NanoMaxx Service Manual P12706-01 April 2010

SonoSite, Inc. 21919 30th Drive SE Bothell, WA 98021-3904 USA Telephone: 1-888-482-9449 or 1-425-951-1200 Fax: 1-425-951-1201 SonoSite Ltd Alexander House 40A Wilbury Way Hitchin, Herts SG4 OAP 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, 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(s) 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

P12706-01 04/2010 Copyright 2010 by SonoSite, Inc. All rights reserved.

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Contents Chapter 1 - Introduction Audience... 1 Conventions ... 1 Contact Information... 1

Chapter 2 - System Overview About the System ... 3 Theory of Operation... 3 System Specifications... 6

Chapter 3- Troubleshooting Periodic Maintenance ... 11 Technical Bulletins ... 11 System and Subsystem Diagnosis... 11 System Repair ... 11 Test Equipment... 11 Failure (Assert) Codes ... 12

Chapter 4- Replacement Procedures Required Tools... 13 Rear Cover Removal ... 14 Rear Cover Installation ... 14 Major System Components ... 15 Front End PCB Replacement ... 16 Power Supply PCB Replacement ... 17 Back End PCB Replacement... 18 Other Major System Components... 19 User Interface PCB Replacement ... 20 Display Backlight Inverter (BLI) PCB Replacement... 21 LCD Replacement... 22

Chapter 5- Performance Testing Overview ... 25 Test Equipment... 25 Set Up Performance Tests ... 25 Basic Operational Tests... 25 2D Performance Tests ... 26 Additional Performance Tests ... 27

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Appendix A - Replacement Parts List Major System Components ... 29 Other System Components ... 30 Miscellaneous System Components ... 31 Ordering Replacement Parts... 31

Appendix B - Service Event Reporting Service Event Report Form ... 34 Service Event Report Instructions... 35 Returning Products to SonoSite ... 36

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Chapter 1: Introduction Before servicing the NanoMaxx ultrasound system, please read this manual. The ultrasound system has multiple configurations and feature sets. All are described in this service manual but not every option may apply to your system. System features depend on your system configuration, transducer, and exam type. Refer to the NanoMaxx Ultrasound System User Guide for additional information regarding safety, system controls, operation, capabilities, and specifications.

Audience The intended audience of this manual is properly trained field and in-house service personnel.

Conventions These conventions are used in this service manual: • A WARNING describes precautions necessary to prevent injury or loss of life. • A Caution describes precautions necessary to protect the products. • Numbered steps must be performed in a specific order. • Bulleted lists present information in list format but do not imply a sequence. • Labeling symbols are in the user guide.

Contact Information Questions and comments are encouraged. SonoSite is interested in your feedback regarding the service manual. If you encounter difficulty with the system, use the information in this manual to help correct the problem. If the problem is not covered here, contact SonoSite Technical Support as follows: Technical Support (USA, Canada) phone:

1-877-657-8118

Technical Support fax:

1-425-951-6700

Technical Support e-mail:

[email protected]

SonoSite Web site:

www.sonosite.com>Support

International Technical Support:

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

European Service Center:

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

Japan Service Center:

+81-3-5304-5337 e-mail: [email protected]

Chapter 1: Introduction

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Chapter 1: Introduction

Chapter 2: System Overview About the System The SonoSite NanoMaxx high-resolution ultrasound system is a portable, software controlled, diagnostic ultrasound system using all digital architecture. The system is used to acquire and display high-resolution, real-time ultrasound data in 2D, Color Power Doppler (CPD), and Color Doppler (Color) or in a combination of these modes. The system provides measurement capabilities for anatomical structures and fetal biometry that provide information used for clinical diagnostic purposes. System features include cine review, image zoom, labeling, needle guidance, measurements, calculations, and image storage/review/printing/recording capabilities. The system/transducer is capable of exceeding a TI or an MI of 1.0 in certain operating modes or mode combinations. The system displays the current output level in terms of one of two bioeffects indices (“Mechanical Index [MI]” and “Thermal Index [TI]”) in accordance with the AIUM/NEMA Standard for Real Time Display of Thermal and Mechanical Acoustic Output Indices on Diagnostic Ultrasound Equipment.

