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Technical Manual

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Terason t3000cv™ Ultrasound

Technical Manual
Terason t3000cv Ultrasound System Technical Manual
Copyright © 1999-2014 by Terason™, a division of Teratech Corporation. All
rights reserved.

Information in this document is subject to change without notice and should not
be construed as a commitment by Terason.

Terason™ is a trademark. Other trade names, trademarks, or registered

trademarks are property of their respective holders. FireWire® is a registered
trademark of Apple Computer, Inc.

Reproduction, adaptation, or translation without prior written permission is

prohibited, except as allowed under copyright laws.

February 2014
Part number 16-3305-01

Terason, a Division of Teratech Corporation

77–79 Terrace Hall Avenue
Burlington, MA 01803
U.S.A.
Contents

Introduction .................................................................................................................................... 6
Chapter 1 Setting Up the Ultrasound System
Upgrading Terason Software .................................................................................. 7

Chapter 2 Terason Probes

Probe Specifications ................................................................................................9
Acoustic Output Reporting for Track 3 ................................................................ 10
Acoustic Output Tables for t3000cv Probes ................................................. 11

Chapter 3 Maintenance
Processing Terason Probes Between Uses ....................................................... 38
Cleaning and Disinfecting Terason Probes .................................................. 38
Noncritical Device Applications ............................................................... 38
Semicritical Device Applications ............................................................. 40
Recommended Maintenance ................................................................................ 42

Chapter 4 System Safety

Infection Control ..................................................................................................... 43
Sterile Probe Covers ....................................................................................... 43
Disinfection ....................................................................................................... 44
Safety Cautions and Warnings ............................................................................. 45
Cautions ............................................................................................................ 45
Sale and Use ............................................................................................. 45
Terason Probes ......................................................................................... 45
Ultrasound System .................................................................................... 45
Allergies ...................................................................................................... 45
System Covers .......................................................................................... 45
Electrical Shock Hazard ........................................................................... 46
Electrical Fast Transients (EFT) .............................................................. 47
Surges to AC Power Mains ...................................................................... 47
RF Interference .......................................................................................... 47
Protection From Liquid Spills, etc. .......................................................... 47
Explosive .................................................................................................... 49
Battery Pack Usage/Disposal .................................................................. 49
Recycling/Disposal After Useful Life ....................................................... 49
Warnings ...........................................................................................................49
Intended Use ..............................................................................................49
Electromagnetic Interference (EMI) ........................................................ 51
Electrostatic Discharge (ESD) .................................................................51
Liquids ......................................................................................................... 51
Couplants ................................................................................................... 51

Terason t3000cv Ultrasound System Technical Manual 3

Contents

Heat ............................................................................................................. 51
Latex ...........................................................................................................51
Care ............................................................................................................. 52
Immersion ................................................................................................... 52
HF (High Frequency) Surgical Equipment ............................................. 52
Labels ...................................................................................................................... 52
System Label Icons ......................................................................................... 52
Manufacturer Mark ................................................................................... 52
Type BF Equipment Applied Part ............................................................ 52
Terason Ultrasound System Emits Ultrasound Energy ........................ 53
Double Insulated ....................................................................................... 53
Indoor Use Only ......................................................................................... 53
CE Mark ...................................................................................................... 53
U.S. and Canada Safety Standards ........................................................ 53
See User Guide ......................................................................................... 54
Dispose of Properly ................................................................................... 54
Shipping Label Icons ....................................................................................... 54
Environmental ............................................................................................ 54
Air Pressure ............................................................................................... 54
Temperature ............................................................................................... 54
Terason Probes ......................................................................................... 54
Safety Standards .................................................................................................... 55
Ultrasound Safety ............................................................................................ 55
Electrical Safety ............................................................................................... 55
Surface Heating of Invasive Probes .............................................................. 55
Indications For Use ................................................................................................ 56
Acoustic Output Indices ......................................................................................... 65
General Description of Indices ....................................................................... 65
MI: The Mechanical Index .............................................................................. 66
TIS: The Soft Tissue Thermal Index ............................................................. 66
TIB: The Bone Tissue Thermal Index ........................................................... 66
TIC: The Cranial (Bone) Thermal Index ....................................................... 67
Relevant Acoustic Output Indices .................................................................67
Acoustic Output Index Displays ..................................................................... 67
Index Display ............................................................................................. 68
Control of Acoustic Index Parameters ....................................................68
Accuracy of Acoustic Output Display ..................................................... 69
Relationship of Index to Display Accuracy ......................................................... 74
Display Precision of TI Values ....................................................................... 74
Display Precision of MI Values ....................................................................... 75
Acoustic Output Tables .......................................................................................... 76
Accuracy Measures ............................................................................................... 77
Distance Accuracy ........................................................................................... 77
Area ................................................................................................................... 78
Circumference .................................................................................................. 78
Volume .............................................................................................................. 78
Compliance and Approvals ................................................................................... 79
Environmental Protection ...................................................................................... 79
Product Recycling and Disposal .................................................................... 79
Caring for Batteries .......................................................................................... 79

Terason t3000cv Ultrasound System Technical Manual 4

Contents

Recycling Batteries .......................................................................................... 80

Disposing of the Packaging Materials ........................................................... 80
Disposing of Components and Accessories ................................................ 81
Energy Conservation ....................................................................................... 81

Chapter 5 System Specifications

Ultrasound System Specifications ....................................................................... 82
Optional Equipment Specifications ...................................................................... 83

Chapter 6 Electromagnetic Tables

Electromagnetic Emissions ................................................................................... 84
All Equipment ................................................................................................... 84
Electromagnetic Immunity ..................................................................................... 85
All Equipment ................................................................................................... 85
Non-Life-Supporting Equipment .................................................................... 86
Separation Distances ............................................................................................. 87

Chapter 7 Formulas Used for Values in the Cardiac Report

Formulas Used for Measurements in the 2D Window ..................................... 88
Formulas Used for Measurements in the M-Mode Window ............................ 90
Formulas Used for Measurements in Doppler Windows .................................. 92

Chapter 8 Gestational Tables

Tables Used in Gestational Calculations ............................................................ 95
Gestational Age ...................................................................................................... 95
Fetal Growth ............................................................................................................ 96
Estimated Fetal Weight ......................................................................................... 96
Fetal Ratios ............................................................................................................. 97
Index .................................................................................................................................................... 98

Terason t3000cv Ultrasound System Technical Manual 5

Introduction

This manual includes safety information, technical data, and formulae required for safe
and proper use of the Terason Ultrasound system.
It also includes maintenance information to help you keep your Terason system operating
properly.
Not all information in this manual applies to all Terason Ultrasound systems. For instance,
your system will not be equipped with every probe listed.
This manual comprises the following chapters:
• Chapter 1, Setting Up the Ultrasound System, on page 7
• Chapter 2, Terason Probes, on page 9
• Chapter 3, Maintenance, on page 38
• Chapter 4, System Safety, on page 43
• Chapter 5, System Specifications, on page 82
• Chapter 6, Electromagnetic Tables, on page 84
For information on how to use the Terason Ultrasound system, refer to the User Guide for
your system.

Terason t3000cv Ultrasound System Technical Manual 6

1 Setting Up the Ultrasound System

When you purchase the Terason Ultrasound System, it comes with all the required
software already installed on the laptop. You may never need the information in this
chapter unless you upgrade your system.
To set up the system after unpacking it, refer to the setup sheet packed with the system.
If you purchased a cart, printer, or other accessory, refer to the setup instructions that came
with the accessory.

Upgrading Terason Software

When upgrading software, the Terason installer first removes the existing version, and
then installs the new version.
To upgrade to a newer version of the Terason software, complete these steps:
1. Exit all applications and unplug the Terason probe from the engine.
2. Insert the Terason CD into the CD-RW drive. The Uninstall dialog opens.
3. Click Next>. The Confirm Uninstall dialog box opens.
4. Click OK to confirm. If you see a dialog box that includes a check box, select the Don’t
display this message again check box and click Yes.

The installer removes all of the previous Terason software and displays a completion
message, recommending that you reboot.

Uninstall Complete Dialog Box

Terason t3000cv Ultrasound System Technical Manual 7

Chapter 1 - Setting Up the Ultrasound System Upgrading Terason Software

5. Click Finish. Keep the Terason CD in the drive and wait while the computer reboots
(restarts).
After the computer finishes starting up, you may have to log on before proceeding.
When you are logged in, the Welcome dialog for the new Terason application opens.
6. Click Next>. The License Agreement dialog appears. Read the License Information
carefully.
7. Click Yes. The Choose Destination Location dialog box opens.
8. Click Next> to install the application in the default location. You can click Browse to
select a different location (not recommended). The wizard reminds you to unplug the
Terason Probe.

Reminder to Unplug the Probe

9. Click OK. The installer copies the files to the selected location. When finished, the
installer displays a setup complete message.

Installation Complete Message

If you see “Rebooting is required,” you must restart your computer before you use the
Terason software.
10. Click Finish.
Remember to connect the probe.

Terason t3000cv Ultrasound System Technical Manual 8

2 Terason Probes
Probe Specifications
The Terason Ultrasound System consists of the probe, electronics envelope, and the
Terason software. All of the Terason probes can be used with all scan modes.
The following table describes the supported probes. Also see Infection Control on
page 43, Indications For Use on page 56, Processing Terason Probes Between Uses on
page 38, and Ultrasound System Specifications on page 82.
Terason Probe Specifications

Probe Elements Description Applications

4V2A 64 Phased-array probe with a Cardiac (adult) Cardiac (pediatric)

a user-controllable field-of-
view

5C2A 128 Curved linear array probe Adult abdominal Pediatric abdominal
with a a user-controllable OB/GYN Musculoskeletal
field-of-view Fetal heart Obstetric (1st trimester)
Renal Obstetric (2nd & 3rd
trimester)
8EC4A 128 Convex-linear endocavity Gynecological Prostate
array probe with a and a Obstetric
140° field-of-view

8V3A 96 Phased-array probe Adult cardiac Pediatric cardiac

12L5A 128 Linear-array probe Arterial Musculoskeletal

Breast (superficial)
Carotid Musculoskeletal (deep)
Testes Venous
Thyroid

12L5V 128 Linear-array probe Arterial Musculoskeletal

Breast (superficial)
Carotid Musculoskeletal (deep)
Testes Venous
Thyroid

PDOF 1 Single-element probe Cardiac

Terason t3000cv Ultrasound System Technical Manual 9

Chapter 2 - Terason Probes Acoustic Output Reporting for Track 3

Acoustic Output Reporting for Track 3

Terason follows Track 3 of the FDA's Information for Manufacturers Seeking Marketing
Clearance of Diagnostic Ultrasound Systems and Probes. Track 3 does not require
evaluation of acoustic output on an application-specific basis, but the global maximum
derated ISPTA must not exceed 720 mW/cm2 and the global maximum MI must not exceed
1.9.
This chapter contains tables that display the Acoustic Output Reporting for Track 3.
Tables are shown for the scanning modes for the following probes:
• 4V2A - see page 11
• 5C2A - see page 16
• 8EC4 - see page 20
• 8V3A - see page 24
• 12L5A - see page 29
• 12L5V - see page 33
• PDOF - see page 31

Terason t3000cv Ultrasound System Technical Manual 10

Chapter 2 - Terason Probes Acoustic Output Reporting for Track 3

Acoustic Output Tables for t3000cv Probes

Acoustic Output Reporting Table for Track 3 for the 4V2A Probe
(Terason t3000cv Ultrasound System in 2D Mode)

MI TIS TIB TIC

Index Label Scan Non- scan Non-
Aapr  1cm2 Aaprt >1cm2 scan
Maximum Index Value 1.57 2.46 - - - 3.98
USFDA Track 3 IEC

pr.3 pra (MPa) 2.62

Wo P (mW) 157.32 - - 198.30
min of [W.3(z1), Min of [P(zs), (mW) -
ITA.3(z1)] Ita, (zs)]
z zs (cm) -
Associated 1
Acoustic zbp zbp (cm) -
Parameter
zsp zb (cm) 3.58 -
deq(zsp) deq(zb) (cm) -
fc fawf (MHz) 2.80 3.29 - - - 1.75
Dim of Aaprt Dim of Aaprt X (cm) 1.02 - - - 1.02
Y (cm) 1.20 - - - 1.20
PD td (µsec) 0.54
PRF prr (Hz) 41.8
Other pr@PIImax pr at max. Ipi (MPa) 3.49
Information deq@PIImax deq at max Ipi (cm) -
Focal Length FL (cm) 4.0 - - 4.0
IPA.3 @MImax Ipa, at max. MI (W/cm2) 278.77

Control 1 X
Operating
Control 2 X
Control
Conditions Control 3 X
Control 4

Note: 1. Information need not be provided for any formulation of TIS not yielding the maximum value of
TIS for that mode.
2. Information need not be provided regarding TIC for any probe assembly not intended for
transcranial or neonatal cephalic uses.
3. Information on MI and TI need not be provided if the equipment meets both exemption clauses
given in 51.2 aa) and 51.2 dd).

ontrol 1: THI = off, Sector depth = 13.0 cm, Focus = 4.0 cm, Frequency = 3.0 MHz, Focus # = 1
Control 2: THI = off, Sector depth = 8.0 cm, Focus = 4.0 cm, Frequency = 4.0 MHz, Focus # = 1
Control 3: THI = on, Sector depth = 6.0 cm, Focus = 4.0 cm, Frequency = 1.71 MHz, Focus # =

Terason t3000cv Ultrasound System Technical Manual 11

Chapter 2 - Terason Probes Acoustic Output Reporting for Track 3

Acoustic Output Reporting Table for Track 3 for the 4V2A Probe
(Terason t3000cv Ultrasound System in M-Mode)

MI TIS TIB TIC

Index Label Scan Non- scan Non-
Aapr  1cm2 Aaprt >1cm2 scan

Maximum Index Value 1.57 2.38 - Note 1 0.41 3.96

USFDA Track 3 IEC

pr.3 pra (MPa) 2.62

Wo P (mW) 152.22 - 19.36 249.44
min of [W.3(z1), Min of [P(zs), (mW) -
ITA.3(z1)] Ita, (zs)]
z zs (cm) -
Associated 1
Acoustic zbp zbp (cm) -
Parameter
zsp zb (cm) 3.58 5.07
deq(zsp) deq(zb) (cm) 0.54
fc fawf (MHz) 2.80 3.29 - - 1.97 1.99
Dim of Aaprt Dim of Aaprt X (cm) 1.02 - - 1.63 1.63
Y (cm) 1.20 - - 1.20 1.20
PD td (µsec) 0.54
PRF prr (Hz) 240
Other pr@PIImax pr at max. Ipi (MPa) 3.49
Information deq@PIImax deq at max Ipi (cm) 0.51
Focal Length FL (cm) 4.0 - - 7.0
IPA.3 @MImax Ipa, at max. MI (W/cm2) 278.77

Control 1 X
Operating
Control 2 X
Control
Conditions Control 3 X
Control 4 X

Control 1: THI = off, Sector depth = 11.0 cm, Focus = 4.0 cm, Frequency = 3.0 MHz
Control 2: THI = off, Sector depth = 6.0 cm, Focus = 4.0 cm, Frequency = 4.0 MHz
Control 3: THI = off, Sector depth = 21.0 cm, Focus = 13.0 cm, Frequency = 2.0 MHz
Control 4: THI = off, Sector depth = 7.0 cm, Focus = 7.0 cm, Frequency = 2.0 MHz

Terason t3000cv Ultrasound System Technical Manual 12

Chapter 2 - Terason Probes Acoustic Output Reporting for Track 3

Acoustic Output Reporting Table for Track 3 for the 4V2A Probe
(Terason t3000cv Ultrasound System in Color Flow Mode)

MI TIS TIB TIC

Index Label Scan Non-scan Non-
Aapr  1cm1 Aaprt >1cm1 scan
Maximum Index Value 1.40 2.13 - - - 4.22
USFDA Track 3 IEC
pr.3 pra (MPa) 2.27
Wo P (mW) 169.81 - - 266.24
min of [W.3(z1), Min of [P(zs), (mW) -
ITA.3(z1)] Ita, (zs)]
z1 zs (cm) -
Associated
Acoustic zbp zbp (cm) -
Parameter zsp zb (cm) 3.95 -
deq(zsp) deq(zb) (cm) -
fc fawf (MHz) 2.65 2.65 - - - 1.99
Dim of Aaprt Dim of Aaprt X (cm) 1.02 - - - 1.63
Y (cm) 1.20 - - - 1.20
PD td (µsec) 1.82
PRF prr (Hz) 1500
Other pr@PIImax pr at max. Ipi (MPa) 3.33
Information deq@PIImax deq at max Ipi (cm) -
Focal Length FL (cm) - - - 7.0
IPA.3 @MImax Ipa, at max. MI (W/cm2) 254.80

Operating Control 1 X
Control Control 2 X
Conditions Control 3 X

Control 1: B-Mode Frequency = 2.0 MHz, sector depth = 18.0 cm, focal depth = 16.0 cm, Color Doppler frequency =
2.7 MHz, Color Doppler focus = 5.5 cm, Frame Rate = 25.5 Hz, Color ROI = 0.83 cm, Packet size = 6,
transmit pulses = 5, PRF = 1500 Hz, Dual Beam on
Control 2: B-Mode Frequency = 2.0 MHz, sector depth = 6.0 cm, focal depth = 4.0 cm, Color Doppler frequency = 2.7
MHz, Color Doppler focus = 4.0 cm, Frame Rate = 3.88 Hz, Color ROI = 5.47 cm, Packet size = 14,
transmit pulses = 10, PRF = 13030 Hz, Dual Beam off
Control 3: B-Mode Frequency = 1.67 MHz, sector depth = 7.0 cm, focal depth = 7.0 cm, Color Doppler frequency = 2.0
MHz, Color Doppler focus = 7.0 cm, Frame Rate = 4.5 Hz, Color ROI = 7.28 cm, Packet size = 14, transmit
pulses = 10, PRF = 7720 Hz, Dual Beam on

Terason t3000cv Ultrasound System Technical Manual 13

Chapter 2 - Terason Probes Acoustic Output Reporting for Track 3

Acoustic Output Reporting Table for Track 3 for the 4V2A Probe
(Terason t3000cv Ultrasound System in Pulsed-Wave Doppler Mode)

MI TIS TIB TIC

Index Label Scan Non- scan Non-
Aapr  1cm2 Aaprt >1cm2 scan

Maximum Index Value 1.57 - - 1.87 5.06 4.16

USFDA Track 3 IEC

pr.3 pra (MPa) 2.43

Wo P (mW) - - 246.16 245.23
min of [W.3(z1), Min of [P(zs), (mW) 164.60
ITA.3(z1)] Ita, (zs)]
z zs (cm) 2.33
Associated 1
Acoustic zbp zbp (cm) 2.29
Parameter
zsp zb (cm) 3.75 4.93
deq(zsp) deq(zb) (cm) 0.56
fc fawf (MHz) 2.40 - - 2.39 1.99 1.99
Dim of Aaprt Dim of Aaprt X (cm) - - 1.52 1.52 1.52
Y (cm) - - 1.20 1.20 1.20
PD td (µsec) 3.18
PRF prr (Hz) 700
Other pr@PIImax pr at max. Ipi (MPa) 3.03
Information deq@PIImax deq at max Ipi (cm) 0.53
Focal Length FL (cm) - - 13.0 16.5
IPA.3 @MImax Ipa, at max. MI (W/cm2) 259.21

Control 1 X
Operating
Control 2 X
Control
Conditions Control 3 X
Control 4 X

Control 1: Sector depth = 24.0 cm, Focus = 3.0 cm, B-Mode Frequency = 3.0 MHz, PWD Frequency = 2.4 MHz, SV
Size = 2.5 mm, SV Depth = 5.5 cm, PRF = 700 Hz, Update = off
Control 2: Sector depth = 24.0 cm, Focus = 3.0 cm, B-Mode Frequency = 3.0 MHz, PWD Frequency = 2.4 MHz, SV
Size = 2.5 mm, SV Depth = 12.4 cm, PRF = 5100 Hz, Update = off
Control 3: Sector depth = 24.0 cm, Focus = 3.0 cm, B-Mode Frequency = 2.0 MHz, PWD Frequency = 2.0 MHz, SV
Size = 5.0 mm, SV Depth = 16.5 cm, PRF = 2000 Hz, Update = off
Control 4: Sector depth = 24.0 cm, Focus = 3.0 cm, B-Mode Frequency = 2.0 MHz, PWD Frequency = 2.0 MHz, SV
Size = 5.0 mm, SV Depth = 16.5 cm, PRF = 1500 Hz, Update = on

Terason t3000cv Ultrasound System Technical Manual 14

Chapter 2 - Terason Probes Acoustic Output Reporting for Track 3

Acoustic Output Reporting Table for Track 3 for the 4V2A Probe
(Terason t3000cv Ultrasound System in Continuous-Wave Doppler Mode)

