SonoSite System Plus User manual

Ultrasound System PLUS Service Manual
:
P02287-01 7/01 Copyright © 2001 by SonoSite, Inc.
All rights reserved. Printed in the USA.
ii
Manufactured by
21919 30th Drive SE
Bothell, WA, USA 98021-3904
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
SonoSite Asian Headquarters
SonoSite China Limited
Unit C, 8F, One Capital Place
18 Luard Road, Wanchai, Hong Kong
Telephone: +852-2529-2881
Fax: +852-2529-5881
CAUTION:
United States federal law restricts this device to sale by or on the order of a physician.
“PowerMap,” “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, D0280762, D0285484, D0286325, D0300241, D0306343, D0328095, D0369307, D0379231. Other patents pending.
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Table of Contents

CHAPTER 1 Introduction 1
1.1 About the System......................................................................1
1.2 Audience ...................................................................................2
1.3 Conventions Used in This Manual............................................2
1.4 About the System Software ......................................................2
1.5 Software Licensing ...................................................................3
CHAPTER 2 Safety 5
2.1 Electrical Safety........................................................................5
2.1.1 Equipment Protection.........................................................7
2.2 Battery Safety............................................................................8
2.3 Biological Safety.......................................................................9
2.4 Labeling Symbols .....................................................................9
CHAPTER 3 System Overview 11
3.1 Theory of Operation................................................................11
3.1.1 Transducer........................................................................12
3.1.2 Acquisition Subsystem.....................................................12
3.1.3 Processing Subsystem ......................................................12
3.1.4 Display Subsystem ...........................................................12
3.1.5 Control Subsystem ...........................................................12
3.1.6 User Interface Subsystem.................................................12
3.1.7 Power Subsystem .............................................................13
3.2 Components ............................................................................13
3.3 Controls...................................................................................14
3.4 Accessories .............................................................................15
3.4.1 Battery Pack .....................................................................15
3.4.1.1 Battery Charge Indicators ............................................16
3.4.2 External Power .................................................................16
3.4.2.1 External System Connections ......................................17
3.4.3 Power Adapter..................................................................17
3.5 System Specifications .............................................................18
3.5.1 Physical Dimensions ........................................................18
3.5.2 Monitor.............................................................................18
3.5.3 Transducers ......................................................................18
3.5.4 Imaging Modes.................................................................19
SonoSite Ultrasound System PLUS Service Manual v
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3.5.5 Image Storage...................................................................19
3.5.6 Temperature, Pressure, and Humidity Limits ..................19
3.5.6.1 System Operating.........................................................19
3.5.6.2 System Shipping/Storage ............................................19
3.5.6.3 Battery Operating.........................................................19
3.5.6.4 Battery Shipping/Storage .............................................19
3.5.6.5 Transducers Operating .................................................19
3.5.6.6 Transducers Shipping/Storage .....................................19
3.5.7 Electrical...........................................................................20
3.6 Battery.....................................................................................20
3.7 Safety Requirements...............................................................20
3.7.1 Meets Electromechanical Safety Standards .....................20
3.7.2 Meets EMC/EMI Standards .............................................21
3.7.3 Meets Airborne Equipment Standards (without ECG Cable
Attached)........................................................................................21
3.7.4 Meets ECG Standard........................................................21
CHAPTER 4 Setup and Operation 23
4.1 Connecting and Removing Transducers .................................23
4.2 Turning the System On and Off..............................................24
4.3 Installing and Removing the Battery ......................................25
4.4 Using AC Power .....................................................................26
4.5 Upgrading the System Software .............................................27
4.6 Obtaining A License Key .......................................................28
4.6.1 Installing A License Key..................................................28
4.6.1.1 Displaying the System Information Screen .................30
4.7 Checking and Charging the Battery........................................30
CHAPTER 5 Cleaning and Disinfecting 33
5.1 Universal Precautions .............................................................33
5.2 Receipt of Suspected Contaminated Materials .......................33
