NanoMaxx User Guide

NanoMaxx 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: +44-1462-444800 F: +44-1462-444801

Caution:

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

NanoMaxx, SiteLink, SonoCalc, SonoHD, SonoMB, 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. The SonoSite ultrasound system referenced in this document may be covered by one or more of the following U.S. patents: 5722412, 5817024, 5893363, 6135961, 6203498, 6364839, 6371918, 6383139, 6416475, 6447451, 6471651, 6569101, 6648826, 6575908, 6604630, 6817982, 6835177, 6962566, 7169108, 7449640, 7534211, 7549961, 7588541, 7591786, 7604596, 7643040, D456509, D461895, D509900, D538432, D544962, D558351, D559390, D591423, D592750, D592760, and by the following counterpart foreign patents: AU727381, AU730822, CA2372158, CA2373065, CN ZL 97113678.5, CN ZL 98106133.8, CN ZL 98108973.9, CN ZL 200830007734.8, DE60021552.0, DE60029777.2, DE60034670.6, DE69730563.5, DE6980539.6, DE69831698.3, DE60 2004 23 816.3-08, FR0815793, FR0875203, FR0881492, FR1175713, FR1180970, FR1589878, GB0875203, GB0881492, GB1175713, GB1180970, GB1180971, GB1589878, IT0815793, IT0881492, IT1175713, IT1589878, KR528102, KR532359, NO326202, NO326814, NZ542968, RCD000897368-0001, SP0815793, SP0881492, SP1589878. Patents pending.

P12529-03 06/2010 Copyright 2010 by SonoSite, Inc. All rights reserved.

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Contents Introduction Conventions ...vii Customer comments ... vii

Chapter 1: Getting Started About the system ... 1 Preparing the system ... 2 Compartments and connectors ... 2 Dock ... 2 Kickstand ... 2 Installing or removing the battery ... 2 Using AC power and charging the battery ... 3 Turning the system on or off ... 3 Connecting transducers ... 3 Inserting and removing USB storage devices ... 4 Screen layout ... 5 General interaction ... 5 Touchscreen ... 5 Knob ... 6 Entering text ... 6 Preparing transducers ... 6 Intended uses ... 7

Chapter 2: System Setup Displaying the setup pages ... 9 Restoring default settings ... 9 Administration setup ... 9 Security settings ... 9 User setup ...10 Exporting or importing user accounts ...10 Exporting and clearing the Event log ...11 Logging in as user ...11 Choosing a secure password ...11 Annotations setup ...12 Audio, Battery setup ...12 Connectivity setup ...12 Date and Time setup ...13 Display Information setup ...13 OB Calculations setup ...13 Presets setup ...13 System Information setup ...13

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USB Devices setup ...14 Limitations of JPEG format ...14

Chapter 3: Imaging Imaging modes ...17 2D imaging ...17 M Mode ...17 CPD and color Doppler imaging ...18 Adjusting depth and gain ...18 Freezing, viewing frames, and zooming ...19 Turning guidelines on and off ...19 Annotating images ...19 Adjusting screen brightness ...20 Patient information form ...20 Patient information form fields ...21 Images ...21 Saving images ...21 Reviewing patient exams ...21 Printing and deleting images ...23 Exporting to a USB storage device ...23 Imaging modes and exams available by transducer ...24

Chapter 4: Measurements and Calculations Measurements ...25 About saving measurements (IMT and OB exam) ...25 Working with calipers ...25 Measuring ...26 Calculations ...27 IMT calculations ...27 OB calculations ...29 Patient report ...31

Chapter 5: Troubleshooting and Maintenance Troubleshooting ...33 Software licensing ...33 Maintenance ...34 Cleaning and disinfecting ...34 Cleaning and disinfecting the ultrasound system ...34 Cleaning and disinfecting transducers ...35 Cleaning and disinfecting the battery or dock ...37

Chapter 6: Safety Ergonomic safety ...39

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Position the system ...40 Position yourself ...40 Take breaks, exercise, and vary activities ...41 Electrical safety classification ...41 Electrical safety ...42 Equipment safety ...44 Battery safety ...44 Clinical safety ...45 Hazardous materials ...46 Electromagnetic compatibility ...46 Manufacturer’s declaration ...47 ALARA principle ...50 Applying ALARA ...51 Direct controls ...51 Indirect controls ...52 Receiver controls ...52 Acoustic artifacts ...52 Guidelines for reducing MI and TI ...52 Output display ...54 MI and TI output display accuracy ...54 Factors that contribute to display uncertainty ...55 Related guidance documents ...55 Transducer surface temperature rise ...56 Acoustic output measurement ...56 In Situ, derated, and water value intensities ...56 Tissue models and equipment survey ...57 Acoustic output tables ...58 Terms used in the acoustic output tables ...68 Acoustic measurement precision and uncertainty ...70 Labeling symbols ...71

