iLook Service Tool Sept 2002

P02975-01 09/02 Copyright 2002 by SonoSite, Inc. All rights reserved. Printed in the USA.

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Manufactured by 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 European Headquarters Baystrait House, Station Road Biggleswade SG18 8AL UK Telephone: +44-1767-313-117 Fax: +44-1767-312-400 Caution:

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

“iLook,” “SiteCharge,” “SitePack,” “SiteStand,” and “SonoHeart,” are trademarks of SonoSite, Inc. Non-SonoSite product names may be trademarks or registered trademarks of their respective owners. SonoSite products may be covered by one or more of the following U.S. patents: 4454884, 4462408, 4469106, 4474184, 4475376, 4515017, 4534357, 4542653, 4543960, 4552607, 4561807, 4566035, 4567895, 4581636, 4591355, 4603702, (4607642), 4644795, 4670339, 4773140, 4817618, 4883059, 4887306, 5016641, 5050610, 5095910, 5099847, 5123415, 5158088, 5197477, 5207225, 5215094, 5226420, 5226422, 5233994, 5255682, (5275167), 5287753, 5305756, 5353354, 5365929, 5381795, 5386830, 5390674, 5402793, (5,423,220), 5438994, 5450851, 5456257, 5471989, 5471990, 5474073, 5476097, 5479930, 5482045, 5482047, 5485842, 5492134, 5517994, 5529070, 5546946, 5555887, 5603323, 5606972, 5617863, (5634465), 5634466, 5636631, 5645066, 5648942, 5669385, (5706819), 5715823, 5718229, 5720291, 5722412, 5752517, 5762067, 5782769, 5800356, 5817024, 5833613, 5846200, 5860924, 5893363, 5916168, 5951478, 6036643, 6102863, 6104126, 6113547, 6117085, 6142946, 6203498 B1, 6371918, 6135961, D0280762, D0285484, D0286325, D0300241, D0306343, D0328095, D0369307, D0379231. Other patents pending.

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Table of Contents CHAPTER

CHAPTER

CHAPTER

1

2

3

Introduction

1

1.1

About the System ...1

1.2

Audience ...2

1.3

Conventions Used in This Manual...3

1.4

About the System Software ...3

1.5

Software Licensing ...3

Safety

5

2.1

Electrical Safety ...5

2.2

Equipment Protection...6

2.3

Battery Safety...7

2.4

Biological Safety...8

2.5

Labeling Symbols ...8

System Overview

9

3.1 Theory of Operation...9 3.1.1 Transducer ...10 3.1.2 Acquisition Subsystem ...10 3.1.3 Processing Subsystem ...10 3.1.4 Display Subsystem ...10 3.1.5 Control Subsystem ...10 3.1.6 User Interface Subsystem ...10 3.1.7 Power Subsystem ...11 3.2

Components ...11

3.3

Controls...11

3.4 Accessories ...12 3.4.1 Battery Pack ...12 3.4.1.1 Battery Charge Indicators ...13 3.4.2 External Power ...13 3.4.2.1 External System Connections ...14 3.4.3 Power Adapter...14

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3.5 System Specifications ...15 3.5.1 Physical Dimensions ...15 3.5.2 Monitor...15 3.5.3 Transducers ...15 3.5.4 Imaging Modes...15 3.5.5 Image Storage...15 3.5.6 Temperature, Pressure, and Humidity Limits ...16 3.5.6.1 Operating Limits: System/Docking Station ...16 3.5.6.2 Shipping/Storage Limits: System/Docking Station without Battery...16 3.5.6.3 Operating Limits: Battery ...16 3.5.6.4 Shipping/Storage Limits: Battery...16 3.5.7 Electrical...16 3.6

Battery...17

3.7 Safety Requirements ...17 3.7.1 Electromechanical Safety Standards ...17 3.7.2 EMC/EMI Standards ...17 3.7.3 Airborne Equipment Standards ...17

CHAPTER

4

Setup and Operation

19

4.1

Turning the System On and Off...19

4.2

Installing and Removing the Battery ...20

4.3

Using AC Power ...21

4.4 System License Keys ...22 4.4.1 Displaying the System Information Screen...23 4.4.2 Displaying the License Update Screen...23 4.4.3 Installing a License Key ...23 4.5

