MicroMaxx User Guide

MicroMaxx 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.

MicroMaxx, SiteLink, SonoCalc, SonoMB, SonoRES, and SonoSite are registered trademarks or trademarks of SonoSite, Inc. CompactFlash is a registered trademark of Symbol Technologies. 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 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. Patents pending. Other international patents may also apply.

P06435-07 07/2008 Copyright 2008 by SonoSite, Inc. All rights reserved.

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Contents Introduction 1 About the User Guide 1 Intended Uses 1 Conventions 4 Symbols and Terms 4 Upgrades and User Guide Updates 4 Customer Comments 4 Contact Information 5 About the System 6 About the System Software 8

Getting Started 9 Healthy Scanning Guidelines 9 System Preparation 11 Installing or Removing Battery 11 Installing or Removing CompactFlash Card 12 Using AC Power/Charging Battery 13 Turning System On/Off 14 Connecting or Removing Transducer 15 System Controls 16 Screen Layout 19 General Interaction 20 Touchpad 20 On-Screen Menus 21 Menu Controls 21 Annotation and Text 22 Forms 23 System Setup 24 Set Security Settings 25 Audio and Battery 31 Cardiac Calculations 32 Connectivity 33 Date and Time 35 Delta Key and Annotation 36 Display Information 38 IMT Calculations 39 OB Calculations Authors 40 OB Custom Measurements 42 OB Custom Tables 43 Presets 45 System Information 47 Network Status 48

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Imaging 49 Patient Information 49 Transducer, Exam Type, and Imaging Mode 52 Transducer Preparation 55 General Use 56 Invasive or Surgical Use 56 Modes 57 2D Imaging 57 M Mode Imaging 61 Color Doppler Imaging 63 Pulsed Wave (PW) and Continuous Wave (CW) Doppler Imaging 65 Clips 68 Clip Acquisition Delay 69 Image and Clip Storage 70 Save to CompactFlash 70 Print to Local Printer 72 Image and Clip Review 72 Patient List 72 Patient Images and Clips 73 Annotations 74 ECG Monitoring 76 Footswitch 77 Bar Code Scanner 78 Needle Guidance 78

Measurements and Calculations 79 Measurements 79 2D Measurements 79 M Mode Measurements 83 Doppler Measurements 85 Calculations 89 Percent Reduction Calculations 90 Volume Calculation 92 Volume Flow Calculation 94 Small Parts Calculations 96 Gyn Calculations 97 OB Calculations 100 Vascular Calculations 108 IMT Calculations 110 Transcranial Doppler Calculations (TCD) 114 Cardiac Calculations 117 Patient Report 135

Connectivity and Configuration 141 System Connectivity Setup 141

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System Configuration for SiteLink 141 Configuring SiteLink for Ethernet 142 Configuring SiteLink for Wireless 143 System Configuration for DICOM 147 Creating Backup for DICOM Settings 147 Configuring Locations 148 Configuring Archivers 154 Configuring Printers 157 Configuring Worklist Servers 161 Configuring Procedures 164 Importing and Exporting Configurations 165 Reviewing the Network Log 166 DICOM Usage 167 DICOM Image Archive and Print 169 Patient Information 171 DICOM Worklists 172

Troubleshooting and Maintenance 175 Troubleshooting 175 Software Licensing 177 Upgrading the System and Transducer Software 177 Upgrading Triple Transducer Connect (TTC) 183 Obtaining a License Key 184 Installing a License Key 185 Maintenance 186 Recommended Disinfectant 186 Safety 186 Cleaning and Disinfecting Ultrasound System 187 Cleaning and Disinfecting Transducers 188 Sterilizing Transducers 190 Cleaning and Disinfecting Transducer Cables 190 Cleaning and Disinfecting Battery 192 Cleaning Footswitch 192 Cleaning and Disinfecting ECG Cables 192

References 201 Display Size 201 Caliper Placement 201 2D Measurements 201 Sources of Measurement Errors 203 Acquisition Error 203 Algorithmic Error 203 Terminology and Measurement Publications 203 Cardiac References 204 Obstetrical References 210 Gestational Age Tables 211

