Philips M2540 User Manual

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1 About This Manual

About This Manual

November 2002

M2540-92000-01 A

Field Service Manual

This manual provides information for troubleshooting and servicing the Philips M2540A ultrasound system. Brief overviews for each section in this book are listed below:

Section 1, “General Information,” presents a product overview and a

description of major features, and lists applicable safety standards.

Section 2, “Specifications,” describes the physical and electrical

specifications of the M2540A.

Section 3, “Safety,” discusses safety issues pertinent to the ultrasound

system, and describes ESD precautions to be taken when servicing the system.

Section 4, “Theory of Operation,” includes a technical overview of

system functions. Functional descriptions are given for each system circuit board. Functional block diagrams show the scanner and the scan converter sections. This section also includes explanations of the theories behind the electrical safety tests in the Performance Tests section.

Section 5, “Installation,” explains how to unpack and assemble the

system, how to install peripheral devices, and how to configure the system’s parameters.

Section 6, “Performance Tests,” comprises all tests and diagnostic

procedures that apply to the M2540A, including electrical safety tests. The chapter emphasizes patient, operator, and service personnel

M2540 Ultrasound System

safety, and system safety. A procedure for verifying complete system operation is included.

M2540-92000-01 A M2540 Ultrasound System Field Service Manual Page 2

About This Manual: About This Manual

Section 7, “Adjustments,” contains instructions for adjusting the system monitor.

Section 8, “Preventive Maintenance,” includes procedures for periodic maintenance of the

system.

Section 9, “Troubleshooting,” contains information and procedures for finding and repairing the

causes of faults in the M2540A, including software error codes. The error-code section opens with a key for interpreting the codes.

Section 10, “Service Procedures,” includes all service procedures, including a discussion of ESD

precautions, component removal and replacement, and peripherals installation. The chapter also presents software procedures for backup and retrieval of customer presets, and for reloading or upgrading system software.

Section 11, “Cabling,” includes tables listing all the standard and optional M2540A cables.

Section 12, “Configuration,” lists the jumper and switch settings for the M2540A’s disk drives.

Section 13, “Parts,” comprises parts lists and exploded diagrams of the M2540A and its

assemblies. Parts ordering methods are discussed.

Section 14, “Transducers,” lists the transducers compatible with the M2540A and their

characteristics.

Audience

Section 15, “Glossary,” is a glossary of terms used in this manual and in the ultrasound imaging

field.

This manual supports the field service maintenance and repair of the M2540A Ultrasound System. The user of this document is a qualified ultrasound electronics technician who has completed training classes on the system and its peripherals.

M2540-92000-01 A M2540 Ultrasound System Field Service Manual Page 3

About This Manual: About This Manual

Format

Conventions

Service Manual Questions or Comments

This manual is in Portable Document Format (PDF), for viewing on a laptop computer using Acrobat Reader. A list of bookmarks functions as a table of contents. Those bookmarks and cross-references use hypertext links to provide access to the referenced information.

The following conventions are used in this manual:

• Hypertext links are blue.

• All procedures are numbered. You must complete steps in the sequence they are presented

to ensure reliable results.

• Bulleted lists indicate general information about a function or a procedure. They do not imply a sequential procedure.

• Control names are spelled and capitalized in the manual as they are on the system.

• Menu items or titles appearing on the display are spelled and capitalized in the manual as they

are on the display.

• An English system is assumed.

If you have questions about the service manual, or if you discover an error in the manual, contact Philips Ultrasound Technical Publications:

• atl-bothell.techpubs@philips.com

• Technical Publications, MS 964, at the first address below

M2540-92000-01 A M2540 Ultrasound System Field Service Manual Page 4

About This Manual: About This Manual

Customer Assistance

Various support locations around the world can provide customers with technical assistance regarding the ultrasound system. Customers should contact the sales office where they purchased the system or the nearest Philips Ultrasound office for assistance.