5.3 Recommended Disinfectants ..................................................34
CHAPTER 6 Troubleshooting 35
6.1 System and Subsystem Diagnosis...........................................35
6.2 System Repair .........................................................................35
6.3 Test Equipment.......................................................................35
6.4 Failures....................................................................................36
vi SonoSite Ultrasound System PLUS Service Manual
6.4.1 Display..............................................................................36
6.4.2 Control Panel....................................................................36
6.4.3 Trackball...........................................................................36
6.4.4 Main PCBA ......................................................................36
6.4.5 Clearing the Main PCBA Failure.....................................37
6.4.6 Battery ..............................................................................37
CHAPTER 7 Replacement Procedures 45
7.1 Display Subassembly Replacement........................................45
7.1.1 Required Parts ..................................................................45
7.1.2 Required Tools and Materials ..........................................45
7.1.3 Removing the Display Subassembly................................46
7.1.4 Replacing the Display Subassembly ................................48
7.2 Control Panel Subassembly Replacement ..............................50
7.2.1 Required Parts ..................................................................50
7.2.2 Required Tools .................................................................50
7.2.3 Removing the Control Panel Subassembly ......................51
7.2.4 Replacing the Control Panel Subassembly.......................53
7.3 Trackball .................................................................................54
7.3.1 Required Parts ..................................................................54
7.3.2 Required Tools .................................................................54
7.3.3 Removing the Trackball ...................................................54
7.3.4 Replacing the Trackball....................................................57
7.4 Main PCBA Subassembly Replacement.................................59
7.4.1 Required Parts ..................................................................59
7.4.2 Required Tools .................................................................60
7.4.3 Removing the Main PCBA Subassembly ........................60
7.4.4 Replacing the Main PCBA Subassembly.........................61
7.5 Transducers.............................................................................64
7.6 AC Power Adapter..................................................................64
7.7 OEM Peripherals.....................................................................65
7.7.1 External Monitor (Sony) ..................................................65
7.7.2 VCR (Sony)......................................................................65
7.7.3 Printer (Sony) ...................................................................65
CHAPTER 8 Performance Tests 67
8.1 Overview.................................................................................67
8.2 Test Equipment: ......................................................................67
8.3 Setting Up Performance Tests ................................................68
8.3.1 Scan Reference Orientation..............................................68
SonoSite Ultrasound System PLUS Service Manual vii
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8.4 Testing 2D Performance .........................................................68
8.4.1 2D Image Quality.............................................................68
8.4.2 Axial Measurement Accuracy..........................................69
8.4.3 Lateral Measurement Accuracy .......................................69
8.4.4 Penetration........................................................................70
8.5 Additional Performance Tests ................................................70
8.5.1 CPD ..................................................................................70
8.5.2 PowerMap DCPD.............................................................71
8.5.3 M-mode Imaging..............................................................71
8.5.4 Tissue Harmonic Imaging ................................................72
8.5.5 Pulsed Wave (PW) Doppler Imaging...............................72
8.5.6 ECG Monitoring...............................................................72
8.5.7 Image Quality Verification Test.......................................73
8.5.8 Image Review...................................................................73
8.5.9 Printer ...............................................................................73
8.5.10 Battery Charging ..............................................................73
8.5.11 Video Output ...................................................................73
8.6 Returning Products to SonoSite..............................................74
8.6.1 Contacting SonoSite Technical Support ..........................74
8.6.2 Shipping Instructions........................................................74
APPENDIX A Parts List 75
APPENDIX B Service Event Report 87
Index 89
viii SonoSite Ultrasound System PLUS Service Manual

CHAPTER 1 Introduction

Before servicing the SonoSite ultrasound system, please read the information in this manual. This text applies to SonoSite ultrasound system products manufactured after April 27, 2001. Please find service information about products manufactured before April 27, 2001 in SonoSite Ultrasound System Service Manual (P00715-02) and SonoSite Ultrasound System C1.75 Service Manual (P01118-01).