CHAPTER

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5

Checking and Charging the Battery...24

Cleaning and Disinfecting

27

5.1

Universal Precautions ...27

5.2

Receipt of Suspected Contaminated Materials ...27

5.3

Recommended Disinfectants ...28

iLook Service Manual

CHAPTER

6

Troubleshooting

29

6.1

System and Subsystem Diagnosis...29

6.2

System Repair ...29

6.3

Test Equipment ...29

6.4 Failures...30 6.4.1 Display...30 6.4.2 Control Panel...30 6.4.3 Main PCBA ...30 6.4.4 Clearing the Main PCBA Failure ...31 6.4.5 Battery ...31

CHAPTER

7

Replacement Procedures

37

7.1 Display Subassembly Replacement ...37 7.1.1 Required Parts ...37 7.1.2 Required Tools and Materials ...37 7.1.3 Removing the Display Subassembly ...38 7.1.4 Replacing the Display Subassembly ...41 7.2 Transducer Subassembly Replacement...43 7.2.1 Required Parts ...43 7.2.2 Required Tools ...43 7.2.3 Removing the Transducer Subassembly ...43 7.2.4 Replacing the Transducer Subassembly...45 7.3 Rear Case with Label Subassembly Replacement ...46 7.3.1 Required Parts ...46 7.3.2 Required Tools ...46 7.3.3 Removing the Rear Case ...46 7.3.4 Replacing the Rear Case...46 7.4 Main PCBA Subassembly Replacement...47 7.4.1 Required Parts ...47 7.4.2 Required Tools ...47 7.4.3 Removing the Main PCBA Subassembly ...47 7.4.4 Replacing the Main PCBA Subassembly ...48 7.5 iLook Docking Station Assembly ...49 7.5.1 iLook Docking Station Disassembly and Reassembly...50 7.5.2 iLook Docking Station/Stand Theory of Operation ...51 7.6 iLook Stand Assembly Service...59 7.6.1 iLook Stand Docking Section Disassembly and Reassembly...60 7.6.2 iLook Stand Theory of Operation ...62

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CHAPTER

8

Performance Tests

63

8.1

Overview...63

8.2

Test Equipment ...63

8.3 Setting Up Performance Tests ...64 8.3.1 Scan Reference Orientation...64 8.4 Testing 2D Performance ...64 8.4.1 2D Image Quality ...64 8.4.2 Axial Measurement Accuracy ...65 8.4.3 Lateral Measurement Accuracy ...66 8.4.4 Penetration...66 8.5 Additional Performance Tests ...67 8.5.1 CPD ...67 8.5.2 DCPD (iLook 15 only) ...67 8.5.3 Tissue Harmonic Imaging (THI) (iLook 15 only) ...68 8.5.4 Image Quality Verification Test...68 8.5.5 Image Review...68 8.5.6 Printer ...69 8.5.7 Battery Charging ...69 8.5.8 Video Output ...69 8.5.9 Touch Screen Calibration...70 8.6 Returning Products to SonoSite ...72 8.6.1 Contacting SonoSite Technical Support ...72 8.6.2 Shipping Instructions...72

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APPENDIX

A

Parts List

73

APPENDIX

B

Service Event Report

87

Index

89

iLook Service Manual

CHAPTER

1

Introduction Before servicing the SonoSite ultrasound system, please read the information in this manual. This manual applies to the iLook® personal imaging tool and accessories.

1.1

About the System The iLook system is a portable, software-controlled, ultrasound system with alldigital architecture. It is used to acquire and display real-time, 2D, color power Doppler (CPD), directional color power Doppler (DCPD), and Tissue Harmonic Imaging ultrasound images. The system includes cine review, a distance measurement, image storage, and image review. Currently, the system supports the C15/4-2 MHz 15-mm microcurved array broadband transducer and an L25/10-5 MHz 25-mm linear transducer. The system accessories include an extra battery, an auxiliary power cable, a stand, and a docking station for charging batteries and downloading images to a personal computer using SiteLink image manager software. Optional peripherals include a medical grade black and white printer and a Kensington Security Cable. Manufacturer’s instructions accompany each peripheral. Instructions for the use of peripherals with the system are covered in the iLook User Guide. The software that runs the system uses graphic display elements similar to those used in many personal computers. System terms and on-screen symbols are explained in the iLook User Guide.

Chapter 1: Introduction

1

The following figure illustrates the iLook system. Transducer

Handle pad Transducer clip

Stylus

Battery I/O connector

Figure 1.1 The iLook System

Table 1.1 The iLook System

1.2

Item

Description

Battery

Two batteries are provided. Fully depleted batteries require approximately two hours to charge to 90% capacity and three hours to charge to 100% capacity.

Handle Pad

Small and large handle pads are provided.

Transducer Clip (C15 only)

Provides a storage area for the C15 transducer during exams or when transporting the system.

