SonoSite M Turbo User manual

M-TurboTM

Ultrasound System

User Guide

M-TurboTM

Ultrasound System

User Guide

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

SonoSite Ltd

Alexander House

40A Wilbury Way

Hitchin

Herts SG4 0AP

UK

T: [phone]

F: [phone]

Caution: Federal (United States) law restricts this device to sale by or on the order of a physician.

M-Turbo, SiteLink, SonoCalc, SonoHD, SonoSite, and the SonoSite logo are registered trademarks or trademarks of SonoSite, Inc.

DICOM is the registered trademark of the National Electrical Manufacturers Association for its standards publications relating to digital communications of medical information.

Non-SonoSite product names may be trademarks or registered trademarks of their respective owners.

The SonoSite product(s) referenced in this document may be covered by one or more of the following US patents: 5722412, 5817024, 5893363, 6135961, 6203498, 6364839, 6371918, 6383139, 6416475, 6447451, 6471651, 6569101, 6648826, 6575908, 6604630, 6817982, 6835177, 6962566, 7169108, D456509, D461895, D509900, D538432, D544962, D558351, D559390, and by the following counterpart foreign patents: AU727381, AU730822, CA2373065, CN98106133.8, CN98108973.9, DE60021552.0, DE60029777.2, DE60034670.6, DE69730563.5, DE6980539.6, DE69831698.3, FR0875203, FR0881492, FR0815793, FR1180970, FR1175713, GB0875203, GB0881492, GB0815793, GB1180970, GB1180971, GB1175713, IT0881492, IT0815793, IT1175713, KR532359, KR528102, NZ542968, RCD000897368-0001, SP0881492, SP0815793. Patents pending.

P07662 02 10/2008

Copyright 2008 by SonoSite, Inc.

All rights reserved

ii

Contents
Introduction
Conventions, symbols, and terms .........................................................................	vii
Customer comments ..................................................................................................	vii
Chapter 1: Getting Started
About the system ..........................................................................................................	1
Preparing the system ...................................................................................................	1
Installing or removing the battery .................................................................	1
Using AC power and charging the battery .................................................	2
Turning the system on or off ............................................................................	3
Connecting transducers ....................................................................................	3
Inserting and removing USB storage devices ............................................	4
System controls ..............................................................................................................	5
Screen layout ..................................................................................................................	7
General interaction .......................................................................................................	8
Touchpad and cursor ..........................................................................................	8
On-screen options ...............................................................................................	8
Annotation and text ............................................................................................	9
Preparing transducers ...............................................................................................	10
Training videos .............................................................................................................	11
Intended uses ...............................................................................................................	11
Chapter 2: System Setup
Displaying the setup pages .....................................................................................	15
Restoring default settings ........................................................................................	15
A & B Key, Footswitch setup ....................................................................................	15
Administration setup .................................................................................................	15
Security settings .................................................................................................	16
User setup .............................................................................................................	16
Exporting or importing user accounts .......................................................	17
Exporting and clearing the Event log .........................................................	17
Logging in as user ..............................................................................................	18
Choosing a secure password .........................................................................	18
Annotations setup ......................................................................................................	18
Audio, Battery setup ...................................................................................................	19
Cardiac Calculations setup ......................................................................................	19
Connectivity setup ......................................................................................................	19
Date and Time setup ..................................................................................................	20
Display Information setup ........................................................................................	20
IMT Calculations setup ..............................................................................................	20
Network Status setup .................................................................................................	20

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OB Calculations setup ................................................................................................	20
OB Custom Measurements setup ..........................................................................	21
OB Custom Tables setup ...........................................................................................	22
Presets setup .................................................................................................................	22
System Information setup ........................................................................................	23
USB Devices setup ......................................................................................................	23
Limitations of JPEG format .............................................................................	23
Chapter 3: Imaging
Imaging modes ............................................................................................................	25
2D imaging ...........................................................................................................	25
M Mode imaging ................................................................................................	26
CPD and color Doppler imaging ...................................................................	27
PW and CW Doppler imaging ........................................................................	28
Adjusting depth and gain ........................................................................................	30
Freezing, viewing frames, and zooming .............................................................	30
Imaging modes and exams available by transducer ......................................	31
Annotating images .....................................................................................................	32
Patient information form ..........................................................................................	33
Images and clips ..........................................................................................................	35
Saving images and clips ..................................................................................	35
Reviewing patient exams ...............................................................................	36
Printing, exporting, and deleting images and clips ...............................	37
ECG Monitoring ............................................................................................................	38
Chapter 4: Measurements and Calculations
Measurements ..............................................................................................................	41
Working with calipers .......................................................................................	41
2D measurements ..............................................................................................	42
M Mode measurements ...................................................................................	43
Doppler measurements ...................................................................................	43
General calculations ...................................................................................................	45
Calculations menu .............................................................................................	45
Performing and saving measurements
in calculations ......................................................................................................	45
Displaying, repeating, and deleting
saved measurements in calculations ..........................................................	46
EMED calculations ..............................................................................................	46
Percent reduction calculations ......................................................................	46
Volume calculations ..........................................................................................	48
Volume flow calculations ................................................................................	48
Exam-based calculations ..........................................................................................	50
Cardiac calculations ..........................................................................................	50
Gynecology (Gyn) calculations ......................................................................	58
IMT calculations ..................................................................................................	59
OB calculations ...................................................................................................	61