• Philips Ultrasound P.O. Box 3003 Bothell, WA 98041-3003 USA (425) 487-7000 or (800) 426-2670

www.ultrasound.philips.com

• Philips Ultrasound 3000 Minuteman Road Andover, Massachusetts 01810-1099 (978) 687-1501

• Authorized EU Representative: Philips Medizin Systeme Boeblingen GmbH Hewlett-Packard-Str. 2 71034 Boeblingen Germany

To find your local service center phone number, go to:

www.philips.medical.com

Non-Philips Medical Systems product names may be trademarks or registered trademarks of their respective owners.

M2540-92000-01 A M2540 Ultrasound System Field Service Manual Page 5

About This Manual: About This Manual

Publication number M2540-98000-01

Edition 1

Published: December 2002

Printed in U.S.A.

Warra nty

The information contained in this document is subject to change without notice.

Philips Medical Systems makes no warranty of any kind with regard to this material, including, but not limited to, the implied warranties or merchantability and fitness for a particular purpose.

Philips Medical Systems shall not be liable for errors contained herein or for incidental or consequential damages in connection with the furnishing, performance, or use of this material.

Tra de mark s

Cannon is a registered trademark of Cannon Corporation.

Windows XP is a trademark of Microsoft Corporation

WARNING

Electrical Shock Hazard

Do not remove system covers. To avoid electrical shock, use only supplied power cords and connect only to properly grounded (3-hole) wall outlets.

Explosion Hazard

Do not operate the system in the presence of flammable anesthetics.

Safety Information

Before you use a specialty transducer for the first time, be sure to read the “Description and Use” section of the chapter that is applicable to your transducer. Also, for TEE and intraoperative transducers, review the “Electrical Safety” sections in those chapters.

Pay special attention to the Warnings and Cautions.

The warnings explain the dangers of electrical shock and explosion hazard, the safety of ultrasound, applications, guidelines for fetal use, and guidelines for setting controls that affect acoustic output and accuracy of clinical measurements.

Warning Symbol Used in the Text:

WARNING

The cautions explain potential damage to equipment.

Caution Symbol Used in the Text:

CAUTION

Symbols on the System

Warning symbols, as well as other symbols appearing on the system or its probes:

This symbol on the system advises

the user documentation for that part of the system.

Monitor Radiation

The monitor used in this system complies with the FDA regulations that were applicable at the date of manufacture (21 CFR Subcategory J).

Prescription Device

The United States Food and Drug Administration requires the following labeling statement:

Caution - Federal Law restricts this device to use by or on the

operators to consult

This symbol on the system indicates a potential for electrical shock.

Important

marking is for

0123

Council Directive 93/42/EEC.

This system complies with the Medical Device Directive.

Authorized EU Representative: Philips Medizinsysteme

Boeblingen GmbH

Hewlett-Packard Strasse 2

71034 Boeblingen, Germany

M2540-92000-01 A M2540 Ultrasound System Field Service Manual Page 6

General Information: Product Overview

1 General Information

This chapter includes the following sections:

• “Product Overview” on page 6

• “System Description” on page 7

• “Optional Peripherals (VCR, Printers, and Image Devices)” on page 9

• “Preset Functions” on page 10

• “Safety Specifications” on page 12

Product Overview

The M2540A ultrasound system comprises a cart, a system control panel, and a monitor. A foot pedal on each caster locks and unlocks the front cart wheels. All four wheels swivel. The system control panel and the monitor adjust up and down and swivel as a unit, and the monitor tilts and swivels on its mount.

The cart’s lower enclosure contains the M2540A’s computer, disk drives, and ultrasound generating and processing boards.

CD-RW and floppy disk drives are standard equipment.

Optional peripheral components include a video cassette recorder, various types of printer, a foot switch, and a magneto-optical disk (MOD) drive. The VCR is available in either NTSC or PAL configuration. For a complete list of optional components, see “Optional Peripherals” on

page 201.

Most peripheral devices mount on top of the lower enclosure. The optional plain-paper printer is not mounted on or powered by the system, but is connected from a remote location.

The Resident Self Test (RST) software verifies system performance and helps diagnose problems.

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General Information: System Description

The system control panel includes four numbered option buttons whose functions are assigned by the customer. See the online Help file for details on configuring these controls.