Transducer

The transducer is permanently attached to the system.

Stylus

Used to tap on-screen menus, caliper placement, and data entry.

I/O Connector

Used to connect system to docking station and auxiliary power.

Audience The intended audience of this manual is properly trained field and depot service personnel.

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iLook Service Manual

1.3

Conventions Used in This Manual These conventions are used in this user guide: • • • • • •

•

1.4

A Warning describes precautions necessary to prevent injury or loss of life. A Caution describes precautions necessary to protect the products. Operating instructions are introduced with a statement in bold-face type that ends with a colon. For example: To read this user guide: When the steps in the operating instructions must be performed in a specific order, the steps are numbered. Bulleted lists present information in list format, but they do not imply a sequence. The left side of the system is to your left as you face the system. The system handle is on the left side of the system, and the battery compartment is at the bottom left of the system. Note: A note cites information that is a general rule for a procedure, gives an exception to a rule, or provides noncritical information of general interest.

About the System Software Your SonoSite system contains software that controls its operation. From time to time, SonoSite may provide new software for use with your system. This software is provided using a method proprietary to SonoSite. This software may be either required or optional. When the new software is required, you must have it installed if you wish to use the new software features. If you choose not to have it installed, please notify SonoSite Technical Support at 877-657-8118. When the software is optional, you can either have it installed or choose to use your existing software.

1.5

Software Licensing Use of software that you receive from SonoSite is controlled by a license key. A license key is a number sequence containing exactly 12 decimal digits. If you require a license key you will be notified by SonoSite. License keys are obtained only from SonoSite or from its authorized representatives. See Section 4.4, System License Keys, on page 22 for information on obtaining a license key.

Chapter 1: Introduction

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4

iLook Service Manual

CHAPTER

2

Safety Please read this information before using the iLook system. It applies to the ultrasound system, transducers, accessories, and peripherals. A Warning describes precautions necessary to prevent injury or loss of life. A Caution describes precautions necessary to protect the products.

2.1

Electrical Safety This system meets EN60601-1, Class I/internally-powered equipment requirements and Type BF isolated patient-applied parts safety requirements. This system complies with the applicable medical equipment requirements published in the Canadian Standards Association (CSA), European Norm Harmonized Standard, and Underwriters Laboratories (UL) safety standards. See Section 3.5, System Specifications, on page 15. For maximum safety observe the following warnings and cautions: Warning:

To avoid the risk of electrical shock or injury, do not open the system enclosures. All internal adjustments and replacements, except battery replacement, must be made by a qualified technician. To avoid the risk of injury, do not operate the system in the presence of flammable gasses or anesthetics. Explosion can result. To avoid the risk of electrical shock, use only properly grounded equipment. Shock hazards exist if the AC power supply is not properly grounded. Grounding reliability can only be achieved when equipment is connected to a receptacle marked “Hospital Only” or “Hospital Grade” or the equivalent. The grounding wire must not be removed or defeated.

Chapter 2: Safety

5

Warning:

To avoid the risk of electrical shock, before using the transducer, inspect the transducer face, housing, and cable. Do not use the transducer if the transducer or cable is damaged. To avoid the risk of electrical shock, always disconnect the AC power supply from the system before cleaning the system. To avoid the risk of electrical shock, do not use any transducer that has been immersed beyond the specified cleaning or disinfection level. See Chapter 5, Cleaning and Disinfecting, on page 27. To avoid the risk of electrical shock and fire hazard, inspect the power supply, AC power supply cord and plug on a regular basis. Ensure they are not damaged. To avoid the risk of electrical shock, use only accessories and peripherals recommended by SonoSite. Connection of accessories and peripherals not recommended by SonoSite could result in electrical shock. Contact SonoSite or your local representative for a list of accessories and peripherals available from or recommended by SonoSite. To avoid the risk of electrical shock, use commercial grade peripherals recommended by SonoSite on battery power only. Do not connect these products to AC power when using the system to scan or diagnose a patient/subject. Contact SonoSite or your local representative for a list of the commercial grade peripherals available from or recommended by SonoSite. To avoid the risk of electrical shock to the patient/subject, do not touch the system battery contacts while simultaneously touching a patient/subject. To prevent injury to the operator/bystander, the transducer must be removed from patient contact before the application of a high-voltage defibrillation pulse.

2.2

Equipment Protection To protect your ultrasound system, transducer, and accessories, follow these precautions. Caution:

Excessive bending or twisting of cables can cause a failure or intermittent operation. Improper cleaning or disinfecting of any part of the system can cause permanent damage. For cleaning and disinfecting instructions, see Chapter 5, Cleaning and Disinfecting, on page 27. Do not use solvents such as thinner or benzene, or abrasive cleaners on any part of the system.