iv

Small Parts calculations ....................................................................................	64
Transcranial Doppler and Orbital calculations ........................................	65
Vascular calculations .........................................................................................	67
Patient report ................................................................................................................	68
Vascular and cardiac patient reports ...........................................................	69
TCD patient report .............................................................................................	69
OB patient report ...............................................................................................	69
EMED worksheets ...............................................................................................	70
Chapter 5: Troubleshooting and Maintenance
Troubleshooting ..........................................................................................................	71
Software licensing .......................................................................................................	71
Maintenance .................................................................................................................	72
Cleaning and disinfecting the ultrasound system .................................	73
Cleaning and disinfecting transducers .......................................................	74
Cleaning and disinfecting the battery .......................................................	75
Cleaning the footswitch ...................................................................................	75
Cleaning and disinfecting ECG cables ........................................................	76
Recommended disinfectants ..................................................................................	77
Chapter 6: Safety
Ergonomic safety .........................................................................................................	85
Position the system ...........................................................................................	86
Position yourself .................................................................................................	86
Take breaks, exercise, and vary activities ...................................................	87
Electrical safety classification ..................................................................................	87
Electrical safety .............................................................................................................	88
Equipment safety ........................................................................................................	90
Battery safety ................................................................................................................	90
Clinical safety ................................................................................................................	92
Hazardous materials ...................................................................................................	93
Electromagnetic compatibility ...............................................................................	93
Manufacturer’s declaration .............................................................................	94
ALARA principle ...........................................................................................................	97
Applying ALARA .................................................................................................	98
Direct controls .....................................................................................................	98
Indirect controls ..................................................................................................	99
Receiver controls ................................................................................................	99
Acoustic artifacts .........................................................................................................	99
Guidelines for reducing MI and TI .........................................................................	99
Output display ...........................................................................................................	102
MI and TI output display accuracy ............................................................	103
Factors that contribute to display uncertainty .....................................	103
Related guidance documents .....................................................................	104
Transducer surface temperature rise ................................................................	104
Acoustic output measurement ............................................................................	105

v

In Situ, derated, and water value intensities ...........................................	105
Tissue models and equipment survey ......................................................	106
Acoustic output tables ............................................................................................	107
Terms used in the acoustic output tables ...............................................	132
Acoustic measurement precision and uncertainty ..............................	133
Labeling symbols ......................................................................................................	134
Chapter 7: References
Measurement accuracy ...........................................................................................	139
Sources of measurement errors ...........................................................................	140
Measurement publications and terminology .................................................	141
Cardiac references ............................................................................................	141
Obstetrical references .....................................................................................	145
Gestational age tables ....................................................................................	146
Growth analysis tables ...................................................................................	148
Ratio calculations .............................................................................................	149
General references ...........................................................................................	149
Chapter 8: Specifications
Dimensions ..................................................................................................................	153
System ..................................................................................................................	153
Display ..................................................................................................................	153
Supported transducers ...........................................................................................	153
Imaging modes ..........................................................................................................	153
Image and clip storage ............................................................................................	153
Accessories ..................................................................................................................	153
Peripherals ..........................................................................................................	154
Temperature and humidity limits ........................................................................	154
Operating ............................................................................................................	154
Shipping and storage .....................................................................................	154
Electrical .......................................................................................................................	154
Battery ...........................................................................................................................	154
Electromechanical safety standards ...................................................................	154
EMC standards classification .................................................................................	155
Airborne equipment standards ............................................................................	155
DICOM standard ........................................................................................................	155
HIPAA standard ..........................................................................................................	155
Glossary
Terms .............................................................................................................................	157
Abbreviations .............................................................................................................	159
Index ...........................................................................................................................	169

vi

Introduction

This M Turbo Ultrasound System User Guide provides information on preparing and using the M Turbo™ ultrasound system and on cleaning and disinfecting the system and transducers. It also provides references for calculations, system specifications, and safety and acoustic output information.

The user guide is for a reader familiar with ultrasound techniques. It does not provide training in sonography or clinical practices. Before using the system, you must have ultrasound training.

See the applicable SonoSite accessory user guide for information on using accessories and peripherals. See the manufacturer’s instructions for specific information about peripherals.

Conventions, symbols, and terms

The user guide follows these conventions:

•A WARNING describes precautions necessary to prevent injury or loss of life.

•A Caution describes precautions necessary to protect the products.

•Numbered steps in procedures must be performed in order.

•Items in bulleted lists do not require a sequence.

•Single step procedures begin with .

Symbols and terms used on the system and transducer are explained in Chapter 1, Chapter 5, Chapter 6, and Glossary.