MI TIS TIB TIC

Index Label Scan Non- scan Non-
Aapr  1cm2 Aaprt >1cm2 scan

Maximum Index Value 0.09 - 1.00 - 3.62 2.56

USFDA Track 3 IEC

pr.3 pra (MPa) 0.12

Wo P (mW) - 104.66 104.66 104.66
min of [W.3(z1), Min of [P(zs), (mW) -
ITA.3(z1)] Ita, (zs)]
z zs (cm) -
Associated 1
Acoustic zbp zbp (cm) -
Parameter
zsp zb (cm) 2.98 2.80
deq(zsp) deq(zb) (cm) 0.44
fc fawf (MHz) 2.00 - 2.00 - 2.00 2.00
Dim of Aaprt Dim of Aaprt X (cm) - 0.69 - 0.69 0.69
Y (cm) - 1.20 - 1.20 1.20
PD td (µsec) -
PRF prr (Hz) -
Other pr@PIImax pr at max. Ipi (MPa) 0.15
Information deq@PIImax deq at max Ipi (cm) 0.43
Focal Length FL (cm) - 8.0 - 4.0
IPA.3 @MImax Ipa, at max. MI (W/cm2) -

Control 1 X X X
Operating
Control 2 X
Control
Conditions Control 3
Control 4

Control 1: Sector depth = 24.0 cm, Focus = 3.0 cm, B-Mode Frequency = 2.0 MHz, CWD Frequency = 2.0 MHz, SV
Depth = 4.0 cm, Update = off
Control 2: Sector depth = 24.0 cm, Focus = 3.0 cm, B-Mode Frequency = 2.0 MHz, CWD Frequency = 2.0 MHz, SV
Depth = 8.0 cm, Update = off

Terason t3000cv Ultrasound System Technical Manual 15

Chapter 2 - Terason Probes Acoustic Output Reporting for Track 3

Acoustic Output Reporting Table for Track 3 for the 5C2A Probe
(Terason t3000cv Ultrasound System in 2D Mode)

MI TIS TIB TIC

Index Label Scan Non-scan Non-
Aapr  1cm 2 2 scan
Aaprt >1cm
Maximum Index Value 1.44 1.44 - - - Note 2
US FDA - Track
IEC
3
pr.3 pra (MPa) 2.45
Wo P (mW) 81.10 - - -
min of [W.3(z1), Min of [P(zs), -
(mW)
ITA.3(z1)] Ita, (zs)]
z1 zs (cm) -
Associated zbp zbp (cm) -
Acoustic zsp zb (cm) 4.60 -
Parameter deq(zsp) deq(zb) (cm) -
fc fawf (MHz) 2.89 3.72 - - - -
X 1.00 - - - -
Dim of Aaprt Dim of Aaprt
(cm)
Y 1.20 - - - -
(cm)
PD td (µsec) 0.46
PRF prr (Hz) 21.8
Other pr@PIImax pr at max. Ipi (MPa) 3.82
Information deq@PIImax deq at max Ipi (cm) -
Focal Length FL (cm) 4.0 - - -
(W/ 319.3
IPA.3 @MImax Ipa, at max. MI
cm2)
Operating Control 1 X
Control Control 2 X
Conditions Control 3
…

Control 1: Freq. = 3.0 MHz, sector depth = 13 cm, focus = 6.0 cm, focus # = 2, Sector width = S, Omni off
Control 2: Freq. = 4.0 MHz, sector depth = 4 cm, focus = 4.0 cm, focus # = 1, Sector width = S, Omni off

Terason t3000cv Ultrasound System Technical Manual 16

Chapter 2 - Terason Probes Acoustic Output Reporting for Track 3

Acoustic Output Reporting Table for Track 3 for the 5C2A Probe
(Terason t3000cv Ultrasound System in M-Mode)

MI TIS TIB TIC

Index Label Scan Non-scan Non-
Aapr  1cm 2 2 scan
Aaprt >1cm
Maximum Index Value 1.44 1.17 - Note 1 0.14 Note 2
US FDA - Track
IEC
3
pr.3 pra (MPa) 2.45
Wo P (mW) 85.32 - 4.27 -
min of [W.3(z1), Min of [P(zs), -
(mW)
ITA.3(z1)] Ita, (zs)]
z1 zs (cm) -
Associated zbp zbp (cm) -
Acoustic zsp zb (cm) 4.60 4.30
Parameter deq(zsp) deq(zb) (cm) 0.34
fc fawf (MHz) 2.89 2.89 - - 2.49 -
X 1.00 - - 1.50 -
Dim of Aaprt Dim of Aaprt
(cm)
Y 1.20 - - 1.20 -
(cm)
PD td (µsec) 0.46
PRF prr (Hz) 240
Other pr@PIImax pr at max. Ipi (MPa) 3.82
Information deq@PIImax deq at max Ipi (cm) 0.32
Focal Length FL (cm) 4.0 - - -
(W/ 319.3
IPA.3 @MImax Ipa, at max. MI
cm2)
Operating Control 1 X
Control Control 2 X
Conditions Control 3 X
…

Control 1: Freq. = 3.0 MHz, sector depth = 8 cm, focus = 6.0 cm, Sector width = L, Omni off
Control 2: Freq. = 3.0 MHz, sector depth = 4 cm, focus = 4.0 cm, Sector width = L, Omni off
Control 2: Freq. = 2.5 MHz, sector depth = 9 cm, focus = 6.0 cm, Sector width = L, Omni off

Terason t3000cv Ultrasound System Technical Manual 17

Chapter 2 - Terason Probes Acoustic Output Reporting for Track 3

Acoustic Output Reporting Table for Track 3 for the 5C2A Probe
(Terason t3000cv Ultrasound System in Color Mode)

MI TIS TIB TIC

Index Label Scan Non-scan Non-
2 2 scan
Aapr  1cm Aaprt >1cm
Maximum Index Value 0.83 2.12 - - - Note 2
US FDA - Track
IEC
3
pr.3 pra (MPa) 1.40
Wo P (mW) 140.24 - - -
min of [W.3(z1), Min of [P(zs), -
(mW)
ITA.3(z1)] Ita, (zs)]
z1 zs (cm) -
Associated zbp zbp (cm) -
Acoustic zsp zb (cm) 4.50 -
Parameter deq(zsp) deq(zb) (cm) -
fc fawf (MHz) 2.84 3.16 - - - -
X 1.00 - - - -
Dim of Aaprt Dim of Aaprt
(cm)
Y 1.20 - - - -
(cm)
PD td (µsec) 3.31
PRF prr (Hz) 1250
Other pr@PIImax pr at max. Ipi (MPa) 2.03
Information deq@PIImax deq at max Ipi (cm) -
Focal Length FL (cm) 4.0 - - -
(W/ 116.9
IPA.3 @MImax Ipa, at max. MI
cm2)
Operating Control 1 X
Control Control 2 X
Conditions Control 3
…

Control 1: B-Mode Frequency = 3.6 MHz, sector depth = 21.0 cm, focal depth = 6.0 cm, Color Doppler frequency = 2.9
MHz, Color Doppler focus = 6.0 cm, Frame Rate = 8.1 Hz, Color ROI = 0.89 cm, Packet size = 14, transmit
pulses = 10, PRF = 1250 Hz, Dual Beam Color, Single Beam B-Mode
Control 2: B-Mode Frequency = 4.0 MHz, sector depth = 26.0 cm, focal depth = 4.0 cm, Color Doppler frequency = 3.2
MHz, Color Doppler focus = 4.0 cm, Frame Rate = 2.3 Hz, Color ROI = 10.48 cm, Packet size = 14,
transmit pulses = 10, PRF = 4500 Hz, Single Beam Color, Single Beam B-Mode

Terason t3000cv Ultrasound System Technical Manual 18

Chapter 2 - Terason Probes Acoustic Output Reporting for Track 3

Acoustic Output Reporting Table for Track 3 for the 5C2A Probe
(Terason t3000cv Ultrasound System in PWD Mode)

MI TIS TIB TIC

Index Label Scan Non-scan Non-
2 2 scan
Aapr  1cm Aaprt >1cm
Maximum Index Value 1.36 - 1.30 Note 1 3.37 Note 2
US FDA - Track
IEC
3
pr.3 pra (MPa) 2.29
Wo P (mW) - 86.20 86.73 -
min of [W.3(z1), Min of [P(zs), -
(mW)
ITA.3(z1)] Ita, (zs)]
z1 zs (cm) -
Associated zbp zbp (cm) -
Acoustic zsp zb (cm) 4.40 1.30
Parameter deq(zsp) deq(zb) (cm) 0.47
fc fawf (MHz) 2.84 - 3.16 - 2.40 -
X - 0.80 - 0.50 -
Dim of Aaprt Dim of Aaprt
(cm)
Y - 1.20 - 1.20 -
(cm)
PD td (µsec) 3.62
PRF prr (Hz) 400
Other pr@PIImax pr at max. Ipi (MPa) 3.51
Information deq@PIImax deq at max Ipi (cm) 0.43
Focal Length FL (cm) - 4.0 - -
(W/ 308.05
IPA.3 @MImax Ipa, at max. MI
cm2)
Operating Control 1 X
Control Control 2 X
Conditions Control 3 X
…

Control 1: Sector depth = 7.0 cm, Focus = 2.5 cm, B-Mode Frequency = 3.6 MHz, PWD Frequency = 2.9 MHz, SV
Size = 3.0 mm, SV Depth = 6.0 cm, PRF = 400 Hz, Update = off
Control 2: Sector depth = 5.0 cm, Focus = 2.5 cm, B-Mode Frequency = 4.0 MHz, PWD Frequency = 3.2 MHz, SV
Size = 12.0 mm, SV Depth = 4.0 cm, PRF = 5000 Hz, Update = off
Control 3: Sector depth = 4.0 cm, Focus = 2.5 cm, B-Mode Frequency = 3.0 MHz, PWD Frequency = 2.4 MHz, SV
Size = 10.0 mm, SV Depth = 2.5 cm, PRF = 6000 Hz, Update = off

Terason t3000cv Ultrasound System Technical Manual 19

Chapter 2 - Terason Probes Acoustic Output Reporting for Track 3

Acoustic Output Reporting Table for Track 3 for the 8EC4A Probe
(Terason t3000cv Ultrasound System in 2D Mode)

MI TIS TIB TIC

Index Label Scan Non- scan Non-
Aapr  1cm 2 2 scan
Aaprt >1cm
Maximum Index Value 1.47 0.60 - - - Note 2
USFDA Track 3 IEC
pr.3 pra (MPa) 3.86
Wo P (mW) 25.39 - - -
min of [W.3(z1), Min of [P(zs), (mW) -
ITA.3(z1)] Ita, (zs)]

Associated z1 zs (cm) -
Acoustic zbp zbp (cm) -
Parameter z zb (cm) 1.50 -
sp
deq(zsp) deq(zb) (cm) -
fc fawf (MHz) 6.93 4.94 - - - -
Dim of Aaprt Dim of Aaprt X (cm) 0.78 - - - -
Y (cm) 0.50 - - - -
PD td (µsec) 0.39
PRF prr (Hz) 150.0
Other pr@PIImax pr at max. Ipi (MPa) 5.19
Information deq@PIImax deq at max Ipi (cm) -
Focal Length FL (cm) 2.5 - - -
IPA.3 @MImax Ipa, at max. MI (W/cm2) 590.94
Control 1 X
Operating
Control 2 X
Control
Conditions Control 3
Control 4

Control 1: Sector depth = 4.0 cm, Focus = 1.5 cm, Frequency = 7.5 MHz, Sector size = 7 lines, Focus # = 2
Control 2: Sector depth = 4.0 cm, Focus = 2.5 cm, Frequency = 5.0 MHz, Sector size = 38 lines, Focus # = 1

Terason t3000cv Ultrasound System Technical Manual 20

Chapter 2 - Terason Probes Acoustic Output Reporting for Track 3

Acoustic Output Reporting Table for Track 3 for the 8EC4A Probe
(Terason t3000cv Ultrasound System in M-Mode)

MI TIS TIB TIC

Index Label Scan Non- scan Non-
Aapr  1cm2 Aaprt >1cm2 scan
Maximum Index Value 1.47 0.60 Note 1 - 0.19 Note 2
USFDA Track 3 IEC
pr.3 pra (MPa) 3.86
Wo P (mW) 25.54 - 4.10 -
min of [W.3(z1), Min of [P(zs), (mW) -
ITA.3(z1)] Ita, (zs)]

Associated z1 zs (cm) -
Acoustic zbp zbp (cm) -
Parameter z zb (cm) 1.50 1.65
sp
deq(zsp) deq(zb) (cm) 0.28
fc fawf (MHz) 6.93 4.92 - - 5.04 -
Dim of Aaprt Dim of Aaprt X (cm) 0.96 - - 1.25 -
Y (cm) 0.50 - - 0.50 -
PD td (µsec) 0.39
PRF prr (Hz) 240.0
Other pr@PIImax pr at max. Ipi (MPa) 5.19
Information deq@PIImax deq at max Ipi (cm) 0.27
Focal Length FL (cm) 3.5 - - -
IPA.3 @MImax Ipa, at max. MI (W/cm2) 590.94
Control 1 X
Operating
Control 2 X
Control
Conditions Control 3 X
Control 4

Control 1: Sector depth = 4.0 cm, Focus = 1.5 cm, Frequency = 7.5 MHz, Sector size = 30 lines
Control 2: Sector depth = 4.0 cm, Focus = 3.5 cm, Frequency = 5.0 MHz, Sector size = 128 lines
Control 3: Sector depth = 10.0 cm, Focus = 4.5 cm, Frequency = 5.0 MHz, Sector size = 15 lines

Terason t3000cv Ultrasound System Technical Manual 21

Chapter 2 - Terason Probes Acoustic Output Reporting for Track 3

Acoustic Output Reporting Table for Track 3 for the 8EC4A Probe
(Terason t3000cv Ultrasound System in Color Flow Mode)

MI TIS TIB TIC

Index Label Scan Non- scan Non-
Aapr  1cm2 Aaprt >1cm2 scan
Maximum Index Value 1.47 0.89 - - - Note 2
USFDA Track 3 IEC
pr.3 pra (MPa) 3.57
Wo P (mW) 37.41 - - -
min of [W.3(z1), Min of [P(zs), (mW) -
ITA.3(z1)] Ita, (zs)]

Associated z1 zs (cm) -
Acoustic zbp zbp (cm) -
Parameter z zb (cm) 1.80 -
sp
deq(zsp) deq(zb) (cm) -
fc fawf (MHz) 5.93 4.97 - - - -
Dim of Aaprt Dim of Aaprt X (cm) 0.78 - - - -
Y (cm) 0.50 - - - -
PD td (µsec) 0.50
PRF prr (Hz) 3704
Other pr@PIImax pr at max. Ipi (MPa) 5.03
Information deq@PIImax deq at max Ipi (cm) -
Focal Length FL (cm) 2.5 - - -
IPA.3 @MImax Ipa, at max. MI (W/cm2) 501.12
Control 1 X
Operating
Control 2 X
Control
Conditions Control 3
Control 4

Control 1: B-Mode Frequency = 9.0 MHz, sector depth = 9.0 cm, focal depth = 2.5 cm, Color Doppler frequency = 6.0
MHz, Color Doppler focus = 2.5 cm, Frame Rate = 17.3 Hz, Color ROI = 0.92 cm, Packet size = 5, transmit
pulses = 3, PRF = 3704 Hz
Control 2: B-Mode Frequency = 7.5 MHz, sector depth = 4.0 cm, focal depth = 2.5 cm, Color Doppler frequency = 5.0
MHz, Color Doppler focus = 2.5 cm, Frame Rate = 1.9 Hz, Color ROI = 7.42 cm, Packet size = 12, transmit
pulses = 10, PRF = 20215 Hz

Terason t3000cv Ultrasound System Technical Manual 22

Chapter 2 - Terason Probes Acoustic Output Reporting for Track 3

Acoustic Output Reporting Table for Track 3 for the 8EC4A Probe
(Terason t3000cv Ultrasound System in Pulsed-Wave Doppler Mode)

MI TIS TIB TIC

Index Label Scan Non- scan Non-
Aapr  1cm2 Aaprt >1cm2 scan
Maximum Index Value 1.46 - 0.65 - 1.82 Note 3
USFDA Track 3 IEC
pr.3 pra (MPa) 3.56
Wo P (mW) - 27.32 22.53 -
min of [W.3(z1), Min of [P(zs), (mW) -
ITA.3(z1)] Ita, (zs)]

Associated z1 zs (cm) -
Acoustic zbp zbp (cm) -
Parameter z zb (cm) 1.60 0.60
sp
deq(zsp) deq(zb) (cm) 0.24
fc fawf (MHz) 5.93 - 4.99 - 4.00 -
Dim of Aaprt Dim of Aaprt X (cm) - 0.90 - 0.27 -
Y (cm) - 0.50 - 0.50 -
PD td (µsec) 1.14
PRF prr (Hz) 800
Other pr@PIImax pr at max. Ipi (MPa) 4.80
Information deq@PIImax deq at max Ipi (cm) 0.21
Focal Length FL (cm) - 4.5 - -
IPA.3 @MImax Ipa, at max. MI (W/cm2) 468.20
Control 1 X
Operating
Control 2 X
Control
Conditions Control 3 X
Control 4

Note: 1. Maximum free air surface temperature of the lens is 37.6° C for this operating mode, assuming
an ambient air temperature of 23.0° C
2. Information need not be provided for any formulation of TIS not yielding the maximum value of
TIS for that mode.
3. Information need not be provided regarding TIC for any probe assembly not intended for
transcranial or neonatal cephalic uses.
4. Information on MI and TI need not be provided if the equipment meets both exemption clauses
given in 51.2 aa) and 51.2 dd).

Control 1: Sector depth = 9.0 cm, Focus = 3.5 cm, B-Mode Frequency = 9.0 MHz, PWD Frequency = 6.0 MHz, SV
Size = 1.0 mm, SV Depth = 2.5 cm, PRF = 800 Hz, Update = off
Control 2: Sector depth = 9.0 cm, Focus = 3.5 cm, B-Mode Frequency = 7.5 MHz, PWD Frequency = 5.0 MHz, SV
Size = 7.0 mm, SV Depth = 4.5 cm, PRF = 4500 Hz, Update = off
Control 3: Sector depth = 12.0 cm, Focus = 3.5 cm, B-Mode Frequency = 4.0 MHz, PWD Frequency = 4.0 MHz, SV
Size = 4.5 mm, SV Depth = 0.8 cm, PRF = 11000 Hz, Update = off

Terason t3000cv Ultrasound System Technical Manual 23

Chapter 2 - Terason Probes Acoustic Output Reporting for Track 3

Acoustic Output Reporting Table for Track 3 for the 8V3A Probe
(Terason Echo Ultrasound System in 2D Mode)

MI TIS TIB TIC

Index Label Scan Non-scan Non-
2 2 scan
Aapr  1cm Aaprt >1cm
Maximum Index Value 1.03 1.52 - - - 1.54
USFDA Track 3 IEC
pr.3 pra (MPa) 2.23
Wo P (mW) 58.89 - - 46.66
min of [W.3(z1), Min of [P(zs), (mW) -
ITA.3(z1)] Ita, (zs)]
z1 zs (cm) -
Associated
Acoustic zbp zbp (cm) -
Parameter zsp zb (cm) 2.70 -
deq(zsp) deq(zb) (cm) -
fc fawf (MHz) 4.67 5.50 - - - 5.63
Dim of Aaprt Dim of Aaprt X (cm) 1.02 - - - 0.56
Y (cm) 0.80 - - - 0.80
PD td (µsec) 0.26
PRF prr (Hz) 81
Other pr@PIImax pr at max. Ipi (MPa) 3.32
Information deq@PIImax deq at max Ipi (cm) -
Focal Length FL (cm) 5.5 - - 3.0
IPA.3 @MImax Ipa, at max. MI (W/cm 2) 359.40

Operating Control 1 X
Control Control 2 X
Conditions Control 3 X

Note: 1. Maximum temperature of the lens while in contact with the patient is 41.5°C for this operating
mode, assuming an ambient temperature of 33.0 °C.
2. Information need not be provided for any formulation of TIS not yielding the maximum value of
TIS for that mode.
3. Information need not be provided regarding TIC for any probe assembly not intended for
transcranial or neonatal cephalic uses.
4. Information on MI and TI need not be provided if the equipment meets both exemption clauses
given in 51.2 aa) and 51.2 dd).