1.1 About the System

The SonoSite system has various configurations and features. All are described in this manual but not every option may apply to your system. System features are dependent on your system configuration, transducer and exam type.
The SonoSite system is a portable, software-controlled, ultrasound system. It has an all-digital architecture. It is used to acquire and display high-resolution, real-time, 2D, Color Power Doppler (CPD), PowerMap Doppler (DCPD), Tissue Harmonic Imaging (THI), M-mode and Pulsed Wave (PW) Doppler ultrasound images. The system has electrocardiography (ECG), cine review, image zoom, labeling, biopsy, measurements and calculations, serial port connection for image transfer, image storage and review, printing and recording capabilities. The system setup also has a selection to support optical character recognition (OCR) of the English character set for time, date, patient name, and patient identification. The OCR screen characters are optimized for use with the ALI NewPORT DICOM image capture station peripheral available from ALI. For more information about the ALI NewPORT 2.1, refer to the ALI NewPORT 2.1 Image Capture Station User’s Guide.
(PM) Directional Color Power
Currently, the system supports the following broadband transducers:
C60/5-2 MHz 60-mm curved array
C15/4-2 MHz 15-mm micro-curved array
C11/7-4 MHz 11-mm micro-curved array
ICT/7-4 MHz 11-mm intracavitary
L38/10-5 MHz 38-mm linear array
SonoSite Ultrasound System PLUS Service Manual 1
Chapter 1: Introduction
System accessories include a SiteStand® mobile docking station and accessories, SiteCharge printer cables, SiteLink image manager software, SiteStand CRT Stand, ScanPack quick access carrier, and SitePack
System peripherals include medical grade (conforming to the requirements of EN60601-1) and non-medical (commercial) grade products. System medical grade peripherals include an external color monitor, video printers, and VCRs. System non-medical grade peripherals include a digital video recorder, a battery charger, a lithium-ion battery, printer, and a handheld monitor. Use of peripherals is covered in the manufacturers’ instructions, which accompany each peripheral. System setup instructions for the use of peripherals are covered in Chapter 3 in the SonoSite Ultasound System User Guide.
dual battery charger, a power adapter, a battery, ECG cable, video and
®
basket, Basic Stand,
protective carry pack.

1.2 Audience

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

1.3 Conventions Used in This Manual

These conventions are used in this user guide:
Warnings and cautions are identified with the arrow symbol.
Control names and references to display elements are presented in bold-face type.
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.
Screen display text is shown in Arial 10 pt. For example:
The left side of the system is to your left as you face the system. The system handle is at the top of the system, the battery compartment is at the bottom 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.
Successful upgrade.

1.4 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 software update module or a transducer. This software may be either required or optional. A single module or transducer can be used to update one or more systems.
When the new software is required, you must install it if you wish to use the new software features (e.g., new transducer). If you choose not to install it, you must
2 SonoSite Ultrasound System PLUS Service Manual
remove the transducer and replace it with one that is compatible with the software that is currently installed in your system.
When the software is optional, you can either install it or choose to use your existing software. If you choose not to install the software, the system will prompt you again whenever the system is started, and whenever the transducer is disconnected and then reconnected to the system. For more information on software upgrades, refer to Chapter 4.5, Upgrading the System Software, on page 27

1.5 Software Licensing

Use of the software that you receive from SonoSite is controlled by a license key. A license key is a number sequence containing exactly 12 decimal digits.
License keys are obtained from SonoSite or from its authorized representatives. You must obtain one key for each system that will use the new software. See Chapter 4.6, Obtaining A License Key, on page 28 license key.
Software that you receive from SonoSite may be installed and will operate for a short period of time without requiring a valid license key. We refer to this period of time as the “grace period.” The grace period is variable.
Software Licensing
.
for information on obtaining a
When you first install your software, your SonoSite system will prompt you for a license key. If you have not yet obtained a valid license key, you can elect to use the software as long as the grace period time has not been fully consumed. We refer to this mode of operation as “running in the grace period.”
When a system is running in the grace period, all system functions are available. As you use the system, the grace period is slowly consumed. When the grace period has expired, the system will not be usable until a valid license key has been entered. Grace period time is not consumed while the system is powered off or when it is in “sleep” mode. Whenever a system is running in the grace period, the grace period time remaining is available on the license update screen. Refer to Chapter 4.6.1.1, Displaying the System Information Screen, on page 30
.
CAUTION:
When the grace period expires, all system functions except for licensing will be
unavailable until you enter a valid license key into the system.
SonoSite Ultrasound System PLUS Service Manual 3
Chapter 1: Introduction
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4 SonoSite Ultrasound System PLUS Service Manual

