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Note: Any rest en-
ergy within our 
scanners or their 
components will be 
below 60V DC or 2 
mJ.
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Device labels
The following table describes the purpose and location of 
safety labels and other important information provided on the 
equipment.
Label/Icon Purpose Location
Identification PlateManufacturers name and address
Model
Electrical ratings
Device Listing/Certification LabelsRear
Equipment Type BF, in which protection 
against electric shock does not rely on basic 
insulation only. Provides additional safety 
precautions such as double insulation or 
reinforced insulation, because there is no 
provision for protective earthing or reliance 
upon installation conditions.Probe 
connectors.
Equipment Type CF, indicates equipment 
having a floating applied part having a 
degree of protection suitable for direct 
cardiac contact.ECG connector
Defibrillator-proof Type CF equipment. ECG connector
Rear of unit.
Alternating current Various
Protective earth (ground) Internal
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Earth (ground) Internal
Equipotentiality: indicates terminal to be 
used for connecting equipotential 
conductors when interconnecting 
(grounding) with other equipment.Rear of unit
Attention - Consult accompanying 
documents: alerts the user to refer to the 
user documentation when complete 
information cannot be provided on the label.Various
CAUTION - Dangerous voltage: used to 
indicate electric shock hazards.Various
ATTENTION - Observe precaution for 
handling electrostatic sensitive device.Rear of unit 
(External I/O)
The system is not designed for use with 
flammable anesthetic gases.Rear of unit 
(Identification 
plate)
The disassembly and parts disposition 
procedure is located on the card cage front 
cover.
To access to the procedure, remove the 
right side panel by unscrewing the two 
screws on the lower part.Rear of unit 
(Identification 
plate) Label/Icon Purpose Location
AP 
						

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This precaution is intended to prevent injury 
that may result if one person attempts to 
move the unit over considerable distances 
or on an incline due to the weight of the unit.Rear of unit 
(Identification 
plate)
CAUTION - Do not move the unit if the 
keyboard console is in the free positionKeyboard 
console
Apply a short push on the ON/OFF button to 
shut down the system.Keyboard 
console Label/Icon Purpose Location
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Acoustic output
Definition of the acoustic output 
parameters
Ther mal Index
TI is an estimate of the temperature increase of soft tissue or 
bone. There are three thermal index categories:
•  TIS: Soft tissue thermal index. The main TI category. Used 
for applications that do not image bone.
•  TIB: Bone thermal index (bone located in a focal region). 
Used for fetal application.
•  TIC: Cranial bone thermal index (bone located close to the 
surface). Used for transcranial application.
Mechanical Index
MI is the estimated likelihood of tissue damage due to 
cavitation. The absolute maximum limits of the MI is 1.9 as set 
by the FDA 510(k) guidance of 1997.
Ispta
The Ispta is the Spatial Peak Temporal Average Intensity. The 
absolute maximum limit of Ispta is 720 MW/cm
2 as set by the 
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Acoustic output and display on the 
Vivid7/Vivid7PRO
In the title bar, two fields are allocated for the display of power 
values as shown in Figure 14-1.
 Figure 14-1: The display of MI and TI on the screen
The Vivid 7/Vivid 7 PRO chooses the correct category based 
on mode of operation and chosen application, and presents 
only one TI to the operator. It is therefore important that the 
operator chooses the right application.
The Vivid 7/Vivid 7 PRO has an internal limit of 3.0 on TI. 
IEC87 has suggested some time dependent thresholds that are 
partly implemented on the Vivid 7/Vivid 7 PRO as color-coding 
of the thermal index. The color-coding scheme together with 
the thermal exposure times in the table below are not meant as 
limits on TI or exposure time, but as an aid for the operator. 
Note that the Vivid 7/Vivid 7 PRO does not monitor the thermal 
exposure time. The displayed TI is coded as follow:
1. Title bar
2. MI
3. TI
TI Color Recommended thermal exposure time
0.0 – 0.4 Dimmed -
0.4 – 1.5 White -
1.5 – 2.0 White < 12 h
2.0 – 3.0 White < 1 h
3.0 – 4.0 Red < 15 min. 
						

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The maximum possible MI and Ispta on the Vivid 7/Vivid 7 PRO 
is within the limits set in Track 3 in the FDA 510(k) guide of 
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directly related to the exposure time.
•  Better image quality yields faster clinical results, making it 
possible to complete the relevant ultrasound examination 
more rapidly. Therefore, any control that improves the 
quality of the examination can help to reduce patient 
exposure, even though it may not directly affect acoustic 
output.
Probe selection
As long as the appropriate application is available, any probe 
can be used with the knowledge that the intensities fall at, or 
below, those stated in the Acoustic Output Data Tables. The 
duration of patient exposure is most likely minimized with the 
use of a probe that is optimized to provide resolution and focal 
depth, appropriate to the examination.
Application selection
Selecting the probe and application preset appropriate to a 
particular ultrasound examination automatically provides 
acoustic output limits within FDA guidelines for that application. 
Other parameters which optimize performance for the selected 
application are also set automatically, and should assist in 
reducing the patient exposure time. See page 53, for 
information on selecting probes and application presets.
Changing imaging modes
Acoustic output depends on the imaging mode selected. The 
choice of mode (2D, M-Mode, Doppler or Color Flow) 
determines whether the ultrasound beam is stationary or in 
motion. This greatly affects the energy absorbed by the tissue.
See Chapter 3, ’Scanning Modes’ on page 89, for complete 
information on changing imaging modes.
When operating in a combined mode, such as 2D and M-Mode, 
the total acoustic output comprises contributions from each 
individual mode. Depending on the modes in use, either or both 
output indices may be affected.
The user can override the default settings, but care should be 
taken to observe the displayed MI and TI values. 
						

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Power
It is possible to change the power in all operating modes so that 
the operator can use the ALARA principle. 
						

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Patient safety
Patient identification
Always include proper identification with all patient data and 
verify the accuracy of the patients name and/or identity number 
when entering such data. Ensure that the correct patient ID is 
provided on all recorded data and hard copy prints. 
Identification errors could result in an incorrect diagnosis.
Diagnostic infor mation
The images and calculations provided by the system are 
intended for use by competent users, as a diagnostic tool. They 
are explicitly not to be regarded as the sole, irrefutable basis for 
clinical diagnosis. Users are encouraged to study the literature 
and reach their own professional conclusions regarding the 
clinical utility of the system.
The user should be aware of the product specifications and of 
the system accuracy and stability limitations. These limitations 
must be considered before making any decision based on 
quantitative values. If in doubt, the nearest GE Ultrasound 
Service Office should be consulted.
Equipment malfunction or incorrect settings can result in 
measurement errors or failure to detect details in the image. 
The user must become thoroughly familiar with the operation of 
the unit in order to optimize its performance and to recognize 
possible malfunctions. Application training is available through 
the sales representative.
Mechanical hazards
Damaged probes or improper use and manipulation of the 
transesophageal probe may result in injury or increased risk of 
WARNINGThe concerns listed in this section can seriously affect the safety 
of the patient undergoing a diagnostic ultrasound examination.
CAUTIONBe certain to ensure privacy data of patient information.