Acuson Aspen Safety Manual PDF

Acuson Ultrasound and Echocardiography Systems
Safety Manual
Siemens Medical Solutions Acuson, a Siemens Company

Ultrasound Division 1220 Charleston Road
European Business Centre Mountain View, CA 94043
125-135 Staines Road
Hounslow, Middlesex TW3 3JF (650) 969-9112
United Kingdom (800) 4-ACUSON
Tel: +44 (0) 208 479 7950 www.acuson.com

Fax: +44 (0) 208 479 7971 1220 Charleston Road
Mountain View, CA 94043
Document No. 58151

Revision No. 4
Language: English
0123
COPYRIGHT Copyright © 2001by Acuson Corporation. All rights reserved.
No part of this publication may be reproduced, transmitted, transcribed, stored in retrieval
systems, or translated into any language or computer language, in any form or by any
means, electronic, mechanical, magnetic, optical, chemical, manual, or otherwise, without
the prior written permission of Acuson Corporation.
Acuson Corporation reserves the right to change its products and services at any time. In
addition, this manual is subject to change without notice. Acuson Corporation welcomes
customer input on corrections and suggestions for improvements to this manual.
Although Acuson Corporation has attempted to ensure accuracy throughout this manual,
Acuson Corporation assumes no liability for any errors or omissions, nor for any damages
resulting from the application or use of this information.
TRADEMARKS ACUSON, MultiHertz, Native, RES, Sequoia, SpaceTime, The Value of Vision, Vector, XP,
128XP, 128XP/4, 128XP/10, and AEGIS are registered trademarks of Acuson Corporation.
128/10c, AcuNav, Aspen, Aspen Advanced, Cadence, CCD, Convergent, CSW3000,
Cypress, DBPro, DELTA, DIMAQ, DS3000, DTI, EF, eUltrasound, FreeStyle, Imagegate,
microCase, MICROSON, Multizone, NewView, Perspective, PerformancePlus, ProtoCALL,
OBPro, QuantX, Quik-Clip, Solo, Signature, SST, SwiftLink, TEQ, ≅TEQ, Tissue
Equalization, ≅Tissue Equalization, WorkPro, WebPro, WS3000, ViewPro, ViewPro-Net, and
Xpress are trademarks of Acuson Corporation. Remote First is a service mark of Acuson
Corporation.
Cidex, Cidex Plus, and Cidex 7 are registered trademarks of Surgikos, Inc. K-Y Lubricating
Gel is a trademark of Johnson & Johnson Products, Inc. IBM is a registered trademark of
International Business Machines Corporation. Metricide is a trademark of Metrex Research
Corporation. Omnicide is a trademark of Cottrell, Ltd. Panasonic is a trademark of
Matsushita Electric Industrial Co. Ltd. Polaroid is a registered trademark of Polaroid
Corporation. 3M is a registered trademark of Minnesota Mining and Manufacturing. Apple,
AppleTalk, EtherTalk, LocalTalk, Macintosh, MultiFinder, and LaserWriter are trademarks
of Apple Computer, Inc. DOT is a registered trademark of Digital Optical Technologies.
Pinnacle Micro Inc., Kodak, and Ektascan are registered trademarks of Eastman Kodak
Company. PostScript is a registered trademark of Adobe Systems, Incorporated. Ricoh is a
trademark of Ricoh Company, Ltd. Sony is a registered trademark of Sony Corporation of
America. Verbatim is a registered trademark of Verbatim Corporation. Tosoh is a trademark
of Tosoh Corporation. Multi-Imager is a trademark of International Imaging Electronics.
All other product names are trademarks of their respective companies.
CAUTION! United States Federal Law restricts use of this device to or on the order of a physician.
LICENSE AGREEMENT All computer programs copyright 1990-2001 by Acuson corporation OR ITS SUPPLIERS.
Such programs are licensed under the following software license agreement:
Acuson or its suppliers retain(s) ownership of and title to any computer program supplied
with the equipment and to the trade secrets embodied in such computer programs. Subject
to the Buyer’s acceptance and fulfillment of the obligations in this paragraph, Acuson grants
the Buyer a personal, non-transferable, perpetual, non-exclusive license to use any
computer program supplied with the Equipment that is necessary to operate the Equipment
solely on the medium in which such program is delivered for the purpose of operating the
equipment in accordance with the instructions set forth in the operator’s manuals supplied
with the Equipment and for no other purpose whatsoever. Buyer may not reverse-assemble,
reverse-compile or otherwise reverse-engineer such computer programs nor may Buyer
make a copy of such program or apply any techniques to derive the trade secrets embodied
therein. In the event of a failure by Buyer to comply with the terms of this license, the license
granted by this paragraph shall terminate. Further, because unauthorized use of such
computer programs will leave Acuson without an adequate remedy at law, Buyer agrees
that injunctive or other equitable relief will be appropriate to restrain such use, threatened
or actual. Buyer further agrees that (i) any of Acuson's suppliers of software is a direct and
intended beneficiary of this end-user sublicense and may enforce it directly against Buyer
with respect to software supplied by such supplier, and (ii) NO SUPPLIER OF ACUSON
SHALL BE LIABLE TO BUYER FOR ANY GENERAL, SPECIAL, DIRECT, INDIRECT,
CONSEQUENTIAL, INCIDENTAL OR OTHER DAMAGES ARISING OUT OF THE
SUBLICENSE OF THE COMPUTER PROGRAMS SUPPLIED WITH THE EQUIPMENT.
ii Acuson 0202
Table of Contents
Preface 1-v
How to Use This Manual 1-v
Other Resources 1-vi
Contacting Acuson 1-vii
Chapter 1 System Components 1-1

Sequoia 512 Ultrasound System Components 1-2
Sequoia C256 Echocardiography System Components 1-3
Aspen System Components 1-4
128XP System Components 1-5
Chapter 2 Basic Safety Precautions 2-1

Basic Precautions 2-2
Protecting Patients 2-3
Reviewing System Requirements 2-4
Using Input and Output Connectors 2-11
Interpreting Symbols on the Systems 2-21
Basic System Operation and Maintenance 2-23
Chapter 3 Transducer Safety and Maintenance 3-1

Transducer Power Safety Considerations 3-2
Observing Clinical Contraindications 3-2
Using Transducer Covers 3-2
Caring for Transducers 3-3
Using Ultrasound Coupling Gels 3-5
Precleaning 3-5
Disinfecting and Sterilizing Procedures 3-8
Transducer Decontamination Methods 3-13
Storing Transducers 3-13
Chapter 4 Intraoperative Transducers 4-1

Using Transducers for Intraoperative Applications 4-2
Complying with Safety Guidelines 4-2
Chapter 5 Transesophageal Transducers Safety Guidelines 5-1

0202 Safety Manual iii

Table of Contents
Clinical Contraindications 5-4

Preventing Transducer Tip Double-Over 5-6
Electrical Safety 5-8
Testing the Transducer Leakage Current 5-9
Chapter 6 Needle Guide Safety and Maintenance Guidelines 6-1

Following Basic Precautions 6-2
Needle Guide Kit 6-3
Assembling and Disassembling 6-4
Cleaning 6-4
Sterilizing 6-4
Endocavity Needle Guide Safety and Maintenance Guidelines 6-5
Chapter 7 System Measurement Accuracy 7-1

Measurements in Color Doppler 7-2
Accuracy of Caliper Measurements of Elapsed Time or Rate 7-3
Accuracy of Caliper Measurements of Distance 7-4
Accuracy of Caliper Measurements of Circumference 7-5
Accuracy of Caliper Measurements of Area 7-6
Accuracy of Angular Measurements 7-7
Chapter 8 ECG and Physiologic Module Safety Guidelines 8-1

Following ECG and Physiologic Module Safety Guidelines 8-2
Index Index-1
iv Acuson 0202
Preface
This manual provides important safety information for the

following Acuson systems:
• Acuson Sequoia® 512 Ultrasound system
• Acuson Sequoia® C256 Echocardiography system
• Acuson Aspen™ Ultrasound system
• Acuson 128XP® Ultrasound system
This manual explains safety considerations for all of the capabilities
available on all systems, including optional packages on the Acuson
ultrasound systems. Depending on your needs when you
purchased it, your system might not have all of these capabilities.
By providing optional features, Acuson allows you to customize or
expand your system to meet your future needs. If you would like to
purchase additional options, contact your Acuson Sales
Representative.
HOW TO USE THIS MANUAL

Before you use an Acuson system, read this manual to familiarize
yourself with safety precautions. After that, refer to this manual
whenever you have a question about ultrasound safety.
IMPORTANT: Read this manual carefully before you begin using the system.
WARNING! United States Federal Law restricts use of this device to or on the
order of a physician.
0202 Safety Manual v

Preface
OTHER RESOURCES
This manual is part of a set that also includes:
• Transducer Specifications Manual, which provides a list of
available transducers, power values, and approved disinfecting
and sterilizing solutions.
• User Manual, which explains how to use the system for typical
exams.
• Administrator Manual, which explains how to customize
features of your Acuson system and perform maintenance
tasks.
A Service Manual is also available for purchase from Acuson.
vi Acuson 0202
Contacting Acuson
CONTACTING ACUSON
For additional information, contact your nearest Acuson office.
U.S.A. England/Great Britain Japan

Acuson Corporation, U.S.A. Acuson Ltd., England Acuson Nippon, K.K.
Telephone: (650) 969-9112 Telephone: (44) (0)208 479 7950 Telephone: (81) 3-5800-3999
or (800) 4-ACUSON Fax: (44) (0) 208 479 7971 Fax: (81) 3-5800-3711
Fax: (650) 964-8331
Asia Pacific/Latin America European Headquarters Latin America

Acuson Asia Pacific/Latin U.K. Acuson Latin America, U.S.A.
America, U.S.A. Telephone: (44) (0)208 479 7950 Telephone: 1 (305) 596-3148
Telephone: (650) 969-9112 Fax: (44) (0) 208 479 7971 Fax: 1 (305) 596-3149
or (800) 4-ACUSON
Fax: (650) 965-9471
Australia Finland Norway

Acuson Pty. Ltd. Acuson OY Acuson AS
Telephone: (61) 2-9201-7777 Telephone: (358) 9-27092290 Telephone: (47) 67-58-02-00
Fax: (61) 2-9869-1600 Fax: (358) 9-27099299 Fax: (47) 67-58-15-30
Belgium France Russia

Acuson SA/NV Acuson S.A.R.L. Acuson Int’l Sales
Telephone: (32) 2-761-06-96 Telephone: (33) 1-6929-8110 Moscow, Russia
Fax: (32) 2-761-06-90 Fax: (33) 1-6446-9840 Telephone: (7) 095-937-7557
Fax: ((7) 095-937-7557
Canada Germany Singapore

Acuson Canada Ltd. Acuson GmbH Acuson Singapore Pte, Ltd.
Telephone: 1 (416) 296-1634 Telephone: (49) 911-25-22-90 Telephone: (65) 560-9806
Fax: 1 (416) 296-1259 Fax: (49) 911-25-22-9-22 Fax: (65) 569-7338
Denmark Hong Kong Sweden

Acuson AS Acuson Hong Kong, Ltd. Acuson AB
Telephone: (45) 39179991 Telephone: (852) 2574-7989 Telephone: (46) 8-594-40660
Fax: (45) 40300796 Fax: (852) 2574-6945 Fax: (46) 8-594-40675
Italy Spain
Acuson S.p.A. Acuson Iberica S.A.
Telephone: (39) 2-982-591 Telephone: (34) 1-327-1755
Fax: (39) 2-982-41107 Fax: (34) 1-372-1478
0202 Safety Manual vii

Preface
viii Acuson 0202

CHAPTER 1
System Components
Sequoia 512 Ultrasound System Components 1-2

Sequoia C256 Echocardiography System Components 1-3
Aspen System Components 1-4
128XP System Components 1-5
0202 Safety Manual 1-1

Chapter 1 - System Components
S E Q U O I A 5 12 U L T R A S O U N D S Y S T E M C O M P O N E N T S
Figure 1-1 shows a full view of the basic Acuson Sequoia 512
Ultrasound system. Your system may also have additional optional
equipment.
Magneto-Optical
Soft Keys Disk Drive
Power Switch
Keyboard
Transducer Cable
Holder
MP
Transducer
and Storage
Ports
Brake/Steering
Controller
Foot Switch
Connector
Figure 1-1 Acuson Sequoia 512 Ultrasound System
1-2 Acuson 0202

Sequoia C256 Echocardiography System Components
S E Q U O I A C 2 56 E C H O C A R D I O G R A P H Y S Y S T E M C O M P O N E N T S
Figure 1-2 shows a full view of the basic Acuson Sequoia C256
Echocardiography system. Your system may also have additional
optional equipment.
Soft Keys
Power Switch
Magneto-Optica
Transducer Holders
Disk Drive
Keyboard
ECG and
Physiological Transducer
Modules Cable Holder
MP Transducer
and Storage
Ports
Brake/Steering
Controller
Foot Switch
Connector
Figure 1-2 Acuson Sequoia C256 Echocardiography System

ASPEN SYSTEM COMPONENTS

Figure 1-3 shows the basic Aspen system components. Your system
may also have additional optional equipment.
Soft Keys
Power Switch
Magneto-Optical
Disk Drive
Transducer Holders
ECG and Physiologic

Modules
Cable Holder
Headphone Connector
Aux CW Transducer P
DL Transducer
MP Transducer Port
Foot Switch Connecto

Wheel Lock
Figure 1-3 Aspen System Components
1-4 Acuson 0202

128XP System Components
12 8X P S Y S T E M C O M P O N E N T S
Figure 1-4 shows the basic 128XP system components. Your system
may also have additional optional equipment.
Aux CW
Transducer Port Transducer
Headphone Storage Shelf
Connector
Pull-out
Transducer
Holder
Transducer
Transducer DL Cable Hook
Port
ECG and
Physiologic
Modules
Wheel Lock
Power Switch Foot Switch

Connector
Figure 1-4 Acuson 128XP System Components

1-6 Acuson 0202

CHAPTER 2
Basic Safety Precautions

Protecting Patients 2-3
Reviewing System Requirements 2-4
Environmental Requirements 2-4
Electrical Requirements 2-5
Electrical Safety Requirements 2-6
Instrument Input Power Rating 2-7
Using Input and Output Connectors 2-11
Using Sequoia Input and Output Connectors 2-11
Using Aspen Input and Output Connectors 2-15
Using 128XP Input and Output Connectors 2-18
Interpreting Symbols on the Systems 2-21
Basic System Operation and Maintenance 2-23
Turning the Systems On and Off 2-23
Moving the System 2-26
Cleaning the System 2-26
Adjusting VCR Signal Output 2-30