CHAPTER 2 Safety

Please read this information before using the SonoSite ultrasound 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. The ECG cable meets safety requirements of EN 60601-2-25 for Type CF patient-applied part.
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 Chapter 3.5, System Specifications, on page 18
For maximum safety observe the following warnings and cautions:
.
WARNINGS:
To avoid discomfort or minor risk of patient injury, keep hot surfaces away from
the patient.
Under certain circumstances, the transducer connector and back of the display
enclosure can reach temperatures that exceed EN60601-1 limits for patient contact, therefore only the operator shall handle the system. This does not include the transducer face.
To avoid discomfort or minor risk of operator injury when handling the transducer
connector, the system should not be operated for more than 60 minutes continuously in a live-scan mode (as opposed to freeze or sleep modes).
SonoSite Ultrasound System PLUS Service Manual 5
Chapter 2: Safety
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 adapter 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.
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 adapter
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 33
.
To avoid the risk of electrical shock and fire hazard, inspect the AC power adapter
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 recommend 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 mains 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 prevent injury, only use market cleared ECG electrodes and cables.To avoid the risk of electrical shock to the patient/subject, ensure proper assembly
of the ECG electrodes and cables.
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.
CAUTIONS:
Although your system has been manufactured in compliance with existing EMC/
EMI requirements (EN60601-1-2), use of the system in the presence of an electromagnetic field can cause degradation of the ultrasound image. If this occurs often, SonoSite suggests a review of the system environment. Identify and remove the possible sources of the emissions or move your system.
Electrostatic discharge (ESD), or static shock, is a naturally occurring
phenomenon. ESD is common in conditions of low humidity, which can be caused by heating or air conditioning. Static shock is a discharge of the electrical energy from a charged body to a lesser or non-charged body. The degree of discharge can
6 SonoSite Ultrasound System PLUS Service Manual
be significant enough to cause damage to a transducer or an ultrasound system. The following precautions can help reduce ESD: anti-static spray on carpets, anti­static spray on linoleum, and anti-static mats.
Do not use the system if an error message appears on the image display: note the
error code; call SonoSite or your local representative; turn off the system by pressing and holding the power switch until the system powers down.
To avoid increasing the system and transducer connector temperature, do not
block the airflow to the ventilation holes on the back of the system.

2.1.1 Equipment Protection

To protect your ultrasound system, transducer, and accessories, follow these precautions.
To protect your ultrasound system, transducer, and accessories, follow these precautions.
CAUTIONS:
The ECG cable emits electromagnetic interference when connected to the
SonoSite system. It is not approved for use in-flight on aircraft.
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 33
Do not submerge the transducer connector in solution. The cable is not liquid-tight
beyond the transducer connector/cable interface.
Do not use solvents such as thinner or benzene, or abrasive cleaners on any part
of the system.
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 the phantom is delicate and can be damaged if handled
improperly. Use minimum force when coupling the transducer to the 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.
Do not touch the scanhead connector pins.
.
Electrical Safety
SonoSite Ultrasound System PLUS Service Manual 7
Chapter 2: Safety

2.2 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.
WARNINGS:
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 SiteCharge dual 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 SiteCharge dual 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 SiteCharge dual 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.
CAUTIONS:
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.
8 SonoSite Ultrasound System PLUS Service Manual

2.3 Biological Safety

Observe the following precautions related to biological safety.
WARNINGS:
To prevent misdiagnosis, do not use the ECG trace to diagnosis cardiac rhythms.
The SonoSite ECG option is a non-diagnostic feature.
To prevent injury, only use market cleared ECG electrodes and cables.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.
Biological Safety