Customer comments

Questions and comments are encouraged. SonoSite is interested in your feedback regarding the system and the user guide. Please call SonoSite at 888 482 9449 in the US. Outside the US, call the nearest SonoSite representative. You can also e mail SonoSite

at [e-mail].

For technical support, please contact SonoSite as follows:

SonoSite Technical Support

Phone (US or	877-657-8118
Canada):
Phone (Outside	425-951-1330
US and Canada):	Or call your local
	representative.
Fax:	425-951-6700
E-mail:	[e-mail]
Web site:	www.sonosite.com
	Click Support & Service.
Europe	[phone]
Service	[e-mail]
Center:

Introduction

vii

viii Customer comments

Chapter 1: Getting Started

About the system

The M Turbo ultrasound system is a portable, software controlled device using all digital architecture. The system has multiple configurations and feature sets used to acquire and display high resolution, real time ultrasound images. Features available on your system depend on system configuration, transducer, and exam type.

A license key is required to activate the software. See “Software licensing” on page 71. On occasion, a software upgrade may be required. SonoSite provides a USB device containing the software. One USB device can be used to upgrade multiple systems.

3

4

1

2

Figure 1 System Front Features:

(1) Control panel, (2) Handle, (3) Display, (4) USB ports for storage, updates, importing, and exporting

1 2 3 4

Figure 2 System Back Connectors:

(1) DC input connector, (2) I/O connector, (3) Battery, and (4) ECG connector

To use the ultrasound system

1 Attach a transducer.

2Turn the system on. (For power switch location, see “System controls” on page 5.)

3Press the PATIENT key, and complete the patient information form.

4 Press an imaging mode key: 2D, M MODE,

COLOR, or DOPPLER

Preparing the system

Installing or removing the battery

WARNING: To avoid injury to the operator and to prevent damage to the ultrasound system, inspect the battery for leaks prior to installing.

To avoid data loss and to conduct a safe system shutdown, always keep a battery in the system.

Started Getting

Chapter 1: Getting Started

1

To install the battery

1

Disconnect the power supply from the

ultrasound system.

2

Remove the system from the mini dock (if

present) and turn it upside down.

3

Place the battery into the battery

compartment, at a slight angle. See Figure 3.

4

Slide the battery forward until it locks into

place.

5

Push down on the two locking levers to secure

Locking levers

the battery.

To remove the battery

1

Disconnect the power supply from the

ultrasound system.

Remove the system from the mini dock (if

2

present) and turn it upside down.

3

Pull up the two locking levers.

4

Slide the battery back.

5

Lift the battery from the compartment.

Using AC power and charging the battery

The battery charges when the system is connected to the AC power supply. A fully discharged battery recharges in less than five hours.

The system can run on AC power and charge the battery if AC power is connected to the system directly, to a mini dock, or to a docking system.

	The system can run on battery power for up to
	two hours, depending on the imaging mode and
	the display brightness. When running on battery
	power, the system may not restart if the battery is
	low. To continue, connect the system to AC
Figure 3 Install the Battery	power.

2Preparing the system

WARNING: The equipment shall be connected to a center-tapped single phase supply circuit when users in the United States connect the equipment to a 240V supply system.

Caution: Verify that the hospital supply voltage corresponds to the power supply voltage range. See “Electrical” on page 154.

Connecting transducers

WARNING: To avoid injury to the patient, do not place the connector on the patient. Operate the ultrasound system in a docking system or on a flat hard surface to allow air flow past the connector.

Caution: To avoid damaging the transducer connector, do not allow foreign material in the connector.

To operate the system using AC power

1 Connect the DC power cable from the power supply to the connector on the system. See Figure 2 on page 1.

2 Connect the AC power cord to the power supply and to a hospital grade electrical outlet.

Turning the system on or off

Caution: Do not use the system if an error message appears on the display. Note the error code and turn off the system. Call SonoSite or your local representative.

To turn the system on or off

Press the power switch. (See “System controls” on page 5.)

To wake up the system

To conserve battery life while the system is on, the system goes into sleep mode if the lid is closed or if the system is untouched for a preset time. To adjust the time for sleep delay, see “Audio, Battery setup” on page 19.

Press a key, touch the touchpad, or open the lid.

Figure 4 Connect the Transducer

Started Getting

Chapter 1: Getting Started

3

To connect a transducer

1Remove the system from the mini dock (if present), and turn it upside down.

2Pull the transducer latch up, and rotate it clockwise.

3Align the transducer connector with the connector on the bottom of the system.

4Insert the transducer connector into the system connector.

5 Turn the latch counterclockwise.

6Press the latch down, securing the transducer connector to the system.

To remove a transducer

1Pull the transducer latch up, and rotate it clockwise.

2Pull the transducer connector away from the system.

WARNING: To avoid damaging the USB storage device and losing patient data from it, observe the following:

•Do not remove the USB storage device or turn off the ultrasound system while the system is exporting.

•Do not bump or otherwise apply pressure to the USB storage device while it is in a USB port on the ultrasound system. The connector could break.

