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infection. Inspect probes frequently for sharp, pointed or rough 
surface damage that could cause injury or tear protective 
barriers (gloves and sheaths).
Transesophageal probe safety 
Never use excessive force when manipulating the 
transesophageal probe. The detailed operator manual 
enclosed with the transesophageal probe must be read 
carefully.
Electrical Hazard 
A damaged probe may increase the risk of electric shock if 
conductive solutions come in contact with internal live pads. 
Inspect probes often for cracks or openings in the housing and 
holes in and around the acoustic lens, or other damage that 
could allow moisture to enter. Become familiar with the use and 
care precautions described in Chapter 10, ’Probes’ on 
page 355. 
						

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Personnel and equipment safety
Explosion hazard
Never operate the equipment in the presence of flammable or 
explosive liquids, vapors or gases. Malfunctions in the unit, or 
sparks generated by fan motors, can electrically ignite these 
substances. Operators should be aware of the following points 
to prevent such explosion hazards.
•  If flammable substances are detected in the environment, 
do not plug in or turn on the system. 
•  If flammable substances are detected after the system has 
been turned on, do not attempt to turn off the unit, or to 
unplug it.
•  If flammable substances are detected, evacuate and 
ventilate the area before turning off the unit.
Implosion hazard
Do not subject the unit to serious mechanical shocks because 
the cathode ray tube (CRT) may implode if struck or jarred. 
This may cause pieces of glass and/or phosphor coating to fly 
into the air and result in serious injury.
Electrical hazard
To avoid injur y:
•  Do not remove the units protective covers. No user-
serviceable parts are inside. If servicing is required, contact 
qualified technical personnel.
•  Connect the attachment plug to a hospital-grade grounding 
outlet to ensure adequate grounding.
•  Do not place liquids on or above the unit. Conductive fluids 
DANGERThe hazards listed below can seriously affect the safety of 
personnel and equipment during a diagnostic ultrasound 
examination.
WARNINGThe internal circuits of the unit use high voltages, capable of 
causing serious injury or death by electrical shock. 
						

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seeping into the active circuit components may cause short 
circuiting, which could result in an electrical fire. 
•  An electrical hazard may exist if any light, monitor or visual 
indicator remains on after the unit is turned off.
Fuses blown within 36 hours of being replaced may indicate a 
malfunctioning electrical circuit within the system. In this event, 
the unit must be checked by GE Ultrasound service personnel. 
No attempt should be made to replace the fuses with others of 
a higher rating.
Moving hazard
Special care must be used to avoid injury when moving or 
transporting the unit.
•  Always be sure the pathway is clear.
•  Limit the speed of movement to a careful walk.
•  Use at least two people when moving the unit on inclines.
Ensure that the unit is well prepared before transporting. Refer 
to ’Moving and transporting the unit’ on page 21 for more 
information.
Biological hazard
For patient and personnel safety, beware of biological hazards 
while performing transesophageal procedures. To avoid the 
risk of disease transmission:
•  Use protective barriers (gloves and probe sheaths) 
whenever necessary. Follow sterile procedures as 
required.
•  Thoroughly clean probes and reusable accessories after 
each patient examination and disinfect or sterilize as 
needed. Refer to Chapter 10, ’Probes’ on page 355, for 
probe use and care instructions.
•  Follow all in-house infection control policies as they apply 
to personnel and equipment.
CAUTIONThe Vivid 7/Vivid 7 PRO unit weighs approximately 190 Kg (419 
lb.). 
						

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Pacemaker hazard
The possibility of the system interfering with pacemakers is 
minimal. However, as this system generates high frequency 
electrical signals, the operator should be aware of the potential 
hazard this could cause. 
						