Control 1: Freq. = 5.0 MHz, sector depth = 10 cm, focus = 4.0 cm, B-Mode lines = 48, focus # = 1
Control 2: Freq. = 8.0 MHz, sector depth = 6 cm, focus = 5.5 cm, B-Mode lines = 128, focus # = 1
Control 3: Freq. = 8.0 MHz, sector depth = 4 cm, focus = 3.0 cm, B-Mode lines = 128, focus # = 1

Terason t3000cv Ultrasound System Technical Manual 24

Chapter 2 - Terason Probes Acoustic Output Reporting for Track 3

Acoustic Output Reporting Table for Track 3 for the 8V3A Probe
(Terason Echo Ultrasound System in M-Mode)

MI TIS TIB TIC

Index Label Scan Non-scan Non-
Aapr  1cm2 Aaprt >1cm2 scan
Maximum Index Value 1.03 1.52 - - 0.10 1.46
USFDA Track 3 IEC
pr.3 pra (MPa) 2.23
Wo P (mW) 58.69 - 2.83 52.74
min of [W.3(z1), Min of [P(zs), (mW) -
ITA.3(z1)] Ita, (zs)]
z1 zs (cm) -
Associated
Acoustic zbp zbp (cm) -
Parameter zsp zb (cm) 2.70 2.60
deq(zsp) deq(zb) (cm) 0.27
fc fawf (MHz) 4.67 5.50 - - 4.67 5.53
Dim of Aaprt Dim of Aaprt X (cm) 1.02 - - 0.80 0.80
Y (cm) 0.80 - - 0.80 0.80
PD td (µsec) 0.26
PRF prr (Hz) 250
Other pr@PIImax pr at max. Ipi (MPa) 3.32
Information deq@PIImax deq at max Ipi (cm) 0.26
Focal Length FL (cm) 5.5 - - 4.0
IPA.3 @MImax Ipa, at max. MI (W/cm2) 359.40

Operating Control 1 X X
Control Control 2 X
Conditions Control 3 X

Control 1: Freq. = 5.0 MHz, sector depth = 10 cm, focus = 4.0 cm, B-Mode lines = 48
Control 2: Freq. = 8.0 MHz, sector depth = 6 cm, focus = 5.5 cm, B-Mode lines = 128
Control 3: Freq. = 8.0 MHz, sector depth = 4 cm, focus = 4.0 cm, B-Mode lines = 128

Terason t3000cv Ultrasound System Technical Manual 25

Chapter 2 - Terason Probes Acoustic Output Reporting for Track 3

Acoustic Output Reporting Table for Track 3 for the 8V3A Probe
(Terason Echo Ultrasound System in Color Mode)

MI TIS TIB TIC

Index Label Scan Non-scan Non-
Aapr  1cm2 Aaprt >1cm2 scan
Maximum Index Value 1.07 1.65 - - - 2.72
USFDA Track 3 IEC
pr.3 pra (MPa) 1.84
Wo P (mW) B-M=8.85 - - 136.34
CF=91.04
min of [W.3(z1), Min of [P(zs), (mW) -
ITA.3(z1)] Ita, (zs)]
z1 zs (cm) -
Associated
Acoustic zbp zbp (cm) -
Parameter zsp zb (cm) 2.60 -
deq(zsp) deq(zb) (cm) -
fc fawf (MHz) 2.99 B-M=5.69 - - - 3.31
CF=3.31
Dim of Aaprt Dim of Aaprt X (cm) 1.02 - - - 1.54
Y (cm) 0.80 - - - 0.80
PD td (µsec) 3.02
PRF prr (Hz) 250
Other pr@PIImax pr at max. Ipi (MPa) 2.39
Information deq@PIImax deq at max Ipi (cm) -
Focal Length FL (cm) 5.5 - - 16.5
IPA.3 @MImax Ipa, at max. MI (W/cm 2) 220.66

Operating Control 1 X
Control Control 2 X
Conditions Control 3 X

Control 1: B-Mode Frequency = 5.0 MHz, sector depth = 8 cm, focal depth = 4.0 cm, Color Doppler frequency = 3.0
MHz, Color Doppler focus = 4 cm, Frame Rate = 29.5 Hz, Color ROI = 0.86 cm, Packet size = 6, transmit
pulses = 5, PRF = 250 Hz
Control 2: B-Mode Frequency = 8.85 MHz, sector depth = 11 cm, focal depth = 5.5 cm, Color Doppler frequency = 3.3
MHz, Color Doppler focus = 5.5 cm, Frame Rate = 10.1 Hz, Color ROI = 4.08 cm, Packet size = 6, transmit
pulses = 5, PRF = 2500 Hz
Control 3: B-Mode Frequency = 8.85 MHz, sector depth = 17 cm, focal depth = 16.5 cm, Color Doppler frequency =
3.3 MHz, Color Doppler focus = 16.5 cm, Frame Rate = 5.1 Hz, Color ROI = 4.19 cm, Packet size = 12,
transmit pulses = 10, PRF = 4435 Hz

Terason t3000cv Ultrasound System Technical Manual 26

Chapter 2 - Terason Probes Acoustic Output Reporting for Track 3

Acoustic Output Reporting Table for Track 3 for the 8V3A Probe
(Terason Echo Ultrasound System in Pulsed-wave Doppler Mode)

MI TIS TIB TIC

Index Label Scan Non-scan Non-
Aapr  1cm2 Aaprt >1cm2 scan
Maximum Index Value 1.37 - Note 1 1.46 3.87 2.93
USFDA Track 3 IEC
pr.3 pra (MPa) 2.50
Wo P (mW) - - 141.88 146.67
min of [W.3(z1), Min of [P(zs), (mW) 92.72
ITA.3(z1)] Ita, (zs)]
z1 zs (cm) 1.80
Associated
Acoustic zbp zbp (cm) 1.88
Parameter zsp zb (cm) 2.20 2.70
deq(zsp) deq(zb) (cm) 0.47
fc fawf (MHz) 3.32 - - 3.31 2.98 2.99
Dim of Aaprt Dim of Aaprt X (cm) - - 1.54 1.54 1.54
Y (cm) - - 0.80 0.80 0.80
PD td (µsec) 2.28
PRF prr (Hz) 500
Other pr@PIImax pr at max. Ipi (MPa) 2.97
Information deq@PIImax deq at max Ipi (cm) 0.43
Focal Length FL (cm) - - 16.5 16.5
IPA.3 @MImax Ipa, at max. MI (W/cm2) 336.58
Control 1 X
Operating Control 2 X
Control
Conditions Control 3 X
Control 4 X

Control 1: Sector depth = 7.0 cm, Focus = 4 cm, B-Mode Frequency = 8.85 MHz, PWD Frequency = 3.3 MHz, SV
Size = 2.0 mm, SV Depth = 3.0 cm, PRF = 500 Hz, Update = off
Control 2: Sector depth = 18.0 cm, Focus = 4 cm, B-Mode Frequency = 8.85 MHz, PWD Frequency = 3.3 MHz, SV
Size = 1.5 mm, SV Depth = 16.5 cm, PRF = 2500 Hz, Update = off
Control 3: Sector depth = 18.0 cm, Focus = 4 cm, B-Mode Frequency = 5.0 MHz, PWD Frequency = 3.0 MHz, SV
Size = 6.0 mm, SV Depth = 7.9 cm, PRF = 7000 Hz, Update = off
Control 4: Sector depth = 18.0 cm, Focus = 4 cm, B-Mode Frequency = 5.0 MHz, PWD Frequency = 3.0 MHz, SV
Size = 1.5 mm, SV Depth = 16.5 cm, PRF = 900 Hz, Update = off

Terason t3000cv Ultrasound System Technical Manual 27

Chapter 2 - Terason Probes Acoustic Output Reporting for Track 3

Acoustic Output Reporting Table for Track 3 for the 8V3A Probe
(Terason Echo Ultrasound System in Continuous-wave Doppler Mode)

MI TIS TIB TIC

Index Label Scan Non-scan Non-
Aapr  1cm2 Aaprt >1cm2 scan
Maximum Index Value 0.06 - 0.79 - 2.67 2.09
USFDA Track 3 IEC
pr.3 pra (MPa) 0.11
Wo P (mW) - 55.32 55.32 55.32
min of [W.3(z1), Min of [P(zs), (mW) -
ITA.3(z1)] Ita, (zs)]
z1 zs (cm) -
Associated
Acoustic zbp zbp (cm) -
Parameter zsp zb (cm) 2.10 1.00
deq(zsp) deq(zb) (cm) 0.38
fc fawf (MHz) 3.00 - 3.00 - 3.00 3.00
Dim of Aaprt Dim of Aaprt X (cm) - 0.43 - 0.43 0.43
Y (cm) - 0.80 - 0.80 0.80
PD td (µsec) N/A
PRF prr (Hz) N/A
Other pr@PIImax pr at max. Ipi (MPa) 0.14
Information deq@PIImax deq at max Ipi (cm) 0.32
Focal Length FL (cm) - 4.0 - 4.0
IPA.3 @MImax Ipa, at max. MI (W/cm2) N/A

Operating Control 1 X X X X
Control Control 2
Conditions Control 3

Control 1: Sector depth = 18.0 cm, Focus = 4 cm, B-Mode Frequency = 5.0 MHz, CWD Frequency = 3.0 MHz, SV
Depth = 4.0 cm, Update = off

Terason t3000cv Ultrasound System Technical Manual 28

Chapter 2 - Terason Probes Acoustic Output Reporting for Track 3

Acoustic Output Reporting Table for Track 3 for the 12L5A Probe
(Terason t3000cv Ultrasound System in 2D Mode)

MI TIS TIB TIC

Index Label Scan Non-scan Non-
2 2 scan
Aapr  1cm Aaprt >1cm
Maximum Index Value 1.04 0.83 - - - 1.13
USFDA Track 3 IEC
pr.3 pra (MPa) 2.68
Wo P (mW) 30.15 - - 61.05
min of [W.3(z1), Min of [P(zs), (mW) -
ITA.3(z1)] Ita, (zs)]
z1 zs (cm) -
Associated
Acoustic zbp zbp (cm) -
Parameter‘ zsp zb (cm) 1.50 -
deq(zsp) deq(zb) (cm) -
fc fawf (MHz) 6.67 6.46 - - - 5.88
Dim of Aaprt Dim of Aaprt X (cm) 1.14 - - - 3.60
Y (cm) 0.40 - - - 0.40
PD td (µsec) 0.19
PRF prr (Hz) 31
Other pr@PIImax pr at max. Ipi (MPa) 3.73
Information deq@PIImax deq at max Ipi (cm) -
Focal Length FL (cm) 3.2 - - 8.0
IPA.3 @MImax Ipa, at max. MI (W/cm 2) 657.82
Control 1 X
Operating Control 2 X
Control
Conditions Control 3 X
Control 4

Control 1: Freq. = 7.5 MHz, sector depth = 5 cm, focus = 1.8 cm, B-Mode lines = 256, focus # = 1
Control 2: Freq. = 7.5 MHz, sector depth = 4 cm, focus = 3.2 cm, B-Mode lines = 504, focus # = 1
Control 3: Freq. = 7.5 MHz, sector depth = 8 cm, focus = 8.0 cm, B-Mode lines = 504, focus # = 1

Terason t3000cv Ultrasound System Technical Manual 29

Chapter 2 - Terason Probes Acoustic Output Reporting for Track 3

Acoustic Output Reporting Table for Track 3 for the 12L5A Probe
(Terason t3000cv Ultrasound System in M-Mode)

MI TIS TIB TIC

Index Label Scan Non-scan Non-
2 2 scan
Aapr  1cm Aaprt >1cm
Maximum Index Value 1.04 0.84 - Note 1 0.06 1.07
USFDA Track 3 IEC
pr.3 pra (MPa) 2.68
Wo P (mW) 30.35 - 0.57 42.11
min of [W.3(z1), Min of [P(zs), (mW) -
ITA.3(z1)] Ita, (zs)]
z1 zs (cm) -
Associated
Acoustic zbp zbp (cm) -
Parameter‘ zsp zb (cm) 1.50 1.35
deq(zsp) deq(zb) (cm) 0.12
fc fawf (MHz) 6.67 6.46 - - 6.67 6.13
Dim of Aaprt Dim of Aaprt X (cm) 1.14 - - 0.66 1.92
Y (cm) 0.40 - - 0.40 0.40
PD td (µsec) 0.19
PRF prr (Hz) 250
Other pr@PIImax pr at max. Ipi (MPa) 3.73
Information deq@PIImax deq at max Ipi (cm) 0.11
Focal Length FL (cm) 3.2 - - 5.6
IPA.3 @MImax Ipa, at max. MI (W/cm 2) 657.82
Control 1 X X
Operating Control 2 X
Control
Conditions Control 3 X
Control 4

Control 1: Freq. = 7.5 MHz, sector depth = 2 cm, focus = 1.8 cm, B-Mode lines = 128
Control 2: Freq. = 7.5 MHz, sector depth = 4 cm, focus = 3.2 cm, B-Mode lines = 128
Control 3: Freq. = 7.5 MHz, sector depth = 6 cm, focus = 5.6 cm, B-Mode lines = 128

Terason t3000cv Ultrasound System Technical Manual 30

Chapter 2 - Terason Probes Acoustic Output Reporting for Track 3

Acoustic Output Reporting Table for Track 3 for the 12L5A Probe
(Terason t3000cv Ultrasound System in Color Mode)

MI TIS TIB TIC

Index Label Scan Non-scan Non-
2 2 scan
Aapr  1cm Aaprt >1cm
Maximum Index Value 1.07 1.45 - - - 2.75
USFDA Track 3 IEC
pr.3 pra (MPa) 2.42
Wo P (mW) 66.36 - - 27.19
min of [W.3(z1), Min of [P(zs), (mW) -
ITA.3(z1)] Ita, (zs)]
z1 zs (cm) -
Associated
Acoustic zbp zbp (cm) -
Parameter‘ zsp zb (cm) 1.35 -
deq(zsp) deq(zb) (cm) -
fc fawf (MHz) 5.12 5.11 - - - 5.13
Dim of Aaprt Dim of Aaprt X (cm) 1.14 - - - 0.12
Y (cm) 0.40 - - - 0.40
PD td (µsec) 0.75
PRF prr (Hz) 3500
Other pr@PIImax pr at max. Ipi (MPa) 2.86
Information deq@PIImax deq at max Ipi (cm) -
Focal Length FL (cm) 3.2 - - 0.3
IPA.3 @MImax Ipa, at max. MI (W/cm 2) 341.26
Control 1 X
Operating Control 2 X
Control
Conditions Control 3 X
Control 4

Control 1: B-Mode Frequency = 12.0 MHz, sector depth = 9 cm, focal depth = 1.8 cm, Color Doppler frequency = 5.14
MHz, Color Doppler focus = 1.8 cm, Frame Rate = 10.2 Hz, Color ROI = 0.51 cm, Packet size = 10,
transmit pulses = 4, PRF = 3500 Hz
Control 2: B-Mode Frequency = 12.0 MHz, sector depth = 4 cm, focal depth = 3.2 cm, Color Doppler frequency = 5.14
MHz, Color Doppler focus = 3.2 cm, Frame Rate = 7.8 Hz, Color ROI = 3.81 cm, Packet size = 14, transmit
pulses = 10, PRF = 19070 Hz
Control 3: B-Mode Frequency = 12.0 MHz, sector depth = 2 cm, focal depth = 0.3 cm, Color Doppler frequency = 5.14
MHz, Color Doppler focus = 0.3 cm, Frame Rate = 6.2 Hz, Color ROI = 3.81 cm, Packet size = 14, transmit
pulses = 10, PRF = 14000 Hz

Terason t3000cv Ultrasound System Technical Manual 31

Chapter 2 - Terason Probes Acoustic Output Reporting for Track 3

Acoustic Output Reporting Table for Track 3 for the 12L5A Probe
(Terason t3000cv Ultrasound System in Pulsed-Wave Doppler Mode)

MI TIS TIB TIC

Index Label Scan Non-scan Non-
2 2 scan
Aapr  1cm Aaprt >1cm
Maximum Index Value 1.42 - 1.93 - 2.20 2.15
USFDA Track 3 IEC
pr.3 pra (MPa) 3.18
Wo P (mW) - 79.61 46.12 116.60
min of [W.3(z1), Min of [P(zs), (mW) -
ITA.3(z1)] Ita, (zs)]
z zs (cm) -
Associated 1
Acoustic zbp zbp (cm) -
Parameter‘ zsp zb (cm) 1.60 1.20
deq(zsp) deq(zb) (cm) 0.31
fc fawf (MHz) 5.01 - 5.10 - 5.11 5.09
Dim of Aaprt Dim of Aaprt X (cm) - 2.31 - 1.14 3.60
Y (cm) - 0.40 - 0.40 0.40
PD td (µsec) 1.13
PRF prr (Hz) 600
Other pr@PIImax pr at max. Ipi (MPa) 4.14
Information deq@PIImax deq at max Ipi (cm) 0.21
Focal Length FL (cm) - 6.5 - 8.0
IPA.3 @MImax Ipa, at max. MI (W/cm2) 718.77
Control 1 X
Operating Control 2 X
Control
Conditions Control 3 X
Control 4 X

Control 1: Sector depth = 9.0 cm, Focus = 2.4 cm, B-Mode Frequency = 10.0 MHz, PWD Frequency = 5.0 MHz, SV
Size = 1.0 mm, SV Depth = 2.4 cm, PRF = 600 Hz, Update = off
Control 2: Sector depth = 9.0 cm, Focus = 2.4 cm, B-Mode Frequency = 12.0 MHz, PWD Frequency = 5.14 MHz, SV
Size = 4.5 mm, SV Depth = 6.5 cm, PRF = 400 Hz, Update = off
Control 3: Sector depth = 9.0 cm, Focus = 2.4 cm, B-Mode Frequency = 12.0 MHz, PWD Frequency = 5.14 MHz, SV
Size = 2.0 mm, SV Depth = 3.2 cm, PRF = 17000 Hz, Update = off
Control 4: Sector depth = 9.0 cm, Focus = 2.4 cm, B-Mode Frequency = 12.0 MHz, PWD Frequency = 5.14 MHz, SV
Size = 0.5 mm, SV Depth = 8.0 cm, PRF = 8400 Hz, Update = off

Terason t3000cv Ultrasound System Technical Manual 32

Chapter 2 - Terason Probes Acoustic Output Reporting for Track 3

Acoustic Output Reporting TableAcoustic Output Reporting Table for Track 3 for the 12L5V Probe
(Terason t3000cv Ultrasound System in 2D Mode)

MI TIS TIB TIC

Index Label Scan Non- scan Non-
Aapr  1cm 2 2 scan
Aaprt >1cm
Maximum Index Value 0.77 1.19 - - - 1.54
USFDA Track 3 IEC
pr.3 pra (MPa) 1.89
Wo P (mW) 41.72 - - 41.72
min of [W.3(z1), Min of [P(zs), (mW) -
ITA.3(z1)] Ita, (zs)]

Associated z1 zs (cm) -
Acoustic zbp zbp (cm) -
Parameter z z (cm) 1.62 -
sp b
deq(zsp) deq(zb) (cm) -
fc fawf (MHz) 5.98 5.98 - - - 5.98
Dim of Aaprt Dim of Aaprt X (cm) 0.72 - - - 0.72
Y (cm) 0.50 - - - 0.50
PD td (µsec) 0.27
PRF prr (Hz) 94
Other pr@PIImax pr at max. Ipi (MPa) 2.59
Information deq@PIImax deq at max Ipi (cm) -
Focal Length FL (cm) 2.0 - - 2.0
IPA.3 @MImax Ipa, at max. MI (W/cm2) 244.84
Control 1 X X X
Operating
Control 2
Control
Conditions Control 3
Control 4

Control 1:Sector depth = 2.0 cm, Focus = 2.0 cm, Frequency = 6.0 MHz, Focus # = 1

Terason t3000cv Ultrasound System Technical Manual 33

Chapter 2 - Terason Probes Acoustic Output Reporting for Track 3

Acoustic Output Reporting Table for Track 3 for the 12L5V Probe
(Terason t3000cv Ultrasound System in M-Mode)

MI TIS TIB TIC

Index Label Scan Non- scan Non-
Aapr  1cm2 Aaprt >1cm2 scan
Maximum Index Value 0.77 0.60 - Note 1 0.04 0.84
USFDA Track 3 IEC
pr.3 pra (MPa) 1.89
Wo P (mW) 21.90 - 0.42 37.19
min of [W.3(z1), Min of [P(zs), (mW) -
ITA.3(z1)] Ita, (zs)]

Associated z1 zs (cm) -
Acoustic zbp zbp (cm) -
Parameter z z (cm) 1.62 1.57
sp b
deq(zsp) deq(zb) (cm) 0.13
fc fawf (MHz) 5.98 7.06 - - 5.98 5.80
Dim of Aaprt Dim of Aaprt X (cm) 1.26 - - 0.72 1.95
Y (cm) 0.50 - - 0.50 0.50
PD td (µsec) 0.27
PRF prr (Hz) 240
Other pr@PIImax pr at max. Ipi (MPa) 2.59
Information deq@PIImax deq at max Ipi (cm) 0.13
Focal Length FL (cm) 3.5 - - 5.5
IPA.3 @MImax Ipa, at max. MI (W/cm2) 244.84
Control 1 X X
Operating
Control 2 X
Control
Conditions Control 3 X
Control 4

Control 1: Sector depth = 2.0 cm, Focus = 2.0 cm, Frequency = 6.0 MHz
Control 2: Sector depth = 4.0 cm, Focus = 3.5 cm, Frequency = 7.5 MHz
Control 3: Sector depth = 6.0 cm, Focus = 5.5 cm, Frequency = 6.0 MHz

Terason t3000cv Ultrasound System Technical Manual 34

Chapter 2 - Terason Probes Acoustic Output Reporting for Track 3

Acoustic Output Reporting Table for Track 3 for the 12L5V Probe
(Terason t3000cv Ultrasound System in Color Flow Mode)

MI TIS TIB TIC

Index Label Scan Non- scan Non-
Aapr  1cm2 Aaprt >1cm2 scan
Maximum Index Value 1.05 1.90 - - - 2.61
USFDA Track 3 IEC
pr.3 pra (MPa) 2.70
Wo P (mW) 67.17 - - 51.87
min of [W.3(z1), Min of [P(zs), (mW) -
ITA.3(z1)] Ita, (zs)]

Associated z1 zs (cm) -
Acoustic zbp zbp (cm) -
Parameter z z (cm) 1.2 -
sp b
deq(zsp) deq(zb) (cm) -
fc fawf (MHz) 6.60 5.91 - - - 5.81
Dim of Aaprt Dim of Aaprt X (cm) 0.87 - - - 0.39
Y (cm) 0.50 - - - 0.50
PD td (µsec) 0.57
PRF prr (Hz) 1500
Other pr@PIImax pr at max. Ipi (MPa) 3.49
Information deq@PIImax deq at max Ipi (cm) -
Focal Length FL (cm) 1.3 - - 0.6
IPA.3 @MImax Ipa, at max. MI (W/cm2) 476.04
Control 1 X
Operating
Control 2 X
Control
Conditions Control 3 X
Control 4

Note: 1. Maximum free air surface temperature of the lens is 38.5° C for this operating mode, assuming
an ambient air temperature of 23.0° C.
2. Information need not be provided for any formulation of TIS not yielding the maximum value of
TIS for that mode.
3. Information need not be provided regarding TIC for any probe assembly not intended for
transcranial or neonatal cephalic uses.
4. Information on MI and TI need not be provided if the equipment meets both exemption clauses
given in 51.2 aa) and 51.2 dd).