System Description

Cart

Major ultrasound system components are described on the following pages. These descriptions include important features of the cart, monitor, system control panel, Physio module, e-box, and system power supply.

References to the left and the right sides of the system are as viewed from the front of the cart.

The cart supports the system and acts as the chassis into which all system components are installed and interconnected.

A height adjustment lets you adjust the system control panel and monitor for operator comfort.

An Input/Output (I/O) panel at the rear of the cart contains three connectors for communication between the system and a network, and for controlling certain legacy printers. The foot switch port, an equipotential lug, and the system ground lug are also on the I/O panel. The panel is at the center of the lower part of the cart, and is accessible to the system operator. See “I/O Panel” on page 45 for more information about the I/O panel.

Cart Wheels

Four wheels at the cart base provide system maneuverability and braking. All four wheels swivel, and the front wheels can be fixed straight and locked. Foot pedals on the two front wheels lock and unlock the front wheels to prevent the cart from rolling. Locking the wheels immobilizes the system during patient procedures.

The M2540A uses a personal computer (PC) as a central processor. The PC houses several components as standard equipment. These include the acoustic processor input/output (APIO) board, a video card, a CD-RW drive, and a floppy disk drive.

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General Information: System Description

The optional Physio module installs in one of the PC’s front drive bays. An optional magneto-optical disk (MOD) drive can also be installed in one of the drive bays. The VCR option includes three boards that reside in the PC’s PCI slots, and a VCR that mounts on the cart.

See “Internal PC” on page 39 for more detailed information about the PC and its components.

System Monitor

e-box

System Control Panel

The monitor at the top of the cart is a 15-inch color display mounted on a “twivel” assembly. The twivel allows tilt and swivel positioning of the display for ease of viewing.

The e-box houses the scanner circuit boards, and is accessible by opening the door at the right rear of the cart.

There are several circuit boards in the e-box:

• Two transmit and receive (TR) boards

• A beam processor/acoustic processor (BPAP) board

• A demodulator board

• The system motherboard

• The distribution board

The system control panel at the top front of the cart is a replaceable, self-contained module. See

“Replacing the System Control Panel” on page 159. The panel interfaces with the imaging system

through a USB cable that connects to the internal PC. Power for the trackball is provided via the USB cable. All the other control-panel functions are powered by a cable from the system power supply.

The system control panel contains a backlit alphanumeric keyboard, slide controls, rotary controls, hard-coded and software-driven keys, and a trackball.

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General Information: Optional Peripherals (VCR, Printers, and Image Devices)

Physio Module

Powe r Supply

Optional

The optional Physio module (see “Physio Module Option” on page 43) installs in one of the PC drive bays. The front panel of the module bears two input connectors:

• A 3-lead ECG physio connector

• An auxiliary analog input (standard ¼-inch phone jack)

An externally generated auxiliary analog input signal using the phone jack can substitute for the 3-lead ECG physio connector at the front panel. You can also input an auxiliary ECG waveform from an external patient monitor and display it, in all modes. The R-wave from this signal can serve as a time reference for the system.

The power supply is an enclosed, self-contained, replaceable module that mounts under the e-box at the right side of the cart. It accepts AC input sources from 100 V to 240 V, at 50 Hz or 60 Hz.

The power supply provides all required AC and DC voltages to the system. Three switched 120 VAC outlets for powering the monitor and two peripheral devices are at the rear of the power supply. An unswitched outlet powers the M2540A’s internal PC. When the system is shut down, only the 120 VAC outlet to the PC is enabled. A green LED on the left front of the power supply lights when the power supply is energized.

The M2540A supports several types of optional peripheral devices:

Peripherals (VCR, Printers, and Image Devices)

• VCRs, including NTSC-format and PAL-format models

• Thermal color and thermal black-and-white printers

• Various biopsy kits (See “Supplies and Accessories” on page 202.)

• A magneto-optical disk (MOD) drive for data storage

“Optional Peripherals” on page 201 lists all peripherals supported by the ultrasound system.