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Electrical safety
Device classifications
The Vivid 7/Vivid 7 PRO ultrasound unit is a Class I device, 
type CF, according to Sub-clause 14 of IEC 60601-1 (1988).
Inter nally connected peripheral devices
The system, together with peripheral devices, such as video 
tape recorders and printers, meets UL 2601-1 and IEC 60601-1 
(1988) standards for electrical isolation and safety. These 
standards are applicable only when the specified peripheral 
devices are plugged into the AC outlets provided in the unit.
Exter nal Connection of other peripheral 
devices
Other external devices, such as laser cameras, printers, VCRs 
and external monitors, usually exceed allowable leakage limits 
and, when plugged into separate AC outlets that are then 
connected to the unit, are in violation of patient safety 
standards. Suitable electrical isolation of such external AC 
outlets may be required in order to meet UL-2601-1 and 
IEC 60601-1 (1988) standards for electrical leakage.
CAUTIONExternal devices can be used only if CE marked and in 
compliance with related standards (EN 60601-1 or EN 60950). 
Conformance to EN 60601-1-1 (2000) must be verified.
External devices meeting EN60950 should be kept outside of the 
patient environment, as defined in IEC 60601-1-1 (2000). 
						

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Allergic reactions to latex-containing 
medical devices
Due to reports of severe allergic reactions to medical devices 
containing latex (natural rubber), the FDA advises health-care 
professionals to identify latex-sensitive patients, and be 
prepared to treat allergic reactions promptly. Latex is a 
component of many medical devices, including surgical and 
examination gloves, catheters, incubation tubes, anesthesia 
masks and dental dams. Patient reaction to latex has ranged 
from contact urticaria, to systemic anaphylaxis.
For more details regarding allergic reaction to latex, refer to 
FDA Medical Alert MDA91-1, March 29. 
						

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Electromagnetic Compatibility (EMC)
This unit carries the 
CE mark. The 
Vivid 7/
Vivid 7 PRO unit 
complies with regu-
latory require-
ments of the 
European Directive 
93/42/EEC con-
cerning medical de-
vices. It also 
complies with emis-
sion limits for a 
Group 1, Class B 
Medical Device as 
stated in EN 60601-
1-2 (2001) 
(IEC 60601-1-2 
(2001)).AII types of electronic equipment may characteristically cause 
electromagnetic interference with other equipment, transmitted 
either through air or connecting cables. The term 
Electromagnetic Compatibility (EMC), indicates the capability 
of the equipment to curb electromagnetic influence from other 
equipment, while at the same time not affecting other 
equipment with similar electromagnetic radiation.
Radiated or conducted EMC can cause distortion, degradation, 
or artifacts in the ultrasound image which could potentially 
obscure diagnostic information.
There is no guarantee that interference will not occur in a 
particular installation. If this equipment is found to cause or 
respond to interference, which may be determined by turning 
equipment on and off, qualified service personnel should 
attempt to correct the problem by one or more of the following 
measures:
•  Re-orient or re-locate the affected device.
•  Increase the separation between the unit and the affected 
device.
•  Power the equipment from a source other than that of the 
affected device.
•  Consult the service representative for further suggestions.
The manufacturer is not responsible for any interference or 
responses caused by the use of interconnecting cables other 
than those recommended, or by unauthorized changes or 
modifications to this unit. Unauthorized changes or 
modifications could void the users authority to operate the 
equipment.
To comply with the regulations on electromagnetic interference, 
all interconnecting cables to peripheral devices must be 
shielded and properly grounded. Use of cables not properly 
shielded and grounded may result in the equipment causing or 
responding to radio frequency interference, in violation of the 
European Union Medical Device Directive and FCC 
regulations.
Do not use devices which intentionally transmit RF signals, for 
example, cellular phones, transceivers, or radio controlled  
						

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products, in the vicinity of this equipment as it may cause 
performance outside the published specifications. Keep the 
power to these types of devices turned off when near this 
equipment. 
						

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Environmental protection
System disposal
Please follow the disassembly procedure and part disposition 
attached inside the unit. To access to the procedure, remove 
the right side panel by unscrewing the two screws on the lower 
part. 
						

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