Chapter 2 - Basic Safety Precautions
This chapter contains important information about electrical safety,

system maintenance, and sterilization procedures.
BASIC PRECAUTIONS
• Do not install the system yourself. An Acuson Customer
Engineer or an authorized Acuson agent must perform the
initial installation. INSTALLING THE SYSTEM YOURSELF
WILL VOID YOUR WARRANTY.
• ALWAYS power the system from a grounded outlet. Ground
integrity of the outlet and system should be checked
periodically.
• Have the system serviced and have regular preventive
maintenance performed by authorized Acuson Customer
Engineers. For additional service information, see “Contacting
Acuson” on page vii.
• Do not operate the Acuson system in the presence of flammable
anesthetics. Such an environment presents the risk of explosion.
• Do not remove any covers or panels from the Acuson system—
doing so may present a risk of electrical shock. There are no
user-serviceable parts.
• Always turn off the system before cleaning and sanitizing the
unit.
• Keep the system clean. Carefully follow procedures described
later in this chapter for cleaning the system, transducers, and
air filters at regular intervals.
• Never allow water or other liquids to drip into the interior of
the cabinet or onto the keyboard.
• Always handle transducers with care. Dropping the transducer
or allowing it to strike a hard surface can damage the
transducer elements and the acoustic lens. Such a collision can
also crack the transducer housing and destroy its electrical
safety features.
• Always maintain an appropriate amount of ultrasound gel on
the transducer active face to ensure adequate ultrasound
transmission throughout the exam.
• Between exams, always put the system in a stand-by mode
(with a frozen display) or disconnect the transducer from the
system. Always put the system in a stand-by mode when the
transducer is not in contact with the patient.
• Service manuals are available for purchase by Acuson system
owners. Please consult your local Acuson Service
Representative or call 1-800-9-ACUSON or (650) 969-9112.
• Follow local governing ordinances and recycling plans
regarding disposal or recycling of device components.
2-2 Acuson 0202

Protecting Patients
PROTECTING PATIENTS
◆ To protect patients:
• Always expose patients to the lowest practical transmit power
levels that provide clinically useful information. The Acuson’s
Output Display system and the United States Food and Drug
Administration (FDA) standards are based on the principle of
using output levels As Low As Reasonably Achievable
(ALARA).
• Properly clean transducers prior to each exam. For more
information, see Chapter 3.
WARNING! Do not use transducers that may have been exposed to Creutzfeld
Jacob disease, because liquid sterilants and disinfectants cannot
assure removal of this contamination. Contact the Acuson Help
Desk before destroying these transducers.
• Identify latex-sensitive patients and be prepared to treat allergic

reactions promptly. For more information on observing the
FDA warnings for latex products, see Chapter 3.
WARNING! Always freeze the system when not imaging to prevent the
transducer from overheating.

REVIEWING SYSTEM REQUIREMENTS

This section describes specific environmental and electrical
characteristics that determine your system’s facility requirements. If
you have additional questions, contact your Acuson Customer
Engineer.
Environmental The system’s environment should be free of fumes, dirt, and

Requirements electrical interference (for example, brush-type motors and large
fields of RF energy). The system’s dimensions and operating limits
are as follows:
Table 2-1 Environmental Requirements

Factor Sequoia 512 Sequoia C256 Aspen 128XP
Temperature 15° to 33°C, 15° to 33°C, 15° to 33°C, 15° to 33°C,
59° to 90°F 59° to 90°F 59° to 90°F 59° to 90°F
Relative Humidity up to 90% up to 90% up to 90% up to 90%
noncondensing noncondensing noncondensing noncondensing
Heat Dissipation 5,000 BTU 5,000 BTU 5,000 BTU 5,000 BTU
per hour per hour per hour per hour
Height with monitor 133 cm (53 in.) 133 cm (53 in.) N/A N/A
and keyboard in the
lowest position
Height with monitor 148 cm (58 in.) 148 cm (58 in.) 135.64 cm (53.4in.) 129.50 cm (51in.)
and keyboard in fully
extended position
Depth 123 cm (48 in.) 123 cm (48 in.) 116.80 cm 90.20 cm (35.5 in.)
(46.0 in.)
Width 66 cm (26 in.) 66 cm (26 in.) 62.9 cm (24.8 in.) 63.50 (25 in.)
Weight 184 kg (406 lbs.) 183 kg (402 lbs.) 217 kg (477 lbs.) 229 kg (504 lbs.)
To provide adequate cooling, maintain the following clearances

when the system is in use:
Left side Right side Rear

128XP 15 cm (6 in) 15 cm (6 in) 30 cm (12 in)
Aspen 15 cm (6 in) 15 cm (6 in) 30 cm (12 in)
Sequoia 512 15 cm (6 in) 15 cm (6 in) 15 cm (6 in)
Sequoia C256 15 cm (6 in) 15 cm (6 in) 15 cm (6 in)
When transporting or storing your Acuson system, do not expose it

to direct sunlight, damp locations, dusty environments, or
temperatures outside the range of -40° C to 70°C (-40°F to 158°F).
Keep the system upright during transport or storage. The Acuson
system should not be transported or stored in any position other
than on its four wheels.
2-4 Acuson 0202

Reviewing System Requirements
Electrical Acuson produces systems that operate with AC line voltages of

Requirements 100V, 115V, 220V, 230V, and 240V. The nameplate on the back of the
system indicates the AC power required for your system. 100V and
115V systems usually require 15A service; however, certain
equipment options may require 20A service. These systems are
equipped with 20A attachment plugs. Units configured for 220,
230V, or 240V generally require 10A service.
For optimal system performance, use a dedicated, interference-free,
isolated, grounded wall outlet. 100V and 115V Acuson systems are
equipped with a hospital-grade attachment plug. To ensure
grounding reliability, connect it only to an equivalent
hospital-grade socket.
WARNING! Before having your system installed by an Acuson Customer

Engineer, ensure that the electrical service in your facility is
adequate. Do not modify the attachment plug or use an adapter—
doing so may overload your building’s power circuits. Using an
extension cord to provide power may cause your system to exceed
leakage current limits.

Electrical Safety The Acuson™ ultrasound systems are classified in accordance with
Requirements the IEC 601-1, the standard for Medical Electrical Equipment as
follows:
Table 2-2 Electrical Safety

Standard Sequoia 512 Aspen 128XP
and C256 IEC 601-1 IEC 601-1
IEC 601-1
Type of protection against electric shock Class I Class I Class I
Degree of protection against electric shock Type BF Type BF Type BF
Degree of protection against ingress of water Ordinary Ordinary Ordinary
WARNING! Accessory equipment connected to the analog and digital

interfaces must be certified according to the respective IEC
standards (IEC 950 for data processing equipment and IEC 601-1
for medical equipment). Furthermore, all configurations shall
comply with the system standard IEC 601-1-1. Any party who
connects additional equipment to the signal input part or signal
output part is considered to be configuring a medical system, and
is therefore responsible for ensuring that the system complies with
the requirements of the system standard IEC 601-1-1. If you have
additional questions, contact your Acuson Customer Engineer.
This equipment has been tested and found to comply with the
limits for medical devices IEC 601-1-2:1993 (EN60601-1-2:1994) or
the Electromagnetic Compatibility Directive 89/336/EEC. These
limits are designed to provide reasonable protection against
harmful interference in a typical medical installation. This
equipment generates, uses, and can radiate radio frequency
energy and, if not installed and used in accordance with the
instructions, may cause harmful interference to other devices in
the vicinity. However, there is no guarantee that interference will
not occur in a particular installation. If this equipment does cause
harmful interference to other devices, which can be determined by
turning the equipment off and on, the user is encouraged to try to
correct the interference by one or more of the following measures:
• Reorient or relocate the receiving device.
• Increase the separation between the equipment.
• Connect the equipment to an outlet on a circuit different from
that to which the other device(s) are connected.
• Consult the manufacturer or field service technician for help.
2-6 Acuson 0202

Instrument Input The instrument input power rating has been established to clarify
Power Rating the maximum power requirement of your system with all
accessories. Depending upon the accessories and options installed,
your system may not draw the full amount of power listed on the
serial plate. Table 2-3 shows typical input power values for various
Acuson system input voltages.
Table 2-3 Input Power Values for Sequoia Systems

System Voltage, Nominal System Power Usage, Acuson System Power Isolated Accessory
VAC VA, including isolated Usage, VA Power Available, VA
accessory power
115-V (U.S.) 1500-VA Continuous 1250-VA 250-VA Continuous
1725 Intermittent a 1250-VA 400-VA Intermittent
115-V (Canada) 1500-VA 1250-VA 250-VA
100-V (Japan) 1500-VA 1250-VA 250-VA
220/230-V 1650-VA 1250-VA 400-VA
a. Requires a dedicated outlet for 15-A service. Some options require 20A service. User must
ensure adequate power is available.
Table 2-4 Input Power Values for Aspen Systems

System Voltage, Nominal System Power Usage, VA, Isolated Accessory Power Available, VA
VAC including isolated accessory power
115V (U.S.) 1400VA 250VA Continuous
1600VAa 400VA Intermittent
115V (Canada) 1500VA 350VA
100V (Japan) 1400VA 165VA
230V 1600VA 400VA
Table 2-5 Input Power Values for 128XP Systems

System Voltage, Nominal System Power Usage, Acuson System Power Isolated Accessory
VAC VA, including isolated Usage, VA Power Available, VA
accessory power
115 V (U.S.) 1500 Continuous 1250-VA 250-VA Continuous
1725 Intermittenta 1250-VA 475-VA Intermittent
115 V (Canada) 1500 VA 1250-VA 250-VA
100 V (Japan) 1800 VA 1250-VA 550-VA
220/240 V 2200 VA 1250-VA 700-VA

Isolated Accessory Acuson systems have isolated accessory receptacles to provide

Outlets power to accessories. The system AUX ON/OFF standby switch
controls power to these outlets. They are isolated to protect against
chassis leakage currents from connected accessories. Plug only
approved accessories into these outlets. The isolated accessory
receptacles are located as follows:
• On the Sequoia 512 and C256 systems, there are a total of four
isolated outlets to provide power to accessories. These outlets
are located on the rear of the systems, inside the rear door.
• On Aspen systems, there are a total of four outlets located on
the rear of the system.
• On 128XP systems, there are a total of six outlets. Two are
located behind the lower cart air filter. Four additional outlets
are located on the lower back panel of the system.
WARNING! The total power available is indicated near the outlets and listed in
Table 2-3. DO NOT overload these outlets as overloading can trip
the system’s or the building’s circuit breakers. Failure to use
isolated outlets for accessories can degrade image quality and
compromise patient safety.
Leakage Current Limits Isolated accessory outlets let you connect approved accessories
without increasing the system’s leakage current. Connecting
accessories powered from nonisolated sources may cause chassis
leakage currents to exceed safe levels.
WARNING! Plug only the proper connectors in the system input and output
connector sockets. Failure to do so can damage the system and
destroy its electrical safety features. For a complete description,
see “Using Input and Output Connectors” on page 2-11.
Leakage Current with Domestic Systems (115V)

Acuson transducers have been evaluated and comply with the
requirements for an Ordinary Patient Connection, as specified in
Underwriters Laboratories’ Standard for Medical and Dental
Equipment, UL 544, when operated with domestic (115V) Aspen™
ultrasound systems. The leakage current on Acuson transducers
will not exceed 50µA.
Leakage Current with International Systems (220/240V)
Acuson transducers meet the International Electrotechnical
Committee Standard for Medical Electrical Equipment, IEC 601, for
Type BF equipment, when operated with international (220/240V)
Aspen systems. The leakage current on Acuson transducers will not
exceed 100µA under loss-of-ground condition, and will not exceed
500µA under single-fault condition with mains voltage applied to
the transducer.
2-8 Acuson 0202

System Circuit Breakers The Acuson systems have two circuit breakers on the rear of the
system. The circuit breakers provide the following protection:
Mains input breaker: This breaker disconnects all parts of the
system from both sides of the mains. It also serves as the mains
disconnecting switch. Note that a portion of the system is energized
whenever the mains input breaker is on.
Isolated accessory outlet breaker (Aux): This breaker protects the
isolated accessory outlets from physical damage due to
overloading.
Isolated
Accessory
Outlets
Aux Breaker
Mains Breaker
Figure 2-1 Sequoia System Circuit Breakers on Rear Panel

Mains Breaker
Aux Breaker
Isolated Accessory
Outlets
Figure 2-2 Aspen System Circuit Breakers on Rear Panel
Aux Breaker
Mains Breaker
Isolated Accessory
Outlets
Figure 2-3 128XP System Circuit Breakers on Rear Panel
2-10 Acuson 0202

Using Input and Output Connectors
USING INPUT AND OUTPUT CONNECTORS
Using Sequoia Input Input and output connectors are located on the front, back, and side
and Output of the system. Figure 2-4 shows the rear door for access to the rear
Connectors panel connectors of the Acuson Sequoia 512 and Sequoia C256
systems. Figure 2-5 shows the rear panel of the Acuson Sequoia 512
and Sequoia C256 systems. Table 2-6 describes the rear panel input
and output connectors.
Figure 2-6 shows the Sequoia 512 and Sequoia C256 systems front
panel. Table 2-7 describes the front panel input and output
connectors.
Figure 2-7 shows the Sequoia 512 and Sequoia C256 systems side
panel. Table 2-8 describes the side panel input and output
connectors. Table 2-9 describes the headphone and microphone
connectors.
WARNING! Interconnection with other equipment may cause chassis leakage

currents to exceed safe levels. For further information, contact your
Acuson Customer Engineer.
Figure 2-4 Sequoia 512 and Sequoia C256 System Rear Door

Figure 2-5 Sequoia Systems Rear Panel Connectors
Table 2-6 Sequoia Systems Rear Panel Input and Output Connectors
Connector Description Interface Connector Input/Output Maximum
Label Name Standard Type Voltage
Computer Progressive RGB MAC II Dsub-15p Output 5V
Video Out
RGB In Interlaced RGB MAC II Dsub-15p Input 5V
RGB Out Interlaced RGB MAC II Dsub-15p Output 5V
RGB Imager Interlaced RGB Serial Proprietary Dsub-37p Input/Output +/- 12V
Port
BetaCam Interlaced YUV Proprietary Dsub-25p Input/Output +/- 12V
(for Acuson use Stereo (Line Level)
only) Serial Port
S-VHS Interlaced Y/C Stereo Proprietary Dsub-25p Input/Output +/- 12V
(Line Level)
Serial Port
B/W Out Interlaced Y(B/W) BNC BNC Output 1Vpp
Color Out Interlaced Y+C BNC BNC Output 1Vpp
B/W Img Out Interlaced Y (B/W) BNC BNC Output 1Vpp
Rmt Exp TTL (B/W Imager) BNC BNC Output 5V
PX Clk TTL (B/W Imager) BNC BNC Output 5V
Aux/0 RS232 RS232 Serial Port 8 wire RS232 Dsub-25p Input/Output +/- 12V
Aux/1 RS232 RS232 Serial Port 8 wire RS232 Dsub-25p Input/Output +/- 12V
Parallel Printer Printer Port Centronix Dsub-25p Input/Output 5V
Ethernet 10BaseT 10BaseT RJ45 Input/Output 5Vpp
2-12 Acuson 0202

Figure 2-6 Sequoia Systems Transducer Ports
Table 2-7 Sequoia Systems Front Panel Input and Output Connectors
Connector Description Interface Connector Input/Output Maximum
Label Name Standard Type Voltage
MP Transducer Plug in transducers MP proprietary Input/Output Use only

ports Acuson
transducers
Foot Switcha Connection for foot proprietary 6-pin Jones Input/Output 5V
switch
AUX CW Auxiliary CW proprietary 10-pin circular Input/Output Use only
transducer Acuson
transducers
a. For location of foot switch connector, see Figure 1-1or Figure 1-2.