Some peripherals mount on a shelf below the system control panel.

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General Information: Preset Functions

Preset Functions

The ultrasound system includes programmable presets that configure the system for best imaging results in a particular situation. Activating a preset initializes system settings to values that are optimal for a chosen exam. The factory installed software includes several presets, tailored to different applications. The user can define as many as 20 additional presets in each of 8 exam types, to adjust system variables (including acoustic power) to any required configuration.

For specific information regarding the configuration and use of presets or other features of the system, see the online Help file.

NOTE Backing up presets to a floppy disk safeguards them and preserves the operator’s

preferred configurations. If preset configurations are subsequently changed, they can be quickly restored from the backup copy, without having to reset them manually. Keeping a backup copy also eliminates the need to manually reconfigure the presets after a software upgrade. See “Backing Up and Restoring Presets” on page 143 for the procedures to back up and restore presets.

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General Information: Keyboard Equivalencies

Keyboard Equivalencies

Some of the keys found on a standard PC keyboard are not present on the M2540A. Many of the functions performed by those keys are mapped to keys that are present on the M2540A keyboard. The M2540 keys act as PC-equivalent keys whenever the ultrasound application is not running. The following table lists the missing PC keys and their equivalents on the M2540A:

Table 1-1 Keyboard Equivalents

PC Key M2540A Key PC Key M2540A Key

F1 Patient F9 Blank 1

F2 Preset F10 Blank 2

F3 Review F11 Blank 3

F4 Report F12 Probe

F5 Setup Esc THI

F6 Help Delete Fusion

F7 VCR Page Up Left

F8 Mic Page Down Right

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General Information: Safety Specifications

Safety Specifications

Safety Limits

This section describes the safety specifications of the M2540A.

Table 1-2 Safety Limits

Parameter Specification

Power supply Complies with IEC60601-1

Ground wire leakage See Section 6, “Performance Tests”, and the Safety and Standards Guide

shipped with the M2540A.

System tip over Will not tip over on an incline of up to 10° under normal use.

Wheel locks With wheel locks engaged, system remains stationary on slopes of up

to 5 ° in any orientation.

System surface temperature

Potentially hazardous components

External sharp edges The system exterior has no sharp edges, in compliance with IEC

System surfaces do not exceed temperature limits specified in IEC 60601-1 and EN 60601-1

The power supply and monitor comply with UL 2601-1 1997.

60601-1 and EN 60601-1

Regulatory Compliance

For information about applicable safety standards and specifications, consult the Safety and Standards Guide shipped with the M2540A.

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Specifications:

2Specifications

This section lists the specifications of the M2540A ultrasound system. The following specification types are included in this section:

• “Physical Dimensions” on page 14

• “Electrical Specifications” on page 19

• “Monitor” on page 19

• “Transducer Specifications” on page 20

• “Connection and Communication Specifications” on page 21

• “Physio Port Specifications” on page 23

• “Audio/Video Specifications” on page 23

M2540-92000-01 A M2540 Ultrasound System Field Service Manual Page 14

Specifications: Physical Dimensions

Physical

The tables and diagrams that follow detail the physical specifications of the M2540A.

Dimensions

Table 2-1 Physical Specifications

Parameter Specification Reference

Dimensions

Depth (front to back) 103 cm (40.5 inches) See Figure 2-2

Width 53.5 cm (21 inches) See Figure 2-1

Height (to monitor top) Lowest position: 129.5 cm (51 inches)

Highest position: 147.5 cm (58 inches)

Height of lower enclosure 76.2 cm (30 inches) See Figure 2-2

Monitor to control panel front edge 43.18 cm (17 inches) See Figure 2-2

Monitor depth (front to back)

Weight Less than 91 kg (200 lbs) including display but no peripherals See Figure 2-2

Environmental Operational

41.71 cm (16.42 inches) See Figure 2-2

Temperature range: 0° to 40° C Relative humidity: 20% to 80% Atmospheric pressure: 572hPa to 1013 hPa

(VCR and printers temperature limit: 0° to 40° C at 80% RH)