Control 1: B-Mode Frequency = 10.0 MHz, sector depth = 2.0 cm, focal depth = 1.3 cm, Color Doppler frequency = 6.7
MHz, Color Doppler focus = 1.3 cm, Frame Rate = 36.5 Hz, Color ROI = 0.48 cm, Packet size = 11,
transmit pulses = 4, PRF = 1500 Hz, High Frame Rate
Control 2: B-Mode Frequency = 9.0 MHz, sector depth = 2.0 cm, focal depth = 1.3 cm, Color Doppler frequency = 6.0
MHz, Color Doppler focus = 1.3 cm, Frame Rate = 7.9 Hz, Color ROI = 3.81 cm, Packet size = 12, transmit
pulses = 7, PRF = 35000 Hz, High Spatial Resolution
Control 3: B-Mode Frequency = 9.0 MHz, sector depth = 2.0 cm, focal depth = 0.6 cm, Color Doppler frequency = 6.0
MHz, Color Doppler focus = 0.6 cm, Frame Rate = 13.6 Hz, Color ROI = 3.81 cm, Packet size = 12,
transmit pulses = 7, PRF = 35000 Hz, High Spatial Resolution

Terason t3000cv Ultrasound System Technical Manual 35

Chapter 2 - Terason Probes Acoustic Output Reporting for Track 3

Acoustic Output Reporting Table for Track 3 for the 12L5V Probe
(Terason t3000cv Ultrasound System in Pulsed-Wave Doppler Mode)

MI TIS TIB TIC

Index Label Scan Non- scan Non-
Aapr  1cm2 Aaprt >1cm2 scan
Maximum Index Value 0.70 - 1.98 - 2.25 2.01
USFDA Track 3 IEC
pr.3 pra (MPa) 2.42
Wo P (mW) - 62.87 51.94 22.26
min of [W.3(z1), Min of [P(zs), (mW) -
ITA.3(z1)] Ita, (zs)]

Associated z1 zs (cm) -
Acoustic zbp zbp (cm) -
Parameter z zb (cm) 1.25 1.15
sp
deq(zsp) deq(zb) (cm) 0.32
fc fawf (MHz) 6.66 - 6.65 - 5.95 6.66
Dim of Aaprt Dim of Aaprt X (cm) - 1.29 - 0.90 0.12
Y (cm) - 0.50 - 0.50 0.50
PD td (µsec) 1.167
PRF prr (Hz) 2000
Other pr@PIImax pr at max. Ipi (MPa) 2.33
Information deq@PIImax deq at max Ipi (cm) 0.23
Focal Length FL (cm) - 6.50 - 0.60
IPA.3 @MImax Ipa, at max. MI (W/cm2) 189.59
Control 1 X
Operating
Control 2 X
Control
Conditions Control 3 X
Control 4 X

Control 1: Sector depth = 7.0 cm, Focus = 3.5 cm, B-Mode Frequency = 10.0 MHz, PWD Frequency = 6.7 MHz, SV
Size = 1.0 mm, SV Depth = 2.0 cm, PRF = 2000 Hz, Update = off
Control 2: Sector depth = 7.0 cm, Focus = 3.5 cm, B-Mode Frequency = 10.0 MHz, PWD Frequency = 6.7 MHz, SV
Size = 6.5 mm, SV Depth = 6.5 cm, PRF = 3000 Hz, Update = off
Control 3: Sector depth = 7.0 cm, Focus = 3.5 cm, B-Mode Frequency = 9.0 MHz, PWD Frequency = 6.0 MHz, SV
Size = 2.0 mm, SV Depth = 4.4 cm, PRF = 14400 Hz, Update = off
Control 4: Sector depth = 7.0 cm, Focus = 3.5 cm, B-Mode Frequency = 10.0 MHz, PWD Frequency = 6.7 MHz, SV
Size = 5.0 mm, SV Depth = 0.6 cm, PRF = 3000 Hz, Update = off

Terason t3000cv Ultrasound System Technical Manual 36

Chapter 2 - Terason Probes Acoustic Output Reporting for Track 3

Acoustic Output Reporting Table for Track 3 for the PDOF Probe
(Terason t3000cv Ultrasound System in Continuous-Wave Doppler Mode)

MI TIS TIB TIC

Index Label Scan Non- scan Non-
Aapr  1cm2 Aaprt >1cm2 scan
Maximum Index Value 0.08 - 0.95 - 3.54 Note 3
USFDA Track 3 IEC
pr.3 pra (MPa) 0.11
Wo P (mW) - 100.00 100.00 -
min of [W.3(z1), Min of [P(zs), (mW) -
ITA.3(z1)] Ita, (zs)]

Associated z1 zs (cm) -
Acoustic zbp zbp (cm) -
Parameter z zb (cm) 2.30 2.10
sp
deq(zsp) deq(zb) (cm) 0.47
fc fawf (MHz) 2.00 - 2.00 - 2.00 -
Dim of Aaprt Dim of Aaprt X (cm) - 0.69 - 0.69 -
Y (cm) - 1.38 - 1.38 -
PD td (µsec) -
PRF prr (Hz) -
Other pr@PIImax pr at max. Ipi (MPa) 0.13
Information deq@PIImax deq at max Ipi (cm) 0.46
Focal Length FL (cm) - 8.0 - -
IPA.3 @MImax Ipa, at max. MI (W/cm2) -
Control 1 X X X
Operating
Control 2
Control
Conditions Control 3
Control 4

Note: 1. Maximum free air surface temperature of the lens is 32.4° C for this operating mode, assuming
an ambient air temperature of 23.0° C.
2. Information need not be provided for any formulation of TIS not yielding the maximum value of
TIS for that mode.
3. Information need not be provided regarding TIC for any probe assembly not intended for
transcranial or neonatal cephalic uses.
4. Information on MI and TI need not be provided if the equipment meets both exemption clauses
given in 51.2 aa) and 51.2 dd).

Terason t3000cv Ultrasound System Technical Manual 37

3 Maintenance

To use the Terason Ultrasound System successfully and safely, Terason provides the
following information:
• Processing Terason Probes Between Uses, see page 38
• Recommended Maintenance, see page 42

Processing Terason Probes Between Uses

Each probe must be processed between uses according to the type of tissue it will contact
during use:
• Non-critical applications in which the device contacts only intact skin –clean the probe.
• Semi-critical use, such as endocavity applications (where the device may contact
mucous membranes) – clean and high-level disinfect the probe. Use of a sheath is
recommended.
• Critical use, in which the device contacts blood, compromised tissue, or is used in a
sterile field – clean and high-level disinfect the probe. Use of a sheath is required.

Warning: In addition to the instructions in this guide, the instructions

provided by the manufacturer of cleaners and disinfectants must
be strictly adhered to.

Warning: Never place the probe connector on the floor when cleaning the
probe. The cable connection to the system must always be higher
than the lowest point of the cable, to prevent fluid from flowing
down the cable to the electronics.

For information on cleaning the laptop computer, refer to the laptop’s user guide.

Cleaning and Disinfecting Terason Probes

Noncritical Device Applications

After use that involves only contact with intact skin, cleaning is generally sufficient.
Follow your institution’s policies on infection control and ultrasound imaging. If high-
level disinfection is required (as in semi-critical or critical uses), the probe must be
processed using the procedure in Semicritical Device Applications on page 40.

Terason t3000cv Ultrasound System Technical Manual 38

Chapter 3 - Maintenance Processing Terason Probes Between Uses

Between patient exams, perform the following steps to clean the probe:
1. Disconnect the probe from the system.
2. If a sheath is installed on the probe, remove it.
3. Wipe all ultrasound transmission gel off the probe.
4. Wash the probe with a solution of enzymatic detergent and water. See Cleaners on
page 40 for a list of approved cleaners.
a. Follow the manufacturer’s instructions for proper dilution of the selected detergent.

Note: Klenzyme detergent packaging may not include dilution instructions. If you find
that to be the case, dilute Klenzyme at 1 ounce Klenzyme to 1 gallon of water (8 ml
to 1 liter of water).

b. Moisten a soft cloth with the detergent solution, and wipe the probe until all visible
soil is removed..
c. Moisten a second cloth with sterile water and wipe all the probe surfaces to remove
any detergent residue and prevent it from drying on the probe.
5. Pat the probe dry using a soft sponge, cloth, or gauze pad.

Warning: Some cleaning techniques can damage probes. Do not sterilize

Terason probes. A sheath is required when using a probe in a
sterile field.
Probes can be submerged up to, but not including, the strain
relief of the probe array. Do not immerse or soak any other part of
a probe in any cleaning material. The following figure defines how
much of the probe can be submerged.

Terason t3000cv Ultrasound System Technical Manual 39

Chapter 3 - Maintenance Processing Terason Probes Between Uses

Do Not Submerge Probes Above Line

Warning: The cable and connector are not waterproof. Do not immerse the
cable or allow liquid to contact the connector.

Warning: The Terason Ultrasound System (electronics), the laptop, and the
AC/DC adapter are not protected from spills or splashes.
Disconnect the probe from the system during cleaning.

Cleaners
The following cleaners have been tested and found compatible with probes used with the
Terason Ultrasound System:
• Enzol
• Klenzyme
• Alkazyme

Semicritical Device Applications

When a probe may contact infection sources such as broken skin, lesions, or post-
operative wounds, always use a sterile sheath.

Probes used in surgically invasive or intraoperative applications must be enclosed in a

sterile sheath marketed for the application. Probes used in such situations should always
be high-level disinfected after such use.
To perform high-level disinfection of probes:
1. Disconnect the probe from the system.
2. If a sheath is installed on the probe, remove it.

Terason t3000cv Ultrasound System Technical Manual 40

Chapter 3 - Maintenance Processing Terason Probes Between Uses

3. Wipe all ultrasound transmission gel off the probe.

4. Wash the probe with a solution of enzymatic detergent and water. See Cleaners on
page 40 for a list of approved cleaners.
a. Follow the manufacturer’s instructions for proper dilution of the selected detergent
.

Note: Klenzyme detergent packaging may not include dilution instructions. If you find
that to be the case, dilute Klenzyme at 1 ounce Klenzyme to 1 gallon of water (8 ml
to 1 liter of water).

b. Moisten a soft cloth with the detergent solution, and wipe the probe until all visible
soil is removed.
5. Disinfect the probe using one of the products listed in High-Level Disinfectants on
page 41. Follow the disinfectant manufacturer’s instructions for use of the product.

Caution:Do not submerge the probe beyond the line shown in the figure labeled Do
Not Submerge Probes Above Line on page 40.

a. Submerge the probe in the high-level disinfectant up to the line shown in the figure
labeled Do Not Submerge Probes Above Line on page 40.
b. Follow the disinfectant manufacturer’s instructions for duration, temperature, etc.
6. Moisten a cloth with sterile water and wipe all the probe surfaces to remove any
disinfectant residue and prevent it from drying on the probe.
7. Pat the probe dry, using a soft sponge, cloth, or gauze pad.
High-Level Disinfectants
The following high-level disinfectants have been tested, found compatible with probes
used with the Terason Ultrasound System, and are cleared for use by the United States
Food and Drug Administration (FDA):
• Cidex 2%
• Cidex OPA
• Cidex Plus

Caution:The 16HL7 probe can be cleaned using only the following disinfectants:
• Alkazyme
• Klenzyme
• Cidex 2%
Using other disinfectants can damage the 16HL7 probe.

Terason t3000cv Ultrasound System Technical Manual 41

Chapter 3 - Maintenance Recommended Maintenance

For more information on infection control, refer to the following articles:

• Design Testing and Labeling of Reusable Medical Devices for Reprocessing in
Healthcare Facilities: A Guide for Manufacturers, AAMI Publishing Company, 1995
• Disinfections and Preservation, Block, Seymour S., Lea and Febiger, 1991
• Sterilants and High Level Disinfectants Cleared by FDA in a 510(k), http://
www.fda.gov/cdrh/ode/germlab.html

Recommended Maintenance
Terason probes require very little maintenance. Probes should be inspected after every
cleaning. If the probe is dropped, examine it immediately for signs of damage. Check for
these potential problems:
• Cracks or damage to the handle, nose piece, or connector
• Cuts or gouges on lens material
• Swelling of lens material
• Cuts or cracks in the cable
Do not expose probes to direct heat such as strong sunlight or a local heat source, as heat
can cause crystal aging and loss of sensitivity.
When storing the Terason Ultrasound System in environments between 0º and 50ºC, the
original shipping container must be used.
All components of the Terason Ultrasound System should be checked monthly for these
potential problems:
• Cuts, cracks or damage to the power cables
• Dents or cracks in the electronics housing
Refer to the laptop manual for information on laptop maintenance.

Warning: Do not use any equipment that is cut, cracked, dented, or

displays any other damage. Use of damaged equipment can
create shock hazards for the operator and patient. Contact
Terason Customer Support for help.

Terason t3000cv Ultrasound System Technical Manual 42

4 System Safety

To use the Terason Ultrasound System successfully and safely, Terason provides the
following information:
• Infection Control on page 43
• Safety Cautions and Warnings on page 45
• Labels on page 52
• Safety Standards, see page 55
• Indications For Use, see page 56
• Acoustic Output Indices, see page 65
• Relationship of Index to Display Accuracy, see page 74
• Acoustic Output Tables, see page 76
• Accuracy Measures, see page 77
• Compliance and Approvals, see page 79
• Environmental Protection, see page 79

Infection Control
Proper infection control procedures are essential for preventing the spread of disease
between patients. This section contains information on the following related topics:
• Sterile Probe Covers on page 43
• Disinfection on page 44

Sterile Probe Covers

When performing intraoperative studies or scanning patients with open wounds, you must
use a sterile sheath on the probe.
The following table lists the appropriate sheath for each Terason probe:
Sterile Probe Sheaths

Probe Sheath

4V2A Civco # 610-044 (latex)

Civco # 610-542 (latex-free)

5C2A Civco # 610-044 (latex)

Civco # 610-542 (latex-free)

8EC4A For endocavity probe covers, refer to the

Civco Website

8V3A Civco # 610-044 (latex)

Civco # 610-542 (latex-free)

Terason t3000cv Ultrasound System Technical Manual 43

Chapter 4 - System Safety Infection Control

Sterile Probe Sheaths

Probe Sheath

12L5A Civco # 610-044 (latex)

Civco # 610-542 (latex-free)

12L5V Civco # 610-044 (latex)

Civco # 610-542 (latex-free)

PDOF Refer to the Civco Website

Caution:When installing a sheath on a probe, always follow the sheath

manufacturer’s instructions.

Disinfection
It is very important that appropriate infection-prevention measures are taken. The type of
use a probe is put to determines what level of disinfection should be used. See Noncritical
Device Applications on page 38 and Semicritical Device Applications on page 40 for
disinfection procedures.

Warning: System operators must take measures to prevent the transfer of

infection between persons.

Warning: Special infection-control precautions must be taken when

scanning patients with open wounds.

Warning: Probes must be enclosed in a sterile sheath during intraoperative

studies. See Sterile Probe Covers on page 43 for recommended
sterile covers for each type of probe. Follow the manufacturer’s
instructions for use of sheaths.

Warning: To prevent cross-contamination and transmission of infectious

disease, high-level disinfection of probes is required after
scanning patients with open wounds. High-level disinfection is
required even if a sterile sheath is used during the study.

Warning: Operators should identify their latex-sensitive patients, and be

prepared to treat allergic reactions promptly. Refer to the FDA’s
March 29, 1991 Medical Alert on Latex products.

For an overview of infection control, refer to the following publication:

Terason t3000cv Ultrasound System Technical Manual 44

Chapter 4 - System Safety Safety Cautions and Warnings

Block, S.S., Disinfection, Sterilization, and Preservation, Chemical Disinfection of

Medical and Surgical Materials, Chapter 35, Lea & Febiger, Philadelphia, 1991.

Safety Cautions and Warnings

Cautions
Closely review the following cautions before using the Terason Ultrasound System for the
first time.

Sale and Use

The Terason Ultrasound System is designed for medical ultrasound imaging. Federal law
restricts this device to sale by or on the order of a physician. The Terason system should
only be used in a medical facility under the supervision of a trained physician.

Caution: Do not use the Terason Ultrasound System during an MRI exam or
when using a defibrillator.

Terason Probes
Each probe model has indications for use (see “Indications For Use” in the Terason
Technical Manual) concerning specific applications.

Ultrasound System
Always position the ultrasound system on a stable surface where it cannot fall on the
patient.

Caution: Do not lift the ultrasound system by the power cable or probe. If either
disconnects, the ultrasound system could fall on the patient.

Allergies
Metals used in some of the decorative exterior plates may contain nickel. If persons using
the system are allergic to nickel, avoid handling the exterior decorative metal.

System Covers
Do not remove any system covers or cables. Only qualified Terason personnel should
service the Terason Ultrasound System.

Warning: Do not open any part of the system, or remove any screws or
covers, or modify the Terason Ultrasound System, probes, or
power supplies in any way. Modifying the system can produce
hazardous conditions. If any part of the system is modified or
tampered with, contact Terason Support immediately and do not
use the system.

Terason t3000cv Ultrasound System Technical Manual 45

Chapter 4 - System Safety Safety Cautions and Warnings

Electrical Shock Hazard

Probe cables have strain relief at terminations. Inspect cables regularly, to detect damaged,
frayed, or broken cables that might contact a patient.

Warning: To avoid the risk of electric shock, this equipment must only be
connected to supply mains that incorporate protective earth.

Caution: Do not use a probe if the probe or cable is damaged. Return damaged
equipment to Terason for replacement. See “Contacting Terason” in the
User Guide for instructions on contacting Terason Support.

Shock hazards exist if the AC power adapter is damaged or is not properly grounded. Use
only the supplied medical grade power cord and power adapter, and connect the adapter
only to a receptacle marked “Hospital Only”, “Hospital Grade,” or equivalent.

Caution: Do not remove or try to circumvent the grounding wire. If the protective
grounding of the system is questionable, disconnect the ultrasound
system from the power source and run it on its internal battery.

Warning: If the ultrasound system is purchased with the cart and printer
option, an integrated multiple-outlet power strip (MSO) is
mounted on the cart for connecting the ultrasound system and
the printer to an AC wall outlet. Connecting equipment to an MSO
creates an ME system, and may produce a reduced level of safety.

Before cleaning the system, always disconnect the AC power adapter from the system.
The Terason Ultrasound System is a Type BF Class I product suitable for continuous
operation when connected as a system to a Medical Grade AC/DC Power Adapter or
operated from the laptop battery.

Caution: Use only Medical-Grade peripherals in the patient environment. See

Patient Environment on page 50 for a diagram of the patient
environment.

Caution: Failure to follow the warnings in this guide may cause the system to no
longer comply with regulatory requirements.

Terason t3000cv Ultrasound System Technical Manual 46

Chapter 4 - System Safety Safety Cautions and Warnings

Caution: Do not block or otherwise obstruct access to the power plug at the wall.
operators must have must be able to quickly unplug the AC cord at the
wall in case of emergency.

Electrical Fast Transients (EFT)

The Terason ultrasound system complies with the IEC 60601-1-2:2001 standard for
susceptibility to electrical fast transients (EFT) on the power line (see “Electromagnetic
Compatibility Tables” in the Terason Technical Manual for specific test and compliance
levels). However, if the ultrasound system experiences EFT on the power line, artifacts
(vertical lines, excessive noise in image, etc.) may appear on the ultrasound image. To
eliminate these artifacts caused by an EFT condition the user should either:
• Remove the power source by unplugging the DC power cord from the laptop, causing
the system to run on battery power.
or
• Unplug the AC power cord from the wall and move to a different AC power source that
is not experiencing this condition.

Surges to AC Power Mains

If the system is powered from AC mains that could experience surges above 1 CV (for
example, from extreme lightning conditions), additional surge suppression is
recommended.

RF Interference
The unit should be operated in a location that is no closer than listed in “Compatibility for
Non-Life-Supporting Equipment” (in the Terason Technical Manual) to any part of RF
communications equipment that may disturb its functions. If abnormal performance is
observed, additional measures may be necessary, such as re-orienting or relocating the
equipment. The Terason Ultrasound System should be separated by at least the distances
specified in the table referenced above.
The Terason Ultrasound System is intended for use in an electromagnetic environment
where radiated RF disturbances are controlled. The customer or the user of the Terason
Ultrasound System can help prevent electromagnetic interference by maintaining a
minimum distance between portable and mobile RF communications equipment
(transmitters) and the Terason Ultrasound System according to the maximum output
power of the communications equipment. See “Electromagnetic Compatibility Tables,” in
the Terason Technical Manual for recommended separation distances.