Theory of Operation The NanoMaxx ultrasound system has seven (7) major functional groups: • Transducer • Acquisition Subsystem • Processing Subsystem • Display Subsystem • Control Subsystem • User Interface Subsystem • Power Subsystem Figure 2.1 shows the relationship of the functional groups.

Chapter 2: System Overview

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Figure 2.1 SonoSite High-Resolution Ultrasound System (NanoMaxx) Block Diagram The Transducer elements convert the pulser voltage to acoustic energy during the transmit portion of the ultrasound acquisition cycle. The elements convert the acoustic echo to voltage in the receive portion of the acquisition. The voltage developed on the transducer elements is sensed by the acquisition subsystem. The system transducers have 64 to 192 elements depending on transducer selected. The Acquisition Subsystem consists of the beamformer and interface to the transducer. The beamformer controls the timing of the transmit pulses to focus the acoustic beam. The beamformer amplifies the low-level received echoes and controls the receive focusing. The system beamformer transmits on up to 128 elements and receives on 64 elements. The Processing Subsystem includes capabilities for interfacing with the beamformer and performing high speed processing. The processing subsystem demodulates, filters, detects, and compresses the signal supplied by the beamformer into display information. The Display Subsystem converts the detected ultrasound data into picture elements (pixels). The software user interface graphics are combined with the ultrasound information and converted to a video stream. The external video port supports NTSC and PAL format. The Control Subsystem consists of the central processing unit, program and video memory, permanent image storage and retrieval memory, external communication interface ports, and connection to the user interface keys. The control software includes the acoustic power and intensity software subsystem, power group monitors, and a beamformer monitor. This software guarantees a level of patient safety by ensuring the system is operating within acoustic power and intensity limits. The User Interface Subsystem represents the software interface and form factor. The software interface is the interaction between the user and the screen layout components. The form factor is the type of physical buttons, location, and grouping of the buttons and the device size, shape, and weight. Dedicated controls are for high usage activities and grouped according to the user workflow. The Power Subsystem provides the system power and protects the hardware from destructive and/or unsafe conditions by detecting failures in the system through hardware and software monitors. Detection of a fault results in disabling of the pulser supply, and the signaling of an error to the Control Group. The power subsystem includes the battery pack and battery charging electronics.

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Chapter 2: System Overview

Description of Operating Modes 2D Mode

2D mode is a two dimensional image of the amplitude of the echo signals. It is used for location and measurement of anatomical structures and for spatial orientation during operation of other modes. In 2D, a two-dimensional cross-section of a 3-dimensional soft tissue structure such as the heart is displayed in real time. Ultrasound echoes of different intensities are mapped to different gray scale or color values in the display. The outline of the 2D cross-section may be a rectangle, parallelogram, trapezoid, sector, or a full circle, depending on the particular transducer used. 2D mode can be used in combination with any other modes.

Color Doppler (Color)

In Color Doppler, a real-time, two-dimensional cross-section of blood flow is displayed. The 2D cross-section may be presented as a rectangle, parallelogram, trapezoid, sector, or a full circle, depending on the particular transducer used. The 2D cross-section is presented as a full color display, with various colors being used to represent the velocity, both positive and negative, of the blood flow echoes. Often, to provide spatial orientation, the full color blood flow cross-section is overlaid on top of the gray scale cross-section of soft tissue structure (2D echo). For each pixel in the overlay, the decision of whether to display color, gray scale (echo) information or a blended combination is based on the relative strength of echoes from the soft-tissue structures and from the red blood cells. A high pass filter (wall filter) is used to remove the signals from stationary or slowly moving structures. Tissue motion is discriminated from blood flow by assuming that blood is moving faster than the surrounding tissue, although additional parameters may also be used to enhance the discrimination. The remaining signal after wall filtering may be averaged over time (persistence) to present a steady state image of blood flow distribution. Variance information may also be displayed to provide information when large variance is observed in the velocity information.

