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[ 1 ] I N S T R U C T I O N S F O R U S E
Biohazard Considerations
WARNING:
This equipment is not suitable for intracardiac use or direct
cardiac contact.
WARNING:
For neonatal head imaging, Siemens 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
transducer easily penetrates the fontanels of the infant.
WARNING:
Siemens makes every effort to manufacture safe and effective
transducers. You must take all necessary precautions to eliminate the possibility
of exposing patients, operators, or third parties to hazardous or infectious
materials. These precautions should be considered in the use of any application
that may indicate the need for such care, and during endocavity or intraoperative
scanning; during biopsy or puncture procedures; or when scanning patients with
open wounds.
WARNING:
To eliminate the possibility of exposing patients, operators, or third
parties to hazardous or infectious materials, always dispose hazardous or
infectious materials according to medical regulations for biohazardous waste.
WARNING:
There have been reports of severe allergic reactions to medical
devices containing latex (natural rubber). Health care professionals are advised
to identify latex-sensitive patients and to be prepared to treat allergic reactions
promptly. For additional information in the U.S.A., refer to FDA Medical Alert
MDA91-1.
WARNING:
Ultrasound energy is transmitted more effectively through water
than through tissue. When using a standoff device of any kind, for example, a
gel pad, the actual mechanical and thermal indices, MI and/or TI, may be higher
than indicated in the output display on the system.
The assessment of the biological effects of diagnostic ultrasound on
humans is a subject of ongoing scientific research. This system, and all
diagnostic ultrasound procedures, should be used for valid reasons, for the
shortest possible period of time, and at the lowest mechanical and thermal
indices necessary to produce clinically acceptable images.
According to the ALARA (As Low As Reasonably Achievable) principles,
acoustic output should be set to the
lowest level required to
satisfactorily perform the examination
.
[1] Instructions for Use
Transducer Care
2-25
System Reference
Acoustic Output
Ch 1
Summary of Contents for SONOLINE G50
Page 9: ...1 Introduction 1 2 1 I N S T R U C T I O N S F O R U S E ...
Page 19: ...1 Introduction 1 12 1 I N S T R U C T I O N S F O R U S E ...
Page 57: ...2 Safety and Care 2 38 1 I N S T R U C T I O N S F O R U S E ...
Page 143: ...3 System Controls 3 86 1 I N S T R U C T I O N S F O R U S E ...
Page 145: ...4 System Setup 4 2 1 I N S T R U C T I O N S F O R U S E ...
Page 183: ...5 Beginning an Examination 5 2 1 I N S T R U C T I O N S F O R U S E ...
Page 229: ...6 Technical Description 6 28 1 I N S T R U C T I O N S F O R U S E ...