Protection From Liquid Spills, etc.

This equipment has a degree of protection from ingress of water and particulate matter. It
is cleared for use in environments where it would not be exposed to excessive contact with
fluids. These environments include, but are not limited to outpatient and private office
procedures such as biopsies, office visits, and other traditional, non-invasive scanning.

Terason t3000cv Ultrasound System Technical Manual 47

Chapter 4 - System Safety Safety Cautions and Warnings

The following table lists the applied parts and their levels of protection.
Spill Protection of Applied Parts

Component Manufacturer Mfr. Part No. Use IPX Level1

Ultrasound system Terason 10-3821-01 Ultrasound system IPX-03

4V2A probe Terason 10-3216 Ultrasound system IPX-72 (at probe head); IPX-0
for cable and connector. See
Chapter 3 - Maintenance
5C2A probe Terason 10-3188 Ultrasound system IPX-72 (at probe head); IPX-0
for cable and connector. See
Chapter 3 - Maintenance

8EC4A probe Terason 10-3374 Ultrasound system IPX-72 (at probe head); IPX-0
for cable and connector. See
Chapter 3 - Maintenance

8V3A probe Terason 10-3319 Ultrasound system IPX-72 (at probe head); IPX-0
for cable and connector. See
Chapter 3 - Maintenance

12L5A probe Terason 10-3276 Ultrasound system IPX-72 (at probe head); IPX-0
for cable and connector. See
Chapter 3 - Maintenance

12L5V probe Terason 10-1176 Ultrasound system IPX-72 (at probe head); IPX-0
for cable and connector. See
Chapter 3 - Maintenance

PDOF Terason 10-3092 Ultrasound system IPX-72 (at probe head); IPX-0
for cable and connector. See
Chapter 3 - Maintenance

DC power adapter Jerome WSZ518M Power source and battery IPX-03

charger for ultrasound system
Power supply cord Interpower 86610820 AC line cord IPX-0
- North America

Power supply cord Interpower 86230060 AC line cord IPX-0

- Europe

ECG module Terason 10-3306 3-lead ECG module to IPX-0

connect to ultrasound system

Footswitch Kinessis FS20A-USB-UL Footswitch programmed for IPX-1

image freeze and image save

Printer Sony UP-D897 B/W thermal printer IPX-0

Cart Terason 15-30083 Cart for ultrasound system N/A

1. IPX-0 = No protection
IPX-1 = Protection against dripping water
IPX-7 = Protection against immersion
2. Refer to Chapter 3 - Maintenance for detailed description of how much of the probe can be immersed during
cleaning.
3. A keyboard cover is available to protect the computer keys and underlying electronics.

Terason t3000cv Ultrasound System Technical Manual 48

Chapter 4 - System Safety Safety Cautions and Warnings

Explosive
This equipment is not suitable for use in the presence of FLAMMABLE ANESTHETIC
MIXTURE WITH AIR OR WITH OXYGEN OR NITROUS OXIDE.

Caution: Do not use the Terason Ultrasound System in an oxygen-rich

environment. Do not use the Terason Ultrasound System if flammable
anesthetics are in use in the patient environment.

Battery Pack Usage/Disposal

Lithium-ion battery packs are labeled with cautions indicating that the device could
present a fire or chemical burn hazard if mistreated.

Caution: Do not disassemble, heat above 60ºC (140ºF), crush, puncture, short
external contacts, or incinerate the battery pack.

Caution: Keep the battery pack away from children. Dispose of used battery
packs according to the manufacturer's instructions. For safety
information, refer to the user guide that was shipped with your
computer.

Recycling/Disposal After Useful Life

This equipment can contain environmentally hazardous materials such as, but not limited
to: heavy metals, general recyclable metals, and plastics. This product should be recycled
according to local and national guidelines for recycling electronic equipment.

Warnings
Observe the following safety precautions when using the Terason Ultrasound System.

Intended Use
The Terason Ultrasound System is designed for use as a diagnostic tool and should only be
operated by someone who has received proper training in the use and operation of an
ultrasound system. This system produces images derived from sound echoes; those images
must be interpreted by a qualified medical professional. This system in no way interprets
these images or provides a medical diagnosis of the patient being examined.
The Terason Ultrasound System has successfully completed compliance tests for IEC
60601-1, IEC 60601-1-1 2nd edition, IEC 60601-1-2, and IEC 60601-2-37 medical
standards for the configuration as originally installed. To maintain compliance with the
stated safety and EMI standards, Terason recommends use of MEDICAL GRADE
PERIPHERALS ONLY. Use of non-medical grade peripherals will result in non-
compliance of safety and EMI standards. Non-conformance to these standards can
produce risks to the patient and operator of this equipment. Terason cannot be held liable
for changes to the system topology that no longer conform to the stated safety and EMI
standards. Changes to the system topology may make it necessary to retest the complete

Terason t3000cv Ultrasound System Technical Manual 49

Chapter 4 - System Safety Safety Cautions and Warnings

system for compliance to these standards. The Terason Ultrasound System User Guide
refers to the potential for connecting the Terason Ultrasound System to peripherals such as
VCRs, TVs, and printers. Note that Terason has not performed compliance tests to the
stated standards with these types of devices connected to the system. Any peripheral
device, such as a network connection, etc. connected to the Terason Ultrasound System
must conform to the IEC standards outlined above (i.e., IEC 60601-1, IEC 60601-1-1 2nd
edition, IEC 60601-1-2, and IEC 60601-2-37).
The Terason Ultrasound System (without peripherals) is suitable for use within the patient
environment, as defined by the following:

Warning: The user should never simultaneously make contact with the
patient and the inside of any equipment where a protective cover
of any kind is removed. This includes the protective covers for
the probe holders containing the ultrasound probe and power
modules located at the patient table.

The patient environment is defined as shown in the following figure.

Overhead view
1.50 m
Patient Table

Side view

2.50m

1.50m 1.50m
Patient Environment

Portable and mobile RF communications equipment can affect medical electrical

equipment such as the Terason Ultrasound System and should not be used in the patient
environment.

Caution: The Terason Ultrasound System should not be used adjacent to or

stacked with other equipment. If adjacent or stacked use is necessary,
the system should be observed to verify normal operation in the
configuration in which it will be used.

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Chapter 4 - System Safety Safety Cautions and Warnings

Electromagnetic Interference (EMI)

Medical electrical equipment such as the Terason Ultrasound System requires special
precautions regarding electromagnetic compatibility, and must be installed and put into
service according to the tables in “Electromagnetic Compatibility Tables” in the Terason
Technical Manual.
To limit exposure to electromagnetic interference from nearby equipment that can degrade
image quality, you should operate the Terason Ultrasound System under EMI conditions
that minimize power supply transients, mechanical interactions, vibration, and thermal,
optical, and ionizing radiation.

Electrostatic Discharge (ESD)

ESD, or static shock, is caused by rapid discharge of electrical energy from one body to another.
ESD is common in conditions of low humidity, such as those resulting from heating or air
conditioning. To avoid damage to probes, electronics or system, use anti-static spray on carpets
and linoleum, and anti-static mats.
The Terason Ultrasound System complies to a level of ± 2kV ESD. The latch for locking
the ultrasound probe and the FireWire port is sensitive to ESD and should not be touched
when operating the system. In cases where an ESD shock discharges to one of these
points, the computer program may freeze or windows may open unexpectedly. In these
cases, the Terason software may require restarting, and you may have to close extra
windows. In extreme cases, the computer may require restarting. These events are not
dangerous to the patient or to the operator.

Liquids
The Terason probe, electronics envelope, and computer are not protected from spilled
liquids. The probe array is watertight up to the strain relief, as specified in “Pre-Cleaning”
in the Terason Technical Manual. If the computer is exposed to liquids or moisture,
purchase a keyboard drape. In addition, the Terason Ultrasound System electronics must
be draped if exposed to liquids or moisture.

Couplants
Use only couplants specifically designed for ultrasound examinations. Do not use mineral-
oil or vegetable-based couplants, which can damage probes.

Heat
Do not expose probes to direct heat such as strong sunlight or local heat sources. Heat ages
the crystal and causes loss of sensitivity.

Latex
Terason strongly recommends that health-care professionals identify their latex-sensitive
patients, and refer to the FDA’s March 29, 1991 Medical Alert on Latex products. Be
prepared to treat allergic reactions promptly.

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Chapter 4 - System Safety Labels

Care
Ultrasound probes and your Terason Ultrasound System are fragile. Handle with care. If
the probe appears damaged, or misuse of the electronics envelope causes a malfunction,
please return the equipment to Terason for service or replacement.

Warning: Do not drop the ultrasound probe! If you accidentally drop the
probe, check it carefully for damage. Perform a sample scan to
make sure it operates correctly. If not, contact Terason for service
or replacement.

Immersion
Do not immerse the probe connector. If the cable connector is immersed, do not plug the
connector into the system. Rinse the connector under running water and dry it thoroughly.
If necessary, contact Terason for service.

HF (High Frequency) Surgical Equipment

Warning: The Terason Ultrasound System is not approved for use with HF
surgical equipment. Use of the Terason Ultrasound System in HF
surgical procedures could result in failure of the electrical
isolation, resulting in injury or death.

Labels
Several labels are attached to the Terason system. The following sections describe what
each label means.
Refer to the laptop user guide for information about its labels and regulatory compliance

System Label Icons

Manufacturer Mark
Manufacturer -- Terason manufactures the Terason Ultrasound System.

Type BF Equipment Applied Part

The Terason Ultrasound System provides protection against electric shock. It is a

Type BF applied part that has a lower leakage current than for non-BF applied
parts.

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Chapter 4 - System Safety Labels

Terason Ultrasound System Emits Ultrasound Energy

This device complies with FDA Track 3 guidelines on acoustic output labeling
for the intended uses of the probes.

Double Insulated

This device is Type 2 (double insulated).

Indoor Use Only

This device is intended for indoor use only.

CE Mark

The Terason Ultrasound System conforms to all applicable European Directives

- specifically, the Council Directive Concerning Medical Devices 93/42/EEC.
The number adjacent to the CE marking (0413) is the number of the EU-notified
body that certified meeting the requirements of Annex II of the Directive.

U.S. and Canada Safety Standards

This certification mark indicates that the Terason Ultrasound System has been
tested to and meets the minimum requirements of widely recognized U.S. and
Canadian product safety standards. It also means that the manufacturing site has
been audited, and that Terason has agreed to a program of periodic factory
follow-up inspections to verify continued conformance.

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Chapter 4 - System Safety Labels

See User Guide

This label indicates that the user should refer to the User Guide for information
on using this equipment.

Dispose of Properly
Do not dispose of by dumping in garbage. Use a separate collection for
electrical and electronic equipment.
Products bearing this symbol are subject to the European Community
directive 2002/96/EC on waste electrical and electronic equipment (WEEE),
amended by directive 2003/108/EC. For collection and disposal of the
product, its components, or its accessories, contact your local Siemens
representative.

Shipping Label Icons

The following symbols appear on the shipping label.

Environmental

The Terason Ultrasound System must be stored in the original shipping container
in environments with 15% to 90% relative humidity and non-condensing.

Air Pressure

The Terason Ultrasound System must be stored in the original shipping container
in environments between 63 kPa (472.5 mmHg) and 101.3 kPa (759.8 mmHg)
air pressure.

Temperature

The Terason Ultrasound System must be stored in the original shipping container
in environments between 0º and 40º C (32º and 104ºF).

Terason Probes
Each Terason probe has a label that indicates its model and serial numbers: The following
figure is an example of a probe label.

Example Probe Label

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Chapter 4 - System Safety Safety Standards

Safety Standards
According to the American Institute of Ultrasound in Medicine (AIUM) Official
Statement of the Clinical Safety of Diagnostic Ultrasound (March 1993):
Diagnostic ultrasound has been in use since the late 1950s. Given its known benefits
and recognized efficacy for medical diagnosis, including use during human
pregnancy, the American Institute of Ultrasound in Medicine herein addresses the
clinical safety of such use: No confirmed biological effects on patients or instrument
operators caused by exposure at intensities typical of present diagnostic ultrasound
instruments have ever been reported. Although the possibility exists that such
biological effects may be identified in the future, current data indicate that the benefits
to patients of the prudent use of diagnostic ultrasound outweigh the risks, if any, that
may be present.
This section addresses the following topics:
• Ultrasound Safety, see page 55
• Electrical Safety, see page 55
• Surface Heating of Invasive Probes, see page 55

Ultrasound Safety
The following is a Prudent Use Statement regarding the use of ultrasound:
Use diagnostic ultrasound only when there is a good medical reason. Also, the Terason
Ultrasound System does not provide explicit control of acoustic power output.
Therefore, to minimize the exposure to ultrasound energy, limit the duration of
ultrasound examinations.

Electrical Safety
The Terason Ultrasound System conforms to the UL 60601-1 electrical safety standard.
Each probe is insulated from the patient to minimize patient exposure in the presence of a
system fault or a fault in other patient-connected equipment. The type of protection
against electric shock is Class I. The degree of protection is Type BF, per safety standard
IEC 60601-1.
To maintain compliance with electrical safety and emissions standards, the Terason
Ultrasound System must be used only with the supplied Medical Grade Power Adapters.

Surface Heating of Invasive Probes

The average and peak radiated acoustic powers of all Terason probes are limited by
detection circuitry, to insure that the surface heating of the probe array is less than 43ºC.
To limit the average acoustic power output, the maximum pulse repetition frequency
(PRF) is tested in hardware by comparing a PRF counter to a preset value. Exceeding the
maximum allowable PRF triggers an error message that displays on the host computer,
and the Terason Ultrasound System acoustic output is disabled. The preset maximum PRF
is chosen to limit the probe case temperature to less than 43ºC when the probe is touching
a patient.

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Chapter 4 - System Safety Indications For Use

The peak acoustic power is constrained by the maximum voltage applied to the probe-
array elements. In hardware, peak power is monitored by a watchdog device that measures
instantaneous power and compares it to two thresholds. The first threshold is a non-
programmable four-watt limit. The second threshold is a programmable limit that Terason
has set in accordance with IEC 60601-2-37 and AIUM Nema UD2 and UD3 (1998 and
2004).

Indications For Use

This section provides Diagnostic Ultrasound Indications for Use forms for the probes
offered with the Terason ultrasound system.
The Terason Ultrasound System is a general-purpose imaging system intended for use by
qualified physicians for analysis by ultrasound imaging or fluid-flow of the human body.
Specific clinical applications and exam types include: Fetal, Abdominal, Pediatric, Small
Organ (thyroid, breast, testes), Neonatal Cephalic, Adult Cephalic, Musculoskeletal
(conventional and superficial), Cardiac (adult and pediatric), and Peripheral Vascular. .

Caution:The Terason Ultrasound System is for prescription use only.

Caution:Federal law restricts this device to sale by or on the order of a physician.

The Terason system should only be used in a medical facility under the
supervision of a trained physician.

Caution:Do not use the Terason Ultrasound System during an MRI exam or when
using a defibrillator.

Note: The Terason Ultrasound System is not approved for ophthalmic use or for any use
that causes the acoustic beam to pass through the eye.

The first table provides indications for use for the system. The remaining tables list the
indications for use for the following:
• Ultrasound system
• 4V2A Probe
• 5C2A Probe
• 8EC4A Probe
• 8V3A Probe
• 12L5A Probe
• 12L5V Probe
• PDOF Probe

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Chapter 4 - System Safety Indications For Use

Indications for use - Diagnostic Ultrasound System

DIAGNOSTIC ULTRASOUND INDICATIONS FOR USE FORM

System: Terason Ultrasound System

Probe: See Comments
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
Clinical Application Mode of Operation
General (Track 1 Color Comb.
Only) Specific (Tracks 1 and 3) B M PWD CWD Doppa Modesb Otherc
Ophthalmic Ophthalmic
Fetal h X X X X X X
d
Abdominal X X X X X X
Intra-operative (Spec.) d,e X X X X X X
Intra-operative (Neuro)
Laparoscopic
Pediatricd
Small Organ (Thyroid, Breast, Testes, X X X X X X
etc.) d
Neonatal Cephalic d
Adult Cephalic d
Trans-rectalf
Trans-vaginal g
Trans-urethral
Trans-esoph. (non-Cardiac)
Musculo-skel. (Conventional) d X X X X X X

Fetal Imaging Musculo-skel. (Superficial) d X X X X X X

and Other Intra-luminal
Other (Specify)
Cardiac Adult X X X X X X
Cardiac Pediatric X X X X X X
Trans-esoph. (Cardiac)
Cardiac Other (specify)
Peripheral Peripheral vessel d X X X X X X
Vessel Other (specify)
aIncludes Color Doppler (CD), Directional Power Doppler (DPD), and (non-directional) Power Doppler (PD).
bB+M;
B+PWD; B+CD; B+DPD; B+PD; B+CD+PWD.
cTissue Harmonic Imaging (THI), Tissue Doppler Imaging (TDI).
d
Includes ultrasound guidance for placement of needles, catheters.
eAbdominal organs and peripheral vessels.
f
Includes ultrasound guidance for placement of needles, catheters, cryosurgery, and brachytherapy.
gIncludes
ultrasound guidance of transvaginal biopsy , infertility monitoring of follicle development.
hIncludes
ultrasound guidance of amniocentesis, infertility monitoring of follicle development.
jIncludes stress echo.

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Chapter 4 - System Safety Indications For Use

Indications for Use - 4V2A Probe

DIAGNOSTIC ULTRASOUND INDICATIONS FOR USE FORM

System: Terason Ultrasound System

Probe: 4V2A
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
Clinical Application Mode of Operation
General Color Comb.
Specific (Tracks 1 and 3) B M PWD CWD Otherc
(Track 1 Only) Doppa Modesb
Ophthalmic Ophthalmic
Fetal Xh Xh Xh Xh Xh Xh
Abdominal Xd Xd Xd Xd Xd Xd
Intra-operative (Specify)
Intra-operative (Neuro)
Laparoscopic
Pediatric Xd Xd Xd Xd Xd Xd
Small Organ (Thyroid, Breast, Testes,
etc.)
Fetal Imaging
and Other Neonatal Cephalic X X X X X X
Adult Cephalic X X X X X X
Trans-rectal
Trans-vaginal
Trans-urethral
Trans-esoph. (non-Cardiac)
Musculo-skel. (Conventional)
Musculo-skel. (Superficial)
Intra-luminal
Other (Specify)
Cardiac Adult X X X X X X X
Cardiac Pediatric X X X X X X X
Cardiac
Trans-esoph. (Cardiac)
Other (Specify)
Peripheral Peripheral vessel
Vessel Other (Specify)
aIncludes
Color Doppler (CD), Directional Power Doppler (DPD), and (non-directional) Power Doppler (PD).
bB+M; B+PWD; B+CD; B+DPD; B+PD; B+CD+PWD.
c
Tissue Harmonic Imaging (THI).
dIncludes ultrasound guidance for placement of needles, catheters.
e
Abdominal organs and peripheral vessels.
fIncludes
ultrasound guidance for placement of needles, catheters, cryosurgery, and brachytherapy.
gIncludes ultrasound guidance of transvaginal biopsy.
h
Includes ultrasound guidance of amniocentesis, infertility monitoring of follicle development.
Includes uses in military field settings in addition to hospital/clinic settings.

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Chapter 4 - System Safety Indications For Use

Indications for Use - 5C2A Probe

DIAGNOSTIC ULTRASOUND INDICATIONS FOR USE FORM

System: Terason Ultrasound System

Probe: 5C2A
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
Clinical Application Mode of Operation
General Color Comb.
(Track 1 Only) Specific (Tracks 1 and 3) B M PWD CWD Doppa Modesb Otherc

Ophthalmic Ophthalmic

Fetal h Xh Xh Xh Xh Xh Xh
Abdominal d Xd Xd Xd Xd Xd Xd
Intra-operative (Specify) d,e
Intra-operative (Neuro)
Laparoscopic
Pediatric d Xd Xd Xd Xd Xd Xd
Fetal Imaging Small Organ (Thyroid, Breast, Testes,
and Other etc.) d
Neonatal Cephalic d
Adult Cephalic d
Trans-rectal f
Trans-vaginal g
Trans-urethral
Trans-esoph. (non-Cardiac)
Musculo-skel. (Conventional) d
Musculo-skel. (Superficial) d
Intra-luminal
Other (Specify)
Cardiac Adult
Cardiac Cardiac Pediatric
Trans-esoph. (Cardiac)
Other (Specify)
Peripheral Peripheral vessel d Xd Xd Xd Xd Xd Xd
Vessel Other (Specify)
aIncludes Color Doppler (CD), Directional Power Doppler (DPD), and (non-directional) Power Doppler (PD).
b
B+M; B+PWD; B+CD; B+DPD; B+PD; B+CD+PWD.
cTissue
Harmonic Imaging (THI), Tissue Doppler Imaging (TDI).
dIncludes ultrasound guidance for placement of needles, catheters.
e
Abdominal organs and peripheral vessels.
fIncludes ultrasound guidance for placement of needles, catheters, cryosurgery, and brachytherapy.
gIncludes
ultrasound guidance of transvaginal biopsy , infertility monitoring of follicle development.
hIncludes
ultrasound guidance of amniocentesis, infertility monitoring of follicle development.
jIncludes stress echo.

