FujiFilm SonoSite S Series Owner's manual

S Series Ultrasound System
User Guide Supplement P13895-06

English Deutsch Español Français Italiano PortuguêsFrançais Nederlands
User Guide Supplement P13895-06
Ergänzung zum Benutzerhandbuch P13895-06
Suplemento del Manual para el usuario P13895-06
Supplément au guide d’utilisation P13895-06
Supplemento al Manuale dell’utente P13895-06
Suplemento do Manual do Usuário P13895-06
Supplement bij gebruikershandleiding P13895-06

Dansk Norsk Svenska Ελληνικά Русский Türkçe 简体中文 繁體中文
Tillæg til brugervejledning P13895-06
Vedlegg til brukerveiledning P13895-06
Tillägg till användarhandbok P13895-06
Συμπλήρωμα στον οδηγό χρήσης P13895-06
Дополнение к руководству пользователя
P13895-06
Kullanıcı Kılavuzu Eki P13895-06
用户指南补充说明 P13895-06
使用者手冊補充說明 P13895-06

ii
S Series, SonoMBe, SonoSite, and the SonoSite logo are registered and unregistered trademarks of FUJIFILM SonoSite, Inc. in various
jurisdictions. FUJIFILM is a registered trademark of FUJIFILM Corporation. Value from Innovation is a trademark of FUJIFILM Holdings
America Corporation.
All other trademarks are the property of their respective owners.
Patents: US 8,376,103; US 8,216,146; US 8,213,467; US 8,137,278; US 8,066,642; US 7,978,461; US 7,804,970; US 7,740,586; US 7,686,766; US
7,591,786; US 7,588,541; US 7,534,211; US 7,449,640; US 7,169,108; US 6,962,566; US 6,648,826; US 6,569,101; US 6,471,651; US 6,416,475;
US 6,383,139; US 6,371,918; US 6,364,839; US 6,135,961; US 5,893,363; US 5,817,024; US 5,782,769; US 5,722,412; USD592,750; USD591,423;
AU 727381; AU 730822; CA 2,371,711; CA 2,372,152; CA 2,373,065; CN 97113678.5; CN 98106133.8; CN 200830007734.8; EP 0875203; EP
0881492; EP 1175713; EP 1180970; EP 1180971; EP 1552792; EP 1589878; JP 4696150; KR 528102; and KR 532359.
P13895-06 06/2019
Copyright 2019 by SonoSite, Inc.
All rights reserved. Printed in the USA.
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
FUJIFILM SonoSite B.V.
Joop Geesinkweg 140
1114 AB Amsterdam,
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.

English Deutsch Español Français Italiano Português
1
Nederlands
S Series Ultrasound System
User Guide Supplement P13895-06
Introduction .............................................................................................................................1
Imaging .....................................................................................................................................1
Safety .........................................................................................................................................4
Introduction
This user guide supplement does the following:
• Updates acoustic output information for the S Series™ ultrasound system
• Describes SonoMBe™ multi-beam imaging, enhanced (MBe), available on the following
transducers:
• C60x/5-2 MHz
• HFL38x/13-6 MHz
• HFL50x/15-6 MHz
• L25x/13-6 MHz
• L38xi/10-5 MHz
Imaging
2D imaging
WARNING: To avoid incorrect needle placement when MBe is on:
• Using movement and fluid injection, verify the needle-tip location and trajectory.
MBe enhances linear structures within a selected angle range on the ultrasound
plane. Linear structures outside the selected angle range or the ultrasound
plane—such as a bent needle—may be less apparent.
• Note that linear structures are enhanced only in an outlined portion of the image.
The area outside the outline remains unchanged. (See Figure 2.)
• Note that the beam divergence of a curved array transducer may prevent a
segment of the needle shaft from showing in the image. (See Figure 3.) The needle
tip may not show.