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iLook Service Manual

Caution:

Remove the battery from the system if the system is not likely to be used for some time. Do not spill liquid on the system. The top membrane of a phantom is delicate and can be damaged if handled improperly. Use minimum force when coupling the transducer to a phantom. Do not handle PCBs without proper static protection. Improper handling may damage components. Incorrect assembly or configuration or using an improper power source may damage the system.

2.3

Battery Safety To avoid the risk of injury, follow the warnings and cautions to make sure that the battery does not burst, ignite, or generate heat or fumes. Warning:

The battery has a safety device. Do not disassemble or alter the battery. Charge the batteries only when the ambient temperature is between 0° and 40°C (32° and 104°F). Do not short-circuit the battery by directly connecting the positive and negative terminals with metal objects. Do not heat the battery or discard it in a fire. Do not expose the battery to temperatures over 60°C (140°F). Keep it away from fire and other heat sources. Do not charge the battery near a heat source, such as a fire or heater. Do not leave the battery in direct sunlight. Recharge the battery only with the docking station battery charger or the system. Do not pierce the battery with a sharp object, hit it, or step on it. Do not use a damaged battery. Do not solder a battery. When connecting the battery to the battery charger or to the system, never reverse the polarity of the battery terminals. The polarity of the battery terminals are fixed and cannot be switched or reversed. Do not force the battery into the system or the battery charger. Do not connect the battery to an electrical power outlet. Do not continue recharging the battery if it does not recharge after two successive six hour charging cycles.

Chapter 2: Safety

7

Caution:

To avoid the battery bursting, igniting, or fumes from the battery and causing equipment damage, observe the following precautions: Do not immerse the battery in water or allow it to get wet. Do not put the battery into a microwave oven or pressurized container. If the battery leaks or emits an odor, remove it from all possible flammable sources. If the battery emits an odor or heat, is deformed or discolored, or in any way appears abnormal during use, recharging or storage, immediately remove it and stop using it. If you have any questions about the battery, consult SonoSite or your local representative. Store the battery between -20°C (-4°F) and 60°C (140°F). Use only SonoSite batteries.

2.4

Biological Safety Observe the following precautions related to biological safety. Warning:

Non-medical (commercial) grade peripheral monitors have not been verified or validated by SonoSite as being suitable for diagnosis. Do not use the system if it exhibits erratic or inconsistent behavior. Discontinuities in the scanning sequence are indicative of a hardware failure that must be corrected before use. Do not use the system if it exhibits artifacts on the LCD screen, either within the clinical image or in the area outside of the clinical image. Artifacts are indicative of hardware and/or software errors that must be corrected before use. Some transducer covers contain natural rubber latex and talc, which can cause allergic reactions in some individuals. Refer to the FDA Medical Alert, March 29, 1991. Perform ultrasound procedures prudently. Use the ALARA (as low as reasonably achievable) principle. SonoSite does not currently recommend a specific brand of acoustic standoff.

2.5

Labeling Symbols Labeling symbols for SonoSite products can be found in the user guide for each product.

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iLook Service Manual

3

System Overview

3.1

Theory of Operation

CHAPTER

The SonoSite ultrasound system has seven major functional groups: the transducer, the acquisition subsystem, the processing subsystem, the display subsystem, the control subsystem, the user interface subsystem, and the power subsystem. Figure 3.1 shows how these functions interact. VBAT

Sys Pwr Sys Clks

Clocks

Power Supplies

Battery

VPWR

VDC

ChgRate

AC/DC Adapter Charger

IIC Bus Power Control

Scanhead

RS232 Frame/ Line Triggers

Xdcr

Front End

Prtr Ctl

Control

Dock

USB

CPU Bus

RF Bus

Signal Processing

Acq Bus

Back End

Video Out

Figure 3.1 iLook Block Diagram

Chapter 3: System Overview

9

3.1.1

Transducer The transducer elements convert the pulser voltage to acoustic energy during the “transmit” portion of the ultrasound acquisition cycle. Also, the transducer elements convert the acoustic echo to voltage in the “receive” portion of the acquisition cycle. The system transducers have 64–128 elements. The acquisition subsystem senses the voltage developed on the transducer elements.

3.1.2

Acquisition Subsystem The acquisition subsystem consists of a beamformer and an interface to the transducer. The beamformer times the “transmit” pulses to focus the acoustic beam. Also, the beamformer amplifies the low-level echo signal and times and focuses the “receive” information.