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Chapter 4 - System Safety Indications For Use

Indications for Use - 8EC4A Probe

DIAGNOSTIC ULTRASOUND INDICATIONS FOR USE FORM

System: Terason Ultrasound System

Probe: 8EC4A
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
Clinical Application Mode of Operation
General Color Comb.
Specific (Tracks 1 and 3) B M PWD CWD Otherc
(Track 1 Only) Doppa Modesb
Ophthalmic Ophthalmic
Fetal X X X X X X
Abdominal
Intra-operative (Specify)
Intra-operative (Neuro)
Laparoscopic
Pediatric
Small Organ (Thyroid, Breast, Testes,
etc.)
Fetal Imaging Neonatal Cephalic
and Other Adult Cephalic
Trans-rectal Xf Xf Xf Xf Xf Xf
Trans-vaginal Xg Xg Xg Xg Xg Xg
Trans-urethral
Trans-esoph. (non-Cardiac)
Musculo-skel. (Conventional)
Musculo-skel. (Superficial)
Intra-luminal
Other (Specify)
Cardiac Adult
Cardiac Pediatric
Cardiac
Trans-esoph. (Cardiac)
Other (Specify)
Peripheral Peripheral vessel
Vessel Other (Specify)
aIncludes Color Doppler (CD), Directional Power Doppler (DPD), and (non-directional) Power Doppler (PD).
bB+M;
B+PWD; B+CD; B+DPD; B+PD; B+CD+PWD.
cTissue Harmonic Imaging (THI), Tissue Doppler Imaging (TDI).
f
Includes ultrasound guidance for placement of needles, catheters, cryosurgery, and brachytherapy.
gIncludes ultrasound guidance of transvaginal biopsy.
l
Other use includes Urology/Prostate.
Includes uses in military field settings in addition to hospital/clinic settings.

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Chapter 4 - System Safety Indications For Use

Indications for Use .- 8V3A Probe

DIAGNOSTIC ULTRASOUND INDICATIONS FOR USE FORM

System: Terason Ultrasound System

Probe: 8V3A
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
Clinical Application Mode of Operation
General Color Comb.
Specific (Tracks 1 and 3) B M PWD CWD Otherc
(Track 1 Only) Doppa Modesb
Ophthalmic Ophthalmic
Fetal
Abdominal X X X X X X
Intra-operative (Specify)
Intra-operative (Neuro)
Laparoscopic
Pediatric X X X X X X
Small Organ (Thyroid, Breast, Testes,
etc.)
Fetal Imaging Neonatal Cephalic X X X X X X
and Other Adult Cephalic X X X X X X
Trans-rectal
Trans-vaginal
Trans-urethral
Trans-esoph. (non-Cardiac)
Musculo-skel. (Conventional)
Musculo-skel. (Superficial)
Intra-luminal
Other (Specify)
Cardiac Adult X X X X X X X
Cardiac Pediatric X X X X X X X
Cardiac
Trans-esoph. (Cardiac)
Other (Specify)
Peripheral Peripheral vessel
Vessel Other (Specify)
a
Includes Color Doppler (CD), Directional Power Doppler (DPD), and (non-directional) Power Doppler (PD).
bB+M;
B+PWD; B+CD; B+DPD; B+PD; B+CD+PWD.
cTissue Harmonic Imaging (THI), Tissue Doppler Imaging (TDI).
fIncludes
ultrasound guidance for placement of needles, catheters, cryosurgery, and brachytherapy.
gIncludes ultrasound guidance of transvaginal biopsy.
l
Other use includes Urology/Prostate.
Includes uses in military field settings in addition to hospital/clinic settings.

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Chapter 4 - System Safety Indications For Use

Indications for Use - 12L5A Probe

DIAGNOSTIC ULTRASOUND INDICATIONS FOR USE FORM

System: Terason Ultrasound System

Probe: 12L5A
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
Clinical Application Mode of Operation
General Color Comb.
Specific (Tracks 1 and 3) B M PWD Otherc
(Track 1 Only) Doppa Modesb
Ophthalmic Ophthalmic
Fetal
Abdominal Xd Xd Xd Xd Xd Xd
Intra-operative
Intra-operative (Neuro)
Laparoscopic
Pediatric Xd Xd Xd Xd Xd Xd
Small Organ (Thyroid, Breast, Testes, Xd Xd Xd Xd Xd Xd
etc.)
Fetal Imaging Neonatal Cephalic X X X X X X
and Other Adult Cephalic X X X X X X
Trans-rectal
Trans-vaginal
Trans-urethral
Trans-esoph. (non-Cardiac)
Musculo-skel. (Conventional) Xd Xd Xd Xd Xd Xd
Musculo-skel. (Superficial) Xd Xd Xd Xd Xd Xd
Intra-luminal
Other (specify)
Cardiac Adult
Cardiac Pediatric
Cardiac
Trans-esoph. (Cardiac)
Other (specify)
Peripheral Peripheral vessel Xd Xd Xd Xd Xd Xd
Vessel Other (specify)
a
Includes Color Doppler (CD), Directional Power Doppler (DPD), and (non-directional) Power Doppler (PD).
bB+M;
B+PWD; B+CD; B+DPD; B+PD; B+CD+PWD.
cTissue Harmonic Imaging (THI), Tissue Doppler Imaging (TDI).
dIncludes
ultrasound guidance for placement of needles, catheters.
eAbdominal organs and peripheral vessels.
k
Abdominal includes GYN/Pelvic.
lOther use includes Urology/Prostate.

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Indications for Use - 12L5V Probe

DIAGNOSTIC ULTRASOUND INDICATIONS FOR USE FORM

System: Terason Ultrasound System

Probe: 12L5V
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
Clinical Application Mode of Operation
General Color Comb.
Specific (Tracks 1 and 3) B M PWD Otherc
(Track 1 Only) Doppa Modesb
Ophthalmic Ophthalmic
Fetal
Abdominal Xd Xd Xd Xd Xd Xd
Intra-operative
Intra-operative (Neuro)
Laparoscopic
Pediatric Xd Xd Xd Xd Xd Xd
Small Organ (Thyroid, Breast, Testes, Xd Xd Xd Xd Xd Xd
etc.)
Fetal Imaging Neonatal Cephalic X X X X X X
and Other Adult Cephalic X X X X X X
Trans-rectal
Trans-vaginal
Trans-urethral
Trans-esoph. (non-Cardiac)
Musculo-skel. (Conventional) Xd Xd Xd Xd Xd Xd
Musculo-skel. (Superficial) Xd Xd Xd Xd Xd Xd
Intra-luminal
Other (specify)
Cardiac Adult
Cardiac Pediatric
Cardiac
Trans-esoph. (Cardiac)
Other (specify)
Peripheral Peripheral vessel Xd Xd Xd Xd Xd Xd
Vessel Other (specify)
a
Includes Color Doppler (CD), Directional Power Doppler (DPD), and (non-directional) Power Doppler (PD).
bB+M;
B+PWD; B+CD; B+DPD; B+PD; B+CD+PWD.
cTissue Harmonic Imaging (THI), Tissue Doppler Imaging (TDI).
dIncludes
ultrasound guidance for placement of needles, catheters.
eAbdominal organs and peripheral vessels.
k
Abdominal includes GYN/Pelvic.
lOther use includes Urology/Prostate.

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Indications for Use - PDOF Probe

DIAGNOSTIC ULTRASOUND INDICATIONS FOR USE FORM

System: Terason Ultrasound System

Probe: PDOF
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
Clinical Application Mode of Operation
General Color Comb.
Specific (Tracks 1 and 3) B M PWD CWD Otherc
(Track 1 Only) Doppa Modesb
Ophthalmic Ophthalmic
Fetal
Abdominal
Intra-operative (Specify)
Intra-operative (Neuro)
Laparoscopic
Pediatric
Small Organ (Thyroid, Breast, Testes,
etc.)
Fetal Imaging Neonatal Cephalic
and Other Adult Cephalic
Trans-rectal
Trans-vaginal
Trans-urethral
Trans-esoph. (non-Cardiac)
Musculo-skel. (Conventional)
Musculo-skel. (Superficial)
Intra-luminal
Other (Specify)
Cardiac Adult X
Cardiac Pediatric X
Cardiac
Trans-esoph. (Cardiac)
Other (Specify)
Peripheral Peripheral vessel
Vessel Other (Specify)
a
Includes Color Doppler (CD), Directional Power Doppler (DPD), and (non-directional) Power Doppler (PD).
b2D+M;
2D+PWD; 2D+CD; 2D+DPD; 2D+PDV
cTissue Harmonic Imaging (THI), Tissue Doppler Imaging (TDI).
dIncludes
ultrasound guidance for placement of needles, catheters.
eAbdominal organs and peripheral vessels.
k
Abdominal includes GYN/Pelvic.
lOther use includes Urology/Prostate.

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Acoustic Output Indices

The Terason Ultrasound System complies with the Standard for Real-Time Display of
Thermal and Mechanical Acoustic Output Indices on Diagnostic Ultrasound Equipment
(UD3-2004).
When operating in any mode with the Freeze function disabled, the window displays the
acoustic output indices relevant to the currently- active probe and operating mode.
As described in this manual, minimizing the real-time displayed index values allows the
practice of the ALARA principle (exposure of the patient to ultrasound energy at a level
that is As Low As Reasonably Achievable).

Warning: Ultrasound procedures should be used for valid reasons, for the
shortest period of time, and at the lowest mechanical/thermal
index setting necessary to produce clinically acceptable images.
The ultrasound system incorporates an output display of
Mechanical and Thermal Indices to allow you to monitor, and to
limit, the amount of ultrasound energy that is transferred to the
patient.
Note: For systems distributed in the United States of America,
refer to the Medical Ultrasound Safety ultrasound education
program brochure produced by the AIUM.

General Description of Indices

For a detailed explanation of the clinical significance and proper use of the real-time
acoustic output indices displayed on the Terason image display, consult relevant literature
and educational materials available from industry and professional organizations
concerned with medical ultrasound. To help understand how adjustment of the controls
may affect the display of indices during an exam, read the following overview.
In general, indexes are described in terms of the following factors.
• Potential bioeffect of concern: Mechanical (cavitation or other non-thermal
mechanical effects), or thermal (heating of tissue through absorption of the ultrasound
energy) -for all indices, an index value less than 1.0 indicates relatively low risk for
harm to the patient when the index is applied properly.
• Type of operating mode: Generally, mechanical effects are a greater concern during
2D-only operation, while thermal effects are a greater concern during any non-2D
operation. Thermal effects of non-scanned modes (M-Mode and Pulsed-Wave Doppler
modes) are calculated separately from effects of scanned modes (Color Doppler and
Power Doppler modes).
• Type of and location of tissue of concern: Bone or soft tissue, located either at the
tissue surface nearest the probe, or at or near the beam focus.
• Measured acoustic parameters: Ultrasound power, time average intensity, or
instantaneous peak pressure used in calculating the index value. All calculations assume
an attenuation (or “derating”) rate of
0.3 dB/cm/MHz.

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MI: The Mechanical Index

MI is of possible clinical interest if the beam focus is close to the surface of lung tissue.
MI has the following characteristics:
• Potential bioeffect: Any possible mechanical or non-thermal mecha-
nisms - although the likelihood of adverse consequences from these
causes is not well understood, such risk may be highest in the pres-
ence of gas-saturated structures such as lung tissue.
• Mode type: Calculated for all modes of operation.
• Tissue type and location: Soft tissue at all locations in the scan field.
• Acoustic parameter: Maximum negative (rarefactional) ultrasound
pressure at focus.

TIS: The Soft Tissue Thermal Index

TIS is of interest in the absence of bone, either at the tissue surface or near the beam focus.
Applications of clinical interest include general abdominal examinations, first-trimester
scanning before fetal bone has ossified, and cardiology. TIS has the following
characteristics.
• Potential bioeffect: Thermal heating of soft tissue due to absorption of ultrasound. The
TIS value is the ratio of the current probe power to the reference level that would cause
a 1ºC temperature rise in soft tissue.
• Mode type: Relevant for all modes, in both scanned and non-scanned modes.
• Tissue type and location: In scanned modes, soft tissue at the surface is of concern. In
non-scanned modes, heating of soft tissue along the beam axis between the surface and
focus is considered.
• Acoustic parameters: For scanned modes, the associated intensity at the surface is
usually related to surface tissue heating. For unscanned modes, the maximum derated
power through a 1-cm2 area anywhere along the beam axis is the basis for estimating
tissue heating: unscanned beams less than 1cm2 in area at the surface are assumed to
contribute only to surface heating, and the calculated effects are combined with those of
scanned modes to estimate total soft-tissue heating at the surface. Unscanned beams
larger than 1 cm2 at the surface are assumed to heat tissue only near the focus. Total
heating effects at the surface and focus are compiled separately, and the larger value is
reported as TIS.

TIB: The Bone Tissue Thermal Index

TIB is of concern when bone is near the beam focus. Applications of clinical interest
include second- and third-trimester Doppler (when the beam focus is near fetal bone), and
Neonatal Cephalic Doppler (when the beam focus is near cranial bone). TIB has the
following characteristics.
• Potential bioeffect: Thermal heating of bone (and indirect heating of adjacent soft
tissue) due to absorption of ultrasound at the bone surface. The TIB value indicates the

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ratio of the current power level from the probe to the reference power level that would
cause a 1ºC steady-state temperature rise in bone located at the beam focus.
• Mode type: Calculated for all operations, in both scanned and non-scanned modes.
• Tissue type and location: In scanned modes, the model for soft tissue at the surface is
also used to calculate the maximum possible heating of bone at the beam focus. For
non-scanned modes, possible heating of bone near the beam focus is considered
directly.
• Acoustic parameters: For scanned modes, the time-average intensity at the probe
surface is closely related to estimated heating effects. For unscanned modes, the
maximum product along the beam axis of both derated power and intensity is the basis
for calculating possible bone heating. Total heating effects for scanned and unscanned
modes are compiled separately, and the larger value is reported as TIB.

TIC: The Cranial (Bone) Thermal Index

TIC is of concern when bone is near the tissue surface and in close proximity to the probe
aperture. Clinical applications of interest are specific to those involving transcranial
scanning. General information about the Cranial Thermal Index follows.
• Potential bioeffect: Thermal heating of cranial bone (with indirect heating of adjacent
brain tissue) due to absorption of ultrasound by the cranial bone. TIC is defined as the
ratio of the current probe power level to the reference power level that would cause a
1ºC steady-state temperature rise in cranial bone located at the probe surface.
• Mode type: Calculated for all operations, in both scanned and non-scanned modes.
• Tissue type and location: Cranial bone, located near the tissue surface and near the
probe aperture.
• Acoustic parameter: For each active mode, the product of estimated power and
intensity at the probe surface is the basis for calculating cranial bone heating. Heating
effects of all modes are combined to calculate the TIC.

Relevant Acoustic Output Indices

When live imaging in any mode, the window displays the indices relevant to the active
probe and operating mode. The definition of relevant indices is as follows:
Acoustic Output Indices for Modes and Probes

Mode Type Currently Relevant

Active Allowed Probe Applications Indices1
All modes Include neither Adult Cephalic MI, TIS, TIB
nor Neonatal Cephalic

All modes Include either Adult Cephalic or MI, TIS, TIB, TIC
Neonatal Cephalic

1. The TIC index can be chosen and displayed even when the connected probe is
not intended for cephalic applications.

Acoustic Output Index Displays

This section describes the acoustic output display in various modes.

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Only certain probes used with the Terason Ultrasound System are intended for transcranial
examinations (Neo-natal Cephalic uses). If the probe used does not support transcranial
exams, the index display does not include TIC.

Warning: For neonatal head imaging, Terason recommends that you

exercise special care during neonatal cephalic scanning to avoid
possible damage to the posterior region of the eye.
The ultrasound energy emitted by the probe easily penetrates the
fontanels of the infant.

Index Display
When any mode is active, a display shows the mechanical index and one thermal index
relevant to the probe in use. The index information appears at the top of the column of text
to the right of the scan image. The indices are TIS (soft tissue), TIB (bone), and TIC
(cranial).
The probe in use may display either the TIS, the TIB, or the TIC.
You can select a different thermal index to display.
To select a thermal index:
1. Click Setup.
2. Click the Display tab.
3. In the TI Selection section, click the desired thermal index.
4. Click OK.
If the value of the selected index is greater than 0.4, the value displays. If the value is
less than 0.4, “<0.4” displays.

Control of Acoustic Index Parameters

For any probe used in the intended clinical applications with the Terason Ultrasound
System in which all relevant acoustic indices are displayed in standard video (without an
associated real-time value), operation is normally without significant risk due to
mechanical effects or heating of tissues by ultrasound energy. No real-time MI or TI
values need be monitored, and the probe may be used without concern for minimizing the
displayed value of any index. However, in keeping with ALARA, the system should
generally be operated in the shallowest depth control setting that yields the desired image
quality (to minimize the MI value).

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For all probes, real-time values are displayed to allow monitoring and control. The
displayed indexes may show the following values (shown along with the corresponding
labels, where x indicates the actual calculated index value):
Acoustic Index Parameters

Display of TI Values Display of MI Values

Range of Range of
calculated value Displayed value calculated value Displayed value
xCalc. xDisplay xCalc. xDisplay
x < 0.4 < 0.4 0x < 0.05 0.0
0.4  x < 0.5 0.4 0.05  x < 0.15 0.1
0.5  x < 0.7 0.6 0.15  x < 0.25 0.2
0.7  x < 0.9 0.8 0.25  x < 0.35 0.3
0.9  x < 1.1 1.0 0.35  x < 0.45 0.4
1.1  x < 1.3 1.2 0.45  x < 0.55 0.5
1.3  x < 1.5 1.4 0.55  x < 0.65 0.6
1.5  x < 1.7 1.6 0.65  x < 0.75 0.7
1.7  x < 1.9 1.8 0.75  x < 0.85 0.8
Etc. Etc. Etc. Etc.

In all operating modes with the Terason Ultrasound System, control of acoustic exposure
is available indirectly. For a description of the indirect effects that certain control
adjustments may have on displayed index values, consult the “Working With Scan
Modes” chapter in the User Guide for your system.

Accuracy of Acoustic Output Display

The acoustic output display indices are calculated on the basis of measured values of
acoustic parameters (acoustic power, intensity, pressure, etc.). The accuracy of the indices
(discussed in the Standard for Real-Time Display of Thermal and Mechanical Acoustic
Output Indices on Diagnostic Ultrasound Equipment) described below refers to accuracy
of the measurement of the acoustic parameters and the effect of these errors on the
estimated index values. (For a discussion of statistical considerations in acoustic
measurement, refer to “Measurement Uncertainty in Ultrasonic Exposimetry”, in
Ultrasonic Exposimetry, M. C. Ziskin and P. A. Lewin, eds., CRC Press).

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The remainder of this section lists the relative errors for the following items:
• Intensity measurements
• Spatial-peak derated pulse-intensity integral, defined as SPPA.3
• Spatial-peak derated temporal average intensity for unscanned modes
• Spatial-peak derated temporal average intensity for scanned modes
• Peak derated rarefactional pressure
• Mechanical Index
• Soft-Tissue Thermal Index for scanned modes, total acoustic power at the scan/beam
entrance to the body
• Soft-Tissue Thermal Index for unscanned modes, when the beam-entrance dimension is
less than 1 cm2 in area
• Soft-Tissue Thermal Index for unscanned modes, when the beam-entrance dimension is
greater than 1 cm2 in area
• Bone Thermal Index for unscanned modes
• Cranial Thermal Index
The relative error in intensity measurements due to uncertainty in the hydrophone
calibration, defined as k, is approximately:
1---
2  2 2
 k = ( + + 2) = %
Cal A V

where the following are defined:

Cal Calibration error, as supplied by Sonic Consulting, Inc.; 21% at the
frequency range of the probes tested.
A Relative error in the reproducibility of positioning the hydrophone at the
point of the spatial peak of the pulse intensity integral, estimated as 5%
V2 Relative error resulting from errors in reading peak squared voltage in the
recorded waveform, estimated as 4%

The relative error in the spatial-peak derated pulse-intensity integral, defined as

SPPA.3,is approximately:
2 2 2 2 2 2 2 1/2
 SPPA.3 =   +  +  + + + +  = %
k TI stab .3 lin v PD

where the following is defined:

TI Relative error due to hydrophone positioning and temporal integra-

tion of the waveform, estimated as 4%
stab Relative error due to temporal instability of the hydrophone, esti-
mated as 1%
.3 Relative error in estimating derating factor, due to uncertainties in
estimating frequency and reproducibility in determining derating
location, estimated as 4%
lin Relative error due to the effects of non-linearities in the pressure
waveform upon the hydrophone and integral amplifier, estimated as
0% for this probe set

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PD Relative error in estimate of pulse duration, estimated as 5%

The relative error in the spatial-peak derated temporal average intensity for
unscanned modes, defined as SPTA.3-unsc., is approximately:
2 2 1/2
 SPTA.3-unsc. =   +  = 3%
SPPII.3 prf

where the following is defined:

prf Relative error in prf estimation for operating condition giving actual
peak ISPTA.3-unsc., estimated as 1%

The relative error in estimating spatial-peak derated temporal average intensity for
scanned modes, defined as SPTA.3-scan., is approximately:
2 2 2 1/2
 SPTA.3-scan. =   + +  = %
SPII.3 srf BOF

where the following are defined:

srf Relative error in estimating srf (scan repetition frequency) for oper-
ating condition giving actual peak ISPTA.3-scan., estimated as 1%

BOF Relative error in estimating BOF (beam-overlap factor) for oper-

ating conditions giving actual peak ISPTA.3-scan., estimated as 5%

The relative error in the peak derated rarefactional pressure, defined as pr.3, is
approximately:

1
 pr.3 =  ---  = %
 2 SPPII.3

Note: In accordance with Subsection 6.4.3 (Measurement of Precision of Peak

Rarefactional Pressure, pr) of the Standard for Real-Time Display of Thermal and
Mechanical Acoustic Output Indices on Diagnostic Ultrasound Equipment, a series
of ten independent measurements on the specified standard test probe/driver
combination yielded a relative standard deviation of pr of less than 1% for the
sample measurements.

