Fujifilm SonoSite X-Porte 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

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

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

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

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

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

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Table 13: Transducer Model: rP19xp Operating Mode: CW Doppler

Index Label M.I.

TIS TIB

TIC

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

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

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Table 15: Transducer Model: rP19xp (Orbital use) Operating Mode: M Mode

Index Label M.I.

TIS TIB

TIC

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

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

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