Chapter 7: References Measurement accuracy ...75 Sources of measurement errors ...75 Measurement publications ...75 IMT references ...75 OB references ...76 Gestational age tables ...76

Chapter 8: Specifications Supported transducers ...79 Imaging modes ...79 Image storage ...79 Accessories ...79 Peripheral ...79 Environmental limits ...79

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Operating ...79 Shipping and storage ...79 Electrical ...80 Battery ...80 Electromechanical safety standards ...80 EMC standards classification ...80 Airborne equipment standards ...80 HIPAA standard ...80

Glossary Terms ...81 Abbreviations ...83

Index ...85

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Introduction

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 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.

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 [email protected]. For technical support, please contact SonoSite as follows: SonoSite Technical Support Phone (US or Canada):

877-657-8118

Phone (Outside US and Canada):

425-951-1330 Or call your local representative.

Fax:

425-951-6700

E-mail:

[email protected]

Web site:

www.sonosite.com Click Resources > Support & Service.

• Numbered steps in procedures must be performed in order. • Items in bulleted lists do not require a sequence. • Single-step procedures begin with ™.

Introduction

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

Europe Service Center Phone

+44-(0)1462-444-800

E-mail:

[email protected]

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

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Customer comments

Chapter 1: Getting Started About the system 1

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Getting Started

The NanoMaxx™ ultrasound system is a portable, software-controlled device that acquires and displays high-resolution, real-time ultrasound images. Features available on your system depend on the configuration, transducer, and exam type. You need a license key to activate the software. See “Software licensing” on page 33.

Basic steps

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1 Turn the system on. 2 Attach a transducer. 3 Tap Patient, and complete the patient information form. 4 Tap Mode and select an imaging mode.

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By default, the system is in 2D imaging.

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Figure 1 System front (top) and back (bottom) 1

Handle

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Knob

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Power switch

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Touchscreen

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Battery compartment

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USB ports (on side)

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Transducer compartment

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Kickstand

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Dock connector (See the table “Connectivity symbols on dock.”)

Chapter 1: Getting Started

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Preparing the system

Kickstand

Compartments and connectors

The kickstand lets you set the system upright on a flat surface. You can extend the kickstand as needed for your optimal viewing angle.

The back of the system has a battery compartment, a transducer compartment, and a connector for the NanoMaxx™ dock. The side has two USB ports. (See Figure 1 on page 1.)

Dock The dock has ports for the power supply, printer cable, and more. It attaches to the back of the system. (See Figure 1 on page 1.) Each port has a symbol that describes its use. Connectivity symbols on dock

Figure 2 Back of system with kickstand extended

Symbol

Definition

Installing or removing the battery

DC input

WARNING:

Audio out Print control Composite video out

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.

Composite video in

To install the battery To connect the dock

1 Disconnect the power supply from the ultrasound system.

WARNING:

2 Slide the two-pronged end of the battery into the end of the battery compartment near the handle.

To avoid electrical shock to the patient, do not simultaneously touch the patient and the dock if it is disconnected from the system and connected to AC power.

™ Insert the dock into its connector on the back

of the system. (See Figure 1 on page 1.) The top of the dock has the SonoSite logo.

3 Push down on the locking lever until the battery snaps securely in place.

To remove the battery 1 Disconnect the power supply from the ultrasound system. 2 Holding the system backside down, carefully push down the locking lever, and catch the battery as it drops from the compartment.

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Preparing the system

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 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 power. WARNING:

Caution:

If users in the United States connect the equipment to a 240V supply system, the equipment shall be connected to a center-tapped single phase supply circuit. Verify that the hospital supply voltage corresponds to the power supply voltage range. See “Electrical” on page 80.

Caution:

To turn the system on or off ™ Press the power switch. (See “System front

(top) and back (bottom)” on page 1.)

To wake up the system To conserve battery life while the system is on, the system goes into sleep mode if untouched for a preset time. To adjust the time for sleep delay, see “Audio, Battery setup” on page 12. ™ Tap the screen.

Connecting transducers WARNING:

To operate the system using AC power

To avoid injury to the patient, do not place the connector on the patient. Operate the ultrasound system in the V-Universal Stand or on a convenient surface to allow air flow past the connector. To avoid the risk of electrical shock, do not touch the transducer connector (which is in the transducer compartment) on the system when the transducer is not connected. See Figure 1 on page 1.