Color Power Doppler (CPD)

In CPD, a real-time two-dimensional cross-section of blood flow is displayed. The 2D cross-section may be presented as a rectangle, parallelogram, trapezoid, sector, or a full circle, depending on the particular transducer used. The 2D cross-section is presented as a full color display, with various colors being used to represent the power in blood flow echoes. Often, to provide spatial orientation, the full color blood flow cross-section is overlaid on top of the gray scale cross-section of soft tissue structure (2D echo). For each pixel in the overlay, the decision of whether to display CPD, gray scale (echo) information or a blended combination is based on the relative strength of echoes from the soft-tissue structures and from the red blood cells. A high pass filter (wall filter) is used to remove the signals from stationary or slowly moving structures. Tissue motion is discriminated from blood flow by assuming that blood is moving faster than the surrounding tissue, although additional parameters may also be used to enhance the discrimination. The power in the remaining signal after wall filtering may be averaged over time (persistence) to present a steady state image of blood flow distribution.

Chapter 2: System Overview

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Additional System Feature Performances Broadband Imaging

This ultrasound acquisition system uses high resolution broadband technology in the transmit pulsers, transducers, and receivers. The receive path can capture and process signals over a wide spectrum from below 2.0 MHz to beyond 10 MHz. For each application the transmit pulse is designed to produce an appropriate bandwidth. For example, in 2D grayscale imaging, a wide band pulse is used to support good axial resolution. For Doppler modes a narrower band pulse is used which improves the spectral resolution of the detected Doppler signal. In addition to transmit pulse control, programmable digital signal processing is used in the receive path to further refine the bandwidth used to produce the final image. Digital filters are applied to the digitized received signal to limit and shape the spectral bandwidth used to generate the displayed output.

Needle Guidance

The system can display a pair of needle guidelines that represent the anticipated path of the needle. The image of the anatomical target, needle guidelines, and a scan plane marker are displayed to assist in guiding the needle to the target. For additional information, see the needle user guides.

Measurement and Calculation Capabilities

The system offers a variety of measurements and calculations specific to exam type and transducer. A list of them, and author references, are in the system user guide. Measurement accuracy is also discussed.

System Specifications This section contains system and accessory specifications and agency approvals. The specifications for recommended peripherals can be found in the manufacturers’ instructions. See the applicable SonoSite accessory user guide for information on the accessories.

System Dimensions Height: 8.2in. (20.8 cm) Width: 14.1 in. (35.8 cm) Depth: 2.3in. (5.8 cm) Weight: 6 lbs. (2.72 kg)

Display Dimensions Length: 8.4 in. (21.34 cm) Height: 6.3 in. (16 cm) Diagonal: 10.4 in. (26.4 cm)

Transducers Note: Each of the NanoMaxx system types (S-ICU, S-Nerve, etc.) supports a unique combination of transducers. C11n/8-5 MHz 11 mm curved array (6 ft./1.8 m) C60n/5-2 MHz 60 mm curved array (5.5 ft./1.7 m) L25n/13-6 MHz 25 mm linear array (7.5 ft./2.3 m) L38n/10-5 MHz 38 mm linear array (5.5 ft./1.7 m) P21n/5-1 MHz 21 mm phased array (6 ft./1.8 m)

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Chapter 2: System Overview

Imaging Modes 2D (256 gray shades) Color power Doppler (CPD) (256 colors) Color Doppler (Color) (256 colors)

Image and Clip Storage The number of images and clips you can save varies with imaging mode and file format. The internal storage can save approximately 40 patients with 50 images each.

Accessories Hardware, Software, and Documentation Battery Carry Case Kensington Security Cable Needle Guides (L25n only) Power supply SonoCalc IMT Software 4.1 V-Universal Stand System User Guide (CD Standard/Hardcopy optional) System AC PowerCcord (10 ft / 3.1 m) VESA Compliant Mounting Video and printer cables

Cables See the NanoMaxx Ultrasound System User Guide or the V-Universal Stand User Guide for information on cables.

Peripherals Peripherals include the following medical grade (conforming to the requirements of EN60601-1) and non-medical grade (commercial) products. Manufacturer’s instructions accompany each peripheral. System setup instructions are in the NanoMaxx Ultrasound System User Guide. Instructions for using peripherals with the system are in the applicable SonoSite accessory user guide.