2
2D controls
MBe Turns on SonoMBe imaging, which enhances linear structures within a selected angle
range and can facilitate needle guidance during catheter placement and nerve-block
procedures. A three- or four-sided outline indicates the affected area. (See Figure 2.)
For curved array transducers, MBe can help identify the direction of the needle,
although only segments of the needle shaft may show in the image. (See Figure 3.)
Use movement and fluid injection to help verify the needle-tip location.
Use a 17-gauge to 25-gauge needle (recommended). Enhancement results can
depend on the type and brand of needle used. For more information, consult the
medical literature on needle visibility in ultrasound-guided procedures.
You can angle the needle up to 50° from the transducer surface. (See Figure 1.) Beyond
50°, the needle may be less enhanced. (MBe has little or no benefit to out-of-plane
procedures. MBe is intended for in-plane procedures only.)
Avoid setting the gain too high, as unnecessarily high gain can cause artifacts in the
image. Also, respiratory and cardiac movement in the image may cause bright
pulsating artifacts.
When MBe is on, additional controls are available:
•L/R Flip flips the affected area (the outline) horizontally on the image.
For reorienting the entire image, use the orientation control .
•Shallow, Medium, or Steep sets the outline’s sloped edge, which is indicated by a
dotted line.
• Linear transducer: Use whichever setting provides best perpendicularity to the
dotted line. Within the affected area, the more perpendicular that a linear
structure is to the dotted line, the more it is enhanced. Similarly, the less
perpendicular (and more parallel) that a linear structure is to the dotted line, the
less it is enhanced.
• Curved array transducer: For a linear structure angled 30° or less from the
transducer surface, use Shallow for best enhancement. For a linear structure
angled 30-40°, use Medium. For a linear structure angled 40° or greater, use
Steep.
The control key of the current selection is outlined.
•Off turns off MBe. Temporarily turning off MBe can help you identify artifacts and
other structures not of interest.
•Back returns to the previous screen. If MBe is on, MBe is highlighted green and MBe
appears in the mode data area. Pressing MBe again redisplays the MBe controls.
Available in Breast, Musculoskeletal, Nerve, Small Parts, Vascular (L25x only), and
Venous (L25x only) exams and in full-screen imaging only. If MBe is on, the MB control
is unavailable.

English Deutsch Español Français Italiano Português
3
Nederlands
Figure 1:For best results, angle the needle only up to 50° from the transducer surface:
Figure 2:Image with MBe on (linear transducer)
1 Needle 2 Transducer
1 Needle
2 Outlined area affected by MBe
3 Dotted line
4Unenhanced area
0 - 50°
2
1
1
2
4
3

4
Figure 3:With a curved array transducer, only segments of the needle shaft may show:
Safety
Output display
1 Upper needle shaft
2 Needle tip
3 Unshown segment of needle shaft
(unshown segment or segments depend
on specific image)
1
2
3
Table 1: TI or MI  1.0
Transducer Model Index 2D/
M Mode
CPD/
Color
PW
Doppler
CW
Doppler
HFL38x MI Yes Yes Yes —
TIC, TIB, or TIS No Yes Yes —
HFL50x MI Yes Yes Yes —
TIC, TIB, or TIS No No Yes —
L25x MI Yes No No —
TIC, TIB, or TIS No No Yes —

English Deutsch Español Français Italiano Português
5
Nederlands
Acoustic output tables
(a) This index is not required for this operating mode; value is <1.
(b) This transducer is not intended for transcranial or neonatal cephalic uses.
# 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.
Table 2: Transducer Model: HFL38x/13-6 Operating Mode: 2D
Index Label MI
TIS TIB
TIC
Scan Non-scan Non-scan
Aaprt1 Aaprt>1
Global Maximum Index Value 1.1 (a) — — — (b)
Associated Acoustic
Parameter
pr.3 (MPa) 2.56
W0(mW) # — — #
min of [W.3(z1),ITA.3(z1)] (mW) —
z1(cm) —
zbp (cm) —
zsp (cm) —
z@PII.3max 1.2
deq(zsp) (cm) —
fc(MHz) 5.33 # — — — #
Dim of Aaprt X (cm) # — — — #
Y (cm) # — — — #
Other
Information
PD (µsec) 0.525
PRF (Hz) 2450
pr@PIImax (MPa) 3.19
deq@Pllmax (cm) —
Focal Length FLx (cm) # — — #
FLy (cm) # — — #
IPA.3@MImax (W/cm2)325.3
Operating
Control
Conditions
Control 1: Exam Type Nrv/Bre/
SmP/Msk
— — — — —
Control 2: Optimization Any — — — — —
Control 3: Depth 3.3 cm — — — — —
Control 4: MBe On — — — — —

