SonoSite C1.9 User manual

C1.9 PLUS Ultrasound System

Service Manual

P02287-03 01/2003

Copyright 2003 by SonoSite, Inc.

All rights reserved. Printed in the USA.

ii C1.9 PLUS Ultrasound System Service Manual

Manufactured by

SonoSite, Inc.
21919 30th Drive SE
Bothell, WA 98021-3904
USA
Telephone: [phone] or [phone]
Fax: [phone]

SonoSite European Headquarters

Baystrait House, Station Road
Biggleswade SG18 8AL
UK
Telephone: [phone]
Fax: [phone]

CAUTION:

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

physician.

“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.

iii

iv C1.9 PLUS Ultrasound System Service Manual

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 ............................................15

3.4.2 External Power .................................................................16

3.4.2.1 External System Connections ......................................16

3.4.3 Power Adapter..................................................................17

3.5 System Specifications .............................................................17

3.5.1 Physical Dimensions ........................................................17

3.5.2 Monitor.............................................................................17

3.5.3 Transducers ......................................................................18

3.5.4 Imaging Modes.................................................................18

v

3.5.5 Image Storage...................................................................18

3.5.6 Temperature, Pressure, and Humidity Limits ..................18

3.5.6.1 System Operating.........................................................18

3.5.6.2 System Shipping/Storage ............................................18

3.5.6.3 Battery Operating.........................................................18

3.5.6.4 Battery Shipping/Storage .............................................18

3.5.6.5 Transducers Operating .................................................18

3.5.6.6 Transducers Shipping/Storage .....................................19

3.5.7 Electrical...........................................................................19

3.6 Battery.....................................................................................19

3.7 Safety Requirements...............................................................19

3.7.1 Meets Electromechanical Safety Standards .....................19

3.7.2 Meets EMC/EMI Standards .............................................20

3.7.3 Meets Airborne Equipment Standards (without ECG Cable

Attached) ..........................................................................20

3.7.4 Meets ECG Standard........................................................20

CHAPTER 4 Setup and Operation 21

4.1 Connecting and Removing Transducers .................................21

4.2 Turning the System On and Off..............................................22

4.3 Installing and Removing the Battery ......................................23

4.4 Using AC Power .....................................................................24

4.5 Upgrading the System Software .............................................25

4.6 Obtaining A License Key .......................................................26

4.6.1 Installing A License Key..................................................26

4.6.1.1 Displaying the System Information Screen .................28

4.7 Checking and Charging the Battery........................................28

CHAPTER 5 Cleaning and Disinfecting 31

5.1 Universal Precautions .............................................................31

5.2 Receipt of Suspected Contaminated Materials .......................31

5.3 Recommended Disinfectants ..................................................32

CHAPTER 6 Troubleshooting 33

6.1 System and Subsystem Diagnosis...........................................33

6.2 System Repair .........................................................................33

6.3 Test Equipment.......................................................................33

vi C1.9 PLUS Ultrasound System Service Manual

6.4 Failures....................................................................................34

6.4.1 Display..............................................................................34

6.4.2 Control Panel....................................................................34

6.4.3 Trackball...........................................................................34

6.4.4 Main PCBA ......................................................................34

6.4.5 Clearing the Main PCBA Failure.....................................35

6.4.6 Battery ..............................................................................35

CHAPTER 7 Replacement Procedures 43

7.1 Display Subassembly Replacement........................................43

7.1.1 Required Parts ..................................................................43

7.1.2 Required Tools and Materials ..........................................43

7.1.3 Removing the Display Subassembly................................44

7.1.4 Replacing the Display Subassembly ................................46

7.2 Control Panel Subassembly Replacement ..............................48

7.2.1 Required Parts ..................................................................48

7.2.2 Required Tools .................................................................48

7.2.3 Removing the Control Panel Subassembly ......................49

7.2.4 Replacing the Control Panel Subassembly.......................51

7.3 Trackball .................................................................................52

7.3.1 Required Parts ..................................................................52

7.3.2 Required Tools .................................................................52

7.3.3 Removing the Trackball ...................................................52

7.3.4 Replacing the Trackball....................................................55

7.4 Main PCBA Subassembly Replacement.................................57

7.4.1 Required Parts ..................................................................57

7.4.2 Required Tools .................................................................58

7.4.3 Removing the Main PCBA Subassembly ........................58

7.4.4 Replacing the Main PCBA Subassembly.........................59

7.5 Transducers.............................................................................62

7.6 AC Power Adapter..................................................................62

7.7 OEM Peripherals.....................................................................63

7.7.1 External Monitor (Sony) ..................................................63

7.7.2 VCR (Sony)......................................................................63

7.7.3 Printer (Sony) ...................................................................63

vii

CHAPTER 8 Performance Tests 65

8.1 Overview.................................................................................65

8.2 Test Equipment:......................................................................65

8.3 Setting Up Performance Tests ................................................66

8.3.1 Scan Reference Orientation..............................................66

8.4 Testing 2D Performance .........................................................66

8.4.1 2D Image Quality.............................................................66

8.4.2 Axial Measurement Accuracy..........................................67

8.4.3 Lateral Measurement Accuracy .......................................67

8.4.4 Penetration........................................................................68

8.5 Additional Performance Tests ................................................68

8.5.1 CPD ..................................................................................68

8.5.2 PowerMap DCPD.............................................................69

8.5.3 M-mode Imaging..............................................................69

8.5.4 Tissue Harmonic Imaging ................................................70

8.5.5 Pulsed Wave (PW) Doppler Imaging...............................70

8.5.6 ECG Monitoring...............................................................70

8.5.7 Image Quality Verification Test.......................................71

8.5.8 Image Review...................................................................71

8.5.9 Printer ...............................................................................71

8.5.10 Battery Charging ..............................................................71

8.5.11 Video Output ...................................................................71

8.6 Returning Products to SonoSite..............................................72

8.6.1 Contacting SonoSite Technical Support ..........................72

8.6.2 Shipping Instructions........................................................72

APPENDIX A Parts List 73

APPENDIX B Service Event Report 85

Index 87

viii C1.9 PLUS Ultrasound System 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 C1.51 Ultrasound System Service Manual (P00715) and C1.75
Ultrasound System Service Manual (P01118).