Caution: If the USB icon does not appear in the system status area on-screen, the USB storage device may be defective or password-protected. Turn the system off and replace the device.

Inserting and removing USB storage devices

Images and clips are saved to internal storage and are organized in a sortable patient list. You can archive the images and clips from the ultrasound system to a PC using a USB storage device or Ethernet connection. Although the images and clips cannot be viewed from a USB storage device on the ultrasound system, you can remove the device and view them on your PC.

There are two USB ports on the system, and one on the mini dock. For additional USB ports, you can connect a USB hub into any USB port.

Note: The system does not support password protected USB storage devices. Make sure that the USB storage device you use does not have password protection enabled.

To insert a USB storage device

Insert the USB storage device into any USB port on the system or mini dock. See Figure 1 on page 1.

The USB storage device is ready when the USB icon appears.

To view information about the device, see “USB Devices setup” on page 23.

To remove a USB storage device

Removing the USB storage device while the system is exporting to it may cause the exported files to be corrupted or incomplete.

1Wait five seconds after the USB animation stops.

2 Remove the USB storage device from the port.

4Preparing the system

System controls

1
																								14
2																														15
3
4																														16
5																													17
																													18
6																														19
7																														20

8 9 10 11 12 13

1	Power switch	Turns system on and off.
2	Alphanumeric keys	Use to enter text and numbers.
3	Annotation keys	See “Alphanumeric keyboard” on page 9.
4	ZOOM	Magnifies the image 100%.
5	DEPTH UP,	Decreases and increases imaging depth.
	DEPTH DOWN
6	AUTO GAIN	Adjusts gain automatically.
7	Gain

		Near	Adjusts the gain applied to the near field of the image.
		Far	Adjusts the gain applied to the far field of the image.
		Gain/	In live imaging, adjusts the overall gain applied to the entire image. On a
			frozen image, moves the cine buffer.
		Cine Buffer

Started Getting

Chapter 1: Getting Started

5

8	AC power indicator	A steady light indicates that AC power is connected. A flashing light
		indicates that the system is asleep.
9	CALIPER	Displays calipers on-screen for measuring.
	CALCS	Turns the calculations menu on and off.
10	Touchpad	Selects, adjusts, and moves items on-screen.
11	FREEZE	Stops live imaging and displays a frozen image.
12	SAVE	Saves an image to internal storage. If configured, also saves calculations to
		the report. See “Presets setup” on page 22.
13	CLIP	Saves a clip to internal storage.
14	Control keys	Control on-screen options.
15	Forms
	SETUP	Displays the system settings.
	REPORT	Accesses the patient report and EMED worksheets.
	REVIEW	Accesses the patient list, saved images, and archiving functions.
	PATIENT	Accesses patient information.
16	EXAM	Opens exam menu.
17	A & B shortcut keys	Keys that you can program to perform common tasks.
18	SET	Sets a trace measurement.
	SELECT	Used with the touchpad to select items on-screen. Also switches between
		Color and Doppler options, calipers for measurement, pictograph-marker
		position and angle, frozen images in duplex and dual screens, and arrow
		position and orientation.
	SAVE CALC	Saves calculations and their measurements to the patient report.
19	UPDATE	Toggles between dual and duplex screens and imaging modes in M Mode
		and Doppler (for example, between D-line and Doppler spectral trace).
20	Imaging Modes
	M MODE	Turns M Mode on, toggles between M-line and M Mode trace.
	DOPPLER	Turns Doppler on, toggles between D-line and Doppler trace.
	COLOR	Turns CPD/Color on and off.
	2D	Turns 2D on.

6System controls

Screen layout

9

1

2

3

4					10
5

6

11

7

8

Figure 1 Screen Layout

1	Mode Data Area	Current imaging mode information (for example, Gen, Res, THI, and PW).
2	Orientation Marker	Provides indication for image orientation. In dual and duplex images, the
		orientation marker is green on the active screen.
3	Text	Text entered using keyboard.
4	Pictograph	Pictograph to indicate anatomy and transducer position. You can select
		anatomy and screen location.
5	Calculations Menu	Contains available measurements.
6	Image	Ultrasound image.
7	Measurement and	Current data on measurements and calculations.
	Calculations Data Area
8	On-screen Options	Options available in the current context.
9	Patient Header	Includes current patient name, ID number, institution, user, and date/time.
10	System Status	Information on system status (for example, exam type, transducer, AC
		connected, battery charging, and USB).
11	Depth Marker	Marks in .5 cm, 1 cm, and 5 cm increments depending on depth.

Started Getting

Chapter 1: Getting Started

7

General interaction

Touchpad and cursor

Use the touchpad to adjust and move objects on screen. The touchpad controls caliper position, CPD or Color box position and size, the cursor, and more. The arrow keys control much of the same functionality as the touchpad.

The cursor appears in the setup pages, the patient information form, and patient report. You control the cursor through the touchpad. For example, in the patient information form, place the cursor over the last name field and press the SELECT key to activate that field. Additionally, you can use the cursor to select check boxes and items in lists.