6
(a) This index is not required for this operating mode; value is <1.
(b) This transducer is not intended for transcranial or neonatal cephalic uses.
# 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.
Table 3: Transducer Model: HFL38x Operating Mode: CPD/Color
Index Label MI
TIS TIB
TIC
Scan Non-scan Non-
scan
Aaprt1 Aaprt>1
Global Maximum Index Value 1.1 1.0 — — — (b)
Associated Acoustic
Parameter
pr.3 (MPa) 2.556
W0(mW) 37.69 — — #
min of [W.3(z1),ITA.3(z1)] (mW) —
z1(cm) —
zbp (cm) —
zsp (cm) 1.2 —
deq(zsp) (cm) —
fc(MHz) 5.328 5.324 — — — #
Dim of Aaprt X (cm) 0.44 — — — #
Y (cm) 0.4 — — — #
Other
Information
PD (µsec) 0.525
PRF (Hz) 2597
pr@PIImax (MPa) 3.187
deq@Pllmax (cm) —
Focal Length FLx (cm) 1.32 — — #
FLy (cm) 2.5 — — #
IPA.3@MImax (W/cm2)325.5
Operating
Control
Conditions
Control 1: Mode Color Color — — — —
Control 2: Exam Type Any Ven — — — —
Control 3: Optimization/Depth/PRF Low/
3.3 cm/
Any
Med/
2.7 cm/
2841
— — — —
Control 4: Color Box Position/Size Any Top/
Short
— — — —

English Deutsch Español Français Italiano Português
7
Nederlands
(a) This index is not required for this operating mode; value is <1.
(b) This transducer is not intended for transcranial or neonatal cephalic uses.
# 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.
Table 4: Transducer Model: HFL38x Operating Mode: PW Doppler
Index Label MI
TIS TIB
TIC
Scan Non-scan Non-scan
Aaprt1 Aaprt>1
Global Maximum Index Value 1.0 — 1.1 — 2.0 (b)
Associated Acoustic
Parameter
pr.3 (MPa) 2.37
W0(mW) — 43.01 43.01 #
min of [W.3(z1),ITA.3(z1)] (mW) —
z1(cm) —
zbp (cm) —
zsp (cm) 0.9 1.1
deq(zsp) (cm) 0.33
fc(MHz) 5.32 — 5.30 — 5.30 #
Dim of Aaprt X (cm) — 1.04 — 1.04 #
Y (cm) — 0.4 — 0.4 #
Other
Information
PD (µsec) 1.29
PRF (Hz) 1008
pr@PIImax (MPa) 2.404
deq@Pllmax (cm) 0.21
Focal Length FLx (cm) — 3.72 — #
FLy (cm) — 2.5 — #
IPA.3@MImax (W/cm2)323.35
Operating
Control
Conditions
Control 1: Exam Type Bre/Vas
SmP/IMT
Any Any
Control 2: Sample Volume 1 mm 1 mm 1 mm
Control 3: PRF 1008 6250 6250
Control 4: Sample Volume Position Zone 2 Zone 7 Zone 7

8
(a) This index is not required for this operating mode; value is <1.
(b) This transducer is not intended for transcranial or neonatal cephalic uses.
# 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.
Table 5: Transducer Model: HFL50x Operating Mode: 2D
Index Label MI
TIS TIB
TIC
Scan Non-scan Non-scan
Aaprt1 Aaprt>1
Global Maximum Index Value 1.3 (a) — — — (b)
Associated Acoustic
Parameter
pr.3 (MPa) 3.051
W0(mW) # — — #
min of [W.3(z1),ITA.3(z1)] (mW) —
z1(cm) —
zbp (cm) —
zsp (cm) —
z@PII.3max 1.2
deq(zsp) (cm) —
fc(MHz) 5.36 # — — — #
Dim of Aaprt X (cm) # — — — #
Y (cm) # — — — #
Other
Information
PD (µsec) 0.521
PRF (Hz) 2733
pr@PIImax (MPa) 3.81
deq@Pllmax (cm) —
Focal Length FLx (cm) # — — #
FLy (cm) # — — #
IPA.3@MImax (W/cm2)493
Operating
Control
Conditions
Control 1: Exam Type Any — — — — —
Control 2: Optimization Any — — — — —
Control 3: Depth 3.3 — — — — —
Control 4: MBe On — — — — —