Figure 2-7 Sequoia Systems DC and Patient Connections Side

Panels
Table 2-8 Sequoia Systems Side Panel Input and Output Connectors
Connector Label Description Interface Connector Input/Output Maximum
Name Standard Type Voltage
Non-isolated
Inputs
• DC A-D For Line-Level physio none 1/4” phone Input/Output +/- 5V
signals
Isolated Inputs
• ECG 3-lead ECG AAMI-ECGC-5/83 ECGC Input/Output +/- .05V
• Heartsound Phonocardiogram none 4-pin Redel Input +/- 5V
Microphone
• Pulse Respiration none 4-pin Redel Input +/- 5V
Thermistor
• Respiration External Pulse none 6-pin Redel Input +/- 5V
Transducer
Table 2-9 Sequoia Systems Headphone and Microphone Connectors

Connector Label Description Interface Connector Input/Output Maximum
Name Standard Type Voltage
Headphone Audio output for use none Stereo phone Output 1Vpp
with headphones jack
Microphone Connection for none Mon. phone Input 5Vpp
external microphone jack
2-14 Acuson 0202

Using Aspen Input Input and output connectors are located on the front and back of the
and Output Aspen system. Figure 2-8 and Table 2-10 show the connectors on the
Connectors front panel. Figure 2-9 and Table 2-11 show the connectors on the
rear panel.
Physio Module
ECG Module
Headphone
Connector
MP Connector
DL Connectors
Inactive Transducer
Storage Ports
Aux CW
Connector
Figure 2-8 Aspen System Front Panel Connectors
Table 2-10 Aspen System Front Panel Input and Output Connectors
Connector Input/Output Description Connector Type
DL transducer connector Input/Output Plug in Acuson DL Acuson DL connector
transducers custom design
MP Transducer connector Input/Output Plug in Acuson MP Acuson MP connector
transducers custom design
Aux CW Connector Input/Output Auxiliary CW Transducer 10-pin Circular
Phono Input Phonocardiogram 1/4” phone
Microphone
Pulse Input External Pulse Transducer 1/4” phone
Respiration Input Respiration Thermistor 1/4” phone
Auxiliary input Input/Output N/A 1/4” phone
ECG Connector Input/Output 3-lead ECG ECGC
Foot Switcha Input/Output Connection for Foot Switch 6-pin Jones
Headphone jack Output Audio output for use with Stereo phone
headphones
a. For location of foot switch connector, see Figure 1-3.

ENG/MFG Support
J13 1
Parallel Printer
J14 2
External SCSI
J15 3
10Base-T
J17 4
RJ-45
Error
Display
10Base-T
LEDS
External Ethernet
5
AVI J19
Aux Serial Port B/C
6
J20
Future Use
7
J21
VCR
8
J22
Betacam
9
J23
Aux RGB In
10
J24
Aux RGB Out
11
J25
RGB Color Camera
12
J26
Y-C Y-C
Out in
J27 J28
13 14
J29 J30 J31

Color Pixel External
Video Clock Trigger
15 16 17
J32
Remote J33 J34
Expose Cam Video B/W Video
18 19 20
Figure 2-9 Aspen System Rear Panel Connectors
2-16 Acuson 0202

Table 2-11 Aspen System Rear Panel Input and Output Connectors
Parallel Printer Output Printer interface 25 pt D sub
External SCSI Input/Output External SCSI interface 50 pt, SCSI 2 type
10BASE-T Input/Output For future use RJ-45
External Ethernet AUI Input/Output For future use 15 pt D sub
Aux Serial Port B/C Input/Output RS232 ports 26 pt D sub, High Density
VCR Input/Output Connect to VCR 25 pt D sub
±2 V maximum on video input
Aux RGB In Input External RGB video in 15 pt D sub
±2V max. on input
RGB Aux Output RGB video aux output 15 pt D sub
RGB Imager Input/Output Connect to RGB Imager 25 pt D sub
Y/C Out Output Y/C video aux output 4 pt Mini Din
Y/C In Input Y/C video aux input 4 pt Mini Din
Color Video Output Connect to video input of color BNC X6
camera
Pixel Clock Output Digital pixel clock output BNC X6
External Trigger Output Aux digital output for trigger of an BNC X6
external device
Cam Expose Control Output Digital output for camera expose BNC X6
control
Cam Video Output Connect to video input of BNC X6
black-and-white multi-image
camera; 75¾, 2V maximum
B/W Video Output Connect to video input of optional BNC X6
black-and-white multi-image
camera

currents to exceed safe levels. Refer to the accessory operator’s
manual before connecting accessory equipment.

Using 128XP Input Input and output connectors are located on the front, back, and side
and Output of the system. Figure 2-10 and Figure 2-11 shows the connectors on
Connectors the rear panel of Acuson systems. Figure 1-4 on page 1-5 shows the
connectors on the front panel. Table 2-12 describes the input and
output connectors.
WARNING! Accessory equipment connected to the analog and digital interfaces

must be certified according to the respective IEC standards (IEC 950 for
data processing equipment and IEC 601--1 for medical equipment).
Furthermore, all configurations shall comply with the system standard
IEC 601-1-1. Anyone who connects additional equipment to the signal
input part or signal output part configures a medical system, and is
therefore responsible for ensuring that the system complies with the
requirements of the system standard IEC 601-1-1. If in doubt, consult
the technical service department or your local representative.
Acuson 128XP black and white systems
Acuson 128XP color systems
Acuson 128XP/4 systems
Figure 2-10 Acuson 128XP Rear-panel Connectors
2-18 Acuson 0202

Camera Video Aux

Exposure Exposure Video Out VCR SCR
Printer
Acuson 128/5 and 128/10 black and white systems
CAM CAM C C AUX1 VCR A AUDIO COMPONENT COLOR CAMERA

EXP VID AUX1 AUX2 REMOTE VIDEO
AUX RGB PRINTER
Acuson 128/5 and 128/10 color systems
Figure 2-11 Acuson 128/5 and 128/10 Rear-panel Connectors

currents to exceed safe levels. Refer to operator’s manual before
connecting accessory equipment.

Table 2-12 Acuson 128XP Input and Output Connectors

Aux CW Input/Output Plug in an Aux CW transducer 10-pin circular
Aux video out Output Plug into an extra monitor or VCR; BNC female jack
(3 connectors) 75Ω
Camera exposure Output Connect to remote expose input of BNC female jack
optional black-and-white multi-image
camera
Camera video Output Connect to video input of optional BNC female jack
black-and-white multi-image camera;
75Ω, 2V max.
DL transducer Input/Output Plug in Acuson transducer DL
connector
MP transducer Input/Output Plug in Acuson V5M transducer MP
connector (only available on systems with V5M
support)
Foot Switcha Input Plug for Acuson foot switch 6-pin Jones
Headphone Output Audio output for use with Stereo phone jack 1/4”
headphones
Printer Output Connect only to a computer printer DB25
(character printer)
SCR Output Signal and control output to Strip D8C8
Chart Recorder
VCR Input/Output Connect to VCR. Includes Video In, Subminiature D
Video Out, Audio In, Audio Out, coaxial,
Record Remote, and Playback 24C7 pin
Remote. ±2 V maximum on input
VCR Input/Output Available only on systems with the DB25
VCR Control Option.
Connect to Acuson VCR Controller.
Connect VCR Controller to VCR.
AEGIS® Input/Output Available only on systems with DB25
AEGIS capabilities
Ethernet Input/Output Available only on systems with Phone jack
AEGIS networking capabilities
Phono Input Phonocardiogram Microphone 1/4” phone
Pulse Input External Pulse Transducer 1/4” phone
Respiration Input Respiration Thermistor 1/4” phone
Auxiliary input Input/Output Preconditioned ECG trace or other 1/4” phone
physiologic DC Input
a. For location of foot switch connector, see Figure 1-4
2-20 Acuson 0202

Interpreting Symbols on the Systems
INTERPRETING SYMBOLS ON THE SYSTEMS

Symbols used on Acuson systems are shown and described in
Table 2-13.
Table 2-13 System Symbols

Symbol Location Meaning
On the serial plate that indicates the serial Alternating current
number and electrical rating
On inputs and physiologic transducers Patient applied part meets the isolation
requirements for type BF equipment
On the back panel by the mains breaker Power on (connected to mains when
switch is flipped towards this symbol)
On the back panel by the mains breaker Power off (disconnected from mains
when switch is flipped towards this
symbol)
On the back panel by the isolated Power on to the accessory breaker
accessory breaker
On the back panel by the isolated Power off to the accessory breaker
accessory breaker
On the warning/caution labels Attention: Consult accompanying

documents
On the warning/caution labels Caution: Dangerous Voltages. Do not

(rear of system) remove cover or back. Refer servicing to
qualified service personnel.
Lower rear of system adjacent to Auxiliary grounding terminal

grounding terminal
On some transducers Do not immerse transducer. For cleaning

IPX0 instructions, see Chapter 3.
On some transducers Patient applied part meets the isolation

requirements for type CF equipment
Button on front of system System on/off/standby

Table 2-13 System Symbols (Continued)

Symbol Location Meaning
Adjacent to microphone connector Microphone input
Adjacent to headphone connector on Headphone output

the side panel
Adjacent to the monitor Monitor controls

(Brightness/Contrast/Degauss)
By rotary controls on front panels To increase turn clockwise; to decrease

or
turn counterclockwise
On the foot pedal Two wheel pivot position
On the foot pedal Four wheel pivot position
On the foot pedal Front wheels locked position
Adjacent to foot switch connector Foot switch
On front of monitor volume knob Increase volume
On front of monitor volume knob Decrease volume
On keyboard labels next to function knobs Turn clockwise to increase and

counterclockwise to decrease value
On keyboard labels next to function knobs Push to select function
2-22 Acuson 0202

Basic System Operation and Maintenance
BASIC SYSTEM OPERATION AND MAINTENANCE
Turning the Systems

On and Off
Sequoia Systems Power The Sequoia systems power switch is located at the left side of the
Button system above the keyboard. Figure 2-12 shows the location of the
system power switch.
System
Power Switch
Figure 2-12 Sequoia 512 and Sequoia C256 System Power

Switch
Aspen System Switch The Aspen system power switch is located at the top left corner of
Location the system, above the keyboard. Figure 2-13 shows the location of
the power switch.
Power Switch
RESET Button TEST Button

Under Keyboard Under Keyboard
(Recessed) (For CE/FAS use only)
Figure 2-13 ASPEN POWER, RESET, and TEST Switch Locations

128XP System Power The system power switch is located at the lower left corner of the
Switch Location system. When the power is on, the green indicator is lit. Figure 2-14
shows the location of the power switch.
C O M P U
T E D S O N O G
R A P H Y
Reset Button
(behind door)
Test Button
(For CE/FAS use only)
ID
POWER
PUSH OPEN CONTRAS
T EMPTY
BASE
1 2 3 4 5 ID
6 C RECORD
7 8 9 0 ER B
TV
25 50 100 mm/s
POWER
Power Switch
Turning On the System Figure 2-14 128XP System On/Off Button

◆ To turn the power on for an Aspen or Sequoia system, push the
power switch. For the 128XP system, toggle the power switch.
When powering up the system, remember:
• Do not flip the switch in the back of the system because it is a
circuit breaker and will interrupt the power up sequence.
• Do not power up the system immediately after it has been
powered down. Wait at least 3 seconds.
When you turn on the system, it runs Power On Diagnostics to
make sure that all parts are working correctly. If the system detects
a problem, it displays an error message.
For assistance, note the error message and call the number
displayed or the Acuson Customer Service Center number listed in
“Contacting Acuson” on page vii. A Customer Engineer will tell
you how to proceed.
Turning Off the System ◆ To turn the power off for an Aspen or Sequoia system, push the
power switch. For the 128XP system, toggle the power switch.
WARNING! Do not unplug the system from the power source or outlet until the
system has completely powered down (when the screen becomes
completely dark).
2-24 Acuson 0202

When powering down the system, remember:

• Always end the current exam before pressing the power switch.
• When the monitor has turned off and the keyboard
downlighting has turned off, the power cord can safely be
removed from the wall.
Do not unplug the system or flip the circuit breakers to turn off the
machine. Aspen and Sequoia systems go through a power down
sequence when shutting off; this allows the current exam to be
written to internal hard disks and/or magneto-optical disks.
Interrupting the sequence can damage the system files on the
internal hard disk, causing the loss of stored exams and potentially
leading to additional problems on the next power up, i.e., failure to
power up, longer power up times, or problems with using the on-
board AEGIS.
WARNING! Failure to follow these instructions can lead to patient data loss
and prolonged power up times. Improper power down can
damage the hard disk drive.
If the hard disk needs to be repaired by the system after premature

power interruption, all AEGIS™ system image capture and review
capabilities are inaccessible to the user until the hard disk drive
completes its repairs.
The system will also power off if one or more of the following
occurs:
• AC input power is lost.
• The Main Power supply detects a fault.
• The main circuit breaker opens.
• System temperature exceeds 65°C.
Restarting the System ◆ To restart the system without powering off, press RESET,
located below the keyboard.
The system runs the Power On Diagnostics and restarts using the
standard settings.
Disconnecting from ◆ To completely disconnect the system from its power source
Power Source (for example, to move it to another location):
1 Push the power switch and wait until the system powers down.
IMPORTANT: When you turn off the system, it writes images in the current exam
to the hard disk and/or magneto-optical disk. Be sure not to
disconnect the system from the power source until you see a
message indicating that this process is complete.
2 Turn off the Mains breaker on the back of the system. See “System
Circuit Breakers” on page 2-9.
3 Remove the power plug from the wall receptacle

Moving the System When you move the system, do so carefully. Be especially careful
when moving it along inclined passages.
Observe the following precautions before moving the system:
• Eject the magneto-optical (MO) disk from the disk drive.
WARNING! You must end your current study BEFORE ejecting the MO disk.
You must eject the MO disk BEFORE moving the system.
• Turn the system off and disconnect the power cord and any
other cords. Store the power cord on the handle on the back of
the system.
• Clamp transducer connectors in the inactive transducer ports
and store transducers in the holders on either side of the
system.
• Make sure that transducer cables are away from the wheels.
Place transducer cables behind the cable hook.
• Make sure the monitor is in the locked position.
• Make sure peripherals are strapped securely in place.
• Make sure the wheels are in the unlocked position. Once you
reach your destination, lock the wheels.
• Use the front handle grips to move the system.
• DO NOT allow the system to strike walls or door frames.
• Use care when moving the system off ramps, curbs, or
elevators. Jarring the system by sudden drops can cause
structural damage to the frame of the system.
Cleaning the System The Acuson system requires proper care and cleaning. IMPROPER
SYSTEM CARE WILL VOID YOUR WARRANTY. System care
includes inspecting and cleaning air filters weekly, cleaning and
sanitizing the cabinet, and inspecting the keyboard lights.
Cleaning and Sanitizing ◆ To clean or sanitize the system:

the System
1 Turn the system off and unplug it from the power outlet.
2 Clean the system cabinet, transducer holders, and storage bay with
a damp cloth soaked in mild soap and water, or sanitize them using
isopropyl alcohol or a sanitizing solution.
DO NOT drip any liquid into the system or onto the keyboard.
2-26 Acuson 0202

Cleaning Sequoia Air The Acuson Sequoia 512 and Sequoia C256 systems have two user-
Filters serviceable air filters. The air filters are located on the upper right
and left sides of the system as illustrated in Figure 2-15.
Remove, inspect and clean the air filters each week.
◆ To remove and clean the air filters:
2 Use the tab on each filter to slide it out and remove it.
3 Wash the filters in water with mild detergent and dry them, or clean
them with a hand-held vacuum cleaner.
4 Replace the filters.
Figure 2-15 Sequoia 512 and Sequoia C256 System Air Filters
Cleaning Aspen Air The Aspen system has three air filters. Two air filters are located on
Filters the rear of the system, in the upper right side and upper left side.
An additional air filter is located on the front left side of the system.
Figure 2-16 illustrates the location of the three air filters.
Remove, inspect, and clean the air filters each week.
2 Remove the air filters located at the rear of the system, by using the
tab at the end of each filter to slide it out.
3 Remove the air filter located on the front left side of the system, by
pulling the air filter cover plate open and removing the filter.