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Growth Analysis Tables 214 Ratio Calculations 215 General References 216

Specifications 219 System Dimensions 219 Display Dimensions 219 Transducers 219 Imaging Modes 220 Image Storage 220 Accessories 220 Hardware, Software, and Documentation 220 Cables 221 Peripherals 221 Temperature and Humidity Limits 221 Electrical 222 Battery 222 Electromechanical Safety Standards 222 EMC Standards Classification 223 Airborne Equipment Standards 223 DICOM Standard 223 HIPAA Standard 223

Safety 225 Ergonomic Safety 225 Electrical Safety Classification 225 Electrical Safety 226 Equipment Safety 228 Battery Safety 228 Biological Safety 230 Electromagnetic Compatibility (EMC) 230 Manufacturer’s Declaration 232 The ALARA Principle 235 Applying ALARA 235 Direct Controls 236 Indirect Controls 236 Receiver Controls 236 Acoustic Artifacts 236 Guidelines for Reducing MI and TI 237 Output Display 239 Mechanical and Thermal Indices Output Display Accuracy 240 Factors that Contribute to Display Uncertainty 240 Related Guidance Documents 241 Transducer Surface Temperature Rise 242 Acoustic Output Measurement 243 In Situ, Derated, and Water Value Intensities 243

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Tissue Models and Equipment Survey 244 About the Acoustic Output Table 245 Acoustic Output Tables 246 Acoustic Measurement Precision and Uncertainty 283 Labeling Symbols 283

Glossary 287 Terms 287 Acronyms 289

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Chapter 1: Introduction Introduction

Please read the information in this user guide before using the SonoSite® MicroMaxx® ultrasound system. It applies to the ultrasound system and transducers.

About the User Guide The MicroMaxx Ultrasound System User Guide provides information on preparing and using the ultrasound system, on upgrading the system and transducers, and on cleaning and disinfecting the system and transducers. It also provides references for calculations, system specifications, and additional safety and acoustic output information. The MicroMaxx Quick Start Cards, located in the back of the user guide, provide an overview of basic system functions. The user guide is designed 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 manufacturers’ instructions for specific information about peripherals.

Intended Uses The intended uses for each exam type are contained here. See the intended transducer for exam type in Table 2, “Transducer, Exam Type, and Imaging Mode” on page 53.

Abdominal Imaging Applications This system transmits ultrasound energy into the abdomen of patients using 2D, M Mode, color Doppler (Color), color power Doppler (CPD), Tissue Harmonic Imaging (THI), and pulsed wave (PW) Doppler to obtain ultrasound images. The liver, kidneys, pancreas, spleen, gallbladder, bile ducts, transplanted organs, abdominal vessels, and surrounding anatomical structures can be assessed for the presence or absence of pathology transabdominally.

Cardiac Imaging Applications This system transmits ultrasound energy into the thorax of patients using 2D, M Mode, color Doppler (Color), Tissue Harmonic Imaging (THI), pulsed wave (PW) Doppler, pulsed wave tissue Doppler (TDI PW), and continuous wave (CW) Doppler to obtain ultrasound images. The heart, cardiac valves, great vessels, surrounding anatomical structures, overall cardiac performance, and heart size can be assessed for the presence or absence of pathology. The patient’s electrocardiogram (ECG) may be obtained and is used for timing of diastolic and systolic function. WARNING: The ECG is not used to diagnose cardiac arrhythmias and is not designed for long term

cardiac rhythm monitoring.

Chapter 1: Introduction

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Gynecology and Infertility Imaging Applications This system transmits ultrasound energy in the pelvis and lower abdomen using 2D, M Mode, color power Doppler (CPD), color Doppler (Color), Tissue Harmonic Imaging (THI), and pulsed wave (PW) Doppler to obtain ultrasound images. The uterus, ovaries, adnexa, and surrounding anatomical structures can be assessed for the presence or absence of pathology transabdominally or transvaginally.

