameter
p
r.3
(MPa) 0.28
W
0
(mW) 33.8 34.4
min of [W
.3
(z
1
),I
TA.3
(z
1
)] (mW) 21.89
z
1
(cm) 3.00
Z
bp
(cm) 2.52
Z
sp
(cm) 3.8
z@PII
.3max
0.8
d
eq
(z
sp
) (cm) 0.79
F
c
(MHz) 2.11 2.09 2.09 2.09
Dim of A
aprt
X (cm) 1.92 1.92 1.92
Y (cm) 1.15 1.15 1.15
Other Information
PD (μsec) 3.67
PRF (Hz) 3906
p
r
@PII
max
(MPa) 0.29
d
eq
@Pll
max
(cm) 0.69
Focal Length FL
x
(cm) 22.0 27.3
FL
y
(cm) 9.0 9.0
I
PA.3
@MI
max
(W/cm
2
)
2.43
Operating
Control
Conditions
Control 1: Exam Type Orb Orb Orb Orb
Control 2: Sample Volume Size 3 mm 9 mm 9 mm 7 mm
Control 3: Sample Volume Position Zone 1
(23 mm)
Zone 11
(220 mm)
Zone 11
(220 mm)
Zone 13
(273 mm)
Control 4: PRF 3906 Hz 2604 Hz 2604 Hz 1953 Hz
Data are not applicable for this transducer/mode.
16 Acoustic output
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Einführung 17
Nederlands
Ergänzung zum rP19xp-Schallkopf-Benutzer-
handbuch von SonoSite X-Porte
Einführung .................................................................................................................................................... 17
Dokumentkonventionen ...................................................................................................................................................................... 17
Weiterführende Informationen ......................................................................................................................................................... 18
Bildgebungsmodi ......................................................................................................................................... 19
Reinigung und Desinfektion ...................................................................................................................... 20
Sicherheit ..................................................................................................................................................... 20
Kompatible Zubehörteile und Peripheriegeräte ...................................................................................................................... 21
Schall-Ausgangsleistung ........................................................................................................................... 21
Richtlinien zur Reduzierung des MI und TI ................................................................................................................................ 21
Ausgangsleistungsanzeige ................................................................................................................................................................. 22
Schallausgangsleistungs-Tabellen .................................................................................................................................................. 23
Einführung
Diese Ergänzung zum Benutzerhandbuch enthält Informationen zum rP19xp-Schallkopf, der mit dem
SonoSite X-Porte-Ultraschallsystem kompatibel ist.
Dokumentkonventionen
Für das Dokument gelten folgende Konventionen:
Ein WARNHINWEIS beschreibt die notwendigen Vorsichtsmaßnahmen zur Vermeidung einer Verletzung
oder eines tödlichen Unfalls.
Ein Vorsichtshinweis beschreibt die notwendigen Vorsichtsmaßnahmen zum Schutz der Produkte.
Ein Hinweis enthält ergänzende Informationen.
Nummerierte oder mit Buchstaben versehene Schritte müssen in einer bestimmten Reihenfolge
durchgeführt werden.
Listen mit Gliederungspunkten stellen Informationen in einem Listenformat dar, schreiben jedoch keine
Reihenfolge vor.
Eine Beschreibung der Kennzeichnungssymbole des Produkts ist unter „Kennzeichnungssymbole“ im
Benutzerhandbuch des Ultraschallsystems zu finden.
18 Einführung
Weiterführende Informationen
Der technische Kundendienst von FUJIFILM SonoSite ist wie folgt erreichbar:
Gedruckt in den USA.
Telefon
(USA und Kanada)
+1-877-657-8118
Telefon
(außerhalb USA und
Kanada)
+1-425-951-1330, oder kontaktieren Sie Ihren Vertreter
vor Ort.
Fax +1-425-951-6700
E-Mail ffss-service@fujifilm.com
Web www.sonosite.com
Europäisches
Servicezentrum
Hauptstelle: +31 20 751 2020
Kundendienst auf Englisch: +44 14 6234 1151
Kundendienst auf Französisch: +33 1 8288 0702
Kundendienst auf Deutsch: +49 69 8088 4030
Kundendienst auf Italienisch: +39 02 9475 3655
Kundendienst auf Spanisch: +34 91 123 8451
Asiatisches
Servicezentrum
+65 6380-5581
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Fujifilm SonoSite X-Porte User Manual Supplement

Tipo
User Manual Supplement