Slide the upper air filters out to Pull down and out to remove the side
remove them and in to replace filter cover plate, and then remove
them. the filter. To replace, snap the filter
and cover plate back into place.
Figure 2-16 Aspen Systems Air Filters
Cleaning 128XP Air The Acuson 128XP system has two air filters. The upper air filter is
Filters located on the right side of the system and the lower filter is located
at the back of the system as shown in Figure 2-17.
2 Remove the upper air filter stand behind the system. The filter is
now on the left side. Loosen and remove the two captive thumb
screws that hold the filter cover plate. Remove the cover plate and
use the tab on the filter to slide it out. There is not a filter on the
back right side.
3 To remove the lower air filters, loosen and remove the four captive
thumb screws that hold the lower filter cover plate. Remove the
filter. Remove only the four captive thumb screws, not the other
screws.
WARNING! Do not replace the filters until they are completely dry.
2-28 Acuson 0202

Upper Air Filter

Captive Thumb
Screws
Captive Thumb
Lower Air Filter
Screws
Figure 2-17 Acuson 128XP System Air Filters
Cleaning Acuson The Acuson 128XP/5 and 128XP/10 systems have three air filters
128XP/5 and 128XP/10 located at the back of the system and one filter located on the side of
Air Filters the system. The upper air filter is located on the upper right side of
the system, the middle filter is located at the back of the system, the
lower filter is located on the lower tray of the system, and the side
air filter is located under the side lip, as shown in Figure 2-4.
2 To remove the upper air filter stand behind the system. The filter is
now on the left side. Loosen and remove the four thumb screws that
hold the filter cover plate. Remove the cover plate and take out the
filter. There is not a filter on the back left side.
3 To remove the middle air filter, grasp one edge of the filter and pull
it from the cabinet, breaking the velcro seal.
4 To remove the lower filter, loosen and remove the two thumb
screws that hold the metal mesh filter in place. Then remove the
filter.

5 To remove the side air filter, pull it from the cabinet, breaking the
velcro seal.
6 Wash the filters in a mild soapy solution and dry them or clean
Upper Air Filter
Side Air Filter
Middle Air Filter
Lower Air Filter
Figure 2-18 Acuson 128/5 and 128/10 System Air Filters
Adjusting VCR You can adjust the system’s VCR signal output level.
Signal Output
WARNING! The adjustment of the video output level affects the video signal
that goes to the system monitor AND to all of the video outputs on
the back panel. For example, adjusting the video output level
affects the dynamic range, available gray scale levels, and B-color
representation. Consult your Acuson Customer Engineer before
adjusting the video output levels.
• On a Sequoia system, press SETUP and select VCR/Ext-Video.

• On an Aspen system, press SETUP and select Misc Setup: VCR
Signal Output Control.
• On a 128XP system, press CODE + SETUP and select VIDEO
SIGNAL OUTPUT CONTROL.
2-30 Acuson 0202

CHAPTER 3
Transducer Safety and Maintenance
Transducer Power Safety Considerations 3-2

Using Transducer Covers 3-2
Observing FDA Warnings for Latex Products 3-3
Caring for Transducers 3-3
Handling Transducers 3-4
Inspecting Transducers 3-4
Procedures that Damage Transducers 3-4
Chemicals that Damage Transducers 3-5
Using Ultrasound Coupling Gels 3-5
Precleaning 3-5
Precleaning Methods 3-5
Precleaning Solution Guidelines 3-7
Disinfecting and Sterilizing Procedures 3-8
External Transducers 3-9
Endocavity Transducers 3-10
Transesophageal Transducers 3-11
Intraoperative Transducers 3-12
Transducer Decontamination Methods 3-13
Storing Transducers 3-13
Endocavity Transducers 3-13

Chapter 3 - Transducer Safety and Maintenance
This chapter contains important information about transducer

safety, maintenance, and sterilization procedures.
IMPORTANT: Read this section carefully before you begin using the system
transducers.
TR A N S D U C E R P O W E R S A F E T Y C O N S I D E R A T I O N S
It is prudent practice to minimize the exposure of the patient to
ultrasound energy during an exam. At the same time, a necessary
level of acoustic output must be employed to achieve the
penetration and sensitivity needed to obtain the desired
information. For detailed information about transducer power
safety considerations and for specific transducer power values, see
your Transducer Specifications manual.
Also refer to the “AIUM Ultrasound Medical Safety” brochure,
available from the American Institute of Ultrasound in Medicine
(AIUM). The AIUM brochure provides a detailed explanation of
potential bioeffects and suggestions for conducting examinations
according to the As Low As Reasonably Achievable (ALARA)
principle. The AIUM is located in Laurel, Maryland, U.S.A., at
(301)498-4100 and on the Internet at http://www.aium.org.
OBSERVING CLINICAL CONTRAINDICATIONS

Use of intraoperative transducers should be restricted to qualified
personnel trained in proper operating room techniques. This
manual provides instructions on how to use Acuson equipment.
The clinician should determine the appropriateness of these
methods and procedures and investigate contraindications for this
exam for each patient.
U S I N G TR A N S D U C E R C O V E R S
Acuson strongly recommends always using a sterile transducer
cover when performing an aseptic or sterile transabdominal or
transthoracic imaging procedure. Always use a sterile transducer
cover with endocavity, transesophageal, and intraoperative
transducers. After each exam, regard the transducer cover and any
other wastes as potentially infectious and dispose of them
accordingly.
Contact your Acuson sales representative for information about
obtaining supplies such as transducer covers.
3-2 Acuson 0202

Caring for Transducers
Observing FDA Several procedures require the use of transducer covers. Such
Warnings for Latex procedures are described in detail later in this manual. In general,
Products transducer covers are made from latex. The U.S. Food and Drug
Administration (FDA) has issued a Medical Alert regarding
“Allergic Reactions to Latex-Containing Medical Devices” (March
29, 1991). Because of reports of severe allergic reactions to medical
devices containing latex (natural rubber), the FDA is advising
health-care professionals to identify latex-sensitive patients and be
prepared to treat allergic reactions promptly. Patient reactions have
ranged from contact urticaria to systemic anaphylaxis. Observe the
following precautions recommended by the FDA:
• When taking general histories of patients, include questions
about latex sensitivity. For surgical and radiology patients,
spina bifida patients, and health-care workers, this
recommendation is especially important. Questions about
itching, rash, or wheezing after wearing latex gloves or inflating
a toy balloon may be useful. Flag the charts of patients with
positive histories.
• If latex sensitivity is suspected, consider using devices made
with alternate materials, such as plastic. For example, if a
patient is sensitive, wear a non-latex glove over a latex glove.
Health professionals with latex sensitivity could use a latex
middle glove. (Latex gloves labeled hypoallergenic may not
always prevent adverse reactions.)
• Be alert to the possibility of an allergic reaction whenever
latex-containing medical devices are used, especially when
latex comes in contact with mucous membranes (such as rectal
mucosa, vaginal mucosa, oral mucosa, or internal organs
during operative procedures).
• If an allergic reaction occurs and latex is suspected, advise the
patient of possible latex sensitivity and consider an
immunologic evaluation.
• Advise the patient to tell health professionals and emergency
personnel about any known latex sensitivity before undergoing
medical procedures. Consider advising patients with severe
latex sensitivity to wear medical identification bracelets.
C A R I N G F O R TR A N S D U C E R S
Transducers require proper handling, care, and cleaning. Improper
transducer care WILL void your warranty. Transducer care includes
daily inspection, daily cleaning, and sterilization whenever
necessary.

Handling It is important to handle transducers properly:

Transducers • DO NOT drop the transducer. Dropping or striking a
transducer against a hard surface can damage the transducer
elements and acoustic lens and damage the electrical safety
features.
• DO NOT use a cracked or broken transducer. Damaged
transducers present a danger of electric shock. If a transducer
cracks or breaks, contact your Acuson Customer Engineer
immediately.
• DO NOT pinch or kink the transducer cable. If the transducer
housing becomes cracked or broken or if there are cuts or
openings in the cable, the electrical safety features of the
transducer could be compromised.
• DO NOT immerse the external transducer beyond the first
seam in any liquid. The transducer is not watertight. Immersing
it beyond the first seam can destroy its electrical safety features.
• Use only recommended ultrasound coupling gels and cleaning
agents and do not use those containing components described
later in this section. Improper transducer care WILL void your
warranty. For specific information, see “Using Ultrasound
Coupling Gels” on page 3-5.
WARNING! DO NOT use a transducer that has been dropped or subjected to a

severe collision until it has been inspected by an Acuson Customer
Engineer. Cracks or other damage to the transducer and cuts or
openings in the transducer cable can damage the electrical safety
features of the transducer.
Inspecting Inspect the transducer lens, case, and cable each day. Check for
Transducers cracks or other damage that may allow liquids to enter the
transducer. If you find damage, do not use the transducer until it
has been inspected and either repaired or replaced by an authorized
Procedures that The following procedures are known to damage transducers. These
Damage procedures may destroy both the electrical safety features and the
Transducers acoustic performance of the transducer.
• Gas sterilization
• Ultraviolet sterilization
• Dry heat sterilization
• Autoclaving
• Soaking a transducer in chlorine bleach
NOTE: To perform a sterile exam, place the transducer in a sterile
sleeve filled with sterile gel.
3-4 Acuson 0202

Using Ultrasound Coupling Gels
Chemicals that Some ultrasound coupling gels, precleaning solutions, and

Damage disinfecting and sterilizing solutions can damage Acuson
Transducers transducers. Use of any of these chemicals or products containing
these chemicals WILL void your transducer warranty. Check with
the product manufacturer regarding the contents of a gel or
solution. If you have additional questions, please contact your
Agents containing the following chemicals are known to damage
transducers:
• Acetone
• Mineral oil
• Iodine
• Oil-based perfume
NOTE: Prolonged exposure to methanol and denatured ethyl
alcohol is not recommended due to incompatibilities with the
materials in the transducers. Prolonged exposure to these alcohols
could impact performance and longevity of the transducer.
USING ULTRASOUND COUPLING GELS

There are many ultrasound coupling gels and lotion products
available worldwide. Your Transducer Specifications Manual lists the
products that Acuson has tested and determined to be compatible
with Acuson transducers. Other products may be compatible, but
have not been tested.
Do not use products that contain chemicals listed in “Chemicals
that Damage Transducers” on page 3-5.
WARNING! For vaginal imaging, be especially careful when choosing an

ultrasound coupling gel. Certain ultrasound coupling gels may be
toxic to human reproductive cells.
PRECLEANING
Precleaning Precleaning is a process of mechanically or chemically removing

Methods material from the surface of a transducer prior to disinfecting,
decontaminating, or sterilizing. The simplest form of precleaning is
the physical scrubbing of a transducer with soap and water to
remove the bulk of biomass (such as blood, mucous, gel, etc.). There
are also sophisticated pump spray applications and enzymatic
soaps which can be used in a precleaning protocol.
A wide variety of precleaning methods are used. Acuson
recommends finding an acceptable method that does not require
immersion of the transducer in liquid. This will allow for a much
wider range of precleaning options, while maintaining the terms of
your warranty or service contract.

According to “APIC Guidelines for Selection and Use of

Disinfectants,” by W. Rutala, Ph. D., MPH, precleaning can be used
to effectively shorten the required soak times by removing most of
the biomass on contaminated tools and permit more thorough
disinfection, decontamination, and sterilization. (American Journal
of Infection Control, February, 1989.)
IMPORTANT: If a transducer is contaminated with blood, body fluids, or other

materials, always high-level disinfect the transducer before
scrubbing it clean. Disinfect or sterilize it again after cleaning.
◆ To preclean a transducer:
1 Unplug the transducer connector from the system.
2 Wipe the transducer with a cloth that has been dipped in a mild
soap and water, isopropyl alcohol, or a precleaning solution listed
in your Transducer Specifications Manual.
OR
2 Mix a dilute chlorine bleach solution from 1/4 cup of bleach
hypochlorite solution and one gallon of tap water.
3 Dip a cloth in the bleach solution and use it to wipe the transducer.
4 To remove any bleach residue, immediately wipe the transducer
with another cloth dipped in water..
IMPORTANT: DO NOT let the cleaning solution get into the transducer
connector or onto the transducer connector contacts. It will
corrode the contacts and internal circuitry and damage the
transducer.
IMPORTANT: Residual bleach can damage the transducer and transducer cable.
DO NOT soak the transducer in bleach, even a diluted solution.
For more information about using a bleach solution to clean

transducers, request “Guidelines for Prevention of Transmission of
HBV and HIV to Health Care and Public Safety Workers,”
(February 1989) from the Centers for Disease Control.
Acuson does not attest to the capabilities of compatible precleaning
solutions. Based on testing done to assess the effect of precleaning
solutions on the physical properties and performance of the Acuson
transducers, we confirm the precleaning solutions listed in your
Transducer Specifications Manual are acceptable for maintaining the
Acuson electrical safety and performance standards, as well as the
general appearance and longevity of Acuson transducers.
Use only these solutions to maintain your system warranty and
service contract status in full. Follow the solution manufacturers’
instructions for proper use of their products. Use of any other
solutions or procedures will void your transducer warranty.
3-6 Acuson 0202

Precleaning
Precleaning Always follow the recommendations of the manufacturer of a

Solution Guidelines precleaning solution and confirm with your infection control
officials that your precleaning protocol is acceptable.
After precleaning a transducer, an appropriate disinfection or
decontamination protocol must be followed to ensure patient and
employee safety for endocavity, transesophageal, intraoperative, or
precaution-patient exams.
There are many different commercially available products that
could be used for precleaning. Some precleaning solutions may
contain chemicals that could damage Acuson transducers. See
“Chemicals that Damage Transducers” on page 3-5. Use of any of
these chemicals or products containing these chemicals will void
your transducer warranty or service contract.
Only products with specific commercial names listed in your
Transducer Specifications Manual are compatible with the material
used in Acuson transducers. Products with variations of these
names, or products that manufacturers insist are equivalent, must
be reviewed by Acuson. For information, please contact Acuson's
Customer Information Center (CIC) at 1 (800) 228-4128. Also,
contact the manufacturer of the solution for information regarding
the solution’s FDA and EPA regulatory status for the purpose of
cleaning, disinfecting, and sterilizing.
The Transducer Specifications Manual lists Acuson compatible
disinfecting and sterilizing solutions. Contact the manufacturers
listed there for information about obtaining these solutions.
A list of precleaning solutions with specified commercial names is
provided in your Transducer Specifications Manual. Many other
solutions are available, but the products listed in your Transducer
Specifications Manual have been tested and determined to be
compatible with Acuson Transducers. We provide this list as a
resource for products rather than as a list of exclusively acceptable
products.
If you choose a precleaning protocol that utilizes a product not on
this list, you are responsible for ensuring that the damaging
chemicals listed in “Chemicals that Damage Transducers” on
page 3-5 are not contained in that precleaning solution.