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

Chapter 1: Introduction 1

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 C1.9 PLUS Ultrasound System 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 25

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 26
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.

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.”

.

for information on obtaining a

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 28

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.

Chapter 1: Introduction 3

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4 C1.9 PLUS Ultrasound System 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 17

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).

Chapter 2: Safety 5

` 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. Refer to the
SonoSite Ultrasound System User Guide for cleaning and disinfection levels.

` 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.

6 C1.9 PLUS Ultrasound System Service Manual

` 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
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, refer to the SonoSite
Ultrasound System User Guide.

` 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.

Chapter 2: Safety 7

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 C1.9 PLUS Ultrasound System 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.

2.4 Labeling Symbols

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

Chapter 2: Safety 9

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10 C1.9 PLUS Ultrasound System Service Manual

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

Chapter 3: System Overview 11

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 C1.9 PLUS Ultrasound System 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.

Chapter 3: System Overview 13

3.3 Controls

Figure 3.2 shows the SonoSite system controls.

1

2

rear view

3

4

5

10

11

12

13

6
7

8

14

15
16

17

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 print key

7 trackball 15 cine arrow keys and Freeze key

8 Patient 16 mode controls

9 Function key

control

17 battery release

Figure 3.2 SonoSite Ultrasound System Controls

14 C1.9 PLUS Ultrasound System Service Manual

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
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 3.1 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 3.2 System Charging Requirements

SYSTEM CHARGING PARAMETER SPECIFICATION

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)

3 hours @ 77°F (25°C)

12 hours @ 77°F (25°C)

Chapter 3: System Overview 15

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.

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.

12 34

Figure 3.3 External System Connections

Table 3.3 External System Connections

NUMBER FEATURE

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

16 C1.9 PLUS Ultrasound System Service Manual

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.

Power Cord

Table 3.4 Power Cord Specifications

° and 104°F (0° and 40°C) to charge a

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

Chapter 3: System Overview 17

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

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.

18 C1.9 PLUS Ultrasound System Service Manual

3.5.6.6 Transducers Shipping/Storage

• -31–149°F (-35–65°C), 15–95% R.H

3.5.7 Electrical

• System optional: 100-120/220-240 V ac, 50/60 Hz input, 16.0 V dc output
power adapter

• 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

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.

Chapter 3: System Overview 19

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.

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.

20 C1.9 PLUS Ultrasound System Service Manual

CHAPTER 4 Setup and Operation

WARNING:

` CRITICAL TEST FUNCTION - Skipping the functional tests in this procedure

could adversely affect safety or effectiveness of the system.

Operation of the SonoSite ultrasound system can be found in the user guide provided
with each system.

4.1 Connecting and Removing Transducers

The system comes with one or more transducers. Only one transducer can be
connected to the system at a time.

WARNING:

` The transducer connector can become hot during operation. This is normal.

Operate the system in the SiteStand mobile docking station or on a flat, hard
surface to allow air flow past the connector.

CAUTION:

` The electrical contacts inside the system transducer connector may be damaged by

foreign material or by rough handling. Do not touch the electrical contacts. Keep
foreign material out of the connector. Keep a transducer connected to the system
whenever possible.

To connect the transducer:

1. On the transducer connector, pull the latch up and rotate it clockwise until it

snaps to a stop (Figure 4.1). The latch should be easy to move. Do not force the
latch.

2. Align the transducer connector with the connector on the rear of the system and

insert it by pushing the transducer connector into the system connector. The
transducer connector should be easy to insert. Do not force the transducer
connector.

3. Turn the latch counterclockwise until it snaps to a stop.

Chapter 4: Setup and Operation 21

4. Press the latch down until it snaps into place, securing the transducer connector

to the system.

Transducer connector Transducer connector latch

Figure 4.1 Connecting the Transducer

To remove the transducer:

1. On the transducer connector, pull the latch up and rotate it clockwise until it

snaps to a stop (Figure 4.1).

2. Carefully pull the transducer connector away from the system.

4.2 Turning the System On and Off

When turning power on or off, you must push and hold the Power switch for
approximately one second before the system responds. This feature prevents battery
discharge, resulting from accidentally turning the system on. It also prevents
accidentally turning the system off during an exam.
The first time you turn on the system, set the date and time. See the SonoSite

Ultrasound System User Guide.

CAUTION:

` Do not use the system if an error message appears on the image display. Note the

error code. Call SonoSite or your local representative. When an error code occurs,
turn off the system by pressing and holding the power switch until the system
powers down.

To turn on power:

1. Locate the Power switch on the back of the left side of the system handle. See

Figure 3.2, SonoSite Ultrasound System Controls, on page 14.

2. Press and hold the Power switch until the system beeps or until you see the

image display.

3. Release the Power switch.

22 C1.9 PLUS Ultrasound System Service Manual