The relative error in the Mechanical Index, defined as MI, is approximately:

2 1/2
 fc
 MI =   pr.3
2 +  -------
2
- 2
+  DAMI 2
+  TVMI 2
+  SVMI  = 31%


where the following is defined:

fc Relative error in estimating center frequency, estimated as 8%.

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DAMI Relative error in displaying the Mechanical Index, estimated as 20%.

TVMI Relative error in the Mechanical Index due to probe variability, esti-
mated as 20%.

SVMI Relative error in the Mechanical Index due to ultrasound system vari-
ability, estimated as 2%.

Note: In accordance with Subsection 6.4.1 (Measurement of Precision of Center

Frequency fc) of the Standard for Real-Time Display of Thermal and Mechanical
Acoustic Output Indices on Diagnostic Ultrasound Equipment, a series of ten
independent measurements on the specified standard test probe/driver combination
yielded a relative standard deviation of fc of less than 1% for the sample
measurements.

The relative error in the Soft-Tissue Thermal Index for scanned modes, defined as
TISscan, is approximately:

2 2 2 2 2 1/2
 TISscan =   + + + +  = 35%
W01 fc DATISscan TVW0 SVW0

where the following is defined:

W01 Relative measurement error in estimating the peak acoustic power from 1cm
width of the active scanned aperture, estimated as 10%.

DATISscan Relative error in displaying the Soft-Tissue Thermal Index for scanned
modes, estimated as 20%.

TVW0 Relative error in peak acoustic power due to probe variability, estimated as
25%.

SVW0 Relative error in peak acoustic power due to ultrasound system variability,
estimated as 2%.

Note: In accordance with Subsection 6.4.2 (Measurement of Precision of Power, W) of

the Standard for Real-Time Display of Thermal and Mechanical Acoustic Output
Indices on Diagnostic Ultrasound Equipment, a series of ten independent
measurements on the specified standard test probe/driver combination yielded a
relative standard deviation of W of less than 4% for the sample measurements.

The relative error in total acoustic power at the scan/beam entrance to the body,
defined as W0, is approximately:

 W0 =  FB = 10%

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The relative error in the Soft-Tissue Thermal Index for unscanned modes, when the
beam-entrance dimension is less than 1 cm2 in area, defined as TISunsc-A<1, is
approximately:
1/2
 TISunsc-A  1 =   +  +  
2 2 2 2 2
+ + = 35%
 W0 fc DA TISunsc-   TVW0 SVW0

where the following is defined:

DA TISunscan<1 Relative error in displaying the Soft-Tissue Thermal Index display
for unscanned modes, when the beam-entrance dimension is less
than 1 cm2 in area, estimated as 20%.

The relative error in the Soft-Tissue Thermal Index for unscanned modes, when the
beam-entrance dimension is greater than 1 cm2 in area, defined as TISunsc-A>1, is
approximately:
1/2
 TISunsc-A  1 =   +  +  
2 2 2 2 2 2
+ + + = 47%
 W0 fc ITA.6 DA TISunsc-   TVITA.6 SVITA.6

where the following is defined:

ITA.6 Relative error in estimating the spatial peak intensity, when derated at 0.6 dB/
cm/MHz, estimated as 23%.

DA TISunsc>1 Relative error in displaying the Soft-Tissue Thermal Index display for
unscanned modes, when the beam-entrance dimension is greater than 1
cm2 in area, estimated as 20%.

TV ITA.6 Relative error in the spatial peak intensity, when derated at 0.6 dB/cm/MHz,
due to probe variability, estimated as 34%.

SV ITA.6 Relative error in the spatial peak intensity, when derated at 0.6 dB/cm/MHz,
due to ultrasound system variability, estimated as 2%.

The relative error in the Bone Thermal Index for unscanned modes, defined as
TIBunsc.,
is approximately:

1 2
 TIBunsc. =  ---   + 
2 2 2 2 2 2 1/2
+ + + + +  = 27%
 2 W0 ITA.6 DATIBunsc TVW0 TVITA.6 SVW0 SVITA.6

where the following is defined:

DATIBunsc Relative error in displaying the Bone Thermal Index for unscanned
modes, estimated as 20%.

The relative error in estimating the Cranial Thermal Index, defined as TIC, is
approximately:
2 2 2 2 2 1/2
 TIC =   + + + +  = 34%
W0 Deq DATIC TVW0 SVW0

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Chapter 4 - System Safety Relationship of Index to Display Accuracy

where the following is defined:

Deq Relative error in estimating the equivalent diameter of the active

aperture, estimated as 2%.

DATIC Relative error in displaying the Cranial Thermal Index, estimated as

20%.

The estimated relative errors of the calculated indices are as follows.

MI= 31%
TISscan= 35%
TISunsc-A<1= 35%
TISunsc-A>1= 47%
TIBunsc= 27%
TIC = 34%

Relationship of Index to Display Accuracy

The discussion above concerns the relationship between the calculated index value
(xCalc.), and the “true” value (xActual), which would be obtained under conditions without
measurement uncertainty. Display precision is the relationship between the displayed
index value (xDisplay) and (xCalc). The displayed values (shown in reverse video along with
the corresponding labels) may take on the following values (where x indicates the actual
calculated index value (xCalc.)

Display Precision of TI Values

The following table indicates the precision of the display for TI values.
TI Value Precision

Range of calculated Displayed value

value xCalc. xDisplay
x < 0.4 <0.4
0.4  x < 0.5 0.4
0.5 x < 0.7 0.6
0.7  x < 0.9 0.8
0.9  x < 1.1 1.0
1.1  x < 1.3 1.2
1.3  x < 1.5 1.4
1.5  x < 1.7 1.6
1.7  x < 1.9 1.8
1.9  x < 2.1 2.0
Etc. Etc.

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Display Precision of MI Values

See the table Acoustic Index Parameters on page 69 for a listing of the precision of the
display for MI values.
When the effects of calculation errors are combined with the effects of display precision,
overall Display Accuracy can be defined as follows:
x Display – x Actual
DisplayAccuracy = ----------------------------------------------------
x Actual

The following table lists the values of Display Accuracy that are estimated to occur with the
Terason Ultrasound System. These values of Display Accuracy are given in conjunction
with the values of relevant indices that may be displayed with probes available with the
system.
Items in the following table correspond to index values actually displayed with the
Terason Ultrasound System. For those indices for which no values are displayed, all
calculated values of the index are less than 1.0 when the given index is considered relevant
to the operating mode and possible intended use of the probe.
Estimated Display Accuracy Values

Display
Value MI TI
0 (1) (2) (a) (b)

0.1 100% to –33% (a) (b)

0.2 33% to –20% (a) (b)

0.3 20% to –14% (a) (b)

0.4 14% to –11% 0% to –20%

0.5 11% to –9%
0.6 9% to –8% 20% to –14%
0.7 8% to –7%
0.8 7% to –6% 14% to –11%
0.9 6% to –5%
1 5% to –5% 11% to –9%
1.1 5% to –4%
1.2 4% to –4% 9% to –8%
1.3 4% to –4%
1.4 4% to –3% 8% to –7%
1.5 3% to –3%
1.6 3% to –3% 7% to –6%
1.7 3% to –3%
1.8 3% to –3% 6% to –5%
1.9 3% to –3%

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Estimated Display Accuracy Values (Continued)

Display
Value MI TI
2 (3) 5% to –5%

2.2 5% to –4%
2.4 4% to –4%
2.6 4% to –4%
2.8 4% to –3%
3 3% to –3%
3.2 3% to –3%
3.4 3% to –3%
3.6 3% to –3%
3.8 3% to –3%
4 3% to –2%
4.2 2% to –2%
4.4 2% to –2%
4.6 2% to –2%
4.8 2% to –2%
5 2% to –2%
5.2 2% to –2%
5.4 2% to –2%
5.6 2% to –2%
5.8 2% to –2%
6 2% to –2%

1. Display Accuracy is not defined for actual

index values (xActual) of zero.
2. xDisplay – xActual is always greater than zero.
3. Mechanical Index (MI) values greater than
1.9 exceed FDA Guideline levels.

Acoustic Output Tables

Terason tests all probes it sells for use on humans, to determine their maximum acoustic
outputs in the scanning modes supported by the probes. When the results of those tests
require reporting, a table is generated and included in Chapter 2, Terason Probes, on page

Terason t3000cv Ultrasound System Technical Manual 76

Chapter 4 - System Safety Accuracy Measures

9. The following table lists which combinations of probe and mode can produce acoustic
outputs that exceed the reporting thresholds. There are also tables for some combinations
that do not produce outputs exceeding the thresholds.
Track 3 Probe/Mode Combination Summary

Mode
Color
Probe Model 2D M PWD CWD Doppler 1 Combined 2 Other
4V2A X X X X X X

5C2A X X X X X

8EC4A X X X X X

8V3A X X X X X X

12L5A X X X X X
12L5V X X X X X

PDOF X

1. Includes Directional Power Doppler (DPD), Non-Directional Power Doppler (PD), and
Color Doppler (CD).
2. 2D+PWD: refer to acoustic output tables for PWD in Chapter 2 - Terason Probes.

Accuracy Measures
The following general assumptions can be made about the accuracy of any ultrasound
system:
• Velocity of sound uncertainty = 5%
• Tissue shape is modeled as an ellipse or an ellipsoid
• Caliper placement accuracy is one pixel (operator dependent)
• Measurement accuracy is based on the root-mean-square combination of all
independent sources of error
• RMS errors are due to velocity of sound uncertainty, pixel error, and typical probe
geometry

Distance Accuracy
Distance accuracy measures are as follows:
Formula:
2
D =  x1 + x2  2 +  y1 + y2 

where (x1,y1) and (x2,y2) are the coordinates of the end points.
Range: 0-20 cm
Accuracy: For a 20 cm measurement, a 1 pixel error is 0.2 mm.

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Chapter 4 - System Safety Accuracy Measures

RMS errors:
• For D = 10mm, accuracy = 9%
• For D = 20mm, accuracy = 6%
• For D > 50mm, accuracy = 5%

Area
Area accuracy measures are as follows:
Assumptions: Circular cross section, length of axes: 2a, 2b
Formula: K=ab
Range: 0-300 cm2
Accuracy: Determined by two independent distance measurements. The derivation of a
particular tissue shape from the circular model cannot be quantified.
RMS errors: For A=3.1 cm2, accuracy=4%

Circumference
Circumference accuracy measures are as follows:
Assumptions: Elliptical cross section, length of axes: 2a, 2b

2 + b2
Formula: C = 2 a-------------------
-
2

Range: 0-60 cm
Accuracy: Determined by two independent distance measurements
RMS errors: For C=6.3 cm, accuracy=6%

Volume
Volume accuracy measures are as follows:
Assumptions: Cylinder, length of axes: 2a, 2b, 2c (height)
Formula: V = 4/3(abc)
Range: 0-3000 ml
Accuracy: Determined by three independent distance measurements. The deviation of a
particular shape from the ellipsoid cannot be quantified.
RMS errors: For V=16 ml, accuracy=8%
Reference information for the above accuracy measures was obtained from the following
source:
Standard Mathematical Tables, 24th Edition, (Cleveland: CRC Press, 1976), 12, 17.

Terason t3000cv Ultrasound System Technical Manual 78

Chapter 4 - System Safety Compliance and Approvals

Compliance and Approvals

The Terason Ultrasound System is in compliance with the following:
• CE Marking: Medical Device Directive, 93/42/EEC (Annex II)
• EN 60601-1 Medical Electrical Equipment – General Requirements for Safety
• IEC 60601-1 Medical Electrical Equipment – General Requirements for Safety
• IEC 60601-1-1 Collateral Standard: Safety Requirements for Medical Electrical
Systems
• UL Std. 60601-1, “Medical Electrical Equipment General Requirements for Safety”;
CAN/CSA C22.2 No. 601.1-M90 “Medical Electrical Equipment, General
Requirements for Safety.”
• Electromagnetic Compatibility: EN60601-1-2, (CISPR11) Group 1, Class B
• Electric Shock: IEC 60601-1, Class I, Type BF

Environmental Protection

Product Recycling and Disposal

Terason has programs for return of used products. For more information, contact your
local Terason representative.
Terason provides disassembly instructions to treatment facilities for the safe and proper
removal and recycling of electronic components in this product. For more information,
contact your local Terason representative.

Caring for Batteries

Warning: Do not strike or drop batteries, allow batteries to contact water or
other fluids, disassemble batteries, allow conductive object to
contact a battery's terminals, cause a battery to become short-
circuited, heat batteries, or expose batteries to fire. Any of these
actions can compromise the structural integrity of a battery.
Compromising the structural integrity of a battery can result in
battery leakage, heat generation, fire, or explosion, causing
possible personal injury.

Warning: Do not use a battery if it leaks fluid or has changed shape. If skin
or clothing comes in contact with fluid from the battery,
thoroughly wash the area immediately with clean water. If any
fluid comes in contact with a user's eyes, immediately flush their
eyes with water and seek medical attention.

The system batteries are not accessible to users. If you suspect a problem with a system
battery, contact your local Terason representative.

Terason t3000cv Ultrasound System Technical Manual 79

Chapter 4 - System Safety Environmental Protection

For maximum battery life, do the following:

• Use the system in an environment with a temperature range between 10°C and 35°C.
• Store the system in an environment with low humidity and a temperature range between
-25°C and 45°C.
• When the system is stored for extended periods, connect the power supply for several
hours every few weeks to prevent the battery from draining completely.

Recycling Batteries
Warning: Never dispose of batteries by burning or by flushing into any
waste water system, for example, a lavatory. Compromising the
structural integrity of a battery can result in leakage or explosion
and the potential for personal injury.

Warning: Do not throw batteries into the trash. Collect and recycle used
batteries separate from other waste.

Estimated Use
Item Period Handling Instructions

lithium manganese dioxide batteries and 300 full charge See also: Caring for Batteries on
lithium-ion polymer batteries and discharge page 79
cycles

Recycle batteries according to local, state, and regional regulations. Use a battery
collection program available in your country to recycle batteries.
To the extent required by local laws and regulations, Terason will collect and recycle
batteries for this product at no charge. Contact your local Terason representative for
battery shipment instructions.

Disposing of the Packaging Materials

To the extent required by local laws and regulations, Terason will collect and dispose of
packaging materials for this product. For more information, contact your local Terason
representative.

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Chapter 4 - System Safety Environmental Protection

Disposing of Components and Accessories

Warning: Observe local, state, and regional regulations for the disposal of
the ultrasound system components and accessories.

Warning: To eliminate the possibility of exposing patients, operators, or

third parties to hazardous or infectious materials, always dispose
of the needle from the needle guide according to local, state, and
regional regulations.

Estimated Use
Component or Accessory Period Handling Instructions

5C2A and 12L5A needle guide single use The needle guide for use with the
bracket assemblies bracket assemblies is a single-use
item. Refer to the in-box
instructions for disposal
procedures.

Energy Conservation
For moderate energy conservation when the system is not in use, exit the ultrasound
system software and place the system in standby status.

To Do This

Exit the ultrasound system software Click the at the top right of the menu bar
Select File>Exit from the menu bar

Activate or exit standby status1 Refer to the Windows help menu for instructions to activate
or exit standby status.

1. Standby status will end the imaging session. Exit the ultrasound system software before
you place the system in standby status.

For maximum energy conservation when the system is in storage, power off and unplug
the system from the power outlet.

Terason t3000cv Ultrasound System Technical Manual 81

5 System Specifications

The following table lists the system specifications for the Terason Ultrasound System.
Gray blocks signify that the category does not apply to that component.

Ultrasound System Specifications

terason Ultrasound System Specifications

Category Specification Terason Ultrasound System Power Adapter

Frequency 4V2A 1.7 - 4 MHz

5C2A 2 - 4 MHz

PDOF 2 MHz

8EC4A 4 - 9 MHz

8V3A 3 - 9 MHz

12L5A; 4.5 - 12 MHz

12L5V 5 - 10 MHz

Frame Rate 2D Imaging 124 Hz Maximum

(based on input
data rate)
Display 15.4” LED backlit wide-screen

Size Width 14.63" (37.2 cm) 3.63" (9.2 cm)

Height 2.4" (6.cm) 2.25" (5.7 cm)

Depth 9.88" (25.1 cm) 6.5" (16.5 cm)

Weight Weight 11.1 lbs (5.03 kg) 1 lbs. (0.45 kg)

Power Adapter Input 100V~/250 V~

Output 18 VDC @ 5 A

Laptop Battery Input Lithium-Polymer Battery (73 Whr)

Leakage Current

Primary
Breakdown
Voltage

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Chapter 5 - System Specifications Optional Equipment Specifications

terason Ultrasound System Specifications (Continued)

Category Specification Terason Ultrasound System Power Adapter

Safety Standards IEC 60950-1:2001 UL60601-1

IEC 60950:1999, Edition 3 UL60950-1,
IEC 60825-1:1993 +A2:2001 C22.2 No. 601-1,
EN 60950-1:2000 C22.2 No. 60950.1
EN 60825:1994 EN 60601-1
+A2:2001 EN 60950-1

Drop Test (to concrete) 3 Feet

Operating Temperature 10-35oC 0-40oC
(50-95oF) (32-104oF)

Humidity 20-80% RH, 10-95% RH,

non-condensing on-condensing

Water Resistance Probe array watertight to the strain relief

Operating Altitude Pressure 63 kPa to 101.3 kPa 70 kPa to 106 kPa

(472.5 to 759.8 mmHg) (525 to 795 mm/Hg)

Storage Temperature –24 to 45oC -40 to 75oC

(–13 to 113oF) (-40 to 167oF)

Humidity 15-90% RH, < 95% RH,

non-condensing non-condensing

Optional Equipment Specifications

The following table lists the system specifications for optional equipment that may be
shipped with the Terason Ultrasound System:
Optional Equipment Specifications

Category Specification ECG ECG Lead Set Printer Footswitch Cart

Size Width 1.5” (3.8 cm) 6” (15.2 cm) 6.25” (15.88 cm) 19.3” (49 cm)

Height 1” (2.5 cm) 3.46” (8.79 cm) 1.2” (3.05 cm) 40.75”

Depth 6” (15.2 cm) 9.45” (24 cm) 6.0” 23.54”

Cable Length 10’ (3 Meters) 29” (74 cm) 9’ (2.74 m) 9.6’ (2.93 m) N/A

Weight Weight 8 oz (0.2 kg) 5.75 lb (2.61 kg) 31 lb (14.1 kg) 75 lb (34 kg)

Power Input 650 mW 1.0 W 1.0 W N/A

Terason t3000cv Ultrasound System Technical Manual 83

6 Electromagnetic Tables

This chapter provides reference tables for emissions and immunity requirements.
The Terason Ultrasound System is intended for use in the electromagnetic environment
specified in the following tables. The customer or user of the Terason system should
ensure that it is used in such an environment.

Electromagnetic Emissions

All Equipment
The t3200 MSK is intended for use in the electromagnetic environment specified below.
The customer or user of the t3200 MSK should ensure that it is used in such an
environment.

Guidance and Manufacturer’s Declaration - Electromagnetic Emissions - All Equipment

Emissions Test Compliance Electromagnetic Environment - Guidance

RF Emissions Group 1 The Terason Ultrasound System uses RF energy only for
CISPR 11 its internal function. Therefore, its RF emissions are very
low and are not likely to cause any interference in nearby
electronic equipment.

RF Emissions Group 2
CISPR 11

RF Emissions Class B The Terason Ultrasound System is suitable for use in all
CISPR 11 establishments, including domestic, and those directly
connected to the public low-voltage power supply
Harmonics Class A or B network that supplies buildings used for domestic
IEC 61000-3-2 purposes.
Flicker Complies
IEC 61000-3-3

RF Emissions Complies The t3200 MSK is not suitable for interconnection with
CISPR 14-1 other equipment.

RF Emissions Complies The t3200 MSK is not suitable for interconnection with
CISPR 15 other equipment.

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Chapter 6 - Electromagnetic Tables Electromagnetic Immunity

Electromagnetic Immunity

All Equipment
The t3200 MSK is intended for use in the electromagnetic environment specified below.
The customer or user of the t3200 MSK should ensure that it is used in such an
environment.
Guidance and Manufacturer’s Declaration - Electromagnetic Immunity - All Equipment

Electromagnetic Environment -
Immunity Test IEC 60601 Test Level Compliance Level Guidance

ESD +6kV Contact As specified Floors should be wood, concrete or

IEC 61000-4-2 +8kV Air ceramic tile. If floors are synthetic, the
relative humidity should be at least 30%

EFT +2kV Mains As specified Mains power quality should be that of a

IEC 61000-4-4 +1kV I/Os typical commercial or hospital
environment.