DISINFECTING AND STERILIZING PROCEDURES
IMPORTANT: Make sure you follow the hospital’s infection control standards.
WARNING! Do not use transducers that may have been exposed to Creutzfeld
Jacob disease, because liquid sterilants and disinfectants cannot
assure removal of this contamination. Contact the Acuson Help
Desk before destroying these transducers.
Basic Precautions There are different procedures for disinfecting and sterilizing
external transducers, such as those used for transthoracic or
abdominal exams, and those used for intracavity exams.
◆ Always follow these basic precautions for cleaning and high-
level disinfecting all transducers:
• The disinfecting and sterilizing solutions must be validated
against transducer damage prior to their use.
• Use only a disinfecting agent that is cleared by FDA and
approved by EPA, such as Cidex, and use only agents approved
and tested by Acuson.
• Only products with specific commercial names listed in your
Transducer Specifications Manual are compatible with the
material used in Acuson transducers. Products with variations
of these names, or products that manufacturers insist are
equivalent, must be cleared by Acuson. Also, contact the
manufacturer of the solution for information regarding the
solution’s regulatory status for the purpose of cleaning,
disinfecting, and sterilizing.
Use only these solutions to maintain your Acuson system
warranty and service contract status in full. Follow the
manufacturers’ instructions for appropriate procedures for the
use of their products. Use of any other solutions or procedures
will void your transducer warranty.
• Acuson does not attest to the infection control capabilities of
compatible agents. Based on testing done to assess the effect of
these agents on the physical properties and performance of the
Acuson transducers, we confirm these solutions are acceptable
to maintaining the Acuson electrical safety and performance
standards.
• Depending on the infectious nature of the patient and the
potential for contamination of the transducer by body fluids, a
longer disinfection time may be necessary. We DO NOT
recommend soaking transducers in a solution any longer than
the manufacturer’s recommendation. Follow the
manufacturer’s recommended disinfecting and sterilizing
durations. DO NOT leave the transducer in a disinfecting
solution for longer than 10 hours.
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Disinfecting and Sterilizing Procedures
• If a transducer is contaminated with body fluids or other

materials, always high-level disinfect the transducer with a
disinfectant/sterilant solution that has been cleared for
marketing by the FDA (for example, Cidex) before cleaning it,
and then disinfect or sterilize it again after cleaning.
• DO NOT soak the transducer in alcohol. Alcohol is inactive
against certain organisms. You may use isopropyl alcohol to
wipe the transducer housing only. Alcohol will remove the
markings from the intracavity cable.
• DO NOT rub the transducer with an abrasive sponge when
washing with soap and water. Use a soft cloth, towel, or gauze.
Use a soft brush to remove any contaminant that may collect in
the transducer grooves.
External ◆ To disinfect or sterilize an external transducer:

Transducers 1 Unplug the transducer connector from the system.
2 Immerse the face of the transducer in an Acuson-compatible
disinfectant solution. For a list of compatible solutions, see your
Transducer Specifications Manual. Follow the disinfecting agent
manufacturer’s instructions for use.
The solution level must not reach the first seam closest to the face of
the transducer, otherwise fluid may seep through the seal.
Figure 3-1 shows the proper immersion technique. This technique
disinfects only the transducer face.
WARNING! External transducers are not watertight. If you immerse them

beyond the first seam, their electrical safety features may be
compromised.
Transducer seam
Figure 3-1 Disinfecting an External Transducer

Endocavity
Transducers
IMPORTANT: High-level disinfect endocavity transducers prior to use and

between exams. Disconnect endocavity transducers from the
system before cleaning, high-level disinfecting, and sterilizing.
◆ To high-level disinfect and sterilize the transducer before the

first exam and between each exam:
1 Unplug the transducer from the system.
2 Follow the disinfecting or sterilizing agent manufacturer’s
instructions for use. Soak the transducer for at least 45 minutes in
one of the compatible disinfecting solutions.
The transducer and cable may be submerged up to, but not
including, the strain relief of the transducer connector (see
Figure 3-2). DO NOT immerse the transducer connector or its strain
relief. Figure 3-2 illustrates the appropriate method for disinfecting
the transducer.
3 After disinfecting or cleaning the transducer, rinse it in sterile or
high-quality tap water, depending on the subsequent use.
Strain Relief Connector
Disinfecting
Solution Bath
Figure 3-2 High-level Disinfection
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Disinfecting and Sterilizing Procedures
Transesophageal Disinfect the transducer intracavity cable and bite guard and clean
Transducers the transducer handle after each use. At the end of the intracavity
cable soaking period, test the leakage current as described later in
“Setting Up the Leakage Current Test” on page 5-10
◆ To high-level disinfect and sterilize the transducer:
1 Fill the disinfecting bath about two-thirds full with an Acuson
compatible disinfecting solution.
Follow the disinfecting agent manufacturer’s instructions for use.
3 Remove the protective cover and dispose accordingly.
4 If build up of visible debris is noted around the flexible neck, swab
lightly with disinfecting solution.
5 Submerge the intracavity cable up to the last depth mark.
Figure 3-3 illustrates the appropriate method for disinfecting the
transducer.
IMPORTANT: DO NOT immerse the transducer intracavity cable past the last
depth mark, as its electrical safety features may be compromised
and the transducer may be damaged beyond repair. This damage
is not covered under the warranty or service contract.
IMPORTANT: DO NOT let the disinfecting or sterilizing solution get into the
transducer connector or onto the transducer connector contacts. It
will corrode the contacts and internal circuitry and damage the
transducer.
6 Follow the solution manufacturer’s procedure for high-level

disinfection or sterilization (if appropriate).
IMPORTANT: DO NOT leave the transducer intracavity cable in the disinfecting

agent for prolonged soaking periods, beyond the time required to
achieve high-level disinfection or sterilization.
7 Perform a leakage current test while you are high-level disinfecting

the transducer.
For instructions on how to perform a leakage current test, see
“Performing the Calibration and Leakage Current Test” on
page 5-11.

8 To clean the transducer handle and cable, use a cloth or pad

moistened with 70% isopropyl alcohol. Carefully dry the transducer
handle and cable with gauze pads or a soft cloth or let air dry for 30
minutes.
Figure 3-3 High-level Disinfection Setup
Intraoperative Follow standard methods for disinfecting, sterilizing, and cleaning

Transducers transducers.
IMPORTANT: The transducers recommended for intraoperative use were

designed to be used sterile with protective covers. Sterility can be
maintained only through use of an intact sterile transducer cover.
After each exam, consider the transducer cover, your gloves, and
any other wastes as potentially infectious, and dispose of them
accordingly. Clean the transducer after each use as described in
“Precleaning Methods” on page 3-5.
The participating surgeon or operating room supervisor or
infection control officer should be consulted well in advance of an
intraoperative imaging procedure to determine whether sanitizing
or disinfecting of the transducer is required. Please consult the
sections on compatible solutions before treating any
intraoperative transducer.
For disinfecting and sterilizing procedures, see “External
Transducers” on page 3-9. For compatible disinfecting and
sterilizing solutions, see your Transducer Specifications Manual.

obtaining supplies such as protective covers.
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Transducer Decontamination Methods
TR A N S D U C E R D E C O N T A M I N A T I O N M E T H O D S
Follow these guidelines for decontaminating transducers:
• Acuson’s transducers can be completely decontaminated
(sterilized) only through the use of liquid sterilizing
solutions, listed in your Transducer Specifications Manual.
• Follow the solution manufacturer’s recommended soak times
and follow Acuson’s instructions as to what components of a
transducer can be immersed in disinfecting/sterilizing
solutions.
WARNING! Alternative sterilization techniques, such as Ethylene Oxide,

Steam or Heat Autoclave, Gamma Ray, E-Beam, Plazlyte (Peracetic
Acid Plasma), Sterrad (Hydrogen Peroxide Plasma), Steris
(Peracetic Acid Washing), and other total transducer immersion
procedures will result in deleterious effects to the materials used in
the construction of the transducer and could compromise
performance as well as patient safety.
• Acuson strongly recommends always using a sterile transducer

cover when performing an aseptic or sterile transabdominal or
transthoracic imaging procedure. Always use a sterile
transducer cover with endocavity, transesophageal, and
intraoperative transducers.
obtaining supplies such as sterile covers.
S T O R I N G TR A N S D U C E R S
To reduce the risk of infectious disease transmission, Acuson
recommends that transducers be disinfected before storage.
Endocavity Store the disinfected transducer in the original shipping case or in a

Transducers clean, dry location.
Transesophageal Store the disinfected transducer in the original shipping case only
Transducers after disinfecting. The Transesophageal Transducer is fragile and
should not be stored in the transducer holders on the system.

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CHAPTER 4
Intraoperative Transducers
Using Transducers for Intraoperative Applications 4-2

Complying with Safety Guidelines 4-2
Observing FDA Warnings for Latex Products 4-2
Observing Power Guidelines 4-2
Disinfecting, Sterilizing, and Cleaning Transducers 4-3
Observing Electrical Safety Guidelines 4-3

Chapter 4 - Intraoperative Transducers
U S I N G TR A N S D U C E R S F O R I N T R A O P E R A T I V E A P P L I C A T I O N S
You can use transducers during an operation to examine the interior
of organs and vessels. Acuson provides several transducers
appropriate for intraoperative scanning applications.
Transducers used for intraoperative applications include:
• V7
• L7
• L7T
• L7L
COMPLYING WITH SAFETY GUIDELINES

This section summarizes important safety procedures for Acuson
intraoperative transducers. For additional information about
general system safety and maintenance procedures, see Chapter 2.
Be sure to read Chapter 2 and this intraoperative transducer chapter
before you perform an exam.
Observing Clinical Use of intraoperative transducers should be restricted to qualified

Contraindications personnel trained in proper operating room techniques. This
The clinician should determine the appropriateness of these
exam for each patient.
Observing FDA Some intraoperative transducer covers are made from latex. Before
Warnings for Latex performing an intraoperative exam, read “Observing FDA
Products Warnings for Latex Products” on page 3-3.
Observing Power For intraoperative usage, observe FDA ultrasound guidelines for
Guidelines transducer power values listed in the Transducer Specifications
Manual.
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Complying with Safety Guidelines
Disinfecting, Follow standard methods for disinfecting, sterilizing, and cleaning

Sterilizing, and transducers, as described in Chapter 3.
Cleaning
Transducers
IMPORTANT: The transducers recommended for intraoperative use were

designed to be used sterile with protective covers. Sterility can be
maintained only through use of an intact sterile transducer cover.
After each exam, consider the transducer cover, your gloves, and
any other wastes as potentially infectious, and dispose of them
accordingly. Clean the transducer after each use as described in
“Precleaning” on page 3-5.
The participating surgeon or operating room supervisor or
infection control officer should be consulted well in advance of an
intraoperative imaging procedure to determine whether sanitizing
or disinfecting of the transducer is required. Please consult the
sections on compatible solutions before treating any
intraoperative transducer.
For disinfecting and sterilizing procedures, see “Disinfecting and
Sterilizing Procedures” on page 3-8. For compatible disinfecting
and sterilizing solutions, see the Transducer Specifications Manual.
Observing Electrical Leakage Current with Domestic Systems (115V)

Safety Guidelines Acuson transducers have been evaluated and comply with the
requirements for an Ordinary Patient Connection, as specified in
Underwriters Laboratories’ Standard for Medical and Dental
Equipment, UL 544, when operated with domestic (115V) Aspen™
ultrasound systems. The leakage current on Acuson transducers
will not exceed 50þµA.
Leakage Current with International Systems (220/240V)
Acuson transducers meet the International Electrotechnical
Committee Standard for Medical Electrical Equipment, IEC 601, for
Type BF equipment, when operated with international (220/240V)
Aspen systems. The leakage current on Acuson transducers will not
exceed 100þµA under loss-of-ground condition, and will not exceed
500þµA under single-fault condition with mains voltage applied to
the transducer.