Interventional and Intraoperative Imaging Applications This system transmits ultrasound energy into the various parts of the body using 2D, color Doppler (Color), color power Doppler (CPD), Tissue Harmonic Imaging (THI), and pulsed wave (PW) Doppler to obtain ultrasound images that provide guidance during interventional and intraoperative procedures. This system can be used to provide ultrasound guidance for 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, neurological surgery, and vascular intraoperative procedures.

Obstetrical Imaging Applications This system transmits ultrasound energy into the pelvis of pregnant women using 2D, M Mode, color Doppler (Color), color power Doppler (CPD), Tissue Harmonic Imaging (THI), and pulsed wave (PW) Doppler to obtain ultrasound images. The fetal anatomy, viability, estimated fetal weight, gestational age, amniotic fluid, and surrounding anatomical structures can be assessed for the presence or absence of pathology transabdominally or transvaginally. CPD and color Doppler (Color) imaging is 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).

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Chapter 1: Introduction

Pediatric Imaging Applications

Prostate Imaging Applications This system transmits ultrasound energy into the prostate of an adult male using 2D, M Mode, color power Doppler (CPD), color Doppler (Color), and pulsed wave (PW) Doppler to obtain ultrasound images. The prostate gland can be assessed for the presence or absence of pathology.

Superficial Imaging Applications This system transmits ultrasound energy into various parts of the body using 2D, M Mode, color Doppler (Color), color power Doppler (CPD), and pulsed wave (PW) Doppler to obtain ultrasound images. The breast, thyroid, testicle, lymph nodes, hernias, musculoskeletal structures, soft tissue structures, and surrounding anatomical structures can be assessed for the presence or absence of pathology. This system can be used to provide ultrasound guidance for biopsy and drainage procedures, vascular line placement, peripheral nerve blocks, and spinal nerve blocks and taps.

Transcranial Imaging Applications This system transmits ultrasound energy into the cranium using 2D, color Doppler (Color), color power Doppler (CPD), and pulsed wave (PW) Doppler to obtain ultrasound images. The anatomical structures and vascular anatomy of the brain can be assessed for presence or absence of pathology. Two exam types support transcranial imaging: TCD and Orb. Imaging can be used temporally, trans-occipitally, or trans-orbitally. WARNING:

To avoid injury to the patient, use only an orbital exam type (Orb) 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 exam type is selected.

Vascular Imaging Applications This system transmits ultrasound energy into the various parts of the body using 2D, M Mode, color Doppler (Color), color power Doppler (CPD), and pulsed wave (PW) Doppler to obtain ultrasound images. 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 can be assessed for the presence or absence of pathology.

Chapter 1: Introduction

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Introduction

This system transmits ultrasound energy into the pediatric patients using 2D, M Mode, color Doppler (Color), color power Doppler (CPD), pulsed wave (PW) Doppler, pulsed wave tissue Doppler (TDI PW), and continuous wave (CW) Doppler to obtain ultrasound images. The pediatric abdominal, pelvic and cardiac anatomy, pediatric hips, neonatal head, and surrounding anatomical structures can be assessed for the presence or absence of pathology.

Conventions These conventions are used in this user guide: • A WARNING describes precautions necessary to prevent injury or loss of life. • A Caution describes precautions necessary to protect the products. • Numbered steps in the procedures must be performed in a specific order. • Bulleted lists present information in list format but do not imply a sequence. • The system handle is on the front of the system, and the battery compartment is on the back of the system.

Symbols and Terms Symbols and terms used on the system and transducer are explained in Chapter 2, “Getting Started”; Chapter 5, “Connectivity and Configuration”; “Glossary” on page 287; and Chapter 9, “Safety.”

Upgrades and User Guide Updates SonoSite may offer software upgrades, new features, and improvements to the system performance. User guide updates accompany the upgrade software and provide detailed information on the enhancements.

Customer Comments Questions and comments are encouraged. SonoSite is interested in your feedback regarding the system and the user guide. Please call SonoSite at 1-888-482-9449. If you are outside the USA, call the nearest SonoSite representative. You can also e-mail SonoSite at [email protected].

