9
General precautions for installing an alternative peripheral device or a network include:
The additional device(s) must have meet the appropriate safety standards and possess a CE mark.
The additional device(s) must only be used for their intended purpose and must have a compatible interface.
CAUTION
:
Ensure that you use ONLY designated USB data carriers or portable media to store or back up
data. Before connecting to the ultrasound system, ensure that you are using the most up-to-date software
on the USB data carrier or portable media, so as to be protected against viruses. It is the responsibility of
the user to ensure that the USB data carrier or portable media is virus-free. Improper use of the USB data
carrier or portable media may cause viruses to be imported into the system, which may cause malfunction-
ing. Such a malfunction can affect the stability, effectiveness, and safety of the system and probes. Users
should immediately discontinue use of the system and probes until the Zimmer-approved technician has re-
viewed the system and confirms the effectiveness and safety of the system and probes.
CAUTION
:
Use only secure local area network (LAN) connections. Do not connect the ultrasound system to
the Internet. Ensure that your hospital firewall software is correctly configured so as to block incoming con-
nection requests from the Internet. Improper use of the network connection may result in viruses being im-
ported into the system, and malfunctions may occur.
2.5
Biological safety
This product, as with all diagnostic ultrasound equipment, should be used only for valid reasons and should be used for
only the shortest period of time and at the lowest power settings necessary (
ALARA
– As Low As Reasonably Achieva-
ble) for producing diagnostically acceptable images. The AIUM (American Institute of Ultrasound in Medicine) offers the
following guidelines:
Clinical safety by AIUM
Released on 26 March 1997
Diagnostic ultrasound has been in use since the late 1950s. Given its known benefits and recognised efficacy for medical
diagnosis, including use during human pregnancy, the American Institute of Ultrasound in Medicine herein addresses the
clinical safety of such use:
There are no confirmed biological effects on patients or device users from exposure to current diagnostic ultrasound
devices. Although the possibility exists that such biological effects may be identified in the future, current data indicate
that the benefits to patients of prudent use of diagnostic ultrasound outweigh the risks, if any are at all present.
Temperature increase: An elevation in tissue temperature during obstetrical examinations raises medical concerns. At
the embryo development stage, the rise in temperature coupled with the length of time exposed to heat may lead to
certain potentially detrimental effects. Particular caution is requested during Doppler/colour examinations. The thermal
index (TI) provides a statistical estimate of the potential temperature elevation (in degrees Celsius) of the tissue. Three
forms of TI are available: Thermal index in soft tissue (TIS), thermal index in bone (TIB) and thermal index in cranial
bone (TIC).
Thermal index in soft tissue (TIS). Is only used when imaging soft tissue and offers the possibility of estimating the
increase in temperature in the soft tissue.
Thermal index in bone (TIB). Is used when the bone is near the focus of the image, such as, for example, in a third
trimester obstetrics examination. It provides an estimate of the potential rise in temperature in the bone or in the adja-
cent soft tissue.
Thermal index in the cranial bone (TIC). Is used when the bone is near the skin surface, such as in a transcranial ex-
aminations, and provides an estimate of the potential temperature increase in the bone or the adjacent soft tissue.
Cavitations: Cavitations may occur when the sound is passed through an area containing a cavity, such as a gas bub-