TELEMED ClarUs User Guide, REV 4.0 2013.12.04
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Ultrasound waves used in diagnostic system have frequencies ranging from
3,5 MHz to 7,5 MHz. Sound waves with such frequencies are weakened in the air, so
can be measured for example in water. Ultrasound waves sent by a converter are so
weak
(medium intensity less than 100mW/cm²), that according to International
Electro technical Commission (IEC 1157) standards (well within AIUM/NEMA
standards) they do not have any impact on patient health (however any unnecessary
exposure should be avoided).
Detailed information is found in
APPENDIX: 1. Guidelines for the safe use of diagnostic ultrasound
.
Acoustic output tables for global maximum values for all systems and
transducer combinations (3 samples of each type of probe) are included
APPENDIX: 2. Acoustic output.
2.5.
Cyber security
Vulnerabilities in cyber security may represent a risk to the safe and effective operation
of networked medical devices. Store only relevant and necessary software on working
computers.
Network administrators in healthcare organizations and information technology
providers should assure an adequate degree of protection from threats such as viruses
and worms to avoid the risk of any unauthorized access to the network or the medical
device/database.
2.6.
Accuracy Measures
CAUTION :
Gas ultrasound contrast agents are used during echocardiography
to enhance a cardiac image but may cause side effects (cardiac
rhythm disturbances during perfusion studies).
Because of this, see the package labelling / insert about the risks of
both cardiopulmonary and hypersensitivity reactions (unstable
status). It is recommended to monitor vital signs, cardiac rhythm
and oxygen saturation, and to have resuscitation equipment and
trained
personnel
readily
available.
Additional Information:
FDA MedWatch Safety Alert. Micro-bubble Contrast Agents
(marketed as Definity (Perflutren Lipid Microsphere) Injectable
Suspension and Optison (Perflutren Protein-Type A Microspheres
for Injection). October 12, 2007.
http://www.fda.gov/medwatch/safety/2007/safety07.htm#bubble
WARNING:
Clinical diagnostic errors may result from the incorrect use of
calculations. Review the referenced source of the stated formula or
method to become familiar with the intended uses and possible
are provided as a tool to assist the user and should not be
considered as an undisputed database when making a clinical