Cycle Moves through a list of settings continuously. The upper control key cycles upward. The lower control key cycles downward.

Up-Down Moves through a list of settings, stopping at the top or bottom. The upper control key moves upward. The lower control key moves downward. By default, a beep sounds when you reach either end of the range. (See “Audio, Battery setup” on page 19.)

On-Off Turns a feature on or off. You can press either control key. In forms, you can instead select the option by using the touchpad and the SELECT key.

Action Performs an action. You can press either control key. Or you can instead select the option by using the touchpad and the SELECT key.

On-screen options

The on screen options let you make adjustments and select settings. The options available depend on context.

Each option is controlled by the pair of keys below it. Depending on the option, the control keys function in one of four ways:

Figure 5 On-screen options (2D imaging shown)

8General interaction

Annotation and text

Alphanumeric keyboard

10

1 2 11 3 4

5

6

7

8

9

Started Getting

1	TAB	Moves cursor among fields
		in the forms, and tabs
		between text position in
		dual screens.
2	CAPS LOCK	Sets the keyboard to
		capital letters.
3	SHIFT	Allows entry of capitalized
		characters and
		international characters.
4	TEXT	Turns the keyboard on and
		off for text entry.
5	PICTO	Turns pictographs on and
		off.
6	ARROW	Displays an arrow graphic
		that can be moved and
		rotated within the image
		area.
7	SPACEBAR	Turns the keyboard on for
		text entry. In text entry,
		adds a space.

8	DELETE	Removes all text from the
		screen during text entry
		and when not measuring.
9	Arrow Keys	Move highlighted selection
		in calculations menu, move
		cursor one space when
		entering text, move caliper
		position, move cine buffer
		forward and backward, and
		move among pages in
		image review and reports.
10	BACKSPACE	Removes the character left
		of the cursor in text-entry
		mode.
11	ENTER	Moves cursor among fields
		in forms and saves
		calculations to report.

Chapter 1: Getting Started

9

Symbols

You can enter symbols and special characters in select fields and forms. The symbols and special characters available depend on context.

Patient information form: Last, First, Middle, Patient ID, Accession, Indications, Procedure ID, User, Reading Dr., Referring Dr., and Institution fields

DICOM or SiteLink configuration page: Alias and AE Title fields

A & B Key, Footswitch setup page: Text field

Text mode (imaging): Annotation field

Figure 6 Symbols Dialog Box

To enter symbols or special characters

1 Select the field, and then select Symbols.

2Select the desired symbol or character.

You can also press the keys on the keyboard.

3 Select OK.

Preparing transducers

WARNING: Some transducer sheaths contain natural rubber latex and talc, which can cause allergic reactions in some individuals. Refer to 21 CFR 801.437, User labeling for devices that contain natural rubber.

Some gels and sterilants can cause an allergic reaction on some individuals.

Caution: To avoid damage to the transducer, use only gels recommended by SonoSite. Using gels other than the one recommended by SonoSite can damage the transducer and void the warranty. If you have questions about gel compatibility, contact SonoSite or your local representative.

SonoSite recommends that you clean transducers after each use. See “Cleaning and disinfecting transducers” on page 74.

Acoustic coupling gel must be used during exams. Although most gels provide suitable acoustic coupling, some gels are incompatible with some transducer materials. SonoSite recommends Aquasonic® gel and provides a sample with the system.

For general use, apply a liberal amount of gel between the transducer and the body. For invasive or surgical use, apply a transducer sheath.

10	Preparing transducers

WARNING: To prevent contamination, the use of sterile transducer sheaths and sterile coupling gel is recommended for clinical applications of an invasive or surgical nature. Do not apply the transducer sheath and gel until you are ready to perform the procedure.

To apply a transducer sheath

SonoSite recommends the use of market cleared, transducer sheaths for intracavitary or surgical applications.To lessen the risk of contamination, apply the sheath only when you are ready to perform the procedure.

1 Place gel inside the sheath.

2 Insert the transducer into the sheath.

3Pull the sheath over the transducer and cable until the sheath is fully extended.

4Secure the sheath using the bands supplied with the sheath.

5Check for and eliminate bubbles between the face of the transducer and the sheath.

Bubbles between the face of the transducer and the sheath may affect the ultrasound image.

6Inspect the sheath to ensure that there are no holes or tears.

Training videos

The SonoSite® Education Key™ training videos are an optional feature.

To display the list of videos

1Insert the Education Key USB device into a USB port on the system.

2 Press the REVIEW key.

3 If there is an active exam, select List on screen.

4 Select the Videos tab.

5If the list does not appear, select the correct USB device:

a Select Select USB.

b In the Select USB device for media playback dialog box, select the Education Key USB device (“Training” appears under Type), and then select Select.

Note: Image Gallery is an unsupported feature.

To view a video

1 Display the list of videos.

2 Select the video.

3 Select View on screen.

The video begins playing.

4Select any of the following, as needed:

• Adjusts the volume. The higher the number, the louder the sound. Zero is mute.

•Back Rewinds the video 10 seconds.