Surge +1kV Differential As specified

IEC 61000-4-5 +2kV Common

Voltage Dips/ >95% Dip for 0.5 Cycle As specified Mains power quality should be that of a
Dropout 60% Dip for 5 Cycles typical commercial or hospital
IEC 61000-4-11 30% Dip for 25 Cycles environment. If the user of the t3200
> 95% Dip for 5 MSK requires continued operation during
Seconds power mains interruptions, it is
recommended that the 35700 be
powered from an uninterruptible power
supply or battery.

Power 3A/m As specified Power Frequency magnetic fields should

Frequency 50/60 be that of a typical commercial or hospital
Hz environment.
Magnetic Field
IEC 61000-4-8

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Chapter 6 - Electromagnetic Tables Electromagnetic Immunity

Non-Life-Supporting Equipment
The t3200 MSK is intended for use in the electromagnetic environment specified below.
The customer or user of the t3200 MSK should ensure that it is used in such an
environment.
Guidance and Manufacturer’s Declaration - Electromagnetic Immunity - Non-Life-Supporting Equipment

Immunity IEC 60601 Test Complianc

Test Level e Level Electromagnetic Environment - Guidance

Portable and mobile communications equipment should be

separated from the Terason Ultrasound System by no less
than the distances calculated/listed below

Conducted 3 Vrms [V1] = 3 3.5

RF 150 KHz to 80 d = ------- P
Vrms V1
IEC 61000-4- MHz
6

Radiated RF 3 V/m [E1]=3V/m 3.5

d = ------- P 80 to 800 MHz
IEC 61000-4- 80 MHz to 2.5 E1
3 GHz

7
d = ------ P 800 MHz to 2.5 GHz
E1

where P is the max power in watts and d is the recommended

separation distance in meters.

Field strengths from fixed transmitters, as determined by an

electromagnetic site survey, should be less than the
compliance levels (V1 and E1).

Interference may occur in the vicinity of equipment containing

a transmitter.

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Chapter 6 - Electromagnetic Tables Separation Distances

Separation Distances
The t3200 MSK is intended for use in the electromagnetic environment in which radiated
disturbances are controlled. The customer or user of the t3200 MSK can help prevent
electromagnetic interference by maintaining a minimum distance between portable and
mobile RF Communications Equipment and the t3200 MSK as recommended below,
according to the maximum output power of the communications equipment.
Separation Distance According to Frequency of Transmitter
Meters (m)
150 kHz to 80 MHz 80 MHz to 800 MHz 800 MHz to 2.5 GHz
Maximum Output Power 3.5 P- = D 3.5 P- = D P- = D
7----------
--------------- ---------------
of Transmitter Watts (W) V1 E1 E1
0.01 0.12 m 0.17 m 0.24 m
0.1 0.37 m 0.37 m 0.74 m
1 1.17 m 1.17 m 2.34 m
10 3.69 m 3.69m 7.38 m
100 11.67 m 11.67 m 23.34 m

For transmitters rated at a maximum output power not listed above, the recommended
separation distance d in meters (m) can be estimated using the equation applicable to the
frequency of the transmitter, where P is the maximum output power rate of the transmitter
in watts (W) according to the transmitter manufacturer.

Note: At 80 MHz and 800 MHz, the separation distance for the higher frequency range
applies.

Note: These guidelines may not apply in all situations. Electromagnetic propagation is
affected by absorption and reflection from structures, objects and people.

Terason t3000cv Ultrasound System Technical Manual 87

7 Formulas Used for Values in the
Cardiac Report

This chapter provides the formulas used to calculate values that display in the Cardiac
Report.

Formulas Used for Measurements in the 2D

Window
2D Formulas

Name Variables Formula Units

LV Volume: adi: ith disk diameter of LV ml

Method of apical 2-chamber (cm)
Disks, Biplane  20 L
bdi: ith disk diameter of LV V = ---  a di b di  ------
4 20
apical 4-chamber (cm) i=1
L: chamber length from the
longer of A4c or A2c (cm)
20: number of disk segments
in ventricle

LV Volume: adi: ith disk diameter of LV 20 ml

 2 L
Method of apical 2- or 4-chamber V = ---
4  a  ------
di 20
Disks, Single (cm) i=1
Plane L: chamber length of cavity

Ejection Vs: LV volume systolic (ml) Vd – Vs %

Fraction Vd: LV volume diastolic (ml) EF =  ---------------------  100
 Vd 

Stroke Volume V: LV volume (ml) ml

s: systole SV = Vd – Vs
d: diastole

Cardiac Output SV: stroke volume (ml) l/min

CO = ---------------------------
SV  HR -
HR: heart rate (bpm) 1000

Cardiac Index CO: Cardiac Output CO- l/min/

CI = -----------
BSA: body surface area (m2 ) BSA m2

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Chapter 7 - Formulas Used for Values in the Cardiac Report Formulas Used for Measurements in the 2D Win-

2D Formulas (Continued)

Name Variables Formula Units

LV Mass A1: SAX epicardial diastolic g

area (cm2)
5 5 
A2: SAX endocardial diastolic LVMass = 1.05  --6-  A 1  L + t   – --6-  A 2  L 
area (cm2)
cm
L: apical length in diastole
(cm) A A
t: mean myocardial thickness t =   -----1- –  -----2- 
     

LV Mass Index LV: (g) m2

LVMass
BSA: body surface area LVMI = -----------------------
BSA

Body Surface W: weight (range: 0.5–160 m2

0.425 0.725
Area kg) BSA = 0.007184  W kg H cm 
H: height (range: 150–204
cm)

Fractional Area LVd: LV diastolic area (cm2) %

LVd – LVs
Change% ?percent?FAC =  ----------------------------  100
LVs: LV systolic area (cm2) LVd

Flow Area d: diameter (cm) 2 cm2

d
FlowArea =    -----
4
Fractional LVd: diastolic dimension (cm) LVd – LVs %
?percent?FS =  ----------------------------  100
Shortening% LVs: systolic dimension (cm)  LVd 

Fractional IVSs: interventricular septum %

Thickening% - in systole
IVSs – IVSd
Interventricular IVSd: interventricular septum ?percent?FT =  ---------------------------------  100
IVSd
Septum in diastole

Fractional LVPWs: left ventricular %

Thickening% - posterior wall in systole
LVPWs – LVPWd
Left Ventricular LVPWd: left ventricular percent?FT =  -------------------------------------------------  100
LVPWd
Posterior Wall posterior wall in diastole

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Chapter 7 - Formulas Used for Values in the Cardiac Report Formulas Used for Measurements in the M-Mode

Formulas Used for Measurements in the M-Mode

Window
M-Mode Formulas

Name Variables Formula Units

Fractional LVd: diastolic dimension LVd – LVs %

Shortening (cm) ?percent?FS =  ----------------------------  100
LVd
% LVs: systolic dimension
(cm)

Fractional IVSs: interventricular %

Thickening septum in systole
IVSs – IVSd
%- IVSd: interventricular ?percent?FT =  ---------------------------------  100
 IVSd 
Interventric septum in diastole
ular Septum

Fractional LVPWs: left ventricular %

Thickening posterior wall in
LVPWs – LVPWd
% - Left systole percent?FT =  -------------------------------------------------  100
 LVPWd 
Ventricular LVPWd: left ventricular
Posterior posterior wall in
Wall diastole

Volume LVID: left ventricle inside 2 ml

Cubed diameter V = LVID

Volume LVID: left ventricle inside ml

Teichholz diameter

7
V =  ----------------------------  LVID 
3
2.4 + LVID

Ejection Vs: systolic volume %

Vd – Vs
Fraction cubed (ml) EF =  ---------------------  100
 Vd 
Cubed Vd: diastolic volume
cubed (ml)

Ejection Vs: systolic volume %

Vd – Vs
Fraction Teichholz (ml) EF =  ---------------------  100
Vd
Teichholz Vd: diastolic volume
Teichholz (ml)

Stroke Vs: systolic volume ml

SV = Vd – Vs
Volume cubed (ml)
Cubed Vd: diastolic volume
cubed (ml)
Stroke Vs: systolic volume ml
SV = Vd – Vs
Volume Teichholz (ml)
Teichholz Vd: diastolic volume
Teichholz (ml)

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Chapter 7 - Formulas Used for Values in the Cardiac Report Formulas Used for Measurements in the M-Mode

M-Mode Formulas (Continued)

Name Variables Formula Units

Cardiac SV: stroke volume cubed l/min

CO = ---------------------------
SV  HR -
Output (ml)
1000
Cubed HR: heart rate (bpm)

Cardiac SV: stroke volume l/min

CO = ---------------------------
SV  HR -
Output Teichholz (ml)
1000
Teichholz HR: heart rate (bpm)
Cardiac CO: Cardiac Output CO- l/min/
Index cubed CI = -----------
BSA m2
Cubed (l/min)
BSA: body surface area
(m2)

Cardiac CO: Cardiac Output CO- l/min/

Index Teichholz CI = -----------
BSA m2
Teichholz (l/min)
BSA: body surface area
(m2)

LV Mass IVSd: interventricular LVMass = 0.8  1.04  g

septum diastole 3 3
  IVSd + LVIDd + LVPWd  – LVIDd  + 0.6
(cm)
LVIDd: left ventricle
inside diameter
diastole
LVPWd: left ventricle
posterior wall
diastole

LV Mass LV Mass: (g) g/m2

Index LVMI = LVMass
-----------------------
BSA: body surface area BSA
Body W: weight (range: m2
0.425 0.725
Surface 0.5–160 kg) BSA = 0.007184  W kg H cm 
Area H: height (range:
150–204 cm)

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Chapter 7 - Formulas Used for Values in the Cardiac Report Formulas Used for Measurements in Doppler Win-

Formulas Used for Measurements in Doppler

Windows
Doppler Formulas

Name Variables Formula Units

Pressure V: velocity 2 mmHg

PG = 4V
Gradient

Mean Velocity V: average velocity between two m/s

successive velocity trace N–1

points  Vi  ti
(m/s) i=1
Vmean = ----------------------
-
N: number of velocity trace points N–1
ti: time between two successive
velocity trace points (sec)
 ti
i=1

Mean V: average velocity between two mmHg

Pressure successive velocity trace N–1
2
Gradient points  4V i  ti
(m/s) i=1
Pmean = ----------------------------
-
N: number of velocity trace points N–1
ti: time between two successive
 ti
velocity trace points (sec) i=1

LV and RV

Time Velocity TVI = area under curve cm

Integral

Stroke Volume ml
SV = TVI  FlowArea
TVI: time velocity integral (cm)
TVI Flow Area
Flow Area: derived from the flow Aortic: AoV TVI LVOT FA
Mitral: MV TVI Mitral FA
diameter (cm2)
Pulmonic: PV TVI Pulmonic FA
Tricuspid: TV TVI Tricuspid FA

Cardiac SV: stroke volume (ml) l/min

CO = ---------------------------
SV  HR -
Output HR: heart rate (bpm) 1000

Cardiac Index CO: Cardiac Output CO- l/min/

CI = -----------
BSA: body surface area (m2) BSA m2

Pressure Half Vmax: Maximum velocity (m/s) 1-  ms

Time  Vmax   1 – ------
Deceleration Slope (ms2)   2 
PHT =  ------------------------------------------------------  1000
 DecelerationSlope
 

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Chapter 7 - Formulas Used for Values in the Cardiac Report Formulas Used for Measurements in Doppler Win-

Doppler Formulas (Continued)

Name Variables Formula Units

Valve Area by PHT: Pressure half time (msec) cm2

PHT

220-
VA = -----------
PHT

Aortic Valve AVA: aortic valve area (cm2) cm2

Area by CSALVOT: cross-section area of
Continuity
Equation LVOT (cm2)
Vmax LVOT
Using Vmax VmaxLVOT: maximum velocity in AVA = CSA LVOT  -----------------------------
Vmax AoV
LVOT (m/s)
VmaxAoV: maximum velocity
across aortic valve (m/s)
LVOT: left ventricular outflow tract

Aortic Valve AVA: aortic valve area (cm2) cm2

Area by CSALVOT: cross-section area of TVI LVOT
Continuity AVA = CSA LVOT  -----------------------
Equation LVOT (cm2) TVI AoV
Using TVI TVILVOT: time velocity integral in
LVOT (m)
TVIAoV: time velocity integral
across aortic valve (m)
LVOT: left ventricular outflow tract

Flow Area d: diameter (cm) 2 cm2

d
FlowArea =    -----
 4

Mitral Valve MVA: mitral valve area (cm2) cm2

Area by CSALVOT: cross-section area of TVI LVOT
Continuity MVA = CSA LVOT  -----------------------
Equation LVOT (cm2) TVI MV
Using Aorta TVILVOT: time velocity integral in
LVOT (m)
TVIMV: time velocity integral of
mitral valve (m)
LVOT: left ventricular outflow tract

Mitral Valve MVA: mitral valve area (cm2) cm2

Area by CSAPA: cross-section area of TVI PA
Continuity 2 MVA = CSA PA  -----------------
Equation pulmonary artery (cm ) TVI MV
Using TVIPA: time velocity integral of
Pulmonary pulmonary artery (m)
Artery TVIMV: time velocity integral of
mitral valve (m)

Terason t3000cv Ultrasound System Technical Manual 93

Chapter 7 - Formulas Used for Values in the Cardiac Report Formulas Used for Measurements in Doppler Win-

Doppler Formulas (Continued)

Name Variables Formula Units

Right PRA: estimated right arterial mmHg

2
Ventricular pressure (mmHg) RVSP = P RA + 4Vmax
Systolic Vmax:regurgitant velocity of
Pressure from tricuspid valve (m/s)
Tricuspid
Regurgitation
Right BPsys: systolic blood pressure mmHg
2
Ventricular (mmHg) RVSP = BP sys – 4Vmax
Systolic Vmax:maximum velocity of
Pressure from ventricular septal defect (m/s)
Ventricular
Septal Defect

Mitral Valve P = mm/Hg mmHg

Left Ventricle dP/dt = 32 mmHg/dt
Pressure t = seconds
Change

Tricuspid P = mm/Hg mmHg

Valve Right dP/dt = 12 mmHg/dt
Ventricle t = seconds
Pressure
Change

Shunt Ratio COQp: pulmonic cardiac output CO Qp —

Qp
(l/min) -------- = ---------------
-
Qs CO Qs
COQs: systemic cardiac output
(l/min)

Shunt COQp: pulmonic cardiac output l/min

Difference (l/min)
COQs: systemic cardiac output Qp – Qs = CO Qp – CO Qs
(l/min)

Terason t3000cv Ultrasound System Technical Manual 94

8 Gestational Tables

Tables Used in Gestational Calculations

This chapter lists the gestational tables for the measurements included with the Obstetrical
exam type:

Gestational Age
Gestational Age Parameter Author
Abdominal Circumference (AC) ASUM
Chitty
Hadlock
Hansmann
Tokyo
Biparietal Diameter (BPD) ASUM
Chitty (o-o)
Chitty (o-i)
Hadlock
Hansmann
Tokyo
Crown-Rump Length (CRL) ASUM
Hadlock
Hansmann
Tokyo
Femur Length (FL) ASUM
Chitty
Hadlock
Hansmann
Tokyo
Gestational Sac Diameter (GSD) Hansmann
Tokyo
Head Circumference (HC) ASUM
Chitty
Hadlock
Hansmann
Humerus Length (HL) ASUM
Jeanty
Occipital Front Diameter (OFD) ASUM
Chitty
Hansmann
Jeanty

Terason t3000cv Ultrasound System Technical Manual 95

Chapter 8 - Gestational Tables Fetal Growth

Radius (RAD) Jeanty

Tibia (TIB) Jeanty
Transverse Cerebellar Diameter (CEREB) Chitty
Ulna (ULNA) Jeanty

Fetal Growth
Fetal Growth Parameter Author
Abdominal Circumference (AC) ASUM
Chitty
Hadlock
Jeanty
Tokyo
Biparietal Diameter (BPD) ASUM
Chitty
Hadlock
Hansmann
Jeanty
Tokyo
Crown-Rump Length (CRL) ASUM
Hadlock
Hansmann
Tokyo
Femur Length (FL) ASUM
Chitty
Hadlock
Jeanty
Head Circumference (HC) ASUM
Chitty
Hadlock
Jeanty
Humerus Length (HL) ASUM
Chitty
Jeanty
Tokyo

Estimated Fetal Weight

Estimate Fetal Weight Input Parameters Author
(AC) Campbell
(AC, BPD) Hadlock
(AC, FL)
(AC, FL, HC)
(BPD, AC, FL)
(BPD, HC, AC, FL)
(BPD, TTD) Hansmann
(BPD, APTD, TTD, FL) Tokyo

Terason t3000cv Ultrasound System Technical Manual 96

Chapter 8 - Gestational Tables Fetal Ratios

Fetal Ratios
Ratios Author
(HC/AC) Campbell
(FL/AC) Hadlock
(FL/HC)
CI = (BPD/OFD)
(FL/BPD) Hohler

Terason t3000cv Ultrasound System Technical Manual 97

Index 12L5A probe, 29, 30, 31, 32
12L5V probe, 33, 34, 35, 36
H
Hazards, 46
4V2A probe, 11, 12, 13, 15 Heat, 51
5C2A probe, 16, 17, 18, 19
Numerics 8EC4A probe, 20, 21, 22, 23 I
12L5A Probe 8V3A probe, 24, 25, 26, 27, IFU. See Indications for Use.
Acoustic output, 29, 30, 31, 32 28 Immersion, 52
Features, 9 PDOF probe, 37 Indications for Use, 56
Indications for Use, 62 ALARA, 65 Indications for use
Sterile sheath, 44 Area measurements, accuracy, 78 5C2A probe, 59
12L5V probe Infection control, 43
Acoustic output, 33, 34, 35, 36 B Intended use, 49
Features, 9 Battery
Indications for Use, 63 Recycling, 49 L
4V2A Probe Usage and disposal of, 49 Labels, system, 52
Acoustic output, 11, 12, 13, 15 Bone Tissue Thermal Index (TIB), Laptop, positioning, 45
Features, 9 66 Latex, 51
Indications for Use, 58 Liquids, 51
Sterile sheath, 43 C
5C2A probe Cardiac report formulas, 88 M
Acoustic output, 16, 17, 18, 19 Care, 52 Maintenance, 38, 42, 43
Features, 9 Cautions, 45 Measurements
Indications for use, 59 Circumference measure, accuracy, Accuracy, 77
Sterile sheath, 43 78 Formulas, 77
8EC4A Probe Cleaning, 46 Mechanical Index (MI), 66
Acoustic output, 20, 21, 22, 23 Couplants, 51 MI. See Mechanical Index.
Features, 9 Cranial Thermal Index (TIC), 67 MRI, 45, 56
Indications for Use, 60
Sterile sheath, 43 D P
8V3A probe Defibrillator, 45, 56 PDOF probe
Acoustic output, 24, 25, 26, 27, Disinfecting probes Acoustic output, 37
28 Noncritical applications, 38 Features, 9
Features, 9 Semicritical applications, 40 indications for use, 64
Indications for Use, 61 Distance measurement accuracy, 77 Peripherals, 49
Sterile sheath, 43 Probe
E Part numbers, 48
A Electrical Spill protection, 48
AC power Fast Transients, 47 Probe covers, 10, 43
Cleaning, 46 Power surges, 47 Probes, disinfecting, 38
Medical grade power cord, 46 Shock hazard, 46
Shock hazard, 46 Electromagnetic Interference (EMI), R
Surges, 47 51 Rate, frame, 82
Accuracy measures, 77 Electrostatic Discharge (ESD), 51 RF Interference, 47
Area, 78 Environmental conditions, 54
Circumference, 78 Explosive warning, 49 S
Distance, 77 Safety, 38, 43
Volume, 78 F Electrical, 55
Acoustic output Formulas for cardiac reports, 88 Infection control, 43
Indices, 65 Frame rate, 82 Standards, 53, 55
Bone tissue thermal index, 66 Ultrasound, 55
Cranial thermal index, 67 G Sheaths, sterile, 43
Mechanical Index, 66 Gel couplants, 51 Shock hazard, 46
Soft tissue thermal index, 66 Gestational measurements Sterile sheaths, 10, 43
Reporting, 10 Tables, 95 System

Terason t3000cv Ultrasound System Technical Manual 98

Index

Labels, 52
Air Pressure, 54
CE Mark, 53
Dispose of Properly, 54
Environmental, 54
Manufacturer, 52
Probe models, 54
Safety Standards, 53
See User Guide, 54
Temperature, 54
Type BF Equipment Applied
Part, 52
Ultrasound Energy, 53
Specifications, 82

T
Terason probes
12L5A, 9
12L5V, 9
4V2A, 9
5C2A, 9
8EC4A, 9
8V3A, 9
Between uses, 38
Disinfecting, 38
Immersion, 52
Label, 54
Liquids, 51
Models, 9
PDOF, 9
Terason software, upgrading, 7
Terason Ultrasound System
Care of, 52
Covers, 45
Indications for Use, 56, 57
Maintenance, 42
Safety and Maintenance, 38, 43
Thermal Index (TIB and TIS), 66
TIB, 66
TIC, 67
TIS, 66
Track 3 reporting, 10

U
Upgrade instructions, 7
Use, intended, 45, 49

V
Volume accuracy, 78

W
Warnings, 49

Terason t3000cv Ultrasound System Technical Manual 99

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