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Chapter 1: Introduction

Contact Information Introduction

For SonoSite technical support, contact us at the following numbers or addresses: Technical Support (USA, Canada):

1-877-657-8118

Technical Support fax:

1-425-951-6700

Technical Support e-mail:

[email protected]

SonoSite website:

www.sonosite.com and select Support

International Technical Support:

Contact your local representative or call (USA) +425-951-1330

Europe Service Center:

+44-(0)1462-444-800 e-mail: [email protected]

Chapter 1: Introduction

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About the System The ultrasound system is a portable, software-controlled, ultrasound system using all-digital architecture. The system has multiple configurations and feature sets used to acquire and display high-resolution, real-time ultrasound images. All are described in this user guide but not every option may apply to your system. Features are dependent on system configuration, transducer, and exam type.

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Figure 1 System Front View Table 1: System Front Features Number

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Feature

1

Control panel

2

Handle

3

Display

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CompactFlash® slots: front for image storage, back for system and transducer updates, import/export OB tables, custom annotations, and user names/passwords, and Digital Imaging and Communications in Medicine (DICOM®) configurations

Chapter 1: Introduction

Introduction

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2

3

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Figure 2 System Back View

Table 2: System Back Connectors Number

Feature

1

DC input connector

2

I/O connector

3

Battery

4

ECG connector

Currently, the system supports the following transducers: • C11e/8-5 MHz • C60e/5-2 MHz • D2/2 MHz • HFL38/13-6 MHz • ICT/8-5 MHz • LAP/12-5 MHz • L25e /13-6 MHz • L38e/10-5 MHz • P10/8-4 MHz • P17/5-1 MHz • SLA/13-6 MHz • SLT/10-5 MHz • TEE/8-3 MHz

Chapter 1: Introduction

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The ultrasound system may include one or more of the following docking systems: • Mobile Docking System enhanced (MDSe) • Mobile Docking System (MDS) • MDS Lite See the applicable SonoSite accessory user guide. See Chapter 8, “Specifications” for a complete list of all system accessories. System peripherals include medical grade (conforming to the requirements of EN60601-1) and non-medical (commercial) grade products. See Chapter 8, “Specifications” for a complete list of compatible peripherals. System setup instructions for the use of peripherals are covered in “System Setup” on page 24. Manufacturer’s instructions accompany each peripheral. Instructions for the use of accessories and peripherals with the system are covered in the applicable SonoSite accessory user guide.

About the System Software The ultrasound system contains software that controls its operation. A software upgrade may be required. SonoSite provides you with a CompactFlash card containing the software. Typically new software provides new capabilities. A single CompactFlash card can be used to update one or more systems. Software upgrades use the back CompactFlash slot on the right hand side of the system. CompactFlash cards installed in the front CompactFlash slot do not upgrade the system.

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Chapter 1: Introduction

Chapter 2: Getting Started This chapter contains information on healthy scanning practices, basic operation, and changing system settings.

Getting Started

Healthy Scanning Guidelines These guidelines are intended to assist you in the comfort and effective use of your ultrasound system. WARNING:

Use of an ultrasound system may be linked to musculoskeletal disordersa,b,c. Use of an ultrasound system is defined as the physical interaction between the operator, the ultrasound system, and the transducer. When using an ultrasound system, as with many similar physical activities, you may experience occasional discomfort in your hands, fingers, arms, shoulders, eyes, back, or other parts of your body. However, if you experience symptoms such as constant or recurring discomfort, pain, throbbing, aching, tingling, numbness, burning sensation, or stiffness, do not ignore these warning signs. Promptly see a qualified health professional. Symptoms such as these can be linked with musculoskeletal disorders (MSDs). MSDs can be painful and may result in potentially disabling injuries to the nerves, muscles, tendons, or other parts of the body. Examples of MSDs include carpal tunnel syndrome and tendonitis. While researchers are not able to definitively answer many questions about MSDs, there is a general agreement that certain factors are associated with their occurrence including: preexisting medical and physical conditions, overall health, equipment and body position while doing work, frequency of work, duration of work, and other physical activities that may facilitate the onset of MSDsd. This chapter provides guidelines that may help you work more comfortably and may reduce your risk of MSDse,f.