See Figure 2-1

Storage Temperature range: –40° to 55° C Relative humidity: 20% to 90%, non-condensing Atmospheric pressure: 572hPa to 1013 hPa

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Specifications: Physical Dimensions

Figure 2-1 System Front Dimensions

Range:

129.5 cm (51 in) -

147.5 cm (58 in)

53.5 cm (21 in)

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Specifications: Physical Dimensions

Figure 2-2 System Side Dimensions

41.71 cm (16.42 in)

43.18 cm (17 in)

99 cm (39 in)

95.25 cm (37.5 in)

74.3 cm (29.25 in)

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Specifications: Physical Dimensions

Figure 2-3 System Rear Dimensions

Range:

129.5 cm (51 in) -

147.5 cm (58 in)

53.5 cm (21 in)

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Specifications: Physical Dimensions

Figure 2-4 System Top Dimensions

39.4 cm (15.5 in)

33 cm (13 in)

72.6 cm (28.5 in)

53.45 cm (21 in)

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Specifications: Electrical Specifications

Electrical Specifications

Monitor

Table 2-2 Electrical Specifications

Parameter Specification

AC input 90 VAC to 264 VAC, 47 Hz to 63 Hz

Ground impedance 200 milliohm maximum

Dielectric withstand 1500 VAC mains to safety ground

2000 V mains to AC secondaries 4000 V mains to DC secondaries

Load 1150 VA maximum.

AC output 120 VAC, 60 Hz, quasi square-wave, 500 VA maximum

Table 2-3 Main Display

Parameter Specification

Screen size 15-inch diagonal

Display format VGA, 800x600

75 Hz refresh rate RGB color display

Features Tilt ±30 degrees

Swivel ±135 degrees

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Specifications: Transducer Specifications

Transducer Specifications

The following table lists the specifications of the transducers that the M2540A supports.

Table 2-4 Transducers

Part

Description

Number Frequency Connector

21330A Cannon

S8 21350A Cannon

S12 21380A Cannon

3540 biopsy capable 1

21321A 3.5 MHz Cannon

EC6509 endocavity 21336A Cannon

L7535 linear

21359A 7.5 MHz Cannon

TEE (Omni II) 21369A 6 MHz Cannon

L1038A small parts 21376A Cannon

15-6L intraoperative 21390A Cannon

PA 4-2 biopsy capable 21422A 2 to 4 MHz Advance Vision

CA 5-2 21425A 2 to 5 MHz Advance Vision

D1914c 21221B 1.9 MHz Pencil

1. This transducer is compatible with the M2540A, but is only sold separately.

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Specifications: Connection and Communication Specifications

Connection and Communication Specifications

System I/O Por ts

The following tables list the communication and connector specifications of the M2540A.

PC Ports

The following table lists the ports on the rear of the internal PC and describes their locations.

Table 2-5 PC Ports

Port Specification

Composite video output (optional)

S-Video output (optional)

S-Video input (optional)

Print trigger output 3.5-mm phone jack on APIO board

VCR audio output (line out) (optional)

VCR audio input (line in)

Female phono (RCA) on TV and video converter board

4-pin mini circular DIN on SVGA to TV video card

4-pin mini circular DIN on video capture card

Green 3.5-mm stereo phone jack on sound card

Blue 3.5-mm stereo phone jack on sound card

Microphone Pink 3.5-mm stereo phone jack

Speakers Green 3.5 mm stereo phone jack to system speaker amplifier

Monitor 15-pin D connector on graphics adapter board

Foot switch 9-pin female D-sub connector on the APIO board that carries

foot switch signals from the external I/O panel

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Specifications: Connection and Communication Specifications

Table 2-5 PC Ports (Continued)

Port Specification

Com 1 9-pin D connector, RS-232; spare serial port used for serial

VCRs

Keyboard DIN circular connector

Mouse DIN circular connector

Token ring 50-pin connector on the APIO board

LAN RJ-45 to I/O panel for network communication

USB USB (A) for data and power to system control panel

USB For black-and-white thermal printer

USB For color printer

USB For remote plain-paper printer

PS-2 keyboard Not used

PS-2 mouse Not used

Parallel port Not used

Audio input on main board Not used

1. Only available with VCR option or external video/print option

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Specifications: Physio Port Specifications

I/O Panel Ports

Physio Port Specifications

The following table lists the ports on the I/O panel and the signals they carry.