2.4 Labeling Symbols

Labeling symbols for SonoSite products can be found in the user guide for each product.
SonoSite Ultrasound System PLUS Service Manual 9
Chapter 2: Safety
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CHAPTER 3 System Overview

3.1 Theory of Operation

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.
Transducer
Acquisition subsystem
RF bus
Processing subsystem
Pulser voltage
AQ bus
Control bus
Display subsystem
Control subsystem
To all subsystems
Figure 3.1 System Block Diagram
Video bus
Serial bus
Display power
Logic power
External video to monitor, VCR, printer ports
User interface subsystem
Power subsystem
Power adapter
External power
Battery pack
SonoSite Ultrasound System PLUS Service Manual 11
Chapter 3: System Overview

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 more than 64 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.
12 SonoSite Ultrasound System PLUS 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 Chapter 1, section 1.2.
Components
SonoSite Ultrasound System PLUS Service Manual 13
Chapter 3: System Overview

3.3 Controls

Figure 3.2 shows the SonoSite system controls. The numbers correspond to the
control names and functional descriptions in Table 3.1
rear view
.
1
10
2
3
4
5
6 7
8
11
12
13
14
15
16
9
Number Feature Number Feature
1 power switch, located on the rear of the
system handle
2 near, affects gain of shallow echoes 10 battery charge indicators
3 far, affects gain of deeper echoes 11 LCD (liquid crystal display) brightness
4 gain, affects overall gain 12 LCD contrast control
5 menu select controls 13 LCD
6 Menu, Depth, and Zoom 14 cine arrow keys and Freeze key
7 trackball 15 mode controls
8 Patient 16 battery release
9 Function key
control
Figure 3.2 SonoSite Ultrasound System Controls
14 SonoSite Ultrasound System PLUS Service Manual
Accessories
Table 3.1 SonoSite Ultrasound System Controls
NUMBER CONTROLS DESCRIPTION
1 power switch (located on the rear
of the system handle)
2 near Affects gain of shallow echoes for 2D.
3 far Affects gain of deeper echoes for 2D.
4 gain Affects overall gain in 2D and CPD gain in CPD.
5 menu select controls Press Patient to access system menus.
6 Menu, Depth, and Zoom Allows access to imaging parameters; changes the
7 trackball Moves objects on the image display.
8 Patient Displays the system menus.
9 Function key Used with number keys (1-6) to display assigned
10 battery charge indicators Indicates a fully-charged battery when all LEDs lit
11 LCD (liquid crystal display)
brightness control
12 LCD contrast control Controls LCD contrast.
13 LCD Adjustable liquid crystal display.
14 cine arrow keys and Freeze key Press to move either way through the cine series of
15 mode controls Press to access imaging modes (keys 7,8,9,0)
16 battery release Press to release the battery.
Turns power on and/or off.
display depth; increases the image size to 2x.
text; used with the “I” key to display system information.
Controls LCD brightness.
images.

3.4 Accessories

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

3.4.1 Battery Pack

CAUTIONS:
Use only the specified SonoSite battery pack.For battery safety notes, see
Chapter 2, Safety, on page 5
The system can be powered from either a battery pack or external power.
The system is powered by a rechargeable, six-cell, 11.1 V dc, 3.0 amp-hours, lithium-ion battery. A fully-charged battery has a run time of 1.5 to 4 hours, depending upon operating conditions. The battery pack case is made of injection molded plastic. When in use, it is inserted into the system. The battery pack has no
.
SonoSite Ultrasound System PLUS Service Manual 15
Chapter 3: System Overview
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.
Table 3.2 Battery Pack Operation Specifications
BATTERY PACK OPERATION
PARAMETER
Operation time during use model 1.5 hours @ 77°F (25°C)
Operation time during power off (leakage and self discharge)
Number of charge discharge cycles (100% depth of discharge)
3.4.1.1 Battery Charge Indicators
The battery charge indicators, which consist of light-emitting diodes (LEDs) on the system, indicate the current battery level.
All LEDs lit mean the system battery is fully charged.
Some LEDs lit mean the system battery is partially charged.
Table 3.3 contains the charging requirements for the system.
Table 3.3 System Charging Requirements
SYSTEM CHARGING
PARAMETER
Charge time to 80% capacity (internal charger) with the system off
Charge time to 80% capacity (internal charger) with the system on
SPECIFICATION
14 days @ 77°F (25°C)
500 @ 70°F (21°C)
SPECIFICATION
3 hours @ 77°F (25°C)
12 hours @ 77°F (25°C)