Chapter 4 - Intraoperative Transducers
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CHAPTER 5
Transesophageal Transducers Safety

Guidelines

Clinical Contraindications 5-4
General Contraindications 5-4
Pediatric Contraindications 5-6
Preventing Transducer Tip Double-Over 5-6
Getting More Information 5-6
Observing Precautions 5-7
Recognizing the Problem 5-7
Correcting the Problem 5-7
Electrical Safety 5-8
Leakage Current with Domestic Systems (115V) 5-8
Leakage Current with International Systems (230V) 5-8
Isolated Accessory Outlets 5-8
Leakage Current Limits 5-8
Testing the Transducer Leakage Current 5-9
Setting Up the Leakage Current Test 5-10
Performing the Calibration and Leakage Current Test 5-11

Chapter 5 - Transesophageal Transducers Safety Guidelines
This section provides additional important safety procedures for

Acuson Transesophageal Transducers. For additional information
about general system safety and maintenance procedures, see
Chapter 2. For Transesophageal Transducer precleaning,
disinfection, sterilization, and storage procedures, see Chapter 3
BASIC PRECAUTIONS
DO NOT use a transducer that has been dropped or struck against
another object. The transducer is fragile and will break. Damage
caused by bite marks, dropping the transducer, striking it against
another object, pinching, kinking, or twisting the cable, or putting
pressure on the flexible neck may cause an electrical or mechanical
hazard to the patient.
The types of damage described above are not covered by the
warranty and service contract. In addition, you MUST take the
precautions listed below to maintain your warranty and service
contract. Failure to do so will void your warranty and service
contract.
• Use a bite guard on patient’s teeth for all transesophageal
exams to reduce the risk of damage to the intracavity cable from
the patient’s teeth. Damage to the intracavity cable can cause an
electrical or mechanical hazard and damage the patient’s teeth.
Damage that occurs from failure to use a bite guard is not
covered under warranty or service contract.
• Perform both a solution conductivity test and a leakage current
test at the end of each disinfecting period or before each exam.
• DO NOT immerse the transducer intracavity cable past the last
depth mark as the transducer handle is not watertight.
• DO NOT spray aerosol anesthetic on the transducer as solvents
in aerosols can damage the transducer. Solvents in the aerosol
may damage the transducer cable. We recommend you spray
the patient’s throat with anesthetic following the
manufacturer’s recommendations and then insert the
transducer.
• DO NOT use conventional coupling gels intended for external
use. They may contain perfuming or coloring agents which can
cause adverse patient reactions.
• Since the thermal sensor is in the transducer lens, the Acuson
Transesophageal Transducers are designed to offer maximum
patient safety during procedures requiring patient
hyperthermia.
• Before high-level disinfecting the transducer, lightly brush or
swab the flexible sleeve adjacent to the transducer tip to remove
any particles. Performing this cleaning before soaking makes it
easier to rinse the transducer after disinfecting it.
5-2 Acuson 0202

Basic Precautions
• Use only the disinfecting agents and cleaning procedures

approved by Acuson, cleared by FDA and approved by EPA
(for example, as Cidex). Follow the disinfecting agent
manufacturer’s instructions for use. For compatible disinfecting
agents, see your Transducer Specifications Manual.
IMPORTANT: If you use a solution not cleared by the FDA, a disinfection or

sterilization validation must be completed prior to its use.
• Transesophageal Transducer covers are made from latex. Before

performing a Transesophageal exam, read “Observing FDA
Warnings for Latex Products” on page 3-3.
In addition, always follow these basic precautions:
• Transesophageal procedures may damage the esophageal wall
if the intracavity cable puts prolonged pressure on the
esophageal tissue. As a precaution, do not lock the transducer
flexible neck in a position that causes the tip to rest against the
wall of the esophagus.1, 2, 3
• Physical damage to the transducer or transducer electrical cable
may create mechanical and/or electrical hazards to the patient.
Visually and manually inspect the transducer prior to use. DO
NOT use the transducer if the housing is cracked or damaged
or if there are cuts, holes, perforations, dents, or abrasions on
either cable.
• Forceful insertion, manipulation, or withdrawal may cause
lacerations or other damage to the esophagus.
• To prevent damage to the esophagus always have the
transducer’s flexible neck in the straight, unlocked position to
insert or remove the transducer from the patient’s esophagus.
• Use a protective transducer cover on the transducer during
patient exams. See “Observing FDA Warnings for Latex
Products” on page 3-3.
• During a transesophageal exam in which highly pathogenic
micro-organisms are known or suspected, use a disposable
drape over the transducer handle and knobs to reduce the
spread of micro-organisms.
• DO NOT place the Transesophageal Transducer in the pull-out
transducer holders on the system. Place the transducer in the
carrying case between patient exams. Store the transducer in
the carrying case or in another safe location.
• Always put the system in a stand-by mode (with a frozen
display) between exams and during an exam when the
transducer is not in active use.
1. Chojkier, M., and Conn, H.O. 1980. Esophageal Tamponade in the Treatment of
Bleeding Varices: A Decadal Progress Report. Digest. Dis. Sci.: 267-272. (April)
2. Conn, H.O. 1958. Hazards Attending the Use of Esophageal Tamponade. New Eng. J.
Med.: 701-706. (October 1958).
3. Magnin, R.R., and Mulligan, L.V. 1968. Technical Refinements in the Use of the
Sengstaken Tube. Am. J. Surg.: 140-141. (July 1968.)

• Always maintain an appropriate amount of ultrasound gel

between the active face of the transducer and the cover to
ensure adequate ultrasound transmission throughout the exam.
For more information, see “Using Ultrasound Coupling Gels”
on page 3-5.
• Disconnect the Transesophageal Transducer from the system
before cleaning and high-level disinfection.
CLINICAL CONTRAINDICATIONS
Use of the Transesophageal Transducer should be restricted to
physicians trained in proper esophogastroscopic techniques. This
The physician should determine the appropriateness of these
exam for each patient. The following reference articles are cited for
your continuing education:
• Seward, J.B., et. al. 1992. Critical Appraisal of Transesophageal
Echocardiology: Limitations, Pitfalls, and Complications.
Journal of the American Society of Echocardiography. 1992; 5:288-
305.
• Seward, J.B., et. al. 1990. Biplanar Transesophageal
Echocardiology: Anatomic Correlations, Image Orientation,
and Clinical Applications. Mayo Clinic Proceedings 65:1193-1213.
• Seward, J.B., et. al. 1988. Transesophageal Echocardiography:
Technique, Anatomic Correlations, Implementation, and
Clinical Applications. Mayo Clinic Proceedings 63:649-680.
• Currie, P.J. and K. Chandrasekaran. 1990. TEE: Current
Applications and Future Directions. Cardio 7 (3):57-69, 133.
General Below is a list of contraindications identified in a literature review

Contraindications and from discussion with consulting physicians. It is recommended
that you perform periodic literature reviews to stay informed of
new developments.
• The physician must determine the patient’s medical history and
general condition to help determine the feasibility of a
transesophageal exam and promote patient comfort. Some
special considerations that may affect the decision to perform
an exam include but are not limited to: existing
gastroesophageal abnormalities or disease such as esophageal
varices, hiatal hernia, tumor, diverticuli, esophageal webs and
rings, fistulae or peptic ulcers, ability of the patient to
accommodate and swallow the transducer, overall effect of
mediastinal radiation, chemotherapy, anticoagulation, steroid
therapy, or other contraindications.
5-4 Acuson 0202

Clinical Contraindications
• You should not perform a transesophageal exam when the

patient is in an upright position with the neck flexed. Published
reports cite transient unilateral vocal cord paralysis for several
hours after neurosurgery in conjunction with a transesophageal
exam in two patients who were in upright positions with their
necks flexed during surgery. 1, 2
• If the patient has, or is suspected of having, highly pathogenic
microorganisms, use a disposable drape to cover the transducer
handle and steering knobs during the procedure to reduce the
spread of microorganisms.
• Follow the manufacturer’s recommendations for using aerosol
anesthetic to numb the patient’s throat before this procedure.
• If patient defibrillation is required, disconnect the transducer
from the system by unplugging the transducer connector and
remove the transducer from the patient. Although the outer
insulating layer of the transducer is designed to withstand the
electrical stress caused by defibrillation, this added precaution
is recommended. Ensure that the transducer cable is intact
before each exam as a hole or tear may result in burns to the
patient as a result of secondary arcing from internal metal parts
of the intracavity cable that could occur during defibrillation. A
latex cover does not provide electrical insulation.
• The use of electrosurgical units and other devices that introduce
radio frequency electromagnetic fields or currents into the
patient can interfere with the ultrasound circuitry and distort
the image. Concurrent failure of devices and damage to a
transducer may cause current from the device to return along
the intracavity cable which may result in burns to the patient at
the area of transducer damage. Ensure that the intracavity cable
is intact before each exam to reduce this risk. A latex cover does
not provide electrical insulation.
For more information about the electrical safety features and
requirements, see Chapter 2.
• If the patient has a pacemaker, you should be aware of any
interference in its operation and immediately turn off the
Acuson system or unplug the transducer. Ultrasound, like other
medical equipment, uses high-frequency electrical signals
which could interfere with pacemakers.
1. Gussenhoven, E.J., et. al. 1986. Transesophageal Two-dimensional

Echocardiography: Its Role in Solving Clinical Problems. J. Am. Coll. Cardiol.: 975-979.
2. Cucchiara, R.F., et al. 1984. Air Embolism in Upright Neurosurgical Patients:
Detection and Localization by Two-dimensional Transesophageal Echocardiography.
Anesthesiology 60:353-355.

Pediatric Observe the following additional contraindications for pediatric

Contraindications patients.
• Perforated hollow viscus
• Active gastrointestinal bleeding
• Unrepaired tracheoesophageal fistula
• Esophageal obstruction or stricture
• Unwilling or uncooperative patients who are not sedated
• Inadequate control of the airway or severe respiratory
decompensation
• Deformity of the oral pharynx.
• Cervical spine injury or deformity
• After esophageal surgery
• Esophageal varices or diverticulum
• Oropharyngeal distortion or deformity
• Severe coagulopathy
The following references contain additional information:
• Fyfe, D.A., et. al. 1992. Guidelines for Transesophageal
Echocardiology: in Children. Journal of the American Society of
Echocardiography. 1992; V.5 No.6:640-644. (This article is the
reference for contraindications listed above.)
• Stumper, O.F.W., “Pediatric Transesophageal
Echocardiography.” Doctoral Thesis. Erasmus University
Rotterdam. 1991.
P R E V E N T I N G TR A N S D U C E R T I P D O U B L E - O V E R
Improper insertion techniques can result in the tip of a
Transesophageal Transducer “doubling over” and becoming lodged
in the esophagus. This problem is not attributed to any particular
transducer design.
Getting More Acuson recommends the following articles for additional

Information information on TEE transducer buckling.
• Kronzon, I., et al. Buckling of the Tip of the Transesophageal
Echocardiography Probe: A Potentially Dangerous Technical
Malfunction. Journal of the American Society of Echocardiography.
1992, 5:176-177.
• Daniel, W.G., et al. Safety of Transesophageal
Echocardiography: A Multicenter Survey of 10,419
Examinations. Circulation. 1991, 83:811-812.
5-6 Acuson 0202

Preventing Transducer Tip Double-Over
• Khandheria B.K, et al. Safety of Transesophageal

Echocardiography: Experience with 2070 Consecutive
Procedures [abstract]. Journal of the American College of
Cardiology. 1991, 17:20A.
Observing The American Society of Echocardiographers publishes training

Precautions guidelines for physicians, both for learning how to insert TEE
transducers and for interpretive skills. Only personnel trained in
proper techniques should perform TEE exams.
Transducer tip buckling can be caused by one of the following
factors:
• Improper insertion technique
• Patient esophageal pathology (See “Clinical Contraindications”
on page 5-4.)
• Presence of other instruments in the esophagus
• Improper transducer maintenance
Avoid the following when inserting the transducer:
• Excessive flexing of the transducer tip before it enters the
esophagus
• Catching the tip in oropharyngeal recesses
• Patients who are especially uncooperative, experiencing
spasms or other convulsions, or who exhibit other
contraindications
Always follow proper care and maintenance instructions for the
TEE transducer. Call your Acuson Customer Engineer if you
experience any problems with the transducer.
Recognizing the Any one or more of the following conditions may indicate
Problem transducer tip buckling:
• Resistance to advancing or withdrawing the transducer
• Inability to rotate the controls
• Both control knobs fixed in the maximum flex position
• Extreme difficulty in obtaining an image
Correcting the Make sure that all personnel involved in TEE exams are aware of
Problem the following corrective procedures in case they are present when a
problem occurs.
To correct tip buckling, carefully advance the transducer into the
stomach, then straighten it, and withdraw it. Attempts to forcibly
straighten or withdraw the transducer directly from the esophagus
might scrape, perforate, or otherwise damage the esophagus. If you
cannot move the transducer in any direction, use X-ray or
fluoroscopy to evaluate the situation. You might also want to
consult a gastroenterologist or anesthesiologist.

As an additional measure to prevent tip buckling, some

practitioners restrict the tip from lateral movement during insertion
by having an assistant restrain the lateral control knob.
ELECTRICAL SAFETY
Always observe the following electrical safety guidelines.
Leakage Current The Transesophageal Transducer has been evaluated and complies
with Domestic with the requirements for an Ordinary Patient Connection as
Systems (115V) specified in Underwriters Laboratories’ Standard for Medical and
Dental Equipment, UL 544, when operated with domestic (115V)
Acuson systems. The leakage current on the Transesophageal
Transducer will not exceed 50 µA.
Leakage Current The Transesophageal Transducer meets the International

with International Electrotechnical Committee Standard for Medical Electrical
Systems (230V) Equipment, IEC 601, for Type BF equipment when operated with
international (230V) Acuson systems. The leakage current on the
Transesophageal Transducer will not exceed 100 µA under loss of
ground condition and will not exceed 500 µA under single fault
condition with mains voltage applied to the transducer.
Isolated Accessory The Acuson system has isolated power receptacles within it for
Outlets connecting accessories. Plug only approved accessories into these
isolated accessory outlets. The total power available is indicated
near the outlets. Overloading these outlets can cause an overload
not only of the system but also of your building’s wiring. Failure to
use isolated outlets can degrade image quality and increase chassis
leakage current.
Leakage Current Isolated accessory outlets let you connect approved accessories
Limits without increasing the system leakage current. Connecting
accessories powered from nonisolated sources may result in leakage
currents exceeding safe levels.
WARNING! Plug only the proper connectors in the input and output
connectors on the back of the system. Never apply voltage to
output connectors. Doing so can damage the system and destroy
its electrical safety features. For a complete description of input
and output connectors, see Chapter 2.
5-8 Acuson 0202

Testing the Transducer Leakage Current
TE S T I N G T H E T R A N S D U C E R L E A K A G E C U R R E N T
The leakage current tester operates by simulating the Acuson
system under fault conditions and measuring its electrical
impedance.
WARNING! If you drop or damage the leakage current tester, DO NOT USE IT.
Contact your Acuson Customer Engineer.
Perform a leakage current test on the transducer at the end of each

transducer high-level disinfection procedure. Retest prior to use if
the transducer has not been used for an extended period of time or
to check the leakage current of the transducer in the event that it
was damaged by being dropped or struck against another object.
Passing the leakage current test assures that, at the time of the test,
the leakage current was within acceptable limits. This test does not
predict that a failure will not occur. Damage to the transducer may
occur during insertion or storage which could render the prior test
invalid.
The leakage current tester has two connectors: an MP connector for
connecting a V5M Transesophageal Transducer and a DL connector
for connecting other Transesophageal Transducers. Figure 5-1
shows the tester and Figure 5-2 shows the test setup.
T.E. LEAKAG
E CURRENT
TESTER
PASS
FAIL
CAL
TEST
TRANSD
U
TEST CER
C O M
P U T
E D
S O N
O G R
A P H
Y
ELECT
RODE
S
Figure 5-1 Transesophageal Leakage Current Tester

Setting Up the ◆ To set up the leakage current test:

Leakage Current 1 Plug one end of the cord into the tester and the other into an
Test electrical wall outlet.
2 Fill the disinfecting bath with a compatible disinfecting agent about
two-thirds full. See your Transducer Specifications Manual for
compatible disinfecting agents.
NOTE: Fill the bath with normal saline if you are performing a
leakage current test as a separate procedure after disinfecting the
transducer or you are retesting the transducer after an extended
period of nonuse.
NOTE: Follow the manufacturer’s protocol for replacing the
disinfecting agent. At that time remove the electrodes and electrode
retainers, rinse them with tap water and dry with gauze.
3 Slide one electrode retainer from the pointed corner of the bath
along the lip until the slot overhangs the bath wall. Slide the other
retainer along the other side of the pointed corner until the slot
overhangs the bath wall. Figure 5-2 shows retainers in the correct
position.
Electrode
Connector
Electrode
Electrode
Cable
Electrode
Retainer
A
R
L
P
T.E. LEAKAG
E CURRENT
TESTER
PASS
FAIL
CAL
TEST
TRANSD
UC
TEST ER
C O M
P U T
E D
S O N
O G R
A P H
Y
ELECTR
ODES
Test Meter
Connector
Figure 5-2 Leakage Current Test Setup
5-10 Acuson 0202

Testing the Transducer Leakage Current
4 Drop each electrode into the electrode retainer hole.