Table 2-6 I/O Panel Ports

Port Connector Signal

Composite video BNC Composite video signal from SVGA board

Foot switch D-sub 9 Control signal from foot switch to APIO board

Defaults are: record, freeze, and record 2 Each signal is a contact closure to ground, active low, and

TTL compatible

Print BNC Trigger signal from APIO board

LAN RJ-45 Communication with local area network

The following table lists the specifications of the M2540A’s physio ports.

Table 2-7 Physio Port Specifications

Port Specification

ECG 3 patient leads with R-wave detection

Monitoring quality only Frequency response: 1 ±0.5 to 30 ±6 Hz

Audio/Video Specifications

Sensitivity: 3 mVpp ±2.5 mV for full scale at 100% gain

Aux 1 3-dB bandwidth: full scale DC to 100 Hz minimum

Maximum input signal: ±4 V Sensitivity: 2.5 ±0.5 Vpp for full scale at 100% gain

The following tables list the audio and video specifications of the M2540A.

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Specifications: Audio/Video Specifications

Audio

Table 2-8 Audio Specifications

Description Specification

Speakers Stereo—VCR, Doppler

Doppler spectrum toward transducer — left speaker Doppler spectrum away from transducer — right speaker Maximum power input: 4 watts Impedance: 8 ohms

External Video

Frequency Response

Microphone Faces front. 10 Hz to 20 KHz electret type

Table 2-9 External Video Specifications

Description Specification

Color Composite NTSC 3.58 (USA), PAL 4.43 (Europe)

Print Trigger 1 signal from the APIO board

130 Hz to 12 KHz

1.0 V p to p ±5% into 75 ohms (only with VCR option)

Active low: ON = 0.5 V max @ 1 mA; OFF = 5.25 VDC maximum voltage

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Specifications: Audio/Video Specifications

Video Output Specifications

Table 2-10 Video Output Specifications

Output Specification

RGBSync to system

0.7 Vpp RGB with TTL sync

monitor

S-Video Output to VCR

1.0 Vpp luminance incorporating sync and 0.3 Vpp chrominance as shown in Ta bl e 2 -9 . This timing is essentially RS-170 (60 Hz) or CCIR (50Hz) video timing.

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Safety:

3Safety

This section provides an overview of safety considerations for the ultrasound system. These safety concerns apply to patients, operators, and service engineers. For more detailed safety information, see the Philips Safety and Standards Guide.

The following topics are included in this section:

• “Transmit Power (Acoustical)” on page 27

• “Acoustic Exposure” on page 27

• “AIUM/NEMA Output Display Standard” on page 28

• “Explosive Hazards” on page 30

• “Electrical Warnings” on page 31

• “Peripheral Connections” on page 31

• “Glutaraldehyde Exposure” on page 32

• “Moving the System” on page 32

• “Electromagnetic Compatibility” on page 35

• “Restrictions for Use” on page 36

• “Electrosurgical Units” on page 37

M2540-92000-01 A M2540 Ultrasound System Field Service Manual Page 27

NOTES

Safety: Transmit Power (Acoustical)

Tr a ns m i t Power (Acoustical)

Acoustic output, expressed as an index, is displayed on the screen to allow the best possible diagnostic image with minimal power output. A display standard presents this index using one of the following four power indices:

• Mechanical index (MI)

• Thermal index for soft tissue (TIS)

• Thermal index for bone (TIB)

• Thermal index for cranial bone (TIC)

The index setting on the System Setup menu selects the power index used. The displayed index is based on this setting and on preset configuration and imaging mode.

• The power index setting on the System Setup menu selects any of the four power indices for display at any time.

• The Powe r rotary control at the right side of the system control panel is the only control that affects transmit power level.