•Pause Pauses the video.

•Play Resumes playing of a paused video.

•Forward Advances the video 10 seconds.

To exit a video

Select one of the following:

•List to return to the video list.

•Done to return to 2D imaging.

Intended uses

This system transmits ultrasound energy into various parts of the patient’s body to obtain ultrasound images, as follows.

For the intended transducer and imaging modes for each exam type, see “Imaging modes and exams available by transducer” on page 31.

Started Getting

Chapter 1: Getting Started

11

Abdominal Imaging Applications You can assess the liver, kidneys, pancreas, spleen, gallbladder, bile ducts, transplanted organs, abdominal vessels, and surrounding anatomical structures for the presence or absence of pathology transabdominally.

Cardiac Imaging Applications You can assess the heart, cardiac valves, great vessels, surrounding anatomical structures, overall cardiac performance, and heart size for the presence or absence of pathology.

You can obtain the patient’s electrocardiogram (ECG). The ECG is used for timing of cardiac events.

WARNING: The ECG is not used to diagnose cardiac arrhythmias and is not designed for long term cardiac rhythm monitoring.

Gynecology and Infertility Imaging Applications

You can assess the uterus, ovaries, adnexa, and surrounding anatomical structures for the presence or absence of pathology transabdominally or transvaginally.

Interventional Imaging Applications You can use the system for ultrasound guidance in biopsy and drainage procedures, vascular line placement, peripheral nerve blocks, spinal nerve blocks and taps, ova harvesting, amniocentesis and other obstetrical procedures, and provide assistance during abdominal, breast, and neurological surgery.

Obstetrical Imaging Applications You can assess the fetal anatomy, viability, estimated fetal weight, gestational age, amniotic fluid, and surrounding anatomical structures for the presence or absence of pathology transabdominally or transvaginally. CPD and Color imaging are intended for high risk pregnant women. High risk pregnancy indications include, but are not limited to,

multiple pregnancy, fetal hydrops, placental abnormalities, as well as maternal hypertension, diabetes, and lupus.

WARNING: To prevent injury or misdiagnosis, do not use this system for Percutaneous Umbilical Blood Sampling (PUBS) or in vitro Fertilization (IVF) The system has not been validated to be proven effective for these two uses.

CPD or Color images can be used as an adjunctive method, not as a screening tool, for the detection of structural anomalies of the fetal heart and as an adjunctive method, not as a screening tool for the diagnosis of Intrauterine Growth Retardation (IUGR).

Pediatric and Neonatal Imaging Applications

You can assess the pediatric and neonatal abdominal, pelvic and cardiac anatomy, pediatric hips, neonatal head, and surrounding anatomical structures for the presence or absence of pathology.

Superficial Imaging Applications You can assess the breast, thyroid, testicle, lymph nodes, hernias, musculoskeletal structures, soft tissue structures, ophthalmic structures, and surrounding anatomical structures for the presence or absence of pathology. You can use the system for ultrasound guidance in biopsy and drainage procedures, vascular line placement, peripheral nerve blocks, and spinal nerve blocks and taps.

12 Intended uses

WARNING: To avoid injury to the patient, use only an Orbital (Orb) or Ophthalmic (Oph) exam type when performing imaging through the eye. The FDA has established lower acoustic energy limits for ophthalmic use. The system will not exceed these limits only if the Orb or Oph exam type is selected.

Transcranial Imaging Applications You can assess the anatomical structures and vascular anatomy of the brain for presence or absence of pathology. You can use imaging temporally, trans occipitally, or trans orbitally.

WARNING: To avoid injury to the patient, use only an Orbital (Orb) or Ophthalmic (Oph) exam type when performing imaging through the eye. The FDA has established lower acoustic energy limits for opthalmic use. The system will not exceed these limits only if the Orb or Oph exam type is selected.

Vascular Imaging Applications You can assess the carotid arteries, deep veins, and arteries in the arms and legs, superficial veins in the arms and legs, great vessels in the abdomen, and various small vessels feeding organs for the presence or absence of pathology.

Started Getting

Chapter 1: Getting Started

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14 Intended uses

Chapter 2: System Setup

The system setup pages let you customize the system and set preferences.

Displaying the setup pages

To display a setup page

1 Press the SETUP key.

2 Select the setup page under Setup Pages.

To return to imaging from a setup page, select Done on screen.

Restoring default settings

To restore default settings for a setup page

On the setup page, select Reset on screen.

To restore all default settings

1 Turn the system off.

2Connect the system to AC power. (See “To operate the system using AC power” on page 3.)

3Simultaneously press 1 and the power key. The system beeps several times.

A & B Key, Footswitch setup

On the A & B Key, Footswitch setup page, you can program the shortcut keys and footswitch to perform common tasks. Select from the following lists:

A Key, B Key The function of the shortcut keys. By default, the A shortcut key is set to Print and the B shortcut key is set to Record. The shortcut keys are below the alphanumeric keypad.

Footswitch (L), Footswitch (R) The function of the left and right footswitches: Save Clip, Record, Freeze, Save Image, or Print. See also “To connect the footswitch.”