5 Plug one end of each electrode cable into the top of the electrode.
6 Insert the other end of each electrode cable into the tester. You can
insert either cable into either connector.
Performing the This test consists of two simple procedures which take just a few
Calibration and moments to perform. The first procedure (CAL TEST) verifies the
Leakage Current calibration of the tester and tests the conductivity of the disinfecting
Test agent or saline. The second procedure (TRANSDUCER TEST) tests
the impedance of the transducer. Both procedures should be
performed at the end of the disinfecting period.
◆ To perform the calibration and transducer leakage current test:
1 Remove the transducer cover and discard as you would any
potentially hazardous, infectious waste.
2 Place the transducer handle on the ledge of the basin and secure it
with the strap.
3 Submerge the transducer intracavity cable up to the last depth
mark.
IMPORTANT: DO NOT submerge the intracavity cable beyond the last depth
mark. Doing so can result in a false reading during the test and
damage the transducer.
4 Connect the transducer to the appropriate connector on the tester.

5 Press and hold the toggle up toward CAL TEST.
6 Look at the indicators and release the toggle.
NOTE: If the green indicator lights, the system passes the CAL TEST.
The disinfecting agent or saline provides adequate conductivity and
the tester is calibrated. Continue with this test procedure. If the red
indicator lights, the system fails the CAL TEST. Ensure that the
electrodes are connected properly and repeat the test. If repeated
attempts fail, the disinfecting agent or saline may be contaminated.
Replace the solution and repeat the test. If repeated attempts fail,
contact your Acuson Customer Engineer.
7 Press and hold the toggle down toward TRANSDUCER TEST.
8 Look at the indicators and release the toggle.
NOTE: If the green indicator lights, the transducer passes the
TRANSDUCER TEST. The electrical impedance of the transducer is
within acceptable limits. You can use this transducer for a patient
exam. If the red indicator lights, the transducer fails the
TRANSDUCER TEST. Ensure that the electrodes are connected
properly and repeat the test. If repeated attempts fail, the test is
invalid or the electrical impedance of the transducer is beyond
acceptable limits. DO NOT use this transducer. Contact your
9 Rinse and dry the transducer as described in Chapter 3.

5-12 Acuson 0202

CHAPTER 6
Needle Guide Safety and Maintenance

Guidelines
Following Basic Precautions 6-2

Needle Guide Kit 6-3
Assembling and Disassembling 6-4
Cleaning 6-4
Sterilizing 6-4
Endocavity Needle Guide Safety and Maintenance Guidelines 6-5

Chapter 6 - Needle Guide Safety and Maintenance Guidelines
Acuson provides two types of Needle Guides:

• Quik-Clip™ Needle Guides clip into the indentations on the
transducer.
• Slide-On Needle Guides slide onto the transducer.
Other Needle Guides are available from third-party vendors. For
information about using these Needle Guides, refer to the
instructions you receive with the guide.
This section summarizes important safety and maintenance
procedures for all Acuson abdominal Needle Guides. For more
information about which Needle Guides are available on your
system and how to use them during an exam, see your User’s
Manual.
WARNING! You must follow these safety and maintenance procedures exactly
to ensure patient safety and maintain your Needle Guide
warranty. Be sure to read these procedures BEFORE you use a
Needle Guide and follow them each time you perform a biopsy.

obtaining supplies such as needle guides.
FOLLOWING BASIC PRECAUTIONS

Always follow these basic precautions:
• Sterilize the Quik-Clip Needle Guide before the first use and
after each subsequent use.
• Avoid pulling on the transducer cable when installing or
removing the Needle Guide or adaptor.
• Always use a protective transducer cover.
• Dispose of the entire procedure kit after use. DO NOT sterilize
or reuse any items in the kit.
• Always handle transducers and Needle Guide adaptors with
care. DO NOT use a transducer or an adaptor if it has been
dropped or struck against a hard surface until it is inspected by
an Acuson Customer Engineer.
• Transducer covers used with Needle Guides are made from
latex. Before performing a Needle Guide procedure, read
“Observing FDA Warnings for Latex Products” on page 3-3.
6-2 Acuson 0202

Needle Guide Kit
• The displayed Needle Guide pathway on the Acuson video

monitor is intended for reference during biopsy procedures. A
variety of factors outside of Acuson’s control, such as changing
tissue density, bending of the needle, off-axis pressure by the
person holding the transducer, and others, may cause deflection
of a needle outside of the displayed video pathway even when
the transducer, Needle Guide, and system software all are
performing as intended and within manufacturing
specification. The specialist performing a biopsy procedure
must be aware of potential external factors when executing an
invasive procedure.
• When selecting the Needle length, the caliper MUST be placed
in the needle path for correct PUNCTURE TO SITE and MIN
NEEDLE measurements. If the caliper is not located in the
needle path, the displayed measurements will be incorrect.
• When assembling the Needle Guide DO NOT overtighten the
barrel tab when locking it in place.
• Once the biopsy needle is inserted into the Needle Guide, do
not reposition the transducer without withdrawing the needle
well away from the opening of the Needle Guide tube at the
tissue. Moving the transducer while the needle is in the tissue
can produce tissue lacerations. When the needle is in the tissue,
it is not always visible within the imaging field of view.
WARNING! Acuson Needle Guides are designed and manufactured to attach

firmly to designated transducers and should not require excessive
force to position or disassemble. If it appears that excessive force
or manipulation is required to position or disassemble Needle
Guide components, please contact your Acuson Customer
Engineer before using the Needle Guide.
NEEDLE GUIDE KIT

The Slide-On Needle Guide starter set contains reusable Needle
Guide adaptors and sterile procedure kits. Each disposable
procedure kit contains the following components:
• Set of sized needle insert barrels
• Transducer cover
• Needle clip (for Slide-On Needle Guides only)
• Sterile packet of coupling gel

ASSEMBLING AND DISASSEMBLING

Always observe the following precautions when assembling and
disassembling Needle Guides:
WARNING! Failure to observe the following precautions when assembling and

disassembling Needle Guides WILL void your Needle Guide
warranty.
• Acuson Needle Guides are designed and manufactured to

attach firmly to designated transducers and should not require
excessive force to position or disassemble.
• Correct technique and preparation will provide long and
accurate use of these Needle Guides.
• If you believe that excessive force is required to prepare or
disassemble Needle Guide setups, please contact your Acuson
Customer Engineer before use.
CLEANING
You should preclean a Needle Guide before sterilizing.
◆ To clean a Quik-Clip Needle Guide or Slide-On adaptor, use a
brush or cloth that has been dampened with soap and water or
with a specialized soap and precleaner.
STERILIZING
Always sterilize Quik-Clip Needle Guides after use. Slide-On
Needle Guide adaptors do not generally require sterilization
because they are used under a sterile sheath.
◆ To sterilize a Quik-Clip Needle Guide, use one of the following:
• Steam sterilization (autoclaving)
• Dry heat
• Gas sterilization
◆ To sterilize a Slide-On Needle Guide, soak the Slide-On adaptor
in a compatible sterilizing solution.
See Transducer Specifications Manual for a list of compatible
solutions. Follow the sterilizing agent manufacturer’s instructions
for use.
6-4 Acuson 0202

Endocavity Needle Guide Safety and Maintenance
ENDOCAVITY NEEDLE GUIDE SAFETY AND MAINTENANCE

GUIDELINES
Always follow these basic precautions:
• INSPECT the Needle Guide daily to ensure that it is not bent or
misshaped. DO NOT use the Needle Guide if it is deformed in
any way. Contact an Acuson Customer Engineer to inspect it.
• Follow all the basic precautions for endocavity transducer
safety and maintenance described in this chapter and your
User’s Manual.
• STERILIZE reusable Needle Guides before each use. These
Needle Guides can be used multiple times and are, therefore,
NOT shipped sterile.
• The EC7 Needle Guide is disposable (intended for single-use
only) and is shipped sterile. It cannot be resterilized.
• DO NOT use any disposable Needle Guides after the sterility
expiration date.
NOTE: If a disposable EC7 Needle Guide is defective, return it to
the Needle Guide manufacturer.

6-6 Acuson 0202

CHAPTER 7
System Measurement Accuracy
Measurements in Color Doppler 7-2

Velocity Accuracy in CD 7- 2
Angle Estimation in CD 7- 2
Registration Accuracy in CD 7- 2
Accuracy of Caliper Measurements of Elapsed Time or Rate 7-3
Sequoia 7- 3
Aspen 7- 3
128XP 7- 4
Accuracy of Caliper Measurements of Distance 7-4
Accuracy of Caliper Measurements of Circumference 7-5
Accuracy of Caliper Measurements of Area 7-6
Accuracy of Angular Measurements 7-7

Chapter 7 - System Measurement Accuracy
This chapter describes the fundamental accuracy measurements

with Acuson ultrasound systems. These measurements apply to all
transducers operating in the modes discussed below.
MEASUREMENTS IN COLOR DOPPLER

Color Doppler (CD) is not intended as a tool for making
quantitative clinical measurements. Rather, CD provides qualitative
information regarding blood flow in the region of investigation.
It is, therefore, used as an adjunct to quantitative techniques,
improving the localization of areas of interest and allowing the user
to observe characteristics of flow in the region. However, you
should be familiar with normal measurement parameters and the
accuracy with which they can be applied in CD.
Velocity Accuracy in String phantom measurements in CD demonstrate that velocity

CD estimates can be achieved within ±10% of the nominal string
velocity for string speeds from 0.3 – 1.0 meters/sec. and with
Doppler angles from –60° to +60°. Factors that limit the accuracy of
velocity measurements in CD include the relatively small sample
volume size and short period of sample volume interrogation.
As stated above, CD gives an indication (at many points
simultaneously) of the presence or absence of flow and its dynamic
behavior during the cardiovascular cycle, rather than a precise
quantification of flow velocity at any single point. Therefore,
quantitative clinical conclusions should not be based solely on CD
information.
Angle Estimation in The precision of angle estimation is ±0.5° with Acuson systems. As
CD with most electronically steered systems, however, the major error
in angle estimation occurs through operator error in adjusting the
angle calipers. Therefore, you should exercise care in the use of the
angle calipers to achieve accuracy in their placement.
NOTE: The magnitude of velocity estimation errors due to errors in
Doppler angle measurement decrease as the Doppler angle
decreases. Whereas only a 1° error in estimating an 80° Doppler
angle could result in an inherent velocity error of 11%, a 1° error in
estimating a 60° Doppler angle would result in a corresponding
velocity error of 3%, and less than a 1% velocity error with a 20°
Doppler angle.
Registration For CD scanning of flow phantoms with the speed of sound

Accuracy in CD controlled at 1540 cm/sec, the registration error between CD and
2-D mode is generally less than 1.0 mm.
7-2 Acuson 0202

Accuracy of Caliper Measurements of Elapsed Time or
ACCURACY OF CALIPER MEASUREMENTS OF ELAPSED TIME

OR RATE
In M-mode, PW Doppler, CW Doppler, and CD modes, records of

tissue motion or blood velocities over time are produced. Acuson
system calipers may be used to analyze these records to measure
the elapsed time between events, or, conversely, to determine the
rate of such events (as in heart rate determinations). The
fundamental accuracy of these measurements depends on the
accuracy of the caliper placement in measuring elapsed time on the
time record.
Since the smallest possible error in placing each caliper is ±1 pixel,
the average minimum error in estimating the elapsed time between
two events is approximately ±1.5 pixels. The error in estimating the
elapsed time between two events occurring 1.0 second apart
depends upon the sweep speed as indicated in Table 7-2. Table 7-2
lists the error of caliper measurements of elapsed time or rate. The
full-scale display width is approximately 500 pixels
Sequoia
Table 7-1 Accuracy of Caliper Measurements of Elapsed Time or Rate

for Sequoia Systems
Sweep Speed Error in Measurement of 1.0 Second
(mm/sec)
NTSC Display Format PAL Display Format
(msec) (msec)
25 2.25 1.88
50 1.12 0.94
100 0.56 0.47
150 0.38 0.31
200 0.28 0.23
Aspen

for Aspen Systems
Sweep Speed Display Width Error in Measurement
1.0 Second
500 pixels/second 1.0 second 0.30%

128XP

for 128XP Systems
Sweep Speed Display Width Error in Measurement
1.0 Second
NOTE: Any errors in estimating times that are longer than one
second are decreased accordingly. Errors in estimating elapsed
times that are shorter than one second are increased accordingly.
ACCURACY OF CALIPER MEASUREMENTS OF DISTANCE

In the imaging modes of 2-D and CD, limits on precision of caliper
placement lead to errors in estimating distance equal to about 0.25%
(or approximately 1 part in 400) of the full-scale display scan length
or Field of View.
Thus, when the image depth or FOV is 10 cm, for example, the
fundamental error in measuring any length is approximately
0.025 cm (0.25% of 10 cm), and the precision error in estimating a
1.0 cm length corresponds to 2.5% (0.025 cm/1.0 cm) of the nominal
measured length. Table 7-4 lists the percent of relative error in
measuring specified nominal lengths.
Table 7-4 Accuracy of Caliper Measurements of Distance

Scan Depth Percent Relative Error in Measuring
Specified Nominal Lengths
1.0 cm 2.0 cm 4.0 cm 8.0 cm
6.0 cm 1.5% 0. 8% 0.4% 0.2%

8.0 cm 2.0% 1.0% 0.5% 0.2%
12.0 cm 3.0% 1.5% 0.8% 0.4%
16.0 cm 4.0% 2.0% 1.0% 0.5%
18.0 cm 4.5% 2.2% 1.1% 0.6%
22.0 cm 5.5% 2.8% 1.4% 0.7%
24.0 cm 6.0% 3.0% 1.5% 0.8%
Typically, variations in the speed of sound in tissue from the

estimated rate of 1540 m/sec are the dominant error mechanism;
given the speeds of sound in blood and fat, the error in distance
measurements from this mechanism may approach ±5%.
7-4 Acuson 0202

Accuracy of Caliper Measurements of Circumference
ACCURACY OF CALIPER MEASUREMENTS OF CIRCUMFERENCE

The measurement of circumference is based on the measurement of
a successive number of smaller lengths. Assuming the caliper-
drawn figure is sufficiently close to the true outline, the error in
measurement due to caliper quantization can be estimated as
approximately 1.5 times that for a distance of equal length, given
the display depth used.
Thus, while caliper error may lead to a minimum 1.0% error in
estimating a 2.0 cm length in an 8.0 cm display field, a minimum
1.5% error would be expected in measuring a 2.0 cm circumference
in the same 8.0 cm field. Table 7-5 lists the percent of relative error
in measuring specified nominal circumference.
Table 7-5 Accuracy of Caliper Measurements of Circumference

Specified Nominal Circumference
1.0 cm 2.0 cm 4.0 cm 8.0 cm
6.0 cm 2.2% 1.1% 0.6% 0.3%
8.0 cm 3.0% 1.5% 0.8% 0.4%
12.0 cm 4.5% 2.2% 1.1% 0.6%
16.0 cm 6.0% 3.0% 1.5% 0.8%
18.0 cm 6.8% 3.4% 1.7% 0.8%
22.0 cm 8.2% 4.1% 2.1% 1.0%
24.0 cm 9.0% 4.5% 2.2% 1.1%
A similar multiple (1.5 times) between length and circumference

would be expected when variations in the speed of sound in tissue
from the assumed 1540 m/sec are the dominant mechanism. Thus,
if errors in distance measurement due to this mechanism approach
±5%, then the resulting errors in circumference measurements may
approach ±7.5%.