1 Connect the dock to the system. 2 Connect the DC power cable from the power supply to its port on the dock. See Figure 1 on page 1. 3 Connect the AC power cord to the power supply and to a hospital-grade electrical outlet.

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

Caution:

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

Chapter 1: Getting Started

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Getting Started

The system can run on AC power and charge the battery if AC power is connected to the system.

Turning the system on or off

Inserting and removing USB storage devices Images save to internal storage and are organized in a sortable patient list. You can archive the images from the ultrasound system to a PC using a USB storage device. Although the images cannot be viewed from a USB storage device on the ultrasound system, you can remove the device and view them on your PC. You can also import and export user accounts and the Event log using a USB storage device. Note: SonoSite supports the USB storage device included optionally with the system. Other brands are untested and may not perform as expected. WARNING:

• 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.

Figure 3 Connect the transducer

To connect a transducer 1 Pull the transducer latch up, and rotate it clockwise. 2 Align the transducer connector with the connector on the back of the system, and insert the transducer. 3 Turn the latch counter-clockwise. 4 Press the latch down, securing the transducer connector to the system.

To remove a transducer 1 Pull the transducer latch up, and rotate it clockwise. 2 Pull the transducer connector away from the system.

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

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.

To insert a USB storage device ™ Insert the USB storage device into a USB

port on the system. 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 14.

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Preparing the system

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

Patient header Includes current patient name, patient ID number, institution, user, date, and time.

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Depth marker Marks in .5 cm, 1 cm, and 5 cm increments depending on depth. To specify style, see “Presets setup” on page 13.

2 Remove the USB storage device from the port.

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Controls available in the current context. See “Touchscreen” on page 5.

Screen layout

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Ultrasound image

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Measurement data

1 Wait at least five seconds after the USB animation stops.

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5

Getting Started

To remove a USB storage device

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General interaction Touchscreen 7

The touchscreen has controls that change dynamically depending on context. For example, freezing an image displays the controls for zooming, performing measurements, and reviewing the cine buffer.

Figure 4 Screen layout

You can also reposition some elements (for example, the zoom box or calipers) by dragging with your finger. For best results, try the following:

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Text Text entered using on-screen keyboard.

• Using the back of your fingernail instead of your fingertip

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Pictograph Indicates anatomy and transducer position. You can select anatomy and screen location.

• Dragging from next to the element, instead of on it

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Orientation marker Shows image orientation.

To select a control, tap it with your finger. A control functions in one of the following ways:

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Measurement

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Mode data and system status Current imaging mode information (such as Gen, MB) and system information (such as exam type, transducer, and battery charging). To specify details, see “System Information setup” on page 13.

• Cycles through a list of settings. Identified by a plus sign .

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• Pressing firmly

• Displays a list from which to select. Identified by an arrow . Tapping the control displays and collapses the list. • Works in conjunction with the knob. Identified by a double circle .

Chapter 1: Getting Started

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• Turns a feature on or off.

• Tap Next to advance to the next field.

• Performs an action such as saving an image.

• Tap Prev to return to the previous field.

The Page x/x control displays additional controls.

4 Tap Done.

Knob

Preparing transducers

The knob works in conjunction with some touchscreen controls and adjusts gain, depth, brightness, annotations, and more.

WARNING:

In forms, you can use the knob instead of the touchscreen controls to navigate through most fields and lists, as follows: • Turn clockwise for the next field.

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

• Turn counter-clockwise for the previous field. • Press to select the highlighted field.

Entering text In forms and annotations, you can enter text in text fields using the on-screen keyboard.

To enter text using the on-screen keyboard 1 Tap a text field. The on-screen keyboard appears with the text field at the top. 2 Tap each character you want to enter. •

turns capital letters on or off for the next letter entered.

• Ä,ñ displays and hides international characters. • Symbols displays symbols and punctuation. • A a turns capital letters on and off. • Delete deletes the character right of the pointer. • < and > reposition the pointer within text entered. You can also tap in the text. 3 (Optional) In forms, navigate among text fields:

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Preparing transducers

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.

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 35.

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.

Intended uses WARNING:

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, install the sheath only when you are ready to perform the procedure. 1 Place gel inside the sheath. 2 Insert the transducer into the sheath. 3 Pull the sheath over the transducer and cable until the sheath is fully extended. 4 Secure the sheath using the bands supplied with the sheath. 5 Check 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. 6 Inspect the sheath to ensure that there are no holes or tears.