3.4.2 External Power

The external power connection provides the system electricity via the power adapter. External power charges the battery pack and powers the system in low battery conditions.
16 SonoSite Ultrasound System PLUS Service Manual
3.4.2.1 External System Connections
Figure 3.3 shows the following external system connections:
A DC line voltage connector (1) connects the system to a power adapter.
An I/O connector (2) provides for connection to a PC or input of an ECG signal for ECG display on the monitor.
A print control connector (3) connects the system to a printer.
A video out connector (4) provides a composite video signal for a VCR, printer, or external video monitor.
Accessories
12 34
Figure 3.3 External System Connections
Table 3.4
NUMBER
1 DC line voltage connector
2 I/O connector
3 Print control connector for a recommended printer
4 Video out connector for a recommended VCR, printer, or external video monitor

3.4.3 Power Adapter

CAUTION:
Use only the specified SonoSite power adapter.
A universal power adapter (50–60 Hz, 100–240 V ac) can power the SonoSite system. When the system is plugged into a wall outlet, the battery pack recharges. Recharging a battery which is not fully discharged will not decrease battery life. Keep the ambient temperature between 32 battery successfully. To maintain battery charge, attach the power adapter to the system when the device is not in use.
° and 104°F (0° and 40°C) to charge a
SonoSite Ultrasound System PLUS Service Manual 17
Chapter 3: System Overview
Power Cord
Table 3.5 Power Cord Specifications
CONFIGU-
RATION
100-120 V ac ACC/ 60 Hz
230 V ac /50 Hz / PAL
230 V ac / 60 Hz
LENGTH RATING MALE PLUG
9 ft. 10 in. 250 V ac MA 5-15P
Hospital grade, grounding type molded on
3 m 250 V ac CEE-7/VII
grounding type with 4.8 mm pins molded on

3.5 System Specifications

This section provides specifications for the SonoSite ultrasound system.

3.5.1 Physical Dimensions

Height: 13.3 in. (33.8 cm)
Width: 7.6 in. (19.3 cm)
Depth: 2.5 in. (6.35 cm)
FEMALE
CONNEC-
TOR
CEE-22, molded on
CEE-22, molded on
APPRO
-VALS
UL, CSA
EU Manufac-
MARKING
Manufac­turer, Agency Approvals
turer, Agency Approvals
Weight: 5.4 lbs (2.46 kg) with the C60 transducer connected

3.5.2 Monitor

Height: 3.1 in. (7.9 cm)
Width: 4.3 in. (10.9 cm)
Diagonal: 5 in. (12.7 cm)
Brightness control
Contrast control

3.5.3 Transducers

C60/5-2 MHz 60-mm
C15/4-2 MHz 15-mm
C11/7-4 MHz 11-mm
ICT/7-4 MHz 11-mm
L38/10-5 MHz 38-mm
18 SonoSite Ultrasound System PLUS Service Manual
System Specifications

3.5.4 Imaging Modes

2D Imaging (256 gray shades)
CPD Imaging (64 colors)
M-mode
PowerMap DCPD Imaging (64 colors)
Pulsed Wave (PW) Doppler
Tissue Harmonic Imaging

3.5.5 Image Storage

Up to 119 images (depending on the configuration of the system)
Cine review

3.5.6 Temperature, Pressure, and Humidity Limits

3.5.6.1 System Operating
50–104°F (10–40°C), 15–95% R.H.
700-1060hPa (0.7 ATM to 1.05 ATM)
3.5.6.2 System Shipping/Storage
-31–149°F (-35–65° C), 15–95% R.H.
500-1060hPa (0.5ATM to 1.05 ATM)
3.5.6.3 Battery Operating
50–104°F (10–40°C), 15–95% R.H.
3.5.6.4 Battery Shipping/Storage
-4–140°F (-20–60°C), 0–95% R.H.
3.5.6.5 Transducers Operating
50–104°F (10–40°C), 15–95% R.H.
3.5.6.6 Transducers Shipping/Storage
-31–149°F (-35–65°C), 15–95% R.H
SonoSite Ultrasound System PLUS Service Manual 19
Chapter 3: System Overview