a. Magnavita, N., L. Bevilacqua, P. Mirk, A. Fileni, and N. Castellino. “Work-related Musculoskeletal Complaints in Sonologists.” Occupational Environmental Medicine. 41:11 (1999), 981-988. b. Craig, M. “Sonography: An Occupational Hazard?” Journal of Diagnostic Medical Sonography. 3 (1985), 121-125. c. Smith, C.S., G.W. Wolf, G. Y. Xie, and M. D. Smith. “Musculoskeletal Pain in Cardiac Ultrasonographers: Results of a Random Survey.” Journal of American Society of Echocardiography. (May1997), 357-362. d. Wihlidal, L.M. and S. Kumar. “An Injury Profile of Practicing Diagnostic Medical Sonographers in Alberta.” International Journal of Industrial Ergonomics. 19 (1997), 205-216. e. Habes, D.J. and S. Baron. “Health Hazard Report 99-0093-2749.” University of Medicine and Dentistry of New Jersey. (1999). f. Vanderpool, H.E., E.A. Friis, B.S. Smith, and K.L. Harms. “Prevalence of Carpal Tunnel Syndrome and Other Work-related Musculoskeletal Problems in Cardiac Sonographers.” Journal of Medicine. 35:6 (1993), 605-610.

Chapter 2: Getting Started

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Position the System Promote comfortable shoulder, arm, and hand postures: • Use a stand to support the weight of the ultrasound system. Minimize eye strain: • When the exam/procedure allows, position the system within reach. • Adjust the angle of the system/display to minimize glare from overhead or outside lighting. Minimize neck strain: • If using a stand, adjust the stand height such that the display is at or slightly below eye level.

Position Yourself Support your back during an exam: • Use a chair that has support for your lower back. • Use a chair that adjusts to your work surface height and promotes a natural body posture. • Use a chair that allows for quick height adjustments. • Always sit or stand in an upright manner. Avoid bending or stooping. Minimize reaching and twisting: • Use a bed that is height adjustable. • Position the patient as close to you as possible. • Face forward. Avoid twisting your head or body. • Move your entire body front to back and position your scanning arm next to or slightly in front of you. • Stand for difficult exams to minimize reaching. Promote comfortable shoulder and arm postures for your scanning arm: • Keep your elbow close to your side. • Relax your shoulders in a level position. • Support your arm using a support cushion or pillow, or rest it on the bed. Minimize neck bending and twisting: • Position the ultrasound system/display directly in front of you. • Provide an auxiliary monitor for patient viewing. Promote comfortable hand, wrist, and finger postures for your scanning arm: • Hold the transducer lightly in your fingers. • Minimize the pressure applied on the patient. • Keep your wrist in a straight position.

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Chapter 2: Getting Started

Take Breaks

Exercise Targeted exercises can strengthen muscle groups, which may help you avoid MSDs. Contact a qualified health professional to determine stretches and exercises that are right for you.

System Preparation Installing or Removing Battery The battery comprises six lithium-ion cells plus electronics, a temperature sensor, and battery contacts. 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 conduct a safe system shutdown, always keep a battery in the system.

Locking levers

Figure 1 Insert Battery into System

Chapter 2: Getting Started

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Getting Started

Minimizing scanning time and taking breaks can be very effective in allowing your body to recover from physical activity, which can help you avoid any MSDs. Some ultrasound tasks may require longer or more frequent breaks. One way of taking a break is to stop and relax. However, simply changing tasks can help some muscle groups relax while others remain or become active. Vary your daily activities: • Plan your work so there are breaks in between ultrasound exams. • Work efficiently when performing an ultrasound exam by using the software and hardware features correctly. Learn more about these features in Chapter 3 of this guide. • Keep moving. Avoid sustaining the same posture by varying your head, neck, body, arm, and leg positions.