ACCURACY OF CALIPER MEASUREMENTS OF AREA

The measurement of area is based on measurements of a successive
number of smaller areas, each formed as the product of successive
length measurements. Assuming the caliper-drawn figure is
sufficiently close to the true outline, the error in measurement of an
area due to caliper quantization is approximately 2.0 times that for a
distance equal to the square root of the area size, given the display
depth used.
Thus, while caliper error may lead to a minimum 1.0% error in
estimating a 2.0 cm length in a 8.0 cm field, a minimum 2.0% error is
expected in measuring a 4 cm2 area in the same 8.0 cm field display
depth. Table 7-6 lists the percent of relative error in measuring
specified nominal areas.
Table 7-6 Accuracy of Caliper Measurements of Area

Specified Nominal Areas
1.0 cm2 4.0 cm2 16.0 cm2 64.0 cm2
6.0 cm 3.0% 1.5% 0.8% 0.4%
8.0 cm 4.0% 2.0% 1.0% 0.5%
12.0 cm 6.0% 3.0% 1.5% 0.8%
16.0 cm 8.0% 4.0% 2.0% 1.0%
18.0 cm 9.0% 4.5% 2.2% 1.1%
22.0 cm 11.0% 5.5% 2.8% 1.4%
24.0 cm 12.0% 6.0% 3.0% 1.5%
A similar multiple (2.0 times) between length and the square root of
area would be expected when variations in the speed of sound from
the assumed rate of 1540 m/sec are the dominant error source.
Thus, if errors in distance measurement due to this mechanism
approach ±5%, then the resulting errors in circumference
measurements may approach ±10%.
7-6 Acuson 0202

Accuracy of Angular Measurements
ACCURACY OF ANGULAR MEASUREMENTS

For angular calculation tools, the angular measurements are based
on the measurements of length. The percent of relative error for
angular measurements increases as angles are defined by shorter
lines and as the measure angle decreases in size.
Table 7-7 lists the percent of relative error in measuring angles.
Table 7-7 Worst Case Error of Angular Measurements

Worst Case Error in Specified Nominal Length of Lines
Angle (Degrees): 6% 3% 1.5% 0.8%
10 8.3% 4% 2% 1%
20 2.0% 1% 0.5% 0.3%
30 0.9% 0.4% 0.2% 0.1%
40 0.5% 0.2% 0.1% 0.06%
50 0.3% 0.1% 0.07% 0.04%
60 0.2% 0.08% 0.04% 0.02%
70 0.1% 0.05% 0.03% 0.01%
80 0.06% 0.03% 0.02% 0.01%
90 0.05% 0.03% 0.01% 0.007%
NOTE: The major error in angle estimation occurs through user

error while adjusting the angle calipers. Therefore, you should
exercise care when using the angle calipers to achieve accurate
placement.

7-8 Acuson 0202

CHAPTER 8
ECG and Physiologic Module Safety

Guidelines
Following ECG and Physiologic Module Safety Guidelines 8-2

ECG Channel 8-2
Auxiliary Input/ DC-A Channel 8-3
Phono Channel 8-3
Pulse Channel 8-3
Respiration Channel 8-3

Chapter 8 - ECG and Physiologic Module Safety Guidelines
F O L L O W I N G E CG A N D P H Y S I O L O G I C M O D U L E S A F E T Y
GUIDELINES
The ECG module consists of several physiologic channels and a DC
Input channel. The physiologic channels, or patient connections,
include ECG, phono (heartsounds), respiration, and pulse. Each
physiologic trace displays the conditioned input from a physiologic
transducer as a waveform on the system display.
The Auxiliary/DC Input (DC-A) displays a waveform from any
electronically compatible accessory or monitor. For example, you
might use the DC-A channel to display the output from a pressure
monitor simultaneously with ultrasound data or to display the
output from a dedicated ECG monitor instead of using the system’s
ECG channel.
NOTE: On Sequoia systems, the DC-B, DC-C, and DC-D channels
are for future use. They do not display waveforms.
WARNING! Read the safety information in this section before you use any of
the physiologic channels. Use only Acuson-approved transducers
with the physiologic channels. For information about obtaining
approved transducers, contact your Acuson Customer Engineer.
The ECG module is not designed for use in conjunction with

electrosurgery or diathermy equipment.
WARNING! ECG and physiologic leads are not defibrillator proof. Leads must
be removed in the event that a defibrillator is used.
ECG and physiologic leads are not for diagnostic purposes.
Signals displayed are for reference or triggering only.
The ECG, phono, pulse, and respiration inputs are isolated to meet
ordinary patient connection leakage current limits and are marked
with the symbol. Connect physiologic transducers only to
inputs marked with this symbol.
Ground-referred input jacks for the DC-A input, Aux input, and
audio phones have jack covers with the symbol. Do not plug
physiologic transducers into any ground-referred jack.
ECG Channel To reduce the risk of electric shock and burns, use ONLY the cable
and patient leads supplied with the ECG unit or those that conform
to the Association for the Advancement of Medical Instruments
(AAMI) standard for ECG Connectors. Use of ECG cables other
than those complying with this standard could defeat the
current-limiting and electrical safety features of the ECG. For best
performance and optimal recovery time, use silver-silver chloride
electrodes. For information about ordering additional cables and
patient lead kits, contact your Acuson Customer Engineer.
8-2 Acuson 0202

Following ECG and Physiologic Module Safety
Auxiliary Input/ The auxiliary input/DC-A channel is not for patient connection.
DC-A Channel Interconnect your Acuson ultrasound systems only with devices
that meet appropriate leakage current limits. The chassis leakage
current of the connected device(s) adds to the chassis leakage
current of the Acuson system.
WARNING! The auxiliary/DC-A input jack is ground-referred. DO NOT plug

physiologic transducers into it.
Phono Channel There are two types of heartsounds transducers (heartsounds

microphones). One type uses suction to adhere to the patient, and
the other type uses adhesive pads.
If your transducer uses suction, use a thin coat of petroleum jelly,
instead of ultrasound coupling gel, to obtain a better seal between
the heartsounds transducer and the chest wall. Ultrasound coupling
gel can accumulate in the microphone head and cause problems
with the operation of the transducer. It can also be aspirated into the
suction tubing: If it is, clean the tubing before using the transducer.
If your transducer uses adhesive pads, use the provided
dual-surface adhesive pads to adhere the flat surface of the
heartsounds transducer to the patient’s chest. You can use either flat
surface. However, Acuson recommends that you use the surface
most distant from the cable insertion point. This protects the device
from possible contamination and damage by ultrasound coupling
gel (which may be in the area of application).
The dual-surface adhesive pads are gentle in their adhesion when
compared to commonly used tapes or electrodes. For optimum
performance, the patient’s skin should be clean and dry before
application. Effective adhesion significantly decreases with
multiple placements of a single pad on the skin.
Pulse Channel Take normal precautions to prevent damaging the pulse transducer.
Do not drop it or strike it against a hard object. Do not use a
damaged transducer.
WARNING! On 128XP and Aspen systems, connect only one physiologic

transducer at a time to the pulse/respiration channel of the
Physiologic Module. The PULSE/A and RESP/B input jacks are
served by a single isolation barrier. DO NOT connect an auxiliary
input to one of these jacks if a physiologic transducer is connected
to the other jack. You can, however, simultaneously connect two
auxiliary inputs.
Respiration Channel The respiration transducer monitors changing temperature

resulting from air flow across its surface to detect the phases of
respiration. If the transducer tip is embedded against the nasal wall,
the transducer cannot properly detect respiration. Be sure the
transducer tip is positioned where it can monitor clear air flow
through the nasal passage.

Chapter 8 - ECG and Physiologic Module Safety Guidelines
The nose clip on the respiration transducer can be cleaned and

disinfected for repeated use, or disposed of after each use. The
transducer tip and adjacent section of the cable can be high-level
disinfected.
Clean the respiration transducer and nose clip by detaching them
from the transducer cable and using an alcohol wipe to gently scrub
them following the manufacturer’s instructions.
High-level disinfect the transducer and nose clip by soaking them
in Cidex. Use of cleaning agents other than Cidex (such as Cidex 7,
Cidex Plus, or alcohol) may damage the transducer cable sheath.
Follow the manufacturer’s instructions for the minimum soaking
time recommended for high-level disinfection.
IMPORTANT: Do not soak the respiration transducer for more than 24 hours, as
damage may occur.
8-4 Acuson 0202

Index
Numerics transporting 2-4

128XP system auxiliary input/DC-A channel 8-3
accessory outlets 2-8
C
air filters 2-28
circuit breakers 2-9
circuit breakers 2-10
cleaning 2-26
cleaning 2-26
clinical contraindications 3-2
electrical requirements 2-5
connectors, input and output
2-6
electrical safety requirements
128XP system 2-18 to 2-19
environmental requirements 2-4
Aspen system 2-15 to 2-17
input and output connectors 2-18 to 2-19
Sequoia system 2-11 to 2-14
input power rating 2-7
moving the 2-26 D
safety see safety DC-A channel/auxiliary input 8-3
starting 2-24 decontaminating transducers 3-13
storing 2-4 diagnostics, Power On 2-24
symbols 2-21 E
system components 1-5 ECG module, safety guidelines 8-2
transporting 2-4 electrical requirements 2-5
A electrical safety requirements 2-6
Acuson, contacting 1-vii Endocavity Transducers
Aspen system cleaning 3-10
accessory outlets 2-8 disinfecting 3-10
air filters 2-27 storing 3-13
circuit breakers 2-10 environmental requirements 2-4
cleaning 2-26 I
electrical requirements 2-5 input power rating 2-7
2-6
electrical safety requirements Intraoperative Transducers 4-1
environmental requirements 2-4 cleaning 3-12, 4-3
input and output connectors 2-15 to 2-17 defined 4-2
input power rating 2-7 electrical safety guidelines 4-3
moving the 2-26 sterilizing 3-12, 4-3
safety see safety
starting 2-23 L
storing 2-4 leakage current limits 2-8

symbols 2-21 N
system components 1-4 Needle Guides
0202 Safety Manual Index-1

Index
assembling and disassembling 6-4 system components

cleaning 6-4 512 1-2
Endocavity 6-5 C256 1-3
latex precautions 6-2 transporting 2-4
maintenance 6-2 setup
safety precautions 6-2 VCR output level 2-30
sterilizing 6-4 starting2-24
symbols 2-21
P
system requirements 2-4
patients, protecting 2-3
phono channel 8-3 T
Physiologic module, safety guidelines 8-2 transducer covers 3-2
precleaning transducers
methods 3-5 damaging
solution guidelines 3-7 chemicals 3-5
transducers 3-6 procedures 3-4
pulse channel 8-3 decontaminating methods 3-13
disinfecting and sterilizing 3-8
R
handling 3-4
respiration channel 8-3
inspecting 3-4
restarting 2-25
intraoperative 4-2
S precleaning 3-6
safety ultrasound gels 3-5
basic precautions 2-2 Transesophageal Transducers
ECG module 8-2 clinical contraindications 5-4
electrical requirements 2-6 electrical safety 5-8
environmental requirements 2-4 general safety guidelines 5-2
Intraoperative Transducers 4-2 preventing tip double-over 5-6
leakage current limits 2-8 storing 3-13
Needle Guides 6-2 testing leakage current 5-9
Physiologic module 8-2
U
ultrasound
Sequoia system
coupling gels 3-5
accessory outlets 2-8
air filters 2-27 V
circuit breakers 2-9 VCRs
cleaning 2-26 output levels 2-30
electrical requirements 2-5
electrical safety requirements 2-6
environmental requirements 2-4
input and output connectors 2-11 to 2-14
input power rating 2-7
moving the 2-26
safety see safety
starting 2-23
storing 2-4
symbols 2-21
Index-2 Acuson 0202

Acuson Ultrasound and
Echocardiography
Systems Safety Manual
Document No. 58151
Revision No. 4
Language: English

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Acuson Ultrasound and Echocardiography Systems

Siemens Medical Solutions Acuson, a Siemens Company

Tel: +44 (0) 208 479 7950 www.acuson.com

Document No. 58151

Chapter 1 System Components 1-1

Chapter 2 Basic Safety Precautions 2-1

Chapter 3 Transducer Safety and Maintenance 3-1

Chapter 4 Intraoperative Transducers 4-1

Chapter 5 Transesophageal Transducers Safety Guidelines 5-1

0202 Safety Manual iii

Clinical Contraindications 5-4

Chapter 6 Needle Guide Safety and Maintenance Guidelines 6-1

Chapter 7 System Measurement Accuracy 7-1

Chapter 8 ECG and Physiologic Module Safety Guidelines 8-1

This manual provides important safety information for the

HOW TO USE THIS MANUAL

0202 Safety Manual v

U.S.A. England/Great Britain Japan

Asia Pacific/Latin America European Headquarters Latin America

Australia Finland Norway

Belgium France Russia

Canada Germany Singapore

Denmark Hong Kong Sweden

0202 Safety Manual vii

viii Acuson 0202

Sequoia 512 Ultrasound System Components 1-2

0202 Safety Manual 1-1

Figure 1-1 Acuson Sequoia 512 Ultrasound System

1-2 Acuson 0202

Figure 1-2 Acuson Sequoia C256 Echocardiography System

0202 Safety Manual 1-3

ASPEN SYSTEM COMPONENTS

ECG and Physiologic

Foot Switch Connecto

Figure 1-3 Aspen System Components

1-4 Acuson 0202

Power Switch Foot Switch

Figure 1-4 Acuson 128XP System Components

0202 Safety Manual 1-5

1-6 Acuson 0202

Basic Safety Precautions

Basic Precautions 2-2

0202 Safety Manual 2-1

This chapter contains important information about electrical safety,

2-2 Acuson 0202

• Identify latex-sensitive patients and be prepared to treat allergic

0202 Safety Manual 2-3

REVIEWING SYSTEM REQUIREMENTS

Environmental The system’s environment should be free of fumes, dirt, and

Table 2-1 Environmental Requirements

To provide adequate cooling, maintain the following clearances

Left side Right side Rear

When transporting or storing your Acuson system, do not expose it

2-4 Acuson 0202

Electrical Acuson produces systems that operate with AC line voltages of

WARNING! Before having your system installed by an Acuson Customer

0202 Safety Manual 2-5

Table 2-2 Electrical Safety

WARNING! Accessory equipment connected to the analog and digital

2-6 Acuson 0202

Table 2-3 Input Power Values for Sequoia Systems

Table 2-4 Input Power Values for Aspen Systems

Table 2-5 Input Power Values for 128XP Systems