English Deutsch Español Français Italiano Português
9
Nederlands
(a) This index is not required for this operating mode; value is <1.
(b) This transducer is not intended for transcranial or neonatal cephalic uses.
# 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.
Table 6: Transducer Model: HFL50x Operating Mode: PW Doppler
Index Label MI
TIS TIB
TIC
Scan Non-scan Non-scan
Aaprt1 Aaprt>1
Global Maximum Index Value 1.2 — 1.1 — 1.9 (b)
Associated Acoustic
Parameter
pr.3 (MPa) 2.69
W0(mW) — 42.6 42.6 #
min of [W.3(z1),ITA.3(z1)] (mW) —
z1(cm) —
zbp (cm) —
zsp (cm) 1.0 1.1
deq(zsp) (cm) 0.33
fc(MHz) 5.34 — 5.34 — 5.34 #
Dim of Aaprt X (cm) — 1.08 — 1.08 #
Y (cm) — 0.40 — 0.40 #
Other
Information
PD (µsec) 1.29
PRF (Hz) 1008
pr@PIImax (MPa) 3.23
deq@Pllmax (cm) 0.22
Focal Length FLx (cm) — 3.72 — #
FLy (cm) — 2.44 — #
IPA.3@MImax (W/cm2)308
Operating
Control
Conditions
Control 1: Exam Type Any — Any — Any —
Control 2: Sample Volume 1 mm — 1 mm — 1 mm —
Control 3: PRF 1008 — 1563 -
3125
— 1563 -
3125
—
Control 4: Sample Volume Position Zone 4 — Zone 8 — Zone 8 —

10
(a) This index is not required for this operating mode; value is <1.
(b) This transducer is not intended for transcranial or neonatal cephalic uses.
# 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.
Table 7: Transducer Model: L25x Operating Mode: 2D
Index Label M.I.
TIS TIB
TIC
Scan Non-scan Non-scan
Aaprt1 Aaprt>1
Global Maximum Index Value 1.2 (a) — — — (b)
Associated Acoustic
Parameter
pr.3 (MPa) 2.87
W0(mW) # — — #
min of [W.3(z1),ITA.3(z1)] (mW) —
z1(cm) —
zbp (cm) —
zsp (cm) 0.8 —
deq(zsp) (cm) —
fc(MHz) 6.11 # — — — #
Dim of Aaprt X (cm) # — — — #
Y (cm) # — — — #
Other
Information
PD (µsec) 0.630
PRF (Hz) 1061
pr@PIImax (MPa) 3.39
deq@Pllmax (cm) —
Focal Length FLx (cm) # — — #
FLy (cm) # — — #
IPA.3@MImax (W/cm2)478
Operating
Control
Conditions
Control 1: Exam Type Nrv/Msk/
Ven/Vas
— — — — —
Control 2: Optimization Any — — — — —
Control 3: Depth 1.9 - 2.2 — — — — —
Control 4: MBe On — — — — —

English Deutsch Español Français Italiano Português
11
Nederlands
(a) This index is not required for this operating mode; value is <1.
(b) This transducer is not intended for transcranial or neonatal cephalic uses.
# 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.
Table 8: Transducer Model: L25x Operating Mode: PW Doppler
Index Label M.I.
TIS TIB
TIC
Scan Non-scan Non-scan
Aaprt1 Aaprt>1
Global Maximum Index Value (a) — (a) — 1.7 (b)
Associated Acoustic
Parameter
pr.3 (MPa) #
W0(mW) — # 32.1 #
min of [W.3(z1),ITA.3(z1)] (mW) —
z1(cm) —
zbp (cm) —
zsp (cm) # 0.75
deq(zsp) (cm) 0.30
fc(MHz) # — # — 6.00 #
Dim of Aaprt X (cm) — # — 0.76 #
Y (cm) — # — 0.30 #
Other
Information
PD (µsec) #
PRF (Hz) #
pr@PIImax (MPa) #
deq@Pllmax (cm) 0.21
Focal Length FLx (cm) — # — #
FLy (cm) — # — #
IPA.3@MImax (W/cm2)#
Operating
Control
Conditions
Control 1: Exam Type — — — — Vas/Ven/
Nrv
—
Control 2: Sample Volume — — — — 8 mm —
Control 3: PRF — — — — 1953 —
Control 4: Sample Volume Position — — — — Zone 7 —