For additional information on acoustical power settings and power index, see the Philips Safety and Standards Guide.

Acoustic Exposure

Although no harmful effects have been demonstrated for any of the ultrasound frequencies, intensities, and exposure times used in examinations with Philips ultrasound systems, Philips recommends that you consider the following, and use the lowest ultrasound exposure that produces diagnostically acceptable information:

• Use diagnostic ultrasound only when there is a good medical reason.

• Reset the controls at the start of every examination.

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Safety: AIUM/NEMA Output Display Standard

• Reduce exposure time, independent of acoustic index value.

• Use techniques that let you collect clinical data quickly and end the examination promptly.

• Select a transducer that provides good resolution and focal depth for the region of interest.

Then use the imaging controls to fine-tune image resolution.

For more detailed information on acoustic exposure, see the Output Display Standards and ODS Acoustic Tables booklet.

AIUM/NEMA Output Display Standard

In compliance with the Output Display Standard (ODS) jointly proposed by the American Institute of Ultrasound in Medicine and the National Electrical Manufacturers Association, the Philips ultrasound system displays power output indices related to the potential for bioeffects.

Real-time information related to the power output is displayed on the monitor, indicating the type of index displayed and the value of that index for the acoustic output currently being used. For example, if the output corresponds to a mechanical index of 0.8, the following is displayed:

MI: 0.8

The displayed index is one of four types: MI, TIS, TIB, or TIC. These ultrasound abbreviations conform to the AIUM/NEMA Output Display Standard.

Soft tissue thermal index (TIS) is used in cardiac, fetal, and abdominal scanning.

The thermal index for bone (TIB) is used in applications such as second or third trimester fetal scanning and neonatal cephalic (through the fontanelle) scanning.

The cranial bone thermal index (TIC) is used for transcranial imaging.

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Safety: AIUM/NEMA Output Display Standard

NOTE The power index displayed on the screen depends on the preset type, the active

transducer type, the imaging mode, and the selected power index. Any of the four power indices is selectable for display at any time, using the power index setting in the

System Setup menu.

Automatic Index Selection

For automatic selection of a power index based on system mode, the user selects the power index setting of Normal from the System Setup menu. This directs the system to choose an index based on the active preset and imaging mode.

When MI is Displayed With the Normal Setting

MI is displayed if any of the following conditions exist:

• 2D Only is the active imaging mode.

• Black-and White MMode Preview is the active imaging mode.

• Black-and White Doppler Preview is the active imaging mode.

• Black-and White Doppler 2D Live is the active imaging mode.

When TIS is Displayed With Normal Setting

If none of the conditions in “When MI is Displayed With the Normal Setting” on page 29 exist, if no transcranial preset is active, and any of the following conditions exist, TIS displays:

• Color is turned on.

• Angio is turned on.

• MMode Trace is the active imaging mode.

• Doppler Spectral is the active imaging mode (with 2D Live off).

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Safety: Explosive Hazards

When TIC is Displayed With Normal Setting

If none of the conditions in “When MI is Displayed With the Normal Setting” on page 29 exist, a transcranial preset is active, and any of the following conditions exist, TIS displays:

• Color is turned on.

• Angio is turned on.

• MMode Trace is the active imaging mode.

• Doppler Spectral is the active imaging mode (with 2D Live off).

If the user selects an ODS setting other than Normal, the selected index type is used as the preferred acoustic power display format, regardless of the mode, the transducer, or the preset that is selected.

The displayed index value does not provide an exact value of the potential for adverse bioeffects in the patient. However, for any patient, the higher the value, the higher the potential for adverse bioeffects. The user can minimize the potential for bioeffects by keeping the index value as low as possible, by choosing the right transducer and making adjustments. Minimizing examination time also minimizes bioeffects.

WAR NING

Explosive Hazards

The ODS power index formulas were defined for reasonable worst case patient conditions. It is

likely that a particular patient's actual conditions are better than indicated by the index. The operator should be aware of patient conditions that mitigate the actual exposure.

Observe the following practices to avoid explosive hazards:

• Do not operate the system in the presence of flammable anesthetics.

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