To connect the footswitch

The SonoSite footswitch allows hands free operation with a customizable two pedal footswitch. The footswitch is an optional feature.

WARNING: To avoid contamination, do not use the footswitch in a sterile environment. The footswitch is not sterilized.

1Connect the cables:

•Y adapter cable to the ECG connector on the mini dock or docking system

•Footswitch cable to Y adapter cable

2On the A & B Key, Footswitch setup page, select a function for the left and right footswitches.

Administration setup

On the Administration setup page, you can configure the system to require users to log in and enter passwords. Required login helps protect patient data. You can also add and delete users, change passwords, import and export user accounts, and view the event log.

Setup

Chapter 2: System Setup

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Security settings

WARNING: Health care providers who maintain or transmit health information are required by the Health Insurance Portability and Accountability Act (HIPAA) of 1996 and the European Union Data Protection Directive (95/46/EC) to implement appropriate procedures: to ensure the integrity and confidentiality of information; to protect against any reasonably anticipated threats or hazards to the security or integrity of the information or unauthorized uses or disclosures of the information.

Security settings on the system allow you to meet the applicable security requirements listed in the HIPAA standard. Users are ultimately responsible for ensuring the security and protection of all electronic protected health information collected, stored, reviewed, and transmitted on the system.

To log in as Administrator

1On the Administration setup page, type

Administrator in the Name box.

2Type the administrator password in the

Password box.

If you don’t have the administrator password, contact SonoSite. (See “SonoSite Technical Support” on page vii.)

3 Select Login.

To log out as Administrator

Turn off or restart the system.

To require user login

You can set the system to display the User Login screen at startup.

1 Log in as Administrator.

2In the User Login list, select On.

•On requires a user name and password at startup.

•Off allows access to the system without a user name and password.

To change the administrator password or let users change passwords

1 Log in as Administrator.

2 Under User List, select Administrator.

3Do any of the following:

•Change the administrator password: Under User Information, type the new password in the Password box and Confirm box. (See “Choosing a secure password” on page 18.)

•Let users change their passwords: Select the Password changes check box.

4 Select Save.

User setup

To add a new user

1 Log in as Administrator.

2 Select New.

3Under User Information, fill in the Name,

Password, and Confirm boxes. (See “Choosing a secure password” on page 18.)

4(Optional) In the User box, type the user’s initials to display them in the patient header and the User field in the patient information form.

5(Optional) Select the Administration Access check box to allow access to all administration privileges.

6 Select Save.

To modify user information

1 Log in as Administrator.

16 Administration setup

2 Under User List, select the user.

3Under User Information, make changes as desired.

4 Select Save.

Any change to the user name replaces the previous name.

To delete a user

1 Log in as Administrator.

2 Under User List, select the user.

3 Select Delete.

4 Select Yes.

To change a user password

1 Log in as Administrator.

2 In the User List, select the user.

3Type the new password in the Password box and Confirm box.

4 Select Save.

Exporting or importing user accounts

The export and import commands let you configure multiple systems and back up user account information.

To export user accounts

1 Insert a USB storage device.

2 Log in as Administrator.

3Select Export on screen. A list of USB devices appears.

4Select the USB storage device, and select

Export.

All user names and passwords are copied to the USB storage device.

To import user accounts

1Insert the USB storage device that contains the accounts.

2 Log in as Administrator.

3 Select Import on screen.

4Select the USB storage device, and select

Import.

5Restart the system.

All user names and passwords on the system are replaced with the imported data.

Exporting and clearing the Event log

The Event log collects errors and events and can be exported to a USB storage device and read on a PC.

To display the Event log

1 Log in as Administrator.

2 Select Log on screen.

The Event log appears.

To return to the previous screen, select Back.

To export the Event log

The Event log and the DICOM network log have the same file name (log.txt). Exporting either one to a USB storage device overwrites any existing log.txt file.

1 Insert a USB storage device.

2Select Log and then select Export on screen. A list of USB devices appears.

3Select the USB storage device, and select

Export.

The Event log is a text file that you can open in a text editing application (for example, Microsoft Word or Notepad).

To clear the Event log

1 Display the Event log.

2 Select Clear on screen.

3 Select Yes.

Setup

Chapter 2: System Setup

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Logging in as user

If user login is required, the User Login screen appears when you turn on the system. (See “To require user login” on page 16.)

To log in as user

1 Turn on the system.

2In the User Login screen, type your name and password, and select OK.

To log in as guest

Guests can scan but can’t access system setup and patient information.

1 Turn on the system.

2 In the User Login screen, select Guest.

To change your password

1 Turn on the system.

2 In the User Login screen, select Password.

3Type your old and new passwords, confirm the new password, and then select OK.

Choosing a secure password

To ensure security, choose a password that contains uppercase characters (A Z), lowercase characters (a z), and numbers (0 9). Passwords are case sensitive.

Annotations setup

On the Annotations setup page, you can customize predefined labels and set the preference for managing text when unfreezing images.