The 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 24. 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. Gynecology and Infertility Imaging Applications You can assess the uterus, ovaries, adnexa, and surrounding anatomical structures for the presence or absence of pathology transabdominally. Interventional Imaging Applications You can use the system to provide ultrasound guidance for biopsy and drainage procedures, vascular line placement, peripheral nerve blocks, spinal nerve blocks and taps, amniocentesis, and other obstetrical procedures and to provide assistance during abdominal and breast 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. CPD and color Doppler (Color) imaging is intended for evaluating the presence or absence of flow.

Chapter 1: Getting Started

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Getting Started

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.

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 following: • Detection of structural anomalies of the fetal heart • Diagnosis of Intrauterine Growth Retardation (IUGR) To avoid errors in fetal growth estimation, do not use the system as a fetal growth screening tool. The system does not provide fetal growth data.

Pediatric and Neonatal Imaging Applications You can assess the pediatric abdominal and pelvic anatomy, pediatric hips, 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, and surrounding anatomical structures for the presence or absence of pathology. You can use the system to provide ultrasound guidance for biopsy and drainage procedures, vascular line placement, peripheral nerve blocks, and spinal nerve blocks and taps. 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 for the presence or absence of pathology.

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Intended uses

Chapter 2: System Setup The setup pages let you customize the system and set preferences.

Displaying the setup pages To display a setup page 1 Tap Options and select Setup. 2 Do any of the following:

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 display the Event log.

Security settings

• Select the setup page from the Page list. • Tap Previous or Next until the page appears.

To return to imaging from a setup page, tap Done.

Restoring default settings To restore default settings for a setup page ™ On the setup page, tap Reset.

To restore all default settings 1 Turn the system off. 2 Connect the system to AC power. (See “To operate the system using AC power” on page 3.) 3 While pressing down the knob, press and release the power switch. Release the knob after two beeps. The system beeps several times.

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.

Setup

• With the Page list highlighted, press the knob. Turn the knob to highlight the page, and then press the knob.

WARNING:

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 1 On the Administration setup page, type Administrator in the Name box. (See “Entering text” on page 6.)

Chapter 2: System Setup

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2 Type the administrator password in the Password box. If you need the administrator password, contact SonoSite. (See “SonoSite Technical Support” on page vii.) 3 Tap 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.

3 Under User Information, fill in the Name, Password, and Confirm boxes. (See “Choosing a secure password” on page 11.) 4 (Optional) In the User box, type the user’s initials to display them in the patient header and in the User box in the patient information form. 5 (Optional) Select the Administration Access check box to allow access to all administration privileges. 6 Tap Save.

To modify user information

1 Log in as Administrator.

1 Log in as Administrator.

2 In the User Login list, select On.

2 Under User List, select the user.

• On requires a user name and password at startup.

3 Under User Information, make changes as desired.

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

4 Tap Save.

To change the administrator password or let users change passwords

Any change to the user name replaces the previous name.

To delete a user

1 Log in as Administrator.

1 Log in as Administrator.

2 Under User List, select Administrator.

2 Under User List, select the user.

3 Do any of the following:

3 Tap Delete.

• 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 11.) • Let users change their passwords: Select the Password changes check box. 4 Tap Save.

4 Tap Yes to confirm deletion.

To change a user password 1 Log in as Administrator. 2 Under User List, select the user. 3 Type the new password in the Password box and Confirm box. 4 Tap Save.

User setup To add a new user 1 Log in as Administrator. 2 Tap New.

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Administration setup

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

3 Select the USB storage device, and tap Export.

1 Insert a USB storage device.

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

2 Log in as Administrator. 3 Tap Export. A list of USB devices appears. 4 Select the USB storage device, and tap Export. All user names and passwords are copied to the USB storage device. Passwords are encrypted.

To import user accounts 1 Insert the USB storage device that contains the accounts. 2 Log in as Administrator. 3 Tap Import.

To clear the Event log 1 Display the Event log. 2 Tap Clear. 3 Tap Yes.

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 10.)

To log in as user 1 Turn on the system.

5 Tap Restart in the dialog box that appears.

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

The system restarts. 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 Tap Log. The Event log appears.

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

To return to the previous screen, tap Back.

To export the Event log The Event log has the file name log.txt. Exporting the Event log to a USB storage device overwrites any existing log.txt file.

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.

1 Insert a USB storage device. 2 Tap Log and then tap Export. A list of USB devices appears.

Chapter 2: System Setup

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Setup

4 Select the USB storage device, and tap Import.