3.5.7 Electrical

System optional: 100-120/220-240 V ac, 50/60 Hz input, 16.0 V dc output
SiteCharge dual battery charger input voltage: 16.0 V dc, 2.8 A
SiteCharge dual battery charger output voltage: 12.6 V dc, 3.0 A (2x)
AC power adapter input: 100-120/220-240 V ac, 50/60 Hz, 1.0-0.50 A
AC power adapter output: + 16.0 V dc, 2.8 A

3.6 Battery

6-cell, 11.1 V dc, 3.0 amp-hours, rechargeable, lithium-ion battery pack
Run time: 1.5 to 4 hours, depending upon operating conditions

3.7 Safety Requirements

power adapter

3.7.1 Meets Electromechanical Safety Standards

EN 60601-1:1997, European Norm, Medical Electrical Equipment–Part 1. General Requirements for Safety.
EN 60601-1-1:1993, European Norm, Medical Electrical Equipment–Part 1. General Requirements for Safety–Section 1-1. Collateral Standard. Safety Requirements for Medical Electrical Systems.
EN 60601-1-2:1998, European Norm, Medical Electrical Equipment. General Requirements for Safety-Collateral Standard. Electromagnetic Compatibility. Requirements and Tests.
EN 60601-2-25: 1996, European Norm, Medical Electrical Equipment–Part 2. Particular Requirements for Safety–Section 25. Specification for Electrocardiographs.
C22.2, No. 601.1:1998, Canadian Standards Association, Medical Electrical Equipment–Part 1. General Requirements for Safety.
CEI/IEC 61157:1992, International Electrotechnical Commission, Requirements for the Declaration of the Acoustic Output of Medical Diagnostic Ultrasonic Equipment.
UL 2601-1:1999, Underwriters Laboratories, Medical Electrical Equipment-Part 1: General Requirements for Safety.
20 SonoSite Ultrasound System PLUS Service Manual

3.7.2 Meets EMC/EMI Standards

IEC 61000-4-2:1999, International Electrotechnical Committee, Electromagnetic Compatibility (EMC)-Part 4. Testing and Measurement Techniques-Section 4.2: Electrostatic Discharge/Immunity Test-Basic EMC Publication
IEC 61000-4-3:1997, International Electrotechnical Committee, Electromagnetic Compatibility (EMC)-Part 4. Testing and Measurement Techniques-Section 3: Radiated Radio-Frequency, Electromagnetic Field Immunity Test.
IEC 61000-4-4:1995, International Electrotechnical Committee, Electromagnetic Compatibility (EMC)-Part 4. Testing and Measurement Techniques-Section 4, Electrical Fast Transient/Burst Immunity Test-Basic EMC Publication.
IEC 61000-4-5:1999, International Electrotechnical Committee, Electromagnetic Compatibility (EMC)-Part 4. Testing and Measurement Techniques-Section 5, Surge Immunity Test.
CISPR11:97, International Electrotechnical Commission, International Special Committee on Radio Interference. Industrial, Scientific, and Medical (ISM) Radio­Frequency Equipment Electromagnetic Disturbance Characteristics-Limits and Methods of Measurement.
Safety Requirements
3.7.3 Meets Airborne Equipment Standards (without ECG Cable Attached)
RTCA/DO160D:1997, Radio Technical Commission for Aeronautics, Environmental Conditions and Test Procedures for Airborne Equipment, Section
21.0 Emission of Radio Frequency Energy, Category B.

3.7.4 Meets ECG Standard

AAMI EC53:1995, Association for the Advancement of Medical Instrumentation, ECG Cables and Lead Wires.
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