3.1.3

Processing Subsystem The high-speed processing subsystem interfaces with the beamformer. The processing subsystem demodulates, filters, detects, and compresses the signal supplied by the beamformer. Next, it sends this data to the display subsystem.

3.1.4

Display Subsystem 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 ports support NTSC and PAL format.

3.1.5

Control Subsystem The control subsystem consists of the central processing unit, program and video memory, permanent image storage and retrieval memory, and a connection to the user interface keys. The control software includes the acoustic power and intensity software power group monitors, and a beamformer monitor. This software makes the system operate within acoustic power and intensity limits, which guarantees a level of patient safety.

3.1.6

User Interface Subsystem The user interface subsystem comprises the software user interface and the form factor. The software user interface is the interaction between the user and the screen layout components. The form factor is the device’s physical attributes: buttons, location and grouping of buttons and the device size, shape, and weight. Dedicated controls, or often-used features, are grouped according to user workflow.

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iLook Service Manual

3.1.7

Power Subsystem The power subsystem provides power and protects the hardware from destructive or unsafe conditions. This subsystem’s hardware and software monitors detect failures in the device. Upon detecting a fault, the system disables the pulser supply, and signals an error to the control subsystem. The power subsystem includes the battery pack and the battery charging electronics.

3.2

Components The SonoSite system components are identified in Section 1.1, About the System, on page 1.

3.3

Controls Figure 3.2 shows the system controls. Directional controller

Freeze

Menu

Patient Save

Touch screen

Power

Figure 3.2 System Controls Table 3.1 System Controls System Control

Icon

Description

Power

Press and hold for 1 beep to turn power on. Press and hold for 2 beeps to turn power off.

Menu

Press to turn the on-screen menu on. Press again to turn the on-screen menu off.

Freeze

Press to freeze an image. Measurements can be made on a frozen image. Press freeze again to unfreeze the image.

Chapter 3: System Overview 11

Table 3.1 System Controls System Control

3.4

Icon

Description

Save

Press to save an image to the internal memory. Storage capacity is up to 74 images.

Patient

Press to access Patient Information, Exam Type, Image Review, and System Set-up. Press again to return to imaging.

Directional Controller

Use to navigate on-screen menus, adjust caliper position, and enter data. Use the right, left, up, or down arrows to highlight menu items. Press the center to select.

Touch Screen

Use stylus to tap on-screen menu options, position calipers, and enter data. The touch screen is not active during live imaging.

Accessories For information about accessories and other SonoSite products, refer to the user guide for each product.

3.4.1

Battery Pack Caution:

Use only the specified SonoSite battery pack. For battery safety notes, see Section 2.3, Battery Safety, on page 7.

The system can be powered from either a battery pack or external power. The system is powered by a rechargeable, 3-cell, 11.4 VDC, lithium-ion battery. A fully charged battery will last for 20 minutes or more, depending on usage. The battery pack case is made of injection molded plastic. When in use, it is inserted into the system. The battery pack has no user-serviceable parts. The operating life of the battery is 1-2 years, depending on how you use the system. Table 3.2 contains battery operating specifications.

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iLook Service Manual

Table 3.2 Battery Pack Operation Specifications Battery Pack Operation Parameter

Specification

Operation time based on usage model:

20 min @ 25°C

In a 2-hour period, the projected conservative power usage model for the imaging physical use is as follows: •

Time spent actively scanning (full power) = 20%

•

Time device is in “Freeze” = 5%

•

Time device is “Off” = 20%

•

Time device is in Docking Station charging = 55%

In a 1-hour period, the projected conservative power usage model for the PICC line use is as follows:

3.4.1.1

•

Time spent actively scanning (full power) = 33%

•

Time device is “Off” = 67%

Operation time during power off (leakage and self discharge)

10 days @ 25°C

Number of charge discharge cycles (100% depth of discharge)

500 @ 25°C

Battery Charge Indicators The battery charge indicators, which consist of light-emitting diodes (LEDs) on the docking station, indicate the current battery level. • •

The green LED lit means the system battery is fully charged. The yellow LED lit means the system battery is partially charged.

Table 3.3 contains the charging requirements for the system. Table 3.3 System Charging Requirements

3.4.2

System Charging Parameter

Specification

Charge time to 100% capacity (internal charger) – power turned off on user interface

3 hours @ 77°F (25°C)

External Power The external power connection provides the system power via the power adapter. External power charges the battery pack and powers the system in low battery conditions.

Chapter 3: System Overview 13