12

English Deutsch Español Français Italiano Português
13
Nederlands
S-Series-Ultraschallsystem
Ergänzung zum Benutzerhandbuch P13895-06
Einführung .............................................................................................................................13
Bildgebung .............................................................................................................................14
Sicherheit ................................................................................................................................18
Einführung
Diese Ergänzung zum Benutzerhandbuch dient folgendem Zweck:
• Aktualisierung der Informationen zur Schallausgangsleistung für das
S Series™-Ultraschallsystem
• Beschreibung der erweiterten SonoMBe™ Multi-Beam-Bildgebung (MBe), die auf den
folgenden Schallköpfen verfügbar ist:
• C60x/5-2 MHz
• HFL38x/13-6 MHz
• HFL50x/15-6 MHz
• L25x/13-6 MHz
• L38xi/10-5 MHz

14
Bildgebung
2D-Bildgebung
2D-Bedienelemente
WARNUNG: So lässt sich eine falsche Platzierung der Nadel bei eingeschalteter MBe-Funktion
vermeiden:
• Mithilfe von Bewegungen und Flüssigkeitsinjektion Position und Wegführung der
Nadel überprüfen. MBe verbessert die Abbildung linearer Strukturen innerhalb
eines ausgewählten Winkelbereichs in der Ultraschallebene. Lineare Strukturen
außerhalb des ausgewählten Winkelbereichs oder der Ultraschallebene – wie
beispielsweise eine gebogene Nadel – können weniger deutlich dargestellt sein.
• Bitte beachten Sie, dass lineare Strukturen nur in dem Teil des Bilds verbessert
dargestellt werden, der durch einen Umriss gekennzeichnet ist. Der Bereich
außerhalb des Umrisses bleibt unverändert (siehe Abbildung 2).
• Bitte beachten Sie, dass die Strahldivergenz bei einem Schallkopf mit gekrümmter
Anordnung dazu führen kann, dass ein Segment des Nadelschafts nicht im Bild
angezeigt wird (siehe Abbildung 3). Die Nadelspitze ist möglicherweise nicht zu
sehen.
MBe Schaltet die SonoMBe-Bildgebung ein, die eine verbesserte Darstellung linearer
Strukturen innerhalb eines ausgewählten Winkelbereichs ermöglicht und die
Nadelführung bei der Positionierung von Kathetern und Nervenblockaden
vereinfacht. Der betroffene Bereich wird durch einen Umriss mit drei oder vier
Seiten gekennzeichnet (siehe Abbildung 2).
Bei Schallköpfen mit gekrümmter Anordnung kann MBe dabei helfen, die Richtung
der Nadel festzustellen, obwohl möglicherweise nur Segmente des Nadelschafts im
Bild angezeigt werden (siehe Abbildung 3). Mithilfe von Bewegung und
Flüssigkeitsinjektion kann die Position der Nadelspitze bestimmt werden.
Verwenden Sie eine 17er- bis 25er-Nadel (empfohlen). Verbesserungen an den
Ergebnissen können von der Art und der Marke der verwendeten Nadel abhängen.
Weitere Informationen über die Nadelsichtbarkeit in ultraschallgeführten Verfahren
finden Sie in der medizinischen Literatur.
Sie können die Nadel bis zu 50° von der Schallkopfoberfläche abwinkeln (siehe
Abbildung 1). Bei mehr als 50° wird die Nadel möglicherweise weniger gut dargestellt.
(MBe hat nur wenig oder keinen Nutzen bei der Nadelführung in der kurzen Achse.
MBe ist nur für die Nadelführung in der langen Achse bestimmt.)