Medical Grade Black-and-white printer

Non-Medical Grade 2GB USB Memory Stick

Chapter 2: System Overview

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Temperature, Pressure, and Humidity Limits Note: The temperature, pressure, and humidity limits apply only to the ultrasound system and transducers. Operating Limits: System, battery, and transducer • 10–40°C (50–104°F), 15–95% R.H. • 700 to 1060hPa (0.7 to 1.05 ATM)

Shipping/Storage Limits: System and transducer • -35–65°C (-31–149°F), 15–95% R.H. • 500 to 1060hPa (0.5 to 1.05 ATM)

Shipping/Storage Limits: Battery • -20–60°C (-4–140°F), 0–95% R.H. (For storage longer than 30 days, store at or below room temperature.) • 500 to 1060hPa (0.5 to 1.05 ATM)

Electrical Power Supply Input: 100-240 VAC, 50/60 Hz, 2.0 A Max @ 100 VAC. Power Supply Output 1: 15 VDC, 5.0A Max (system) Power Supply Output 2: 12 VDC, 2.3A Max (battery) Combined output not exceeding 75W.

Battery 6-cell, 11.2 VDC, 5.2 amp-hours, rechargeable lithium ion battery pack. Run time is up to 2 hours, depending on imaging mode and display brightness.

Electromechanical Safety Standards EN 60601-1:1997, European Norm, Medical Electrical Equipment–Part 1. General Requirements for Safety. EN 60601-1-1:2001, European Norm, Medical Electrical Equipment–Part 1. General Requirements for Safety–Section 1-1. Collateral Standard. Safety Requirements for Medical Electrical Systems. EN 60601-1-2:2001, European Norm, Medical Electrical Equipment – Part 1-2: General Requirements for Safety - Collateral Standard: Electromagnetic compatibility - Requirements and tests EN 60601-2-37:2001 + Amendment A1:2005, European Norm, Particular requirements for the safety of ultrasonic medical diagnostic and monitoring equipment. CAN/CSA C22.2, No. 601.1-M90, Canadian Standards Association, Medical ElectricalEquipment.Part 1. General Requirements for Safety (including CSA 601.1 Supplement 1:1994 and CSA 601.1 Amendment 2:1998) CEI/IEC 61157:1992, International Electrotechnical Commission, Requirements for the Declaration of the Acoustic Output of Medical Diagnostic Ultrasonic Equipment. UL 60601-1 (1st Edition), Underwriters Laboratories, Medical Electrical Equipment - Part 1: General Requirements for Safety.

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Chapter 2: System Overview

EMC Standards Classification EN 60601-1-2:2001, European Norm, Medical Electrical Equipment. General Requirements for Safety-Collateral Standard. Electromagnetic Compatibility. Requirements and Tests. CISPR11:2004, International Electrotechnical Commission, International Special Committee on Radio Interference. Industrial, Scientific, and Medical (ISM) Radio-Frequency Equipment Electromagnetic Disturbance Characteristics-Limits and Methods of Measurement. The Classification for the SonoSite system, V Universal Stand, accessories, and peripherals when configured together is: Group 1, Class A.

Airborne Equipment Standards RTCA/DO-160E:2004, Radio Technical Commission for Aeronautics, Environmental Conditions and Test Procedures for Airborne Equipment, Section 21.0 Emission of Radio Frequency Energy, Category B.

DICOM Standard NEMA PS 3.15: 2000, Digital Imaging and Communications in Medicine (DICOM)-Part 15: Security Profiles.

HIPAA Standard The Health Insurance and Portability and Accountability Act, Pub.L. No. 104-191 (1996). 45 CFR 160, General Administrative Requirements. 45 CFR 164, Security and Privacy.

Chapter 2: System Overview

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Chapter 2: System Overview

Chapter 3: Troubleshooting This chapter contains information to help you correct problems with system operation and provides instructions on the proper care of the system, transducer, and accessories.

Periodic Maintenance There is no recommended periodic or preventive maintenance required for the system, transducers, or accessories. There are no internal adjustments or alignments required. There are no functions that require periodic testing or calibration. Performance tests are described in Chapter 5, “Performance Testing,” of this manual. Performing maintenance activities not described in this manual may void the product warranty. Local regulations may require electrical safety testing. Contact SonoSite Technical Support for any maintenance questions.

Technical Bulletins Product Technical Bulletins describing known system issues are periodically placed on SonoSite.com. Select Support and then follow the links to NanoMaxx Support Documents.

System and Subsystem Diagnosis This section covers basic diagnostic and troubleshooting procedures you may follow if the system does not operate properly. To diagnose system failures, consult the referenced diagnostic figures that follow or call SonoSite Technical Support. Table 3.1: Troubleshooting Subassemblies and Diagnostic Figures Subassemblies

Diagnostic Figures or Table

Display

TBA

Battery

TBA

Control Panel

TBA

System Repair The system is repairable through subassembly replacement or through replacement of parts as recommended by SonoSite in Chapter 4, “Replacement Procedures.” Component level repair of Printed Circuit Board Assemblies is performed only at the SonoSite repair facility. Replacement of board level components by unauthorized service facilities voids the SonoSite warranty.

Test Equipment Test equipment is not required for this troubleshooting section. Troubleshooting test aids include an external monitor and a spare battery.

Chapter 3: Troubleshooting

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Failure (Assert) Codes ʺAssertʺ or ʺAssert Codeʺ are software error codes that are generated by all Sonosite products when certain hardware or software fault conditions exist. Providing the Assert Code to the Technical Support Group may assist in quicker and more accurate fault diagnosis. Hardware Assert Codes typically cannot be reset and will usually require Main PCB replacement. Many software Assert Codes can be reset and the system may recover and operate normally, usually requiring a reboot. Handling Assert Codes 1 Record the Assert Code. The Assert Code is a four or five digit number shown on the C: line of the Maintenance Screen. A typical Maintenance Screen with an Assert Code is shown in Figure 3.1.

Assert Code

Figure 3.1 Maintenance Screen with Assert Code 2 Press and release the Power button to power the system down. It may be necessary to hold down the Power button as long as 10 seconds in some cases. 3 Press the Power button again to power the system up. • If the system powers up normally, it has recovered from the fault (software assert) and you may use the system. • If the Assert Code remains, corrective action must be taken; usually replacement of the the Back End PCB is required. Contact SonoSite Technical Support for assistance and to obtain repair parts. If the Power button is not functional, all sources of power must be removed to allow the system to power down. i.e., disconnect AC power and remove the battery.

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Chapter 3: Troubleshooting

Chapter 4: Replacement Procedures Caution:

Always use correct ESD procedures. ESD damage is cumulative and may not be noticeable at first. Initial ESD symptoms may be slightly degraded performance or image quality.

Required Tools • #1 and #2 Phillips screwdrivers • #1 and #2 Flat Blade screwdrivers • 3 mm Allen Key • 3/16” Nut Driver or equivalent wrench/socket • Kapton tape • Torque screwdriver, 2.0–10.0 inch pounds (23–110 newton-centimeters) • Cotton swabs (Q Tips) • Anti-static mat & wrist grounding strap

Chapter 4: Replacement Procedures

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Rear Cover Removal Removal of the Rear Cover is required to access all other system components. 1 Remove the battery from the system. 2 Remove the six screws from the Rear Cover as shown in Figure 4.1 Caution:

There are several cables connecting the top and bottom halves of the system. Use caution when removing the rear cover to prevent cable or PCB damage.

Battery removed

Screws (6x)

Figure 4.1 Rear Cover Removal 3 Disconnect the three cables connecting the upper and lower halves of the system as show in Figure 4.2

Disconnect cables

Figure 4.2 Disconnecting Cables

Rear Cover Installation 1 Reconnect the three cables. 2 Insert the top of the Rear Cover under the top cap, and press down to mate with the Front Enclosure. 3 Install the six screws removed from the Rear Cover and torque to 5.5 inch/pounds (62 newton-centimeters). 4 Install the battery.

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Chapter 4: Replacement Procedures

Major System Components Fan Battery Well

Power Supply PCB (shown with shield removed)

Front End PCB Back End PCB Nest Frame Assembly

Figure 4.3 Major System Components

Chapter 4: Replacement Procedures

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Front End PCB Replacement Required Parts • P12717 Service Assembly, Front End PCB, NanoMaxx

Front End PCB Removal 1 Remove the Rear Cover as described in “Rear Cover Removal” on page 14. 2 Remove the ten screws shown in Figure 4.4.

Remove P09037 M3.5x6mm screws (10x).

Figure 4.4 Front End PCB Replacement

Front End PCB Installation 1 Reinstall the ten screws shown in Figure 4.4, and torque to 5.5 inch/pounds (62 newton-centimeters). 2 Reinstall the Rear Cover as described in “Rear Cover Installation” on page 14.

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Chapter 4: Replacement Procedures