For instructions to annotate images, see “Annotating images” on page 32.

To predefine a label group

You can specify which labels are available for an exam type when annotating an image. (See “To place text on an image” on page 32.)

1In the Exam list on the Annotations setup page, select the exam type whose labels you want to specify.

2For Group, select A, B, or C for the label group you want associated with that exam.

The preset labels appear for the selected group.

3Do any of the following:

•Add a custom label to the group: Type the label in the Text box, and select Add.

•Rename a label: Select the label, type the new name in the Text box, and select

Rename.

•Move a label within the group: Select the label, and then select the on screen up or down arrow.

•Delete a label from a group: Select the label, and select Delete.

You can use symbols in labels. See “Symbols” on page 10.

To specify text retention when unfreezing

You can specify which text to keep when you unfreeze an image or change the imaging layout.

In the Unfreeze list on the Annotations setup page, select Keep All Text, Keep Home Text, or Clear All Text.

The default setting is Keep All Text. For information on setting the home position, see “To reset the home position” on page 33.

To export predefined label groups

1 Insert a USB storage device.

2On the Annotations setup page, select Export. A list of USB devices appears.

3Select the USB storage device, and select

Export.

A copy of all predefined label groups for all exams saves to the USB storage device.

18 Annotations setup

To import predefined label groups

1Insert the USB storage device that contains the label groups.

2On the Annotations setup page, select Import on screen.

3Select the USB storage device, and then select

Import.

4Select Done in the dialog box that appears.

All predefined label groups for all exams are replaced with those from the USB storage device.

Audio, Battery setup

On the Audio, Battery setup page, you can select options in the following lists:

Key click Select On or Off for keys to click when pressed.

Beep alert Select On or Off for the system to beep when saving, warning, starting, or shutting down.

Sleep delay Select Off, or 5 or 10 minutes to specify the period of inactivity before the system goes into sleep mode.

Power delay Select Off, or 15 or 30 minutes to specify the period of inactivity before the system automatically turns off.

Cardiac Calculations setup

On the Cardiac Calculations setup page, you can specify measurement names that appear in the Tissue Doppler Imaging (TDI) calculations menu and on the report page.

See also “Cardiac calculations” on page 50.

To specify cardiac measurement names

Under TDI Walls on the Cardiac Calculations setup page, select a name for each wall.

Connectivity setup

On the Connectivity setup page, you specify options for using non USB devices and for alerts when internal storage is full. You also import wireless certificates and specify settings (including Transfer Mode and Location) for SiteLink and DICOM, which are optional features. Refer to the SiteLink and DICOM documentation.

To configure the system for a printer

1Set up the printer hardware. (See instructions included with the printer or docking system.)

2In the Printer list on the Connectivity setup page, select the printer.

To configure the system for a DVD recorder, PC, or serial bar code scanner

1On the Connectivity setup page, do the following:

•(DVD recorder) In the Video Mode list, select the video standard: NTSC or PAL.

•In the Serial Port list, select the peripheral.

Computer (PC) allows patient report data to be sent as ASCII text from the system to a PC. The PC must have third party software to acquire, view, or format the data into a report. Check the compatibility of your software with SonoSite Technical Support. (See also “To send a patient report to a PC” on page 69.)

Note: Because these peripherals use the same RS 232 connector on the mini dock, you can connect only one of them at a time.

2 Restart the system.

3Attach a serial cable (RS 232) from the serial port on the mini dock or docking system to the peripheral.

Setup

Chapter 2: System Setup

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To receive storage alerts

On the Connectivity setup page, select

Internal Storage Capacity Alert.

The system displays a message if internal storage is near capacity when you end an exam. The system then deletes archived patient exams if specified in DICOM.

Date and Time setup

WARNING: To obtain accurate obstetrics calculations, an accurate date and time are critical. Verify that the date and time are accurate before each use of the system. The system does not automatically adjust for daylight saving time changes.

To set the date and time

On the Date and Time setup page, do the following:

•In the Date box, type the current date.

•In the Time box, type the current time in 24 hour format (hours and minutes).

Display Information setup

On the Display Information setup page, you can specify which details appear on screen during imaging. You can select settings in the following sections:

Patient Header Information that appears in the patient header.

Mode Data Imaging information.

System Status System status information.

IMT Calculations setup

On the IMT Calculations setup page, you can customize the IMT calculations menu. You can specify up to eight measurement names for both right side and left side calculations. The measurement names also appear in the patient report.

See also “IMT calculations” on page 59.

To customize the IMT calculations menu

On the IMT Calculations setup page, do the following:

•Under IMT Calculations, select measurement names from the lists, or select None.

The selected names appear in the calculations menu and in the patient report.

•Type the desired width in the

Region width (mm) box.

Network Status setup

The Network Status setup page displays information on system IP address, Location, Ethernet MAC address, and the wireless connection if any.

OB Calculations setup

On the OB Calculations setup page, you select authors for OB calculation tables. You can also import or export additional OB calculation tables.

See also “OB calculations” on